Patent Publication Number: US-2019192280-A1

Title: System for Adjusting the Shape of a Breast Implant

Description:
FIELD OF THE INVENTION 
     The present invention relates generally to medical and aesthetic implants, and particularly to methods and systems for shaping a breast implant. 
     BACKGROUND OF THE INVENTION 
     Various types of implants containing filling material, such as breast implants, are known in the art. 
     For example, U.S. Patent Application Publication 2010/0114311 describes a valve assembly for a mammary implant having a chamber defined by a flexible membrane. The implant includes a valve and a flexible filling tube, which includes a relatively short semi-rigid tubular structure that extends into the chamber and defines a passageway. 
     U.S. Pat. No. 5,456,716 describes an elastomeric valve assembly designed for use in an inflatable surgical implant to provide a self-sealing means for filling the implant. The valve assembly incorporates vulcanized elastomeric strips molded between two larger silicone sheets, wherein the strips form a collapsible self-sealing channel through which a fill needle may be inserted through slits in the strips and sheets. 
     SUMMARY OF THE INVENTION 
     An embodiment of the present invention that is described herein provides an implant including a hollow container and a valve. The hollow container is configured to be implanted in an organ of a patient, and to contain filling material. The valve has first and second position sensors coupled thereto, and is configured to allow passage of the filling material to and from the container, so as to vary a volume of the implant. 
     In some embodiments, the valve is configured to allow passage of a syringe therethrough, so as to allow the passage of the filling material to and from the container using the syringe. In other embodiments, the first and second position sensors are configured to produce first and second signals indicative of first and second respective positions of the first and second sensors in a coordinate system of a position tracking system. In yet other embodiments, the hollow container includes an inner hollow container and an outer hollow container disposed around the inner hollow container. 
     In an embodiment, the inner and outer hollow containers are coupled to the valve at first and second respective positions located at predefined respective first and second distances from the first and second position sensors. In another embodiment, the valve is configured to seal the outer hollow container. In yet another embodiment, the valve is configured to (i) allow passage of a syringe therethrough, so as to allow the passage of the filling material to and from the inner hollow container, and (ii) when no syringe is being passed therethrough, block the passage of the filling material through the inner hollow container. 
     In some embodiments, the hollow container includes a flexible shell configured to contain the filling material. In other embodiments, the filling material includes at least one of silicone gel and saline solution. In yet other embodiments, the implant includes circuitry, which is configured to receive, from the first and second position sensors, signals indicative of first and second positions of the first and second position sensors, and to transmit an output signal indicative of the first and second positions. 
     In an embodiment, the circuitry is configured to wirelessly receive electrical power from a device external to the patient. In another embodiment, the implant includes a power source disposed inside the hollow container and configured to be charged wirelessly from a device external to the patient and to provide electrical power to the first and second position sensors. 
     There is additionally provided, in accordance with an embodiment of the present invention, a system for shaping an implant, the system includes a receiver and a processor. The receiver is configured to receive (i) a first signal indicative of respective positions of one or more position sensors coupled to a valve, which allows passage of filling material to and from the implant, and (ii) a second signal indicative of a position of a position sensor coupled to a syringe that is used, when inserted into the valve, for injecting or extracting the filling material. The processor is configured to calculate and display to a user, based on the first signal and the second signal, an indication of alignment between the syringe and the valve. 
     In some embodiments, the receiver is configured to receive at least one of the first and second signals wirelessly. In other embodiments, the processor is configured to detect that a misalignment between the syringe and the valve is above a predefined threshold level, and in response to issue a warning. 
     There is further provided, in accordance with an embodiment of the present invention, a method for shaping an implant, the method includes receiving a first signal indicative of respective positions of one or more position sensors coupled to a valve, which allows passage of filling material to and from the implant. A second signal, which is received, is indicative of a position of a position sensor coupled to a syringe that is used, when inserted into the valve, for injecting or extracting the filling material. Based on the first signal and the second signal, an indication of alignment between the syringe and the valve is calculated and displayed to a user. 
     The present invention will be more fully understood from the following detailed description of the embodiments thereof, taken together with the drawings in which: 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic, pictorial illustration of a system for shaping a breast implant, in accordance with embodiments of the present invention; 
         FIG. 2  is a sectional isometric-view of a breast implant, in accordance with embodiments of the present invention; 
         FIG. 3  is a sectional side-view of a valve of a breast implant, in accordance with embodiments of the present invention; and 
         FIG. 4  is a flow chart that schematically illustrates a method for shaping an implanted breast implant, in accordance with an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
     Overview 
     Breast implants are prostheses, typically used for reconstructing a human breast after excision, or for shaping the size and contour of breasts in cosmetic applications. A breast implant typically comprises a filling material, also known as implantable material, such as silicone gel that conforms to the texture of natural tissue of the breast. 
     A typical breast implant further comprises a biocompatible shell adapted to encapsulate the implantable material and to be implanted in the human breast so as to resemble the texture of the breast tissue. The shell typically comprises a soft and flexible material that has no physical or chemical interactions with the surrounding tissue. In some cases, there might be a need or desire to adjust the shape, i.e., the size and contour of the breast implant after the implantation. 
     Embodiments of the present invention that are described herein provide adjustable-shape breast implants, and systems for adjusting the shape of an implanted breast implant. In some embodiments, a breast implant comprises inner and outer hollow shells that are adapted to contain a suitable filling material. The outer shell is typically filled with silicone gel, whereas the inner shell is filled with a saline solution, referred to herein as “filling material (FM)”. 
     In some embodiments, the implant comprises a valve adapted to (i) seal the outer shell and (ii) allow passage of a syringe configured to inject or extract FM to or from the inner shell, so as to shape (e.g., vary the volume of) the breast implant. 
     In some embodiments, the valve comprises outer and inner fasteners located, respectively, at the outer and inner ends of the valve. The outer fastener is coupled to the outer shell of the implant, and the inner fastener is coupled to the inner shell of the implant. 
     In some embodiments, two position sensors of a position tracking system are coupled to the valve. An outer position sensor is coupled adjacent to the outer fastener and an inner position sensor is coupled adjacent to the inner fastener. 
     In some embodiments, a user (the patient or another person) adjusts the shape of the breast implant by inserting a syringe into the valve, so as to exchange (e.g., inject and/or extract) some FM with the inner shell. In some embodiments, an additional position sensor, referred to herein as a syringe position sensor, is coupled to the distal end of the syringe. 
     In some embodiments, the system comprises a processor and an interface. The interface is configured to receive signals indicative of the positions of the outer and inner position sensors of the valve, and of the position of the syringe position sensor. The positions of the sensors are measured in the coordinate system of the position tracking system. In an embodiment, the processor is configured to calculate, based on the received signals, an indication of the alignment between the syringe and the valve, and to display the indication on a suitable display device coupled to the processor. 
     In some embodiments, the user may navigate the distal end of the syringe, through the valve and into the inner shell, based on the displayed alignment indication. Subsequently, the user may inject FM to, or extract FM from, the inner shell so as to vary the size and contour of the breast implant. 
     In the context of the present disclosure and in the claims, the terms “shape,” “size” and “volume” are used interchangeably and refer to the shape of the breast implant implanted in the breast of the patient. 
     The disclosed techniques enable controlling the shape of the breast implant using a procedure that may be carried out by the patient herself, e.g., at home, or by a physician or a nurse at a medical facility or at any other suitable location. 
     System Description 
       FIG. 1  is a schematic, pictorial illustration of a system  90  for shaping a breast implant  20  implanted in a breast of a patient  11 , in accordance with embodiments of the present invention. In some embodiments, system  90  comprises implant  20 , which is a prosthesis having an adjustable-shape implanted in the patient breast having natural tissue  28  surrounding implant  20 . The implanted prosthesis thus shapes the size and contour of the patient breast. 
     In some embodiments, implant  20  comprises a hollow outer shell  24  configured to encapsulate one or more types of soft filling material that resemble the texture of tissue  28 . In some embodiments, shell  24  physically isolates between the filling material and tissue  28 . The filling material is adapted to shape the size and contour of breast implant  20 . 
     In the context of the present disclosure and in the claims, the terms “shell” and “container” are used interchangeably and refer to a hollow, typically flexible, implantable prosthesis configured to contain any suitable filling material, so as to shape the patient breast. 
     In some embodiments, implant  20  comprises a valve  22 , which is configured to allow passage of the filling material to and from implant  20 , so as to control the volume of implant  20 . 
     In some embodiments, implant  20  further comprises a battery  70  or any other suitable power source, such as electrical circuitry or a capacitor (not shown) configured to be charged wirelessly. In some embodiments, implant  20  comprises communications circuitry  72 , which is configured to wirelessly transmit radio-frequency (RF) signals  80  to a computer  16 . In some embodiments, RF signals  80  modulate current levels sensed by one or more position sensors that are fitted on valve  22  and shown in  FIG. 3  below. 
     In some embodiments, system  90  comprises a syringe  26 , which is configured to exchange (e.g., inject to implant  20 , or extract from implant  20 ) any suitable fluid of filling material (FM)  50 , such as a saline solution, with an internal volume of implant  20 . In some embodiments, syringe  26  comprises a needle  30  configured to be inserted, through tissue  28  and valve  22 , into implant  20  so as to inject FM  50  to, or to extract FM  50  from, implant  20 . 
     In some embodiments, syringe  26  comprises a barrel  17 , a plunger  15 , and a flexible filling tube  32  coupled between barrel  17  and needle  30 . Barrel  17  is adapted to contain FM  50 , and plunger  15  is configured to inject FM  50  to, or extract FM  50  from, implant  20 , via flexible filling tube  32 . 
     In some embodiments, a position sensor (shown in  FIG. 3  below) of the position tracking system is coupled to the distal tip of needle  30 , and is configured to send, via a cable  46 , electrical signals indicative of the position of the distal tip of needle  30  in the coordinate system of the position tracking system. 
     In some embodiments, the position of valve  22  and the distal tip of needle  30  in the heart cavity are typically measured using position sensing techniques. This method of position sensing is implemented, for example, in the CARTO™ system, produced by Biosense Webster Inc. (Irvine, Calif.) and is described in detail in U.S. Pat. Nos. 5,391,199, 6,690,963, 6,484,118, 6,239,724, 6,618,612 and 6,332,089, in PCT Patent Publication WO 96/05768, and in U.S. Patent Application Publications 2002/0065455 A1, 2003/0120150 A1 and 2004/0068178 A1, whose disclosures are all incorporated herein by reference. 
     In some embodiments, computer  16  comprises a driver circuit  41 , which drives, via a cable  27 , magnetic field generators (not shown) of a location pad  36  placed at a known position external to patient  11  lying on a table  29 , e.g., below the patient torso. 
     In some embodiments, computer  16  comprises a processor  19  having suitable front end and interface circuits for receiving signals from circuitry  72  and needle  30 , and for displaying, on a display  18 , information of components of system  90 , as will be described below. 
     In some embodiments, processor  19  typically comprises a general-purpose processor, which is programmed in software to carry out the functions described herein. The software may be downloaded to the computer in electronic form, over a network, for example, or it may, alternatively or additionally, be provided and/or stored on non-transitory tangible media, such as magnetic, optical, or electronic memory. 
     Implant  20 , valve  22  and syringe  26  are depicted in detail in  FIGS. 2 and 3  below. 
     In some embodiments, the injection and extraction of FM  50  may be carried out by patient  11  herself, e.g., at home, or by a physician or a nurse, e.g., at a medical facility. In the example of  FIG. 1 , patient  11  conducts the procedure at home, e.g., by inserting needle  30  using one hand, and injecting FM  50  using the other hand. We generally assume that patient  11  inserts needle  30  using her left hand  13 A, and injects FM  50  using her right hand  13 B (as shown in  FIG. 1 ) but patient  11  may alternatively insert needle  30  using her right hand  13 B and inject FM  50  using her left hand  13 A. In other embodiments, patient  11  may insert the syringe and inject FM  50  to, or extract FM  50  FROM, IMPLANT  20 , in any other suitable manner. 
     In some embodiments, processor  19  is coupled to display  18  via a cable  29 . The processor is configured to display on display  18 , markers  10  and  12  indicating the position of the two position sensors coupled to valve  22 , and a marker  14 , indicating the position of the distal tip of needle  30 . In some embodiments, markers  10 ,  12  and  14  provide patient  11  with an indication of an alignment level between valve  22  and the distal tip of syringe  30 . In some embodiments, processor  19  is configured to display markers  10 ,  12  and  14  in a common coordinate system so that the user is able to evaluate the positions of the respective sensors relative to one another. 
     In other embodiments, markers  10 ,  12  and  14  may be displayed on a hand-held device (not shown), such as a mobile phone or any other device that may receive the relative positions of markers  10 ,  12  and  14  wirelessly, or via a wire. 
     In some embodiments, location pad  36  may be located under the torso of patient  11 , as shown in  FIG. 1 . In alternative embodiments, patient  11  may hold location pad  36  below her implanted breast during the insertion of needle  30  into implant  20 , and subsequently, may inject FM  50  into implant  20 . 
     In some embodiments, patient  11  may use both hands  13 A and  13 B to extract some FM  50  from implant  20 , for example, by holding barrel  17  using one hand, and pulling plunger  15  using the other hand. 
     The configuration of system  90  shown in  FIG. 1  is an example configuration that is shown purely for the sake of conceptual clarity. In alternative embodiments, any other suitable configuration can be used. For example, any other suitable power source, such as an alternating current (AC) voltage source may be used instead of battery  70 . 
     In some embodiments, circuitry  72  is configured to charge battery  70  (or any other device, such as a capacitor) using RF signals (not shown) received wirelessly from an external unit (not shown) so that battery  70  may power circuitry  72  and the position sensors of valve  22 . 
     Adjusting the Shape of a Breast Implant 
       FIG. 2  is a sectional isometric-view of breast implant  20 , in accordance with embodiments of the present invention. In some embodiments, breast implant  20  comprises a flexible inner shell  34  and flexible outer shell  24  coupled to one another by valve  22 . In some embodiments, the arrangement of shells  24  and  34  forms an outer volume between outer shell  34  and inner shell  34 . The outer shell is sealed by valve  22  and the outer volume is filled with a soft filling material that resembles the texture of tissue  28 , such as silicone gel  52 . 
     In some embodiments, an inner volume filled with FM  50  is formed within inner shell  34 . As described above, the inner volume may be filled with any suitable filling material, such as a saline solution. In this configuration, the amount of material filling the inner volume within shell  34  determines the size and shape of implant  20 . 
     In some embodiments, valve  22  is configured to allow passage of FM  50 , via needle  30 , to and from inner shell  34 , so as to control the amount of FM  50  within inner volume of implant  20 . Note that in this configuration, gel  52  is sealed within the outer volume of implant  20 . In an embodiment, FM  50  can be injected to, or extracted from, the inner volume only when the distal end of needle  30  is inserted through valve  22 , into the inner volume of implant  20 . 
     In some embodiment, valve  22  has a funnel-shaped outer edge (shown in  FIG. 2 ) so as to lead needle  30  conveniently into valve  22 . 
     In some embodiments, battery  70  is electrically connected, via wires  25 , to the position sensors (shown in  FIG. 3  below) of valve  22 . In an embodiment, circuitry  72  is electrically coupled to battery  70  using any suitable coupling or packaging technique. 
     In some embodiments, battery  70  and circuitry  72  are disposed within the outer volume of implant  20 , for example, coupled to an outer surface of inner shell  34  at close proximity to valve  22 , as shown in  FIG. 2 . 
     In other embodiments, battery  70  and circuitry  72  may be disposed at any other suitable location in implant  20 , such as within the internal volume of implant  20 . Note that battery  70  and circuitry  72  may be packaged together (e.g., to reduce their combined volume) or disposed as two separate components at two different respective locations within implant  20 . 
     The configuration of valve  22 , battery  70  and circuitry  72  are depicted by way of example, and any other suitable configurations can also be used to comply with medical, aesthetic and/or technical requirements. For example, disposing circuitry  72  as close as possible to outer shell  24  may reduce the operational power consumption of circuitry  72  by reducing the thickness of the medium (e.g., gel  52 ) through which RF signals  80  traverse between circuitry  72  and computer  16 . However, it is also desired to minimize the length of wires  25  and to maintain the uniform external texture of implant  20 , so that in another configuration, battery  70  and circuitry  72  may be physically coupled to valve  22 . 
       FIG. 3  is a sectional side-view of valve  22 , in accordance with embodiments of the present invention. In some embodiments, valve  22  comprises a funnel-shaped outer fastener  38 , which is configured to fasten outer shell  24  to valve  22 . As described in  FIG. 2  above, the funnel shape of fastener  38  assists in leading a distal end  60  of needle  30  into valve  22 . 
     In some embodiments, valve  22  comprises an inner fastener  39 , which is configured to fasten inner shell  34  to valve  22 . 
     In some embodiments, valve  22  comprises an outer housing  43  and an inner housing  45 , which are configured to contain an outer position sensor  40  and an inner position sensor  42 , respectively. In some embodiments, position sensors  40  and  42  may be single axis sensors (SAS), each of them made from a single coil. In alternative embodiments, at least one sensor among sensors  40  and  42  may comprise multiple coils, e.g., three coils, so as to form a three-axis sensor. This configuration may provide the user of system  90  with multi-dimensional positioning, but typically consumes more (e.g., triple) power from battery  70 . 
     In some embodiments, battery  70  and circuitry  72  are coupled to one another and attached to inner shell  34 . Note that wires  25  are electrically connecting between each of sensors  40  and  42 , and battery  70 . In an embodiment, wires  25  are further configured to conduct signals, indicative of the position of position sensors  40  and  42 , to circuitry  72 . In another embodiment, sensors  40  and  42  may be electrically connected to circuitry  72  using another set of electrical wires (not shown). 
     Reference is now made to an inset  58 . In some embodiments, distal end  60  of needle  30  comprises an outer tube  56  disposed (e.g., coaxially) around an inner tube  54 . In an embodiment, outer tube  56  is configured to puncture the skin and tissue  28  of patient (or any soft container) so as to enable contact between inner tube  54  and valve  22 . In another embodiment, the puncturing of the patient skin may be carried out using a puncturing shaft threaded through inner tube  54  for puncturing and retracted out of needle  30  after puncturing, or using any other suitable puncturing technique. 
     In some embodiments, a single coil is wrapped around the distal tip of inner tube  54 , so as to serve as a single-axis position sensor  44 . In some embodiments, sensor  44  is electrically coupled to processor  19 , via cable  46  that is threaded along needle  30  between inner tube  54  and outer tube  56 . In other embodiments, cable  46  may be printed, for example, on the outer surface of inner tube  54 . 
     In these embodiments, cable  46  may comprise multiple wires, such that one or more wires provide power supply from computer  16  to sensor  44 , and one or more other wires of cable  46  may conduct, between sensor  44  and processor  19 , electrical signals indicative of the position of sensor  44 . 
     In other embodiments, position sensor  44  may comprise multiple (e.g., three) coils so as to form a three-axis position sensor (TAS). In these embodiments, power consumption is received from computer  16  so that power consumption by sensor  44  is not limiting the operation of system  90 . In this configuration the TAS (not shown) is typically disposed between tubes  54  and  56 , so as to enable free passage of FM  50  through tube  54 . 
     In these embodiments, sensor  44  may comprise a flat multi-axis sensor (e.g., TAS) printed, for example, on a flexible printed circuit board (PCB) wrapped around inner tube  54 . In an embodiment, such a TAS is depicted, for example, in U.S. patent application Ser. No. 15/433,072, filed Feb. 15, 2017, which is incorporated herein by reference. 
     Reference is now made to  FIG. 1 . In some embodiments, during the injection procedure, a receiver (e.g., interface circuits) of processor  19 , is configured to receive from circuitry  72 , signals  80  indicative of the position of sensors  40  and  42  coupled to valve  22 , and from needle  30  signals indicative of the position of sensor  44  coupled to distal end  60 . 
     In these embodiments, processor  19  is configured to display to patient  11  (or to any other user of system  90 ) on display  18 , markers  10  and  12 , which are indicative of the respective positions of the inner and outer housings of valve  22 . In some embodiments, patient  11  may navigate needle  30  through valve  22 , based on the displayed alignment between markers  10  and  12  indicating the position of valve  22 , and marker  14  indicating the position of distal end  60 . 
     In the example of  FIG. 1 , marker  14  indicates that distal end  60  of needle  30  passed through valve  22 , so that patient  11  may stop the insertion of needle  30  and inject FM  50  into the inner volume of implant  20 . 
     In some embodiments, processor  19  is configured to issue a warning signal in case the distance between sensors  14  and  12 , or the distance between sensor  14  and  10 , exceed a predefined distance. This warning signal indicates to the operator of system  90  (e.g., patient  11 ) that distal end  60  is either not inserted into valve  22  (sensed by exceeded distance between sensors  10  and  14 ), or inserted too deep into the internal volume of shell  24  (sensed by exceeded distance between sensors  12  and  14 ), thereby risking a puncture of shell  24  by needle  30 . 
     In other embodiments, an RF transmitter (not shown) may be coupled to needle  60  and electrically coupled to computer  16 , or to any external power source. In these embodiments, the RF transmitter is configured to wirelessly charge battery  70  (or the capacitor described above) with electrical power, so that battery  70  (or the capacitor) may power circuitry  72  and position sensors  40  and  42  of valve  22 . In an embodiment, the RF transmitter may be coupled to the distal end of inner tube  54  and may receive power via cable  46  or via a dedicated cable coupled to computer  16  or to any other suitable external power source. 
       FIG. 4  is a flow chart that schematically illustrates a method for shaping breast implant  20 , in accordance with an embodiment of the present invention. 
     The method begins with patient  11 , or any other user of system  90 , inserting needle  30  into the breast of patient  11 , at a needle insertion step  100 . In some embodiments, position sensor  44  is coupled to needle  30  of syringe  26 , which is configured to exchange FM  50  between barrel  17  and the internal volume of implanted implant  20 . 
     In some embodiments, patient  11  may have location pad  36  placed at a known position external to her body, e.g., below her torso, as depicted in  FIG. 1  above. In other embodiments, during the insertion of needle  30  into her implanted breast, patient  11  may hold location pad  36  below her implanted breast, e.g., using one of her hands, and insert needle  30  using her other hand. In these embodiments, patient  11  may sit or stand so as to enable the positioning of location pad  36  below her implanted breast. 
     At a markers identification step  102 , patient  11  identifies on display  18 , markers  10  and  12  indicating respective positions of outer housing  43  and inner housing  45  of valve  22 , and further identifies marker  14  indicative of the position of distal end  60 . 
     At a navigation step  104 , based on the locations of markers  10 ,  12  and  14 , patient  11  navigates distal end  60  to pass, via valve  22 , through outer shell  24  and inner shell  34  of implant  20 , so as to insert distal end  60  into the inner volume of implant  20 . In some embodiments, navigation step  104  is concluded after patient  11  verifies, on display  18 , that distal end  60  is positioned at the inner volume of implant  20 . 
     At an injection step  106 , patient  11  injects FM  50  from barrel  17  into the inner volume of implant  20 , so as to increase the volume of implant  20 . In some embodiments, after injecting FM  50  into implant  20 , patient  11  may check the size of her implanted breast. Based on the volume of the implanted breast, patient  11  may inject additional FM  50  into implant  20 , or alternatively, may extract some FM  50  from implant  20  into barrel  17 , so as to reduce the volume of the implanted breast. 
     At a needle extraction step  108 , after obtaining the desired volume of the implanted breast, patient may retract needle  30  out of valve  22  while tracking the position of marker  14  relative to the positions of markers  10  and  12 , and may conclude the method after retracting needle  30  out of her breast. 
     As described above, the method depicted in  FIG. 4  may be carried out by patient  11  herself at home, or alternatively, may be carried out by a physician or a nurse at a clinical facility. 
     Although the embodiments described herein mainly address breast implants, the methods and systems described herein can also be used in other applications, such as in any shape-controlled implantable device. 
     It will thus be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art. Documents incorporated by reference in the present patent application are to be considered an integral part of the application except that to the extent any terms are defined in these incorporated documents in a manner that conflicts with the definitions made explicitly or implicitly in the present specification, only the definitions in the present specification should be considered.