EP2139983A1

EP2139983A1 - Device for the slow penetration of a biological barrier or of a biological tissue or compound with a sharp object

Info

Publication number: EP2139983A1
Application number: EP07785568A
Authority: EP
Inventors: Günter FUHR; Klaus Peter Koch; Wigand Poppendieck; Hagen Thielecke
Original assignee: Fraunhofer Gesellschaft zur Forderung der Angewandten Forschung eV
Current assignee: Fraunhofer Gesellschaft zur Forderung der Angewandten Forschung eV
Priority date: 2007-04-30
Filing date: 2007-06-27
Publication date: 2010-01-06
Also published as: DE102007020376B4; DE102007020376A1; WO2008131709A1

Abstract

The present invention relates to a device for penetrating a biological barrier or a biological tissue or compound, comprising at least one object (1) with at least one sharp end at the front and at least one body with a thickness that reduces either by itself or due to outside influences over time. The body is disposed on the object (1) such that the sharp end of the object penetrates the barrier or the tissue or the compound when pressure is applied against the barrier or the tissue or the compound almost independently of the contact pressure with a velocity that is determined by the reduction of the thickness of the body over time. The device allows the object to be inserted very slowly, thus preserving the tissue.

Description

Device for slowly penetrating a biological barrier or a biological tissue or composite with a pointed object

Technical application

The present invention relates to a device for penetrating a biological barrier or a biological tissue or composite, in particular for a slow, tissue-sparing penetration of a pointed object through a biological membrane. Such a device can be used for example for the implantation of needle electrodes in the cortex, which should proceed with the least possible destruction of the brain tissue.

State of the art

For the stimulation and dissipation of electrical signals in vivo, the implantation of suitable electrode systems in the biological tissue is required. It is, for example, known from PJ Rousche et al., "A method for pneumatically inserting an array of penetrating cements into cortical tissue", Annais of Biomedical Engineering, Vol. 20, pages 413 to 422, 1992, to use a pneumatic electrode array with the aid of a pneumat The high speeds of> 8.3 m / s are required to bring all the electrodes of the array sufficiently deep into the tissue, but lead to an undesirable destruction of the tissue. R. Eckhorn et al., "A new method for the insertion of multiple microprobes into neural and muscular tissue, including fiber electrodes, fine wires, needles and microsensors", Journal of Neuroscience Methods, 49 (1993), pages 175 to 179 a method implantation of fine fiber or needle electrodes, in which they are introduced separately from each other with a micromotor driven device with increments of 1 micron in the tissue.

An electrode system for stimulating and draining bioelectrical signals, in which the electrodes can be moved and readjusted in the implanted state, is described by J. Muthuswany et al, "An Array of Micro-actuated Microelectrodes for Monitoring Single-Neuronal Activity in Rodents", IEEE Transactions on Biomedical Engineering, Vol 52, No. 8, August 2005, pages 1470 to 1477. This electrode system utilizes thermally based microactuators to move the

Electrodes. The movement is not continuous, but gradually with step willow of 8.8 microns.

DE 10 2004 053 596 A1 discloses a method for cell-friendly manipulation of individual cells, in which cell damage is avoided by a very slow manipulation speed. During the manipulation, the cells are given sufficient time to rearrange themselves, so that a cell damage can be bypassed. In this document, the manipulation tool is provided with a piezoelectric drive or a magnetic drive. drove, which allows adjustment of the slow propulsion speed.

The object of the present invention is to provide a device for slowly penetrating a biological barrier or a biological tissue or composite, which can be realized with less control effort.

Presentation of the invention

The object is achieved with the device according to claim 1. Advantageous embodiments of the device are the subject of the dependent claims or can be found in the following description and the embodiments.

The proposed device comprises at least one object with at least one front pointed end and at least one body with a thickness which decreases either by itself or by external influence with time, the body being arranged on the object such that the pointed end of the Object upon pressure against the barrier or tissue or composite penetrates the barrier or tissue or composite at a rate determined by reducing the thickness of the body over time. The penetration rate can not be controlled significantly by the contact pressure, but is primarily determined by the rate of change in the thickness of the body, which is at least almost independent of the contact pressure. - A -

In this case, the body preferably consists of a material with externally influenceable material properties, which makes it possible to reduce the thickness of the body over time by influencing the material properties. The pointed end of the object then penetrates against the barrier or tissue or composite, such as a cell composite, while simultaneously affecting the material properties of the material to reduce the thickness of the body with the corresponding one

Velocity into the barrier or tissue or composite.

The use of the present device does not require a special drive device with which very slow movement speeds must be achieved with high accuracy. Rather, when using the present device, the object only has to be pressed for a long time against the biological barrier or biological tissue or biological composite to be penetrated. This can be done by any means. Alternatively, in one embodiment of the device, the biological barrier or the biological tissue or the biological composite can also apply a corresponding pressure to the biological barrier

Exercise body. Here, a receiving surface of the body opposite the pointed end of the object is advantageous for the compressive force, which should have an area ratio of at least 10: 1, preferably> 100: 1, particularly preferably> 1000: 1, for the cross-sectional area of the pointed end. The pointed object, when pressed against the biological barrier or tissue or composite, penetrates it at a rate which reduces the thickness of the body caused by the external influence of the material properties of the material of the body. By choosing a biodegradable material, this is determined by the rate at which the material degrades in contact with the barrier or fabric or composite. By defined choice of biodegradable material in

Dependent on the properties of the biological barrier or the biological tissue or composite, the speed at which the object penetrates the biological barrier or the biological tissue or the biological composite can be set via the degradation time. Preferably, a biodegradable material is used, which allows a directional degradation. Directed degradation is understood here to mean that the body, upon contact with the biological barrier or the biological tissue or composite, does not decompose simultaneously in the entire volume but mainly from the contact surface.

Likewise, by choosing another suitable material, it is also possible to set the rate at which the object penetrates the biological barrier or tissue or biological composite. With many suitable materials, this speed can also be controlled by the targeted external influencing of the material properties of the material. Preferably, the material of the body is chosen so that a penetration rate between 0.1 .mu.m / h and 500 .mu.m / h, particularly preferably between 1 .mu.m / h and 100 .mu.m / h, can be achieved. Due to the correspondingly slow penetration into the biological cell aggregates, tissue damage during penetration is minimized or prevented.

The material for the body is preferably degradable, shrinking, or volatilizing materials over time. These can be different material classes. Examples of such material classes are:

- biodegradable materials hydrogenatable or dehydrogenatable materials SoI gel transitions chemically convertible materials (e.g., outgassing) polymers with variable degree of polymerisation - materials with modifiable modulus of elasticity

(e.g., shape memory materials) Materials with variable mechanical stability (e.g., porous, sponge-like structures) - biological materials liquid or gaseous materials.

For controlling the material properties, in particular for swelling or shrinking of the materials, the following mechanisms can, for example, be used:

heating up Leakage of the Materials Via Openings - Influence on the Chemical Environment Initiation of a chemical process by light, chemicals, temperature, stress (layered) or ultrasonic mechanical change or destruction of porous

Materials by ultrasound

Modification of Young's modulus (e.g.

Shape memory materials) - use of biological material, for example of the body's own materials, which grow or degenerate, such as bone / muscle tissue, growth via stress, cell movement (migration), attracting cells into existing structures, use of biochemical elements (artificial muscle)

Another way of controlled penetration of the one or more preferably needle-shaped objects is that a bellows or

Hose, for example. Instead of the use of piezo elements, is used. The bellows or hose is filled with liquid or gas which, for example, can diffuse through the permeable wall of the bellows or hose. For example, DI water may diffuse through the wall due to the osmotic pressure drop, thereby decreasing the volume and thus the thickness of the bellows or hose and moving the needles into the fabric or composite. Again, a control or a reversal of the movement is possible.

In a further variant, the shrinking or swelling material is provided with a thin protective layer, For example, a gold layer, coated. If a potential is applied via this protective layer, the layer dissolves with a suitable choice of material, so that the shrinkage / swelling process can be initiated thereby. The potential is preferably applied so that there is a potential difference between the outside and the inside of the layer.

The pointed end of the object preferably has a diameter at the tip which is <200 μm, better <10 μm, particularly preferably <1 μm. The preferably blunt body at the front then has a larger diameter than the tip at the front.

In one embodiment of the device, the object is embedded in the body from the tip to a length which at least corresponds to the intended penetration depth of the object into the biological cell network. The shape of the body of biodegradable material is insignificant, as long as the front of this body, with which the body is pressed against the biological barrier or the biological tissue or the composite, is not sharp or sharp. The

Front can be in the region of the tip of the object, for example, flat or rounded. The body may, for example, have the shape of a plate or a cylinder.

The object itself may, for example, comprise electrode contacts for stimulation or derivation of bioelectric signals from the tissue. Others too - S -

Embodiments, for example as capillary tubes are of course possible. The particular design depends only on the application, on the basis of which the object is to penetrate the biological barrier or the biological tissue or the biological composite.

Of course, several objects, even in a coherent form, can be embedded in the biodegradable body. In this way, it is also possible, for example, to implant an array of needle electrodes in the cortex in a tissue-protecting manner.

The force required for the penetration of the object with which the object must be pressed against the biological barrier or the biological tissue or the biological composite (or vice versa) can either be determined experimentally beforehand or derived from possibly known investigations. For example, M. A. Howard et al. , "Measurement of the Force Required to Move to a Neurosurgical Probe Through In Vivo Human Brain Tissue", IEEE Transactions on Biomedical Engineering 46, No. 7, Juicy 1999, pp. 891-894, a measurement of the forces required for the intrusion of objects in the cortex are required.

In one embodiment of the device, the object lies with its rear side against a substrate on which the body is applied as a layer. The object is completely embedded in the layer or the body. The for the penetration of the biological

Barrier or the biological tissue or composite force required with the object is in this case exercised on the substrate and the body. In many embodiments of the device, the tip of the object preferably terminates flush with the front of the body. Of course, this is not always necessary.

If a layer of material remains between the tip of the object and the front of the body, the penetration process does not begin until the layer has been removed. Furthermore, between the body and the barrier or the fabric or composite there may also be a perforated plate having one or more openings through which the one or more tips of the object penetrate into the barrier or tissue or composite.

In a further embodiment, in which the

Body is formed of a degradable material, bioreactive substances are stored in the body, which are released with the degradation of the body. These may in particular be medicaments which, for example, alleviate or inhibit inflammatory reactions in the tissue or which reduce the cell adhesion of the tissue cells to one another in order to facilitate penetration into the tissue.

In an embodiment of the proposed

Device is the object completely embedded in the body, wherein the back of the object is spaced from the rear boundary of the body. This allows complete implantation of the object into the biological tissue, for example the cortex.

Complete implantation is complete once the material has degraded or shrunk to the back of the body. Until that time, the Body pressed with the appropriate force against the biological barrier or the biological tissue or biological composite or the biological barrier or the biological tissue or the biological composite exerts a pressure on the body,

Brief description of the drawings

The proposed device will be explained in more detail with reference to embodiments in conjunction with the drawings without limiting the scope defined by the claims protection. Hereby show:

Figure 1 is a schematic representation of an embodiment of the proposed device prior to the penetration of a biological barrier or a biological tissue or composite.

FIG. 2 shows the device according to FIG. 1 after a partial penetration into biological tissue; FIG.

FIG. 3 shows the device of FIG. 1 after the complete penetration of the object; FIG.

4 is a schematic representation of another embodiment of the proposed device prior to the intrusion of the object,

FIG. 5 shows the device of FIG. 4 after the complete penetration of the object into the biological tissue; FIG. FIG. 6 shows the apparatus of FIG. 4 after complete decomposition of the biodegradable material; FIG.

Fig. 7 shows another example of an embodiment of the proposed device;

8 shows a further example of an embodiment of the proposed device;

9 shows another example of an embodiment of the proposed device;

10 shows another example of an embodiment of the proposed device;

Fig. 11 is another example of an embodiment of the proposed device;

Fig. 12 is another example of an embodiment of the proposed device;

Fig. 13 is another example of an embodiment of the proposed device; and

Fig. 14 shows another example of an embodiment of the proposed device.

Means for Carrying out the Invention When implanting objects in biological tissue, for example when implanting needle electrodes in the cortex in vivo, the object has to pass through a biological barrier or tissue invade a biological composite. Ingress usually results in the destruction of biological cells as the penetrating object penetrates or ruptures the cell membrane. Destruction can be avoided if the speed of the penetration movement is sufficiently low, in particular smaller than the rate of rearrangement of the cytoskeleton of the cells at the biological barrier. This is the case for individual cells for speeds of <300 μm / h.

In the proposed device, the low speed is set in one embodiment by the use of a biodegradable material, in particular a biodegradable polymer. The object is first embedded in the biodegradable polymer. This composite is pressed against the biological tissue or biologic barrier using a bias force. The polymer degrades from the surface, gradually releasing the embedded object. Due to the bias or the applied force, it penetrates very slowly into the tissue. Upon complete degradation of the polymer, the object has reached its final position in the tissue.

FIGS. 10 to 14 show further design possibilities in which other materials with externally influenceable material properties are used, via which a low penetration speed of the object can be achieved. Figure 1 shows an exemplary embodiment of the proposed device in a schematic representation. The needle-shaped object 1 in this example, which is intended to penetrate the biological tissue 2 or the biological composite or the biological barrier, is initially completely embedded in a layer 3 of the degradable polymer. The needle-shaped object 1 is attached to a substrate 4 of non-degradable material. A pressure force 5 is transmitted to the needle-shaped object 1 and the degradable polymer layer 3 via this substrate 4.

By selecting a degradable polymer that degrades from the surface in contact with the biological barrier, the material is dissolved at the interface between the polymer layer 3 and the biological tissue 2 over time. The needle-shaped object 1 is slowly exposed and penetrates under the action of the pressure force 5 in the biological tissue 2 a. Since the degradation of the polymer is very slow, the rate of penetration of the needle-shaped object 1 is so slow that it is below the rate of rearrangement of the cytoskeleton of the cells at the biological barrier, thereby minimizing damage to the cells. A suitable degradable polymer is, for example, polyorthoester.

FIG. 2 shows an intermediate state in which a thin layer of the biodegradable polymer has already been degraded and the needle-shaped object 1 has partially penetrated the biological tissue 2. FIG. 3 shows the final state in which the polymer has completely degraded, so that the needle-shaped object 1 has completely penetrated the biological tissue 2 at this point in time.

Figure 4 shows a further exemplary embodiment possibility of the proposed device in a schematic representation. The needle-shaped object 1 is in this case also completely embedded in the layer 3 of the biodegradable polymer, wherein between the rear boundary surface of the polymer body and the back of the needle-shaped object 1 is a distance. By this distance is still biodegradable material behind the needle-shaped object 1. With such a configuration of the device, the needle-shaped object 1 can completely penetrate the biological barrier and close behind again, as shown in Figures 5 and 6.

The needle-shaped object 1 can in this case, for example, consist of a biodegradable material in which bioreactive materials, in particular medicaments, are stored. These drugs are then released with the breakdown of the biodegradable material. The biodegradable material of the needle-shaped object 1 is of course chosen so that it degrades more slowly than the biodegradable material 3 of the body, in which the needle-shaped object 1 is first embedded.

Again, the body or layer 3 of biodegradable polymer and thus on the needle shaped object 1 exerted a force 5, with which the body or the needle-shaped object 1 is pressed against the biological tissue 2. After the degradation of the biodegradable polymer to a thickness exceeding the length of the needle-shaped object 1, the needle-shaped object 1 has completely penetrated into the tissue 2, as can be seen from FIG. The degradable material immediately behind the rear end of the needle-shaped object 1 also builds up from the side over time, so that the opening in the fabric 2 slowly closes again. FIG. 6 shows the final state in which the polymer is completely degraded so that the needle-shaped object 1 is here completely implanted in the biological tissue 2.

The embodiments of the preceding figures each show a substrate 4 behind the body or the layer 3 of biodegradable polymer. This is not essential. Instead, the pressure force 5 can also be exerted directly on the body of biodegradable polymer or the needle-shaped object. This can take place via the biological tissue itself or, for example, also via a stamp 7, as shown schematically in FIG. In this example, the body 3 of biodegradable material is cylindrical and is guided in a guide sleeve 6. The guide sleeve 6 is widened in this example on the side facing the tissue and rests on the fabric 2. By

Exerting a force 5 on the punch 7 is also the needle-shaped object 1 at the speed of Degradation of the biodegradable polymer is slowly pressed into the tissue 2.

The body of biodegradable material may be formed in a further embodiment, for example. Spherical, with a plurality of aligned in the radial direction needle-shaped objects are embedded in the body. The diameter of the body can be, for example, <50 μm in such an embodiment. One or more of these bodies are then introduced into the biological tissue, for example injected. The pressure exerted on the body by the tissue destroys the biodegradable material of the body and the needle-shaped objects slowly penetrate the cell membrane of the neighboring cells. The needle-shaped objects must be smaller than the cells dimensioned. With such a procedure, for example, substances can be introduced into individual cells.

FIG. 8 shows a further example of the proposed device in which the needle-shaped object or instrument, in this case an electrode structure 13, is held in the desired position via a sleeve made of a rigid capsule 11 which can be tightened and tightened by means of screws , With this device, electrodes or other instruments can be introduced into living tissue 16, here a human leg. The electrode structure 13 is embedded in a defined shrinking or dissolving mass 14 of a suitably variable material, comparable to the body 3 of the preceding figures. About the elastic layer 12, which also consists of a resilient Material system is applied, a constant force is applied to the electrode structure 13, which is held by the cuff in days or weeks in exact position. The inner part of the device, ie the shrinking or dissolving mass 14 and with the electrode structure 13 can additionally be stabilized by mechanical side elements 15 and held in position.

FIG. 9 shows a further exemplary embodiment of the proposed device. This device can also be placed on a tissue 23, for example the surface of an organism, in order to allow the electrode system 21 to penetrate into the tissue 23 of the organism by shrinking or disappearing the variable material of the body 22. To generate a constant pressure force on the electrode structure 21 and the material 22, the elastic material 24 or another deformable system is used. Scales 26 are fixedly connected to the electrode system 21, from which it is possible to read from outside how far the electrode system 21 has already penetrated into the tissue 23. To keep the distance constant, a rigid support system 27 is used, which is supplemented by a support plate 25, which may also have a curved geometric shape. A rigid enclosure 28 holds the device in an exact position.

FIG. 10 shows an example in which an electrode structure 31 with differently configured needle-shaped electrodes is pressed into a tissue. The electrode structure 31 is thereby with an asymmetrical contact force F in the tissue 34th pressed in. The penetration is done by reducing the thickness of the material 32 very slowly, in the range of 1 to 100 microns / h. If, for example, the material 32 is a gel that shrinks due to dehydration, this process can be controlled by heating elements 33 which are arranged around the body of the material 32. Apertures 35 allow the escape of water or water vapor from the otherwise sealed gel 32. Alternatively, instead of the heating elements 33, elements may also be provided which alter the pH of the gel or passive materials which deprive the gel of water. A reverse reaction, ie swelling of the gel, is also possible if moisture depots are applied at this point.

FIG. 11 shows a section of an example of a device which operates similar to the device of FIG. The changing material is hereby replaced by piezoelectric body 44. On a front side arranged perforated plate 42 are the

Electrodes 41 are introduced into the fabric 45 by the control elements 44 are moved controlled. By varying the voltage U across the actuating elements 44, the electrodes 41 can be moved out of the tissue 45 both into the tissue 45 and with nanometer precision. The holder and the device for spatial positioning of the entire system are not shown in the figure.

FIG. 12 shows another example of an embodiment of the proposed device. The needle-shaped objects 51 in the swelling or shrinking material 52 are in this case in a housing 58 introduced, which has a perforated plate 53 for the passage of the needle-shaped objects 51 on one side. The housing includes filler neck 56 and drain port 57 for a liquid or gas 510. At the back of the needle-shaped objects 51 are each elastic body 59 is arranged, which are supported on the inside of the housing 58 and the needle-shaped objects 51 acted upon by a force in the direction of the holes of the perforated plate 53. About the filler neck 56 is a liquid or gas

510 introduced into the housing 58. The liquid or gas 510 may be changed via the filler neck 56 and the drain neck 57. This allows controllable swelling or shrinkage of the material 52 by appropriate choice or modification of the liquid or gas, causing the pointed objects 51 to slowly move into the tissue 54 through the perforated plate 53. The perforated plate 53 ensures a better guidance of the tips of the needle-shaped objects 51. The additional openings 55 allow a better contact between the gas or the liquid 510 and the material 52. The swelling or shrinkage of the material 52 may, for example, by an osmotic Pressure gradient between the material 52 and the liquid or the gas 510 can be achieved. For example, with a suitable choice of the material 52, z. As a hydrogel, and filling DI water as a liquid 510, the material 52 absorb water and thus increase its volume. The reverse case arises when using a solution containing much salt as liquid 510. Figure 13 shows another example of a device according to the present invention. This device comprises two electrodes 63, 64 on both sides of the material body 62 which can be controlled in terms of volume or thickness

Voltage between the electrodes 63 and 64, the conversion process, the thickness or the distance-defining material 62 can be controlled. As a result, the pointed objects 61 can be slowly pressed into the tissue 65 or pulled out of it by the additional action of a compressive force 66. By structuring the electrodes 63, 64 (shown by way of example separately for the electrode 64a in the figure), local field strength increases can be achieved. As a result, a layer-wise influencing of the material 62 is possible. Through channels in the electrodes, cf. For example, electrode 64b, the material 62 may possibly flow.

FIG. 14 shows another embodiment of the proposed device. In this embodiment, the tips of the object 71 are not embedded in the body of variable material 72. Rather, the object 71 in this case only by this body, which is arranged laterally in the present example, supported. In this example, where the tip tip object 71 is again disposed in a housing having a perforated plate 73 for passage, the variable material 72 is a variable modulus material, such as a shape memory material. By changing the modulus of elasticity, for example, as a result of a temperature change, this material defining the distance enables the tips of the object 71 can be slowly pushed into the tissue 75 under the action of a force caused by an elastic material 74 force through the perforated plate 73 or pulled out again.

In the embodiment of the needle-shaped object 1 as a tube (micropipette), which is introduced into the tissue and remains there, an artificial channel is created, which can be used, for example, for introducing and discharging liquids through the membrane. The needle-shaped object 1 can also carry electrode contacts, the z. B. can be used for stimulation and signal transmission in nerve cells. Furthermore, with appropriate configuration of the needle-like object, use in the field of microfluidics is also possible. Of course, this is not an exhaustive list of possibilities. The function of the object, which need not be configured needle-shaped in each case, can rather be chosen arbitrarily, since the penetration of the device as possible with the tissue preserving effect does not depend on this function of the object.

The device can also be used to penetrate a biological barrier or a biological

Tissue or composite outside the human or animal body, for example. Use in cell cultures.

The proposed device is of course not limited to the illustrated embodiments. Thus, for example, those described in the claims, the description and the embodiment Combine examples of features listed in another way.

LIST OF REFERENCE NUMBERS

1 acicular object 2 biological tissue or biological barrier or biological composite

3 layer of body of e.g. biodegradable polymer

4 substrate

5 force 6 guide sleeve

7 stamps

11 rigid capsule of a cuff

12 elastic layer

13 Electrode Structure 14 Mass of variable material

15 mechanical side elements

16 living tissue

21 electrode system

22 bodies of variable material 23 tissue or biological barrier or biological composite

24 elastic material

25 platen

26 scale 27 support system

28 rigid cladding

31 electrode structure

32 variable material

33 heating elements 34 tissue or biological barrier or biological

composite

35 passage openings

41 electrodes 42 perforated plate

44 piezo body

45 tissue or biological barrier or biological composite 51 needle-shaped object

52 variable material

53 perforated plate

54 tissue or biological barrier or biological composite 55 openings

56 filler neck

57 drainage nozzle

58 housing

59 elastic body 510 liquid or gas

61 object with points

62 variable material

63 electrode

64 electrode 65 tissue or biological barrier or biological

composite

66 pressure force

64a structured electrode

64b structured electrode with channels 71 object with tips and holder

72 variable material

73 chamber with perforated plate

74 elastic material

75 tissue or biological barrier or biological composite

Claims

claims

An apparatus for penetrating a biological barrier or biological tissue or composite comprising at least one object (1) having at least one front tip end and at least one body having a thickness which decreases either by itself or by external influence over time , wherein the body is arranged on the object (1) that the pointed end of the object at a

Pressing against the barrier or tissue or composite almost invariably, regardless of contact pressure, penetrates the barrier or tissue or composite at a rate determined by the reduction in body thickness over time.

2. Device according to claim 1, wherein the body is formed of a material with externally influenceable material properties, which allows a reduction in the thickness of the body over time by influencing the material properties.

3. A device according to claim 2, wherein the material is selected so that by influencing the material properties of the material from the outside, a reduction in the thickness of the body at a rate of <500 microns / h is possible .

4. Apparatus according to claim 3, wherein the material is selected so that by influencing the material properties of

Material from the outside a reduction in the thickness of the body at a rate of ≤ 100 microns / h is possible.

5. The device of claim 1, wherein the body is selected so that a reduction of the thickness of the body at a speed of <500 microns / h is possible.

6. The device of claim 5, wherein the body is selected so that a reduction in the thickness of the body at a speed of ≤ 100 microns / h is possible.

7. Device according to one of claims 1 to 6, wherein the body is formed so that it also allows an increase in thickness over time by external interference.

8. Device according to one of claims 1 to 7, wherein the object is embedded at least in the region of the pointed end in the body.

9. Apparatus according to claim 8, wherein the object (1) is fully embedded in the body, wherein between a rear end of the object (1) and a rear boundary of the Body is a gap.

A device according to any one of claims 1 to 7, wherein the body forms a spacer between the barrier or the fabric or composite and a rear portion of the object.

11. Device according to one of claims 1 to 10, wherein the object (1) rests with the rear end to a substrate (4).

12. The device according to 11, wherein the body is formed as a layer on the substrate (4).

A device according to any one of claims 1 to 12, further comprising a collar through which the object can be held in position during penetration at the barrier or tissue or composite.

14. Device according to one of claims 1 to 13, wherein at a rear end of the object, an elastic or resilient material system is arranged, via which a quasi-static force on the rear end of the object is exercisable.

15. The apparatus of claim 14, wherein the object is enclosed with the body at least at the rear end of the object by a rigid shell, wherein the elastic or resilient material system between the rear end of the Object and the shell acts.

16. The apparatus of claim 15, wherein at the rear end of the object, one or more scales are fixed, which extend through openings in the sheath parallel to the direction of penetration of the pointed end to the rear and from the outside reading a penetration depth of the pointed end into the barrier or allow the tissue or the composite.

17. Device according to one of claims 14 to 16, wherein the sheath forms a support for the device on the barrier or the fabric or the composite.

18. Device according to one of claims 1 to 17, wherein the body is at least partially enclosed by a device which is designed to influence the material properties of the material of the body.

19. The apparatus of claim 18, wherein the device allows escape or introduction of liquid, vapor or gaseous material.

20. Device according to one of claims 1 to 19, wherein the pointed end of the object (1) is flush with a front side of the body.

21. Device according to one of claims 1 to 19, wherein the at the front tip end of the object a perforated plate is arranged with at least one hole through which the pointed end moves when penetrating through the barrier or the fabric or composite.

22. The apparatus of claim 21, wherein the perforated plate is part of a rigid enclosure for the object and the body.

23. The apparatus of claim 22, wherein the enclosure comprises one or more inlet and outlet ports for the supply or the outlet of media.

24. An apparatus according to any one of claims 1 to 23, wherein the body is made of a biodegradable material (3) which degrades upon contact of the front of the body with the barrier or the fabric or composite from the front of the body.

25. The device according to claim 24, wherein bioreactive substances, in particular medicaments, are incorporated in the body of biodegradable material (3).

26. Device according to one of claims 1 to 25, wherein the object (1) consists of biodegradable material, bioreactive substances, in particular medicines, are embedded in the object.

27. Device according to one of claims 1 to 26, wherein the object (1) formed as a tube is.

28. Device according to one of claims 1 to 27, wherein the object (1) carries electrodes for stimulation and / or dissipation of bioelectric signals.

29. Device according to one of claims 1 to 28, wherein the object has a plurality of pointed ends or in which a plurality of objects (1) with one or more pointed ends are arranged side by side.

30. Use of the device according to one of claims 1 to 29 for penetrating a biological

Barrier or a biological tissue or composite outside the human or animal body with the object (1), in which the object (1) and the biological barrier or the biological tissue or the biological composite are pressed against each other so that the object is the biological barrier or penetrates the biological tissue or the biological composite almost independently of the contact pressure at a speed with which the thickness of the body is reduced by external influence or by itself.

31. Use of the device according to one of claims 1 to 29 for penetrating a biological barrier or a biological tissue or

Compound on the human or animal body with the object (1), in which the object (1) and the biological barrier or the biological tissue or the biological composite is pressed against each other so that the object penetrates the biological barrier or the biological tissue or the biological composite almost independently of the contact pressure at a speed with which the thickness of the body is reduced by external influence or by itself.