Implant

Abstract

To provide, instead of an absolute pressure sensor, a pressure difference sensor that can measure the pressure difference between two places partitioned by biological diaphragm.SOLUTION: An implant comprises: a housing that has a cabinet; a sensor unit; a first film that covers the cabinet in a first pressure side part; and a second film that covers the cabinet on a second pressure side part. The cabinet includes pressure transmission means that is in contact with the first film and the second film, and is in contact with the sensor unit arranged in the cabinet between the first film and the second film, and a sensor control unit is arranged inside the housing. The sensor unit is configured to determine the pressure difference between the pressure on the first pressure side part of the cabinet and the pressure on the second pressure side part of the cabinet.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE Embodiments of the present invention relate to an implant having a differential pressure sensor and a method for manufacturing the same. Generally, embodiments relate to the concept of measuring differential pressure within the body. [Background technology]

[0002] There are currently many applications for measuring pressure in or within the human body. Examples include:

[0003] -Measurement of pressure difference between eye and body fluids -Measurement of pressure difference between reservoir and cuff for sphincter cuff -Measurement of pressure difference between vascular blood reservoir pressure or cardiac pressure and systemic pressure However, body pressure is not constant. When the pressure of the environment changes, body pressure follows the atmospheric pressure. Here are some reasons why:

[0004] The change in pressure due to normal changes in atmospheric pressure at a given location Pressure changes due to altitude (e.g. when climbing) Pressure changes inside the aircraft The magnitude of these atmospheric pressure changes is comparable to or exceeds the pressure differential measurements. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 4,460,568 Summary of the Invention [Problem to be solved by the invention]

[0006] Prior art documents, described with reference to Figures 1a-1c, disclose pressure sensors. Figure 1a shows an implantable absolute pressure sensor, for example a pressure sensor called HELGA. The pressure sensor is embedded in a liquid in a hermetically sealed titanium housing. A thin titanium foil transfers the pressure from the body to the liquid and then to the sensor.

[0007] However, since this is only an absolute pressure sensor, environmentally induced pressure changes can lead to situations where the pressure value cannot be used correctly. The reason for this is that in some applications, for example, the pressure difference between the implant and the surrounding body fluids is important. Therefore, if the body fluid pressure changes due to environmental conditions, the pressure at the implant also needs to be changed. An absolute pressure value is not useful.

[0008] Figure 1b shows a similar sensor to the HELGA sensor where the sensor is embedded in oil, which also suffers from the same problems.

[0009] US Patent No. 4,660,568 discloses an implantable differential pressure sensor. Figure 1 of the patent is shown in Figure 1c. The pressure sensor uses two diaphragms. However, there is a fixed relationship between the pressure sensor and the diaphragms. This can cause problems of high stress and drift on the pressure sensor. Figure 1d shows the differential pressure sensor (www.eastsensor.com / blog / capacitance-differential-pressure-tran s (see mitter-working-principle / ).

[0010] The object of the present invention is to provide an implant concept which allows solving the above mentioned problems. [Means for solving the problem]

[0011] This object is solved by the subject matter of the independent claims.

[0012] According to an embodiment of the present invention, an implant is provided, comprising a housing and a sensor unit. The implant further comprises a first membrane covering a chamber at a first pressure side and a second membrane covering the chamber at a second pressure side (e.g. for sealing the implant against its surroundings). The chamber includes pressure transmitting means in contact with the first membrane and the second membrane and in contact with the sensor unit arranged within the chamber between the first membrane and the second membrane. Furthermore, a sensor control unit is arranged in the housing. The sensor unit is configured to determine a pressure difference between a pressure at the first pressure side of the chamber and a pressure at the second pressure side of the chamber.

[0013] In some embodiments, the sensor unit may include a membrane, the membrane configured to measure a relative pressure between a pressure applied to a first side of the membrane from the first pressure side and a pressure applied to a second side of the membrane from the second pressure side. This embodiment has the advantage that the relative pressure / differential pressure can be measured directly. According to another embodiment, the sensor control unit may include a first pressure sensor and a second pressure sensor, the first pressure sensor configured to measure the pressure at the first pressure side and the second pressure sensor configured to measure the pressure at the second pressure side, where the differential pressure is determined from the two absolute pressures and the calculation of the differential pressure is performed by the sensor unit.

[0014] The embodiment of the invention is based on the principle that if the housing of the implant has a chamber, for example formed by a hole / opening in the housing, it is possible to arrange the sensor part in the chamber so that a first pressure from a first pressure side and a second pressure from a second pressure side can be applied to the sensor. This allows a local separation of the problem of sealing (by a membrane) from the problem of packaging with low stress the pressure difference measuring sensor part (arranged in the pressure transmitting means). For example, the chamber can extend from the first pressure side to the second pressure side and pass through the housing. This configuration allows the pressure sensor to directly determine the differential pressure between the two sides.

[0015] In some embodiments, the housing may include a diaphragm on which the sensor portion and / or the sensor control portion may be disposed. For example, the diaphragm may be disposed within the chamber, where the diaphragm may, in some embodiments, separate the chamber into a first portion and a second portion, such that the sensor portion may be attached to the diaphragm and centrally disposed within the chamber.

[0016] According to further embodiments, a first foil can be used as a first membrane for the first pressure side or a second foil can be used as a second membrane for the second pressure side. Here, the housing includes the first foil and the second foil. The foils can be arranged such that the sensor part is arranged between the foils. In some embodiments, the first foil covers the chamber at the first pressure side and the second foil covers the chamber at the second pressure side. In some embodiments, the first foil at the first pressure side and the second foil at the second pressure side seal the chamber (i.e. the sensor part is arranged within the chamber). According to further embodiments, the sensor control part can also be sealed in the housing, for example by using the first foil and the second foil. In some embodiments, the pressure at the first pressure side is applied to the pressure sensor via the first foil and the pressure at the second pressure side is applied to the pressure sensor via the second foil. In particular, the pressure on the first pressure side can be applied to a first side of the pressure sensor through the first foil, while the pressure on the second pressure side can be applied to a second side of the pressure sensor through the second foil. Connecting the first and second foils to the housing and sealing the housing without the sensor part being in contact with the first and second foils has the advantage that the sensor part is not affected during the manufacturing process. On the other hand, the foil can "pass" the pressure on two different sides. In some embodiments, the first and second foils can be made of titanium foil, thin titanium foil, or PEEK foil (polyetheretherketone).

[0017] The chamber, for example the chamber closed by the first and second foils, can be filled with air, oil, liquid or mould as pressure transmission medium. The oil or liquid, preferably a non-conductive, biocompatible and non-corrosive liquid or mould, is incompressible, allowing optimal pressure application from the foil to the sensor. In some embodiments, the chamber and / or the first and second foils can comprise guides for guiding the liquid, oil or mould during injection.

[0018] According to further embodiments, the housing may comprise a filter, a grid, a grid including a filter, a rigid grid or a perforated component, for example surrounding the chamber on the first and second pressure sides and / or surrounding the sensor part from both pressure sides and / or surrounding the first and second foils of the housing. This rigid grid has the advantage that it prevents the foil or the chamber or the sensor part from being trapped by biological material.

[0019] In another embodiment, there is provided a method of manufacturing an implant as described above, comprising the step of disposing the sensor portion within the chamber (e.g. between the two foils). In some embodiments, the method may further comprise the step of injecting the chamber and / or the area between the two foils, wherein the injecting step may be performed before or after attaching the foils (first and second foils) to the housing. [Brief description of the drawings]

[0020] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. [Figure 1a] FIG. 1 is a schematic diagram of a prior art solution for an implant. [Figure 1b] FIG. 1 is a schematic diagram of a prior art solution for an implant. [Figure 1c]FIG. 1 is a schematic diagram of a prior art solution for an implant. [Figure 1d] FIG. 1 is a schematic diagram of a prior art solution for an implant. [Diagram 2] FIG. 1 is a schematic diagram of a basic realization of an implant according to a first embodiment. [Figure 3a] FIG. 1 is a schematic diagram showing an advanced implementation of an implant, in some embodiments using two different sensor portions. [Figure 3b] FIG. 1 is a schematic diagram showing an advanced implementation of an implant, in some embodiments using two different sensor portions. [Figure 4a] 13 is a schematic diagram of another implementation of an implant according to another embodiment. [Figure 4b] FIG. 4b is a schematic diagram of the implant of FIG. 4a implanted within a body according to another embodiment. [Diagram 5] FIG. 3b is a schematic diagram showing a variant development of the implant of FIG. 3a according to a further embodiment. [Figure 6a] FIG. 4b is a schematic diagram showing a variant development of the implant of FIG. 4a according to a further embodiment. [Figure 6b] FIG. 4b is a schematic diagram showing a variant development of the implant of FIG. 4a according to a further embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. Elements or structures having the same or similar functions are given the same reference numerals so that the descriptions are mutually applicable and interchangeable.

[0022] 2 shows an implant 10 with a housing 12 that contains a chamber 12c within which a sensor portion 14 may be located. A sensor control portion 16 may be located anywhere within the housing 12.

[0023] The chamber 14c may be formed, for example, by a hole extending from a first side of the housing 12 to a second side of the housing 12. The sides are designated 12s1 and 12s2. Through the side 12s1, a first pressure P1 may be applied to the sensor 14 and a second pressure P2 may be applied to the sensor 14. Since two pressure levels P1 and P2 are applied from the two sides 12s1 and 12s2, the two sides 12s1 and 12s2 are also referred to as a first pressure side and a second pressure side.

[0024] In some embodiments, the pressure sensor 14 can be a membrane that is subjected to two pressures P1, P2 from two pressure sides 12s1, 12s2, where P1 is applied to a first side of the membrane and P2 is applied to a second side of the membrane. The membrane moves in response to the pressure difference between P1, P2, which can be determined in a (preferably) piezoelectric, piezoresistive or capacitive manner. For example, a piezoresistive pressure (differential pressure) sensor uses a combination of a strain gauge and a membrane to determine the deflection of the membrane and from there the applied pressure. In a piezoelectric system, the membrane can be made of a specific material, such as quartz, which allows the strain on the membrane and from there the pressure to be measured directly. Alternatively, the first electrode can be made of a membrane and the second electrode can be made of a grating arranged parallel to the membrane. This configuration forms a (differential pressure) pressure sensor. In an alternative variant, the sensor part 14 may be formed by two independent pressure sensors, each of which determines one of the two pressures P1, P2, so that the pressure difference between P1, P2 can be calculated, for example, using the sensor control unit 16. Between the membranes 20s1, 20s2 and the sensor part 14, so-called pressure transmission medium means, for example a fluid or oil, are arranged, which transmit the pressures p1, p2 from the first pressure side 12s1 and the second pressure side 12s2, respectively, to the sensor 14. In this way, the sensor part 14 can be embedded in the pressure transmission means.

[0025] In some embodiments, the chamber 12 can be covered by a respective foil (membrane). For example, a first foil 20s1 can be provided on the first side 12s1 of the chamber 12, and a second foil 20s2 can be provided on the second side 12s2. These two foils 20s1, 20s2 cover the chamber 12 from the two sides 12s1, 12s2, thereby sealing, for example, the chamber 12c and the components arranged therein. In particular, the pressure sensor 14 can be arranged between the two foils 20s1, 20s2. Here, the two foils 20s1, 20s2 can be configured to "pass on" the pressures P1, P2 to the sensor 14.

[0026] Further optional features according to embodiments will now be described with reference to the further figures.

[0027] Before describing these further embodiments and in particular their advantages in various applications, the field of application is described: Preferably, the pressure measuring device can be used to measure intrabody pressure.

[0028] ·The human body is a system with many different pressure areas (brain, eyes, inner ear, large intestine) and flows occur in response to pressure differences. These pressure differences can be very large (e.g. body pressure) or very small. The only technology currently available is to measure two absolute pressures and take their difference. Since body pressure varies with atmospheric pressure, these measured pressures also vary with atmospheric pressure. Therefore, measuring these small pressure differences within the body is extremely difficult.

[0029] If technology existed to measure the actual pressure difference between two locations in the body, it could tell us a lot about how the body functions.

[0030] Therefore, what is needed is not an absolute pressure sensor, but a differential pressure sensor capable of measuring the pressure difference between two locations separated by a biological diaphragm.

[0031] To measure the differential pressure, the pressure sensor must be in contact with both pressure areas to be measured. The pressure sensor then needs to make electrical contact and therefore an electrical connection to the implant's system control. These electrical contacts need to be hermetically sealed. However, pressure sensors are extremely sensitive to stress. Hermetic bonding, for example to a titanium housing, would result in high stress shocks.

[0032] Therefore, it is nearly impossible to hermetically bond a pressure sensor chip having pressure contact points with two pressure areas to an implant without causing significant stress to the pressure sensor.

[0033] However, as mentioned above, this problem can be solved by improving the design of the implant so that the housing constitutes a chamber. This solution is based on arranging and sealing the pressure sensor / differential pressure sensor in the chamber, for example using a foil arranged to transmit the external pressure to the internal sensor part. Such a foil can be applied in a stress-free manner. An embodiment comprising such a foil, here a thin titanium foil, is described with reference to figures 3a and 3b. Both embodiments of figures 3a and 3b are similar except for the different sensors used.

[0034] FIG. 3a shows an implant 10 in which the housing 12 includes two housing parts 12a, 12b (located against a first and second side of the chamber 12c). A differential pressure sensor 14 is arranged in the chamber 12c. In this embodiment, the pressure sensor 14 is attached to a diaphragm 15, which allows for pressure separation (e.g., non-hermetic). The diaphragm 15 runs along the length of the implant 10 / housing 12 and separates the chamber 12c into a first chamber part 12c1 and a second chamber part 12c2. The first chamber 12c1 is arranged on the side 12s1, and the second chamber 12c2 is arranged on the second side 12s2. It should be noted that the diaphragm allows for the separation of the chamber 12c into an upper part and a lower part of the chamber 12c, and can be realized by a foil that is very thin with respect to the living body, as follows:

[0035] On the one hand, it is hermetically attached to the implant housing.

[0036] On the other hand, the sheet stiffness, defined by the geometric dimensions and Young's modulus of the foil, must be low enough that the inherent stresses of the foil caused by the pressure changes to be measured do not significantly affect the measurement signal.

[0037] Alternatively, the diaphragm 15 may be rigid or have low flexibility.

[0038] The chamber 12c1 is covered with a thin foil, in this case a thin titanium foil 17s1, and the chamber 12c2 is covered with a similar foil, for example a similar foil 17s2. These two foils 17s1, 17s2 are used to seal the chamber 12 from the environment.

[0039] In this embodiment, the housing 12 includes a separate enclosure for the control system 14. In this case, the control system 14 is located within a sealed titanium housing.

[0040] In some embodiments, the chamber 12, in particular the first chamber part 12c1 and the second chamber part 12c2, can be filled with oil or a molding, which is indicated by the reference number 13. The purpose of the oil or molding is to apply the pressure applied to the foils 17s1, 17s2 to the membrane of the pressure sensor 14. The pressure sensor 14 in the sensor chamber 12c is embedded in this oil. Instead of oil, a non-conductive, non-compressible harmless liquid can be used, for example a biocompatible oil 13. Regarding the liquid, it is also possible in a preferred embodiment to inject a non-compressible liquid into the chamber 12c, which preferably does not produce bubbles. Since gas is compressible, bubbles may be generated, which may affect the measurement.

[0041] In this embodiment, the implant can be positioned within the human body such that two different internal body pressures can be measured, for example, a body pressure P2 can be measured on the second pressure side 12s2, while a reservoir or cuff pressure P1 can be measured on the first pressure side 12s1.

[0042] In other words, according to this embodiment, the pressure difference between the upper region 12c1 and the lower region 12c2 of the chamber 12c can be measured by using a differential pressure sensor 14 located in the pressure measurement chamber 12. Here, the pressure sensor 14 is mounted on a diaphragm 15 that separates the upper part 12c1 and the lower part 12c2 of the chamber 12c. In a further embodiment, the diaphragm 15 is rigid. The diaphragm can be housed in an electrical conductor to allow the pressure sensor to be guided to the system control 16 for reading the sensor 14. The pressure sensor 14 can be mounted to the chamber 12c by applying prior art methods for mounting pressure sensors with low stress.

[0043] FIG. 3b shows an implant 10′ similar to implant 10 with respect to the housing 12, the chamber 12c, the control 16 and the diaphragm 15. This implant 10′ further comprises two foils 17s1, 17s2 covering the chamber 12c. In this chamber 12c, two pressure sensors 14s1, 14s2 are arranged. These two pressure sensors 14s1, 14s2 are arranged on two opposite sides of the diaphragm 15, so that the pressure sensor 14s1 is arranged to determine the pressure P1 at the side 12s1, while the pressure sensor 14s2 is arranged to determine the pressure P2 at the side 12s2. In other words, the two absolute pressure sensors 14s1, 14s2 are mounted such that one contacts the upper chamber and the other contacts the lower chamber. The differential pressure can be determined by calculating the difference between the two pressure values. This packaging is simpler and easier to achieve than the packaging of FIG. 3a since no holes are required in the rigid isolation chamber.

[0044] In both embodiments of the implant 10, 10', the sealing problem and the problem of differential pressure measurement can be solved. According to further embodiments, additional sensors, e.g. N sensors (both differential or absolute pressure sensors), can be arranged in the chamber 12c. For example, a plurality of N sensors can be fixed to the diaphragm 15.

[0045] With reference to Figures 4a and 4b, another implant 10" is described. Figure 4a shows an implant 10" with a housing 12", in which a relatively large chamber 12c" can be formed. As explained with reference to Figures 3a and 3b, a diaphragm 15" can run substantially parallel to the foils 17s1", 17s2" enclosing the chamber 12c" and penetrate the chamber 12c". The sensor 14 and the control elements 16a", 16t" (e.g. ASIC and transponder) can be arranged on the diaphragm 15". The two components 16a", 16t" can be arranged on the same side with respect to the pressure sensor 14 or on different sides.

[0046] All three components 16a", 14, 16t" are disposed within a small chamber 12c" which may be filled with liquid or oil. In this manner, the electronics 16a", 16t" and the sensor 14 are embedded in the oil 13. This arrangement allows the pressure difference measuring unit 10" to be miniaturized. Here, the thickness of the sensor may be 1 mm or less.

[0047] With reference to FIG. 4b, a method of fixing the pressure differential sensor implant 10″ in the human body is described. Here, the implant 10″ is attached to a biological diaphragm 22. This diaphragm 22 separates the two pressure zones P1, P2. The housing 12″ (in this case a titanium housing) can be attached to the biological diaphragm 22 using a biocompatible fixing material 23. Preferably, the titanium sensor element 10″ is combined with a biocompatible material so that the titanium housing and the biological diaphragm 22 can be fixed by the surgeon.

[0048] FIG. 5 shows the implant 10 with the housing 12. The chamber 12c is filled with oil. In this respect, two different injection methods are available. Firstly, the injection can be carried out before the second foil 17s2 is hermetically attached to the housing 12. The advantage is that no injection procedure or injection ports are necessary. However, it can be difficult to handle liquids during the process parameters of the sealing process. Alternatively, the injection can be carried out after the foils 17s1, 17s2 are hermetically attached to the housing 12. In this case, injection ports (not shown) are used to perform the injection in the chamber areas 12c1, 12c2. These ports can be arranged as follows:

[0049] For example, inlets and outlets for both the upper and lower parts of the chamber, ie, four injection ports, are required.

[0050] Compared to foil, it may be easier to seal these injection ports after injection.

[0051] · To facilitate injection without bubbles in the chambers, both chambers may be provided with "guiding structures". These structures may be serpentine in shape to prevent bubbles from remaining on the edges of the chambers. The guiding structures are required not to disturb the pressure measurement function.

[0052] Instead of oil, a very weakly castable but incompressible (compared to air) compound may be used in place of the liquid oil, which may be allowed to fill the chamber before sealingly attaching the second titanium foil during the pressure sensor diaphragm installation process.

[0053] During injection into the chamber 12c, air bubbles 13a may form within the chamber, as shown in Figure 5. The effect of this gas bubble 13a within the sensor chamber 12c will now be described.

[0054] In the sensor chamber (upper chamber or lower chamber), volume V gas , atmospheric pressure p O If air (or gas) bubbles occur, the measurement accuracy will be affected.

[0055] Calculation: Fluid Capacity of Thin Titanium Foil, Cm

[0056]

number

[0057] Gas bubbles (atmospheric pressure p O The fluid volume of the liquid (assuming that the liquid is in a liquid state) can be approximately determined by the isotherm of state:

[0058]

number

[0059]

number

[0060]

number

[0061]

number

[0062] In some embodiments, the chamber 12c may be filled with air instead of liquid, the advantage being that no filling step is required, simplifying the manufacturing process. During measurement, the titanium diaphragm moves according to the compressibility of the air. The inherent stress of the curved titanium foil affects the measurement.

[0063] If the absolute pressure changes (e.g. a patient in an aircraft), the fluid volume of the trapped air bubble changes and with it the correction factor for the pressure measurement.

[0064] It should be noted that with respect to the control electronics 16, in some embodiments a temperature sensor may be integrated with the implant 10 to compensate for temperature changes within the body, such as due to fever.

[0065] Next, a few words about materials.

[0066] In principle, any material suitable for long-term implantation may be used. For example, PEEK is available as an implantable material, but it is nearly impossible to seal with a thin PEEK foil. In practice, titanium seems to be the preferred solution for both the housing and the foil.

[0067] It is believed that the above-mentioned functions can be ensured if the foil is a titanium foil having a thickness of 20 to 50 μm and a lateral dimension (pressure measurement area) of 5 to 15 mm.

[0068] Additional features are explained with reference to Figures 6a and 6b.

[0069] FIG. 6a illustrates the implantation state of FIG. 4b, where the implant 10'' is attached to a biological diaphragm 22 using a biocompatible fixation material 23.

[0070] A problem with measuring pressure or pressure differences within the body is that after a period of time the pressure sensor may become trapped within the biological material 26. This can result in two problems:

[0071] A layer of biological material 26 accumulates on the pressure-sensing sides 12s1, 12s2 causing mechanical stress on the diaphragm, which affects the measurement result of the pressure sensor.

[0072] This layer can act as a pressure barrier, which can result in a pressure drop across it.

[0073] A solution to this problem is shown in FIG. 6b. The configuration shown in FIG. 6b is the same as that shown in FIG. 6a, except that the implant 10″ is improved by a filter bag 28f, which can be combined with the support 28 and serves to separate the pressure-sensitive titanium diaphragm 10″ from the living body 26. The filter bag 28f is supported by a rigid grid 28, which prevents mechanical shocks, forces or pressures on the measuring diaphragm. This allows only very small molecules (water, oxygen, CO2, glucose, etc.) to pass through the filter 28f, but not cells or other molecules that may stratify. It should be noted that instead of the filter 28f or the grid 28 with the filter bag 28f, a conventional grid, a rigid grid or generally a porous component may be used. The pores of the porous component, the filter 28f or the grid may preferably be smaller (e.g. less than 200 nm, or less than 50 nm) than the cells or other biological constituents that may aggregate and / or deposit on the pressure-sensitive titanium diaphragm.

[0074] The area of ​​filter 28f is large enough to completely confine pressure sensor 16 during the anticipated implant period without causing a significant pressure drop between the tissue and the area above the titanium membrane.

[0075] Also, there is no material passing through the filter area that can cause stress in the titanium film 10''.

[0076] It should be noted that the differential pressure sensor and / or implant 10, 10', 10" may include fasteners for connection to a body membrane separating two different pressure side zones in the body. Another application is in combination with a cuff reservoir.

[0077] In this case, the above-described differential pressure measurements can be used in artificial implantable urethral sphincter prostheses (or alternatively as replacements for other natural sphincter functions, such as the anal sphincter, upper esophageal sphincter, pyloric sphincter, ileocecal sphincter, etc.). Hydraulically actuated implants that can close the urethra, allowing the patient to tolerate incontinence, or open the urethra, allowing the patient to urinate The hydraulic fluid is salt water, moved by a mechanically or electrically driven pump.

[0078] To open and close the urethra, an inflatable, long, thin balloon (a so-called cuff) is wrapped around the urethra in a circular shape to replace the previous closing function of the human sphincter.

[0079] A second inflatable reservoir (a so-called balloon reservoir) is placed inside the patient's abdomen to store the pumped fluid. Urine drains when the cuff is opened.

[0080] Measuring urethral closure pressure relative to ambient body pressure is important for system control and to prevent excessive compression of the urethral tissue.

[0081] In this case, the following pressures can be determined:

[0082] Abdominal pressure measurements can be made by sensing the pressure in the balloon reservoir fluid line.

[0083] Urethral closure pressure measurements can be performed within the cuff fluid line.

[0084] In this manner, the above-mentioned sensor values ​​can be obtained from a differential pressure sensor located between two fluid lines within the implant.

[0085] Optional specifications for this application include:

[0086] -Tightness between the fluid lines and the sensor electronics Perfect differential pressure measurement between urethral cuff pressure and in vivo abdominal pressure In this application, the implantable differential pressure sensor is embedded in an environment that has saline solution rather than body fluids. No body fluids are present on either pressure side. In this case, no additional measures to protect the diaphragm (Figure 6) are required.

[0087] Additionally, the pressure sensor may be used to measure the pressure differential between a saline solution reservoir and bodily fluids.

[0088] Although some aspects have been described in the context of an apparatus, it is clear that each of these aspects also represents a description of a corresponding method, with a block or apparatus corresponding to a method step or feature of a method step. Similarly, an aspect described in the context of a method step also represents a description of a corresponding block or item or feature of a corresponding apparatus. Some or all of the method steps may be performed by (or using) a hardware apparatus, such as a microprocessor, a programmable computer or an electronic circuit. In some embodiments, one or more of the most important method steps may be performed by such an apparatus.

[0089] Some embodiments according to the invention include a data carrier having electronically readable control signals stored thereon and capable of cooperating with a programmable computer system to cause one of the methods described herein to be performed.

[0090] A further embodiment comprises a processing means, for example a computer, or a programmable logic device, configured to or adapted to perform one of the methods described herein.

[0091] A further embodiment comprises a computer having installed thereon the computer program for performing one of the methods described herein.

[0092] In some embodiments, a programmable logic device (e.g., a field programmable gate array) may be used to perform some or all of the functions of the methods described herein. In some embodiments, a field programmable gate array may cooperate with a microprocessor to perform one of the methods described herein. In general, the methods may be performed by any hardware device.

[0093] The above-described embodiments merely exemplify the principles of the present invention. It is understood that modifications and variations of the arrangements and details described herein will be apparent to those skilled in the art. It is therefore intended to be limited only by the scope of the appended claims and not by the specific details presented as descriptions and explanations of the embodiments herein.

Claims

1. An implant (10, 10', 10") comprising: a housing (12) having a chamber (12c); A sensor unit (14); a first membrane (20s1) covering said chamber (12c) on a first pressure side (12s1); and a second membrane (20s2) covering the chamber (12c) at the second pressure side (12s2). ) and The small chamber (12c) is in contact with the first membrane (20s1) and the second membrane (20s2). and the small portion is formed between the first film (20s1) and the second film (20s2). a pressure transmitting means in contact with the sensor portion (14) disposed in the chamber (12c); A sensor control unit (16) is disposed within the housing (12); The sensor portion (14) is provided on the first pressure side portion (12s1) of the small chamber (12c). the pressure at the second pressure side (12s2) of the chamber (12c) The implant is configured to determine a difference.

2. An implant (10, 10', 10'') according to claim 1, The sensor portion (14) includes a membrane, the membrane being configured to have the first electrode positioned against a first side of the membrane. A pressure applied from the pressure side portion (12s1) and a second side of the membrane of the sensor portion (14) The relative pressure between the pressure applied from the second pressure side portion (12s2) to the surface is measured.

4. The implant, comprising:

3. An implant (10, 10', 10'') according to claim 1, The sensor unit (14) has a sensor configuration including a first pressure sensor and a second pressure sensor. The first pressure sensor measures the pressure at the first pressure side (12s1). The second pressure sensor is configured to detect the pressure on the second pressure side (12s2). The implant is configured to measure a pressure applied to the implant.

4. An implant (10, 10', 10'') according to any one of claims 1 to 3, 、 The small chamber (12c) extends from the first pressure side (12s1) to the housing (12). to said second pressure side (12s2).

5. An implant (10, 10', 10'') according to any one of claims 1 to 4, 、 The housing (12) includes the sensor unit (14) and / or the sensor control unit (16). and / or a diaphragm (15) to which the The diaphragm (15) passes through the chamber (12c).

6. An implant (10, 10', 10'') according to any one of claims 1 to 5, 、 The first film (20s1) comprises a first foil (20s1), and the second film (20s2) includes a second foil (20s2).

7. An implant (10, 10', 10'') according to claim 6, The chamber (12c) is provided with the first pressure side ( 12s1) is covered with the first foil (20s1) and the second pressure side (1 2s2) covered with said second foil (20s2), and / or The first foil (20s1) on the first pressure side (12s1) and the second pressure said second foil (20s2) on the force side (12s2) seals said chamber (12c); and / or The housing (12) encloses the sensor control unit (16).

8. An implant (10, 10', 10'') according to claim 6 or 7, The pressure of the first pressure side (12s1) is applied to the first foil (20s1) and the pressure transfer a pressure sensor connected to said second pressure side (12s2) through a connecting means (13) The pressure at the pressure sensor 14 is transmitted to the pressure sensor 14 via the second foil 20s2 and the pressure transmitting means 13. Added to the force sensor, or The pressure on the first pressure side (12s1) is applied to the first foil (20s1) and A pressure sensor is connected to a first side of the pressure sensor via a pressure transmitting means (13), and the second pressure The pressure at the side (12s2) is transmitted through the second foil (20s2) and the pressure transmitting means (1 3) attached to a second side of the pressure sensor.

9. An implant (10, 10', 10'') according to claim 6, 7 or 8, The first and / or second foil (20s2) may be a titanium foil, a thin titanium foil, or a PEEK foil. Foils included, implants.

10. An implant (10, 10', 10'') according to claim 5, 6, 7, 8 or 9, 、 The housing (12) separates the chamber (12c) into a first portion and a second portion. and / or the diaphragm (15) is the sensor portion. (14) An implant that holds

11. An implant (10, 10', 10'') according to any one of claims 1 to 10. hand, The chamber (12c), or the first and second portions of the chamber (12c), filled with oil (13), liquid or casting forming the force transmission means (13) and / or teeth, The chamber (12c), or the first and second portions of the chamber (12c), The control means (13) is filled with oil (13), liquid or castings forming the force transmission means (13). The part (16) is embedded in the oil (13), the liquid, or the casting. Runt.

12. An implant (10, 10', 10'') according to any one of claims 1 to 11. hand, The chamber (12c), or the first and second portions of the chamber (12c), may be filled with a liquid, The implant includes a guide for guiding the oil (13) or the mold.

13. An implant (10, 10', 10'') according to any one of claims 1 to 12. hand, The housing (12) includes the chamber (12c), the sensor portion (14), or the A filter, a filter, or a filter that surrounds the foil of the housing (12) or the first and second foils (20s2) Inclusions include filter bags, grids, grids containing filters, rigid grids, or perforated components. plant.

14. An implant (10, 10', 10'') according to any one of claims 1 to 13. hand, The sensor part (1) includes a fixture connected to a biological membrane that separates two different pressure sides. 4) determining the pressure difference between the two different pressure sides; and / or The implant (10, 10', 10'') is realized as part of a cuff reservoir, The sensor portion (14) is disposed within the cuff reservoir or between the cuff reservoir and the surroundings. determining the pressure difference between two different pressures of the implant.

15. Manufacturing an implant (10, 10', 10'') according to any one of claims 1 to 14 The method comprises the steps of: placing the sensor part (14) in the chamber (12c) and / or between two foils; The method comprises the step of placing

16. 16. The method of claim 15, Injecting the chamber (12c) and / or the area between the two foils; and and / or The step of performing the injection may include pre-treating the foil and / or the first and second foils (20s2). The method is performed before or after mounting to the housing (12).

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