Implant

Abstract

The invention relates to an implant (1) which can vary in size, the implant comprising the following: - a base plate (2); - a dome-shaped body (3), which is supported on the base plate (2), to change the extension of the implant; - at least one actuator unit (40, 41, 42, 43, 44, 45, 50) for changing the position of the dome-shaped body (3); - a control unit for activating the at least one actuator unit (40, 41, 42, 43, 44, 45, 50), wherein the dome-shaped body (3) is formed from two or more dome segments (20, 21, 22, 23, 24, 25, 30) which are substantially separated from one another by gap distances (95) and can be adjusted independently of one another in their position and / or orientation by the at least one actuator unit (40, 41, 42, 43, 44, 45, 50) in order to control the changes in the size and the shape of the implant in different regions independently of one another.

Description

[0001] IMPLANT

[0002] The invention relates to an implant which can be varied in size, the implant comprising a base plate, a dome-shaped body supported on the base plate in order to change the extension of the implant, at least one actuator unit for changing the position of the dome-shaped body and a control unit for controlling the at least one actuator unit.

[0003] In plastic and reconstructive surgery, the treatment of patients with silicone implants that remain permanently in the body is a routine procedure.

[0004] These surgical procedures are usually used in the field of reconstruction in cases of breast cancer or other reconstructive procedures in other parts of the body, e.g. in the context of tumor diseases.

[0005] Silicone implants also play a role in the aesthetic desire for breast enlargement to improve body image.

[0006] The surgical procedure under general anesthesia for implantation is always similar for breast surgery: Access to the body of the person being operated on is gained through an incision in the inframammary fold on the chest. Depending on the indication, a tissue pocket is then created either under the pectoralis major or between the pectoralis muscle and the actual mammary gland. This pocket represents the so-called implant bed, into which the permanent silicone implant can then be inserted. Since this implant bed varies in size depending on the anatomical configuration of the person being operated on's chest and the skin, manufacturers also provide implants of different shapes and sizes.Although the approximate size estimate for the implants to be used later is initially determined prior to surgery by measuring the breasts, it usually becomes apparent intraoperatively that these estimates are not always accurate. Deviations from the estimate can occur, both upward and downward.

[0007] Therefore, implant manufacturers also provide so-called sizers. These are then implanted on a trial basis to determine the final implant size more accurately. It may be necessary to try out several trial sizer implants of different sizes until an aesthetically pleasing result is achieved. This then determines the shape and size of the

[0008] Def initivimplantates, which is inserted after removal of the sizer and then remains permanently in the body.

[0009] A sizer is a trial implant with a fixed or adjustable size, which is achieved by filling it with saline solution. It is used to simulate the desired final size during intraoperative placement of definitive silicone implants. It is removed after the size has been determined and replaced with a definitive implant of the simulated size.

[0010] An expander, on the other hand, is an implant of variable size that is needed to stretch the skin. In the case of breast cancer, it can happen that the skin, areola, and the actual mammary gland have to be removed. In these cases, it is not possible to insert an implant of a sufficient size immediately during the primary procedure, as the skin would be too small. Therefore, expanders are surgically inserted into the body. By filling them with saline solution from the outside via a valve, they can gradually stretch the skin over a long period of time (weeks) sufficiently to accommodate an implant of the required size.

[0011] It is possible to use such expanders on other parts of the body than just the chest region and an expander can also be used as a definitive implant and remain in the body permanently.

[0012] Even with a sizer with variable size or an expander the adjustment possibilities are limited, as these are restricted to the essentially radial expansion or contraction of an elastic shell, which causes a change in size that is equally strong in all spatial directions, so that individual peculiarities often cannot be taken into account.

[0013] US 2004 / 0147953 A1 discloses a tissue expansion device with a dome-shaped body adjustable by an actuator for changing the size of an implant. This document also describes an embodiment with several differently aligned expansion dies, which, however, cannot be moved independently of one another, but rather only undergo a completely symmetrical change in shape and whose ends are spaced very far apart.

[0014] The object of the invention is to create an implant with a high degree of adjustability and high stability, so that the desired shape of the body area can be adjusted more precisely - without discontinuities in the process - and the settings made can also be adjusted over time or maintained permanently.

[0015] According to the invention, this is achieved in an implant of the type mentioned at the outset in that the dome-shaped body is formed from two or more dome segments which are essentially separated from one another by gap distances and which can be adjusted in their position and / or orientation independently of one another by the at least one actuator unit in order to control changes in the size and shape of the implant in different areas independently of one another.

[0016] The dome-shaped body is thus divided into two or more dome segments which are adjustable independently of one another. The implant according to the invention is therefore variable in its shape and size, with asymmetrical changes in shape also being possible. After insertion into a surgically created body opening, the implant site, it allows an enlargement or expansion of an overlying body region. The control unit controls the actuator unit or units in such a way that the one or more dome segments whose position and / or orientation are adjustable are brought into a specific position and / or orientation in order to achieve the desired appearance of the body region.

[0017] The implant according to the invention can be used as a sizer and / or as an expander.

[0018] The operator, e.g. a surgeon, can thus adjust the dome segment(s) within the body opening until he or she can see the desired result directly from the outside, in order to then either select and insert a corresponding permanent implant in the case of a sizer or, in the case of an expander, leave the setting as it is or readjust it after some time.

[0019] The dome segment(s) can be, for example, rigid elements that can be extended and retracted linearly and / or pivoted to form the dome-shaped body, which then supports the body region resting on it inside the implant bed or pre-tensions it outwards.

[0020] A further embodiment of the invention may consist in that the at least one actuator unit comprises a central actuator unit and peripheral actuator units, wherein the central actuator unit is arranged in the center of the base plate and the peripheral actuator units are arranged around the central actuator unit.

[0021] The at least one actuator unit can be a drive unit, such as a motor, which causes a linear or pivoting movement of the dome segments.

[0022] The control unit assigned to the respective actuator unit controls, for example, the drive current of the motor or pump or valves. Since the control unit can be implemented electronically and / or in software in any way known to those skilled in the art, it is in no way restricted to a specific position inside or outside the implant according to the invention. Parts of the control unit can be hardware, such as power transistors, or software routines on a computer or a radio telephone, in particular a smartphone. A radio or wired connection or the like can exist between the parts of the control unit.

[0023] By forming two or more independently adjustable dome segments, the number of degrees of freedom can be increased accordingly, so that a change in the position and / or location or extent of the dome segments in different spatial directions can take place independently of each other and thus the adjustable shape of the implant according to the invention can be varied accordingly, whereby adaptation to body areas that deviate greatly from the norm is possible.

[0024] In a further embodiment of the invention, it can be provided that the base plate is circular and that the peripheral actuator units are arranged at equal angular intervals around the central actuator unit, whereby a high degree of rotational symmetry is achieved and relatively uniform loads can be effected.

[0025] According to a further embodiment of the invention, the dome-shaped body as well as the at least one actuator unit and associated parts can be at least partially surrounded by a flexible sheath, whereby all mechanical and electronic components are separated from the surrounding body area, so that particles or liquids cannot penetrate into the body.

[0026] Preferably, medical-technical materials and components known to those skilled in the art are used to provide the implant according to the invention, which are suitable for absorption into an organism and with which a harmful effect on the body is avoided. In this sense, in a further embodiment of the invention, the flexible shell can be made of silicone or another inert, stretchable material in order to enable the highest possible biocompatibility and to prevent rejection reactions by the body. As a medical device, the implant according to the invention is completely surrounded by a shell, which provides a barrier between the device and living tissue.

[0027] The dome segments together span the dome-shaped body. Between the dome segments, there are also gaps with a predeterminable maximum width. The dome segments are not subject to any restrictions in their shape. Flat or curved elements can be used. The maximum gap spacing is dimensioned such that a smooth, rounded transition of the implant between the dome segments is achieved and that no cracks or corners occur in the shape of the implant.

[0028] Preferably, the dome segments may have a curved shape in order to together form the dome-shaped body on which the respective body parts are supported in the inserted state in order to develop the effect of an implant.

[0029] Within the scope of the invention, dome segments of any shape, e.g. spherically curved, can be used to form the dome-shaped body.

[0030] In one embodiment of the invention, it can be provided - without being limited thereto - that the at least two adjustable dome segments comprise at least one curved trapezoidal plate and at least one curved hexagonal plate.

[0031] In order to achieve the purpose of independent controllability of the dome segments, any suitable actuators, such as drive units, e.g. of the electromechanical, hydraulic, pneumatic type or the like, can be used.

[0032] A reliable and space-saving embodiment of the invention can consist in that the one or more adjustable dome segments is / are connected on its / their inner side to the distal end of an associated telescopic rod, which is connected at its proximal end to one of the at least one actuator unit which is mounted on the base plate and with which the respective dome segment and the associated telescopic rod can be adjusted between a retracted position and an extended position in order to vary the shape and size of the implant.

[0033] In addition to the linear movement, further degrees of freedom can be realized, e.g. by pivoting the dome segments, etc.

[0034] Furthermore, in a further embodiment of the invention, it can be provided that the central actuator unit is formed by a central lifting unit for a central one of the telescopic rods for vertical retraction and extension movement, and the further actuator units arranged around the central actuator unit are formed by obliquely oriented peripheral lifting units for further telescopic rods for retraction and extension movement, each at an oblique angle to the base plate. In a further development of the invention, the at least one actuator unit can include an electromechanical, pneumatic, or hydraulic propulsion of controlled cylinders.

[0035] In a further embodiment of the invention, the control unit can be connected to the at least one actuator unit via a cable or a wireless transmission unit.

[0036] In order to achieve a precise adjustment of the position / location or extent of the dome segments or to measure them, each actuator unit can be assigned a sensor unit that records current position data and is connected to the control unit.

[0037] Through electromechanical, pneumatic, or hydraulic propulsion, e.g., controlled cylinders, a targeted change in the shape and size of the implant is possible. A bidirectional connection, for example, via cable, Wi-Fi, or Bluetooth, with a control unit and suitable sensors makes it possible to measure and change all necessary parameters.

[0038] Furthermore, the control unit can be connected to an inventory management database to enable the forwarding of sensor data and the automatic selection of available permanent implants or the display of a suggestion for such implants. Built-in sensors and the control unit can report certain parameters back to an extracorporeal management unit (e.g., a mobile phone). This compares the data with a database, which, taking into account the patient's current inventory of implants, suggests a recommendation for the selection of suitable implants.

[0039] Furthermore, the control unit can be connected to an input and display device.

[0040] The invention will be explained in detail below with reference to the exemplary embodiments shown in the drawings.

[0041] Fig.l is a broken side view of an embodiment of the implant according to the invention;

[0042] Fig.2 and 3 each show an oblique view of the implant according to Fig.1 from above in an extended position;

[0043] Fig.4 an oblique view of the implant according to Fig.l from above in a retracted position.

[0044] Figs. 1, 2, 3 and 4 show an implant whose size can be varied and which can be used as a sizer or as an expander, with a substantially planar base plate 2 which, when the implant is inserted, rests on the breast area, for example. Furthermore, a dome-shaped body 3 is supported on the base plate 2 and is formed from several dome segments 20, 21, 22, 23, 24, 25, 30 which are adjustable in position and separated from one another essentially by gap distances 95 in order to vary the shape and size of the implant. Depending on the position in which the dome segments are placed, the gap distance 95 existing between the adjacent dome segment changes. However, due to the dense arrangement of the dome segments, this gap distance can only reach a predetermined maximum size, so that overall a flowing, rounded shape of the implant without jumps or discontinuities is ensured.

[0045] When comparing the extended position of the dome segments 20, 21, 22, 23, 24, 25, 30 shown in Fig.2 and the retracted position of the dome segments 20, 21, 22, 23, 24, 25, 30 shown in Fig.4, it can be seen that in the extended position (Fig.2) the gap distances 95 are the largest, but the distance between the dome segments is still sufficient to ensure a continuous course of the implant.

[0046] On the base plate 2, actuator units 40, 41, 42, 43, 44, 45, 50 for changing the position / location of the adjustable dome segments 20, 21, 22, 23, 24, 25, 30 and a control unit (not shown) for controlling the actuator units are mounted.

[0047] The base plate 2 is circular but could be provided in any other geometric shape. A flexible silicone sleeve 5 is attached to the outer edge of the base plate 2, partially surrounding the dome-shaped body 3 and the actuator units 20, 21, 22, 23, 24, 25, 30, so that they are hermetically sealed by the flexible sleeve 5 and the base plate 2. The flexible sleeve 5 could be made of any other expandable, inert material; it could also completely enclose the components of the implant according to the invention to prevent particles, liquids, and gases from escaping.

[0048] The adjustable dome segments are formed from several curved trapezoidal plates 20, 21, 22, 23, 24, 25 and a centrally arranged curved hexagonal plate 30, thus spanning the dome-shaped body 3. The number, shape, and size of the dome segments are not subject to any restrictions within the scope of the invention.

[0049] As already explained, the independent mobility of the dome segments 20, 21, 22, 23, 24, 25, 30 can be realized in any manner known to those skilled in the art. In the present embodiment, each of the dome segments 20, 21, 22, 23, 24, 25, 30 is connected on its inner side to the distal end of an associated telescopic rod 71, 72, 73, 74, 75, 76, 80, which is connected at its proximal end to one of the actuator units 40, 41, 42, 43, 44, 45, 50, which are mounted on the base plate 2 and with which the respective dome segment and the associated telescopic rod can be adjusted between a retracted position and an extended position in order to vary the shape and size of the implant.

[0050] The type of drive used to move the coupling segments between their retracted and extended positions can vary. In the present case, a central actuator unit 50 and six peripheral actuator units 40, 41, 42, 43, 44, 45 are provided on the base plate 2, which can be controlled independently of one another. The central actuator unit 50 is arranged at the center of the circular base plate 2, and the six peripheral actuator units 40, 41, 42, 43, 44, 45 are arranged at equal angular intervals around the central actuator unit 50.

[0051] The central actuator unit 50 can be formed by a central lifting unit for a central one of the telescopic rods for vertical retraction and extension movement, and the six actuator units 40, 41, 42, 43, 44, 45 arranged around the central actuator unit 50 can be formed by obliquely oriented peripheral lifting units for further telescopic rods for retraction and extension movement, each at an oblique angle to the base plate. The actuator units can include an electromechanical, pneumatic, or hydraulic propulsion of controlled cylinders or the like, but are not limited to these types of actuation.

[0052] In addition to the lifting movement, the actuator units could also perform a pivoting movement of the dome segments in order to change their position or orientation.

[0053] Furthermore, each of the actuator units 40, 41, 42, 43, 44, 45, 50 is assigned a sensor unit that records current position and / or attitude data and is connected to the respective control unit (not shown). The control unit can be connected to the actuator units via a cable or a wireless transmission unit.

[0054] The adjustable dome segments 20, 21, 22, 23, 24, 25, 30 could also be formed by inflatable cushions which are adjustable in their extension.

[0055] The control unit can be connected to a merchandise management database and is also connected to an input and display device.

Claims

PATENT CLAIMS 1. Implant (1) which is variable in size, wherein the Implant comprising: a base plate (2), a dome-shaped body (3) supported on the base plate (2) to change the extension of the implant; at least one actuator unit (40, 41, 42, 43, 44, 45, 50) for changing the position of the dome-shaped body (3), a control unit for controlling the at least one actuator unit (40, 41, 42, 43, 44, 45, 50), characterized in that the dome-shaped body (3) is formed from two or more dome segments (20, 21, 22, 23, 24, 25, 30) which are essentially separated from one another by gap distances (95), which can be adjusted independently of one another in their position and / or orientation by the at least one actuator unit (40, 41, 42, 43, 44, 45, 50) in order to control the changes in the size and shape of the implant in different areas independently of one another.

2. Implant according to claim 1, characterized in that the at least one actuator unit comprises a central actuator unit (50) and peripheral actuator units (41, 42, 43, 44, 45), wherein the central actuator unit (50) is arranged in the middle of the base plate (2) and the peripheral actuator units (41, 42, 43, 44, 45) are arranged around the central actuator unit (50).

3. Implant according to claim 1 or 2, characterized in that the base plate (2) is circular and that the peripheral actuator units (41, 42, 43, 44, 45) are arranged at equal angular intervals around the central actuator unit (50).

4. Implant according to claim 1, 2 or 3, characterized in that the two or more adjustable coupling segments (20, 21, 22, 23, 24, 25, 30) are connected on their inner side to the distal end of an associated telescopic rod (71, 72, 73, 74, 75, 76, 80), which is connected at its proximal end to one of the at least one actuator unit (40, 41, 42, 43, 44, 45, 50) which is mounted on the base plate (2) and with which the respective coupling segment (20, 21, 22, 23, 24, 25, 30) and the associated telescopic rod (71, 72, 73, 74, 75, 76, 80) between a retracted position and extended Position is adjustable to vary the shape and size of the implant (1).

5. Implant according to one of the preceding claims, characterized in that the dome-shaped body (3), the at least one actuator unit (40, 41, 42, 43, 44, 45, 50) and associated parts are at least partially surrounded by a flexible sheath (5).

6. Implant according to claim 5, characterized in that the flexible sheath is made of silicone or a similar stretchable material.

7. Implant according to one of claims 1 to 6, characterized in that the one or more adjustable coupling segments (20, 21, 22, 23, 24, 25, 30) have at least one curved trapezoidal plate and at least one curved hexagonal plate.

8. Implant according to claims 1 to 7, characterized in that the one or more adjustable coupling segments (20, 21, 22, 23, 24, 25, 30) is / are connected on its / their inner side to the distal end of an associated telescopic rod (71, 72, 73, 74, 75, 76, 80), which is / are connected at its proximal end to one of the at least one actuator unit (40, 41, 42, 43, 44, 45, 50) which is mounted on the base plate (2) and with which the respective coupling segment (20, 21, 22, 23, 24, 25, 30) and the associated telescopic rod (71, 72, 73, 74, 75, 76, 80) can be moved between a retracted position and extended position is adjustable to vary the shape and size of the implant (1).

9. Implant according to one of claims 2 to 8, characterized in that the central actuator unit (50) is formed by a central lifting unit for a central one of the telescopic rods for vertical retraction and extension movement and the further actuator units (41, 42, 43, 44, 45) arranged around the central actuator unit (50) are formed by obliquely oriented peripheral lifting units for further telescopic rods for retraction and extension movement, each at an oblique angle to the base plate (2).

10. Implant according to one of claims 1 to 9, characterized in that the at least one actuator unit (41, 42, 43, 44, 45, 50) includes an electromechanical, pneumatic or hydraulic propulsion of controlled cylinders.

11. Implant according to one of the preceding claims, characterized in that the control unit is connected to the at least one actuator unit (41, 42, 43, 44, 45, 50) via a cable or a wireless transmission unit.

12. Implant according to one of claims 1 to 11, characterized in that each of the at least one actuator unit (41, 42, 43, 44, 45, 50) is assigned a sensor unit which detects current position data and which is connected to the control unit.

13. Implant according to one of claims 1 to 12, characterized in that the control unit can be connected to a merchandise management database.

14. Implant according to one of claims 1 to 13, characterized in that the control unit is connected to an input and display device.

15. Use of an implant according to one of claims 1 to 14 as a sizer for temporary implantation in a human body.

16. Use of an implant according to one of claims 1 to 14 as an expander for temporary or permanent implantation in a human body.

Images