Abstract
A tissue expansion system includes an expandable bladder for placement beneath the skin corresponding to a tissue to be expanded, a fluid source, a pump coupled to both the fluid source and the expandable bladder to deliver inflation medium thereto, a controller for the pump, a pressure sensor for monitoring pressure within the expandable bladder and informing the action of the controller, and a carrier for holding at least the fluid source, pump, and controller. The carrier is wearable as a bra or form-fitting vest and is shaped to mimic the appearance of natural breasts for the patient. The fluid source can have an outward facing surface that is relatively rigid to maintain a curved shape mimicking that of natural breast(s). The inward facing surface of the fluid source may be flexible to conform to the shape of the underlying skin and tissue as it is expanded.
Claims
1. A system for expanding tissue, said system comprising: (a) an expandable bladder adapted to be located beneath a region of skin to be expanded; (b) a pump adapted to be connected to a source of inflation medium and to deliver said inflation medium to the expandable bladder; and (c) a portable carrier configured to hold one or more of the source of inflation medium and the pump, wherein the portable carrier is adapted to be worn by a patient.
2. A system as in claim 1, wherein the portable carrier is configured to hold both the source of inflation medium and the pump.
3. A system as in claim 1, wherein the portable carrier comprises one or more pouches for holding the one or more of the source of inflation medium and the pump.
4. A system as in claim 1, further comprising: (a) a pressure sensor adapted to monitor a pressure within the expandable bladder on a substantially continuous basis; and (b) a controller which receives pressure data from the pressure sensor.
5. A system as in claim 4, wherein the controller is configured to control the pump to deliver the inflation medium to the expandable bladder when the pressure within the expandable bladder falls below a lower threshold value.
6. A system as in claim 4, wherein the controller is configured to control the pump to deliver the inflation medium to the expandable bladder until a predetermined volume of the inflation medium is delivered to the expandable bladder.
7. A system as in claim 4, wherein the controller is programmable.
8. A system as in claim 4, wherein the controller is configured to control the pump to deliver the inflation medium, terminate delivery of the inflation medium, and/or resume delivery of the inflation medium after a predetermined interval.
9. A system as in claim 8, wherein the predetermined interval is at least one hour.
10. A system as in claim 4, wherein the controller is programmed to deliver the inflation medium until the pressure within the expandable bladder reaches an upper threshold value.
11. A system as in claim 10, wherein the upper threshold level is in the range from about 5 mmHg to about 35 mmHg.
12. A system as in claim 4, wherein the controller is programmed to stop delivering the inflation medium after a target total volume of inflation medium has been delivered to the patient.
13. A system as in claim 12, wherein the target total volume of inflation medium is in the range from about 150 cc to about 800 cc.
14. A system as in claim 13, wherein the target total volume of inflation medium is in the range from about 200 cc to about 600 cc.
15. A system as in claim 4, wherein the portable carrier comprises a pouch for holding the controller.
16. A system as in claim 15, wherein the pouch is located on a lateral side of the portable carrier.
17. A system as in claim 4, wherein the controller is configured to receive an activation device for activating operation of the pump.
18. A system as in claim 17, wherein the activation device comprises a subscriber identification module (SIM) card.
19. A system as in claim 17, wherein the activation device is configured to enable operation of the pump for a prescribed duration after being received by the controller.
20. A system as in claim 19, wherein the prescribed duration is about 1 day, about 2 days, about 1 week, about 2 weeks, about 1 month, or about 3 months.
21. A system as in claim 4, wherein the pump and the controller are disposed with the same housing.
22. A system as in claim 1, wherein the pump comprises a syringe pump.
23. A system as in claim 1, wherein the pump comprises a peristaltic pump.
24. A system as in claim 1, wherein the portable carrier comprises a bra-like jacket, vest, a backpack, or a belt.
25. A system as in claim 24, wherein the bra-like jacket is shaped to mimic natural breasts.
26. A system as in claim 1, wherein the expandable bladder is configured to be placed in a subpectoral pocket of the patient following a mastectomy.
27. A system as in claim 26, wherein the expandable bladder is initially inflated with a volume of saline in the range from about 50 cc to about 100 cc.
28. A system as in claim 1, wherein the inflation medium comprises saline.
29. A system as in claim 1, further comprising the source of the inflation medium.
30. A system as in claim 29, wherein the source of the inflation medium is housed within the portable carrier.
31. A system as in claim 29, wherein the source of inflation medium is at least partially shaped to mimic the shape of one or more natural breasts.
32. A system as in claim 29, wherein the portable carrier comprises a pouch for holding the source of inflation medium.
33. A system as in claim 32, wherein the pouch is located on a lateral side of the portable carrier.
34. A system as in claim 1, further comprising an activation device for activating operation of the pump.
35. A system as in claim 34, wherein the activation device comprises a subscriber identification module (SIM) card.
36. A system as in claim 34, wherein the activation device is configured to enable operation of the pump for a prescribed duration after being received by the controller.
37. A system as in claim 36, wherein the prescribed duration is about 1 day, about 2 days, about 1 week, about 2 weeks, about 1 month, or about 3 months.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure may be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the accompanying drawings of which:
[0040] FIG. 1 is a block diagram illustrating the system components of the systems of the present disclosure.
[0041] FIG. 2 illustrates a vest adapted to carry certain system components used with an implantable inflatable bladder according to the present disclosure.
[0042] FIG. 3 is a block flow diagram illustrating the system components of an exemplary system constructed in accordance with the principles of the present disclosure.
[0043] FIG. 4 is a perspective, partially disassembled view of a driver assembly which forms a portion of the exemplary system of FIG. 3.
[0044] FIGS. 5A and 5B are front and rear views of the driver assembly of FIG. 3.
[0045] FIGS. 6A and 6B are detailed views taken along the line 6A-6A and line 6B-6B of FIG. 5B.
[0046] FIG. 7 is an exploded view of the exemplary system of the present disclosure showing the individual system components.
[0047] FIG. 8 is a logic diagram illustrating an exemplary operation protocol for the systems of the present disclosure.
[0048] FIG. 9A illustrates an embodiment of a wearable device adapted to carry components of the system used with an implantable inflatable bladder according to the present disclosure.
[0049] FIG. 9B is a schematic diagram of the device of FIG. 9A.
[0050] FIG. 10 illustrates another embodiment of a wearable device adapted to carry components of the system used with an implantable inflatable bladder according to the present disclosure.
[0051] FIG. 11A illustrates an exemplary front depiction of the device of FIG. 10 being worn by a user.
[0052] FIG. 11B illustrates an exemplary side depiction of the device of FIG. 10 being worn by a user.
[0053] FIG. 12A illustrates an exemplary depiction of a pump and controller housing for an embodiment disclosed herein.
[0054] FIG. 12B illustrates a top view of the pump and controller housing from FIG. 12A.
DETAILED DESCRIPTION
[0055] Referring to FIG. 1, a system 10 constructed in accordance with the principles of the present disclosure comprises a pump 12, a controller 14, and an inflatable bladder 16 connected to the pump by connecting tube 18. A pressure sensor 20 is connected to the connecting tube 18 (directly or indirectly) so that it may sense a static pressure within the inflation bladder 16. The pressure sensor is also connected to the controller 14 to provide a continuous realtime or periodic reading of the pressure in the bladder to the controller. The controller 14 typically comprises a digital microprocessor which has been programmed by conventional means to control the pump 12 as described above. A fluid supply 22, typically comprising an incompressible liquid such as saline, is attached to an input port of pump 12 so that it may be, in turn, be pumped to the inflatable bladder 16. The fluid supply typically has a port 24 to allow refilling of the supply with the desired fluid. Most portions of these system 10 may be maintained externally to the patient, as shown above the broken line in FIG. 1, while the inflatable bladder 16 and a portion of the connecting tube 18 may be implanted in the patient (below broken line). Typically, the connecting tube 18 may be transcutaneously placed through the patient’s skin and have a connecting end adapted for removable connection to the pump. Alternatively, the inflatable bladder may be connected through a connection port which lies substantially at the patient’s skin just beyond the transcutaneous insertion point. The corresponding portion of the tube may then be connected and disconnected from the pump as desired. Further inflation controllers that may be used with the system 10 are described in U.S. Pat. Application Nos. 15/147,481, filed on May 5, 2016 and 14/468,908, filed Aug. 26, 2014 and now issued as U.S. Pat. No. 9,393,390 on Jul. 19, 2016, the full disclosures of which are incorporated herein by reference.
[0056] As illustrated in FIG. 2, the external system components of the system 10 may be mounted on a patient-wearable support, such as vest 30. The vest 30 may have the general layout of a vest garment including armholes 32, and may be further provided with the system components mounted on an interior and/or exterior surface thereof. As shown in FIG. 2, the pump 12 includes a short connecting tube 34 which extends to a connecting port 36 which may be removably attached to the connecting tube 18. The pressure sensor 20 may be located on the tube 34. Typically, a battery 35 or other power supply may also be provided to power the pump and controller.
[0057] Referring in particular to FIG. 3, an exemplary system 100 constructed in accordance with the principles of the present disclosure comprises a driver assembly 112 which includes a controller 114, a syringe 116, and a motor 118. Typically, the motor may drive a lead screw 120 as shown in FIGS. 4 and 5A in order to advance a carriage 122 which is coupled to a plunger 124 of the syringe. The plunger 124, in turn, may either be advanced in a distal direction (to the right in FIG. 4) in order to deliver inflation medium from a barrel 126 of the syringe or may be retracted in a proximal direction in order to draw new inflation medium into the barrel, as will be described in more detail below. While a syringe or a piston or plunger-based pump is described, other pumps such as rotary and peristaltic pumps may also be suitable for use.
[0058] Referring now to FIGS. 3, 4, and 7, a connector 128 at a distal end of the syringe barrel 26 may be removably connected to a Y-fitting 132 which has two ports which are connected to a first one-way valve 134 and a second one-way valve 48, respectively. The first one-way valve 134, in turn, is removably connected to a connecting tube 138 which connects, at its distal end, to a pressure sensor 136. Pressure sensor 136, in turn, is connected to cable 130 which provides a pressure signal to the controller 114 within the delivery assembly 112. The pressure sensor 136 is further removably connected to a catheter 40 which in turn delivers inflation medium to the expandable and inflatable bladder 42. The first one-way valve 134 is oriented so that it allows flow from the syringe 116, which is caused by advancement of the plunger 124, to pass through the fitting 132, through the fitting 134, to the tube 138, through the pressure sensor 136, and finally through the catheter 40 into the inflatable bladder. The one-way valve 134 may prevent any backflow from the bladder 42 or elsewhere back into the syringe 116, thus reducing the risk of contamination.
[0059] The second one-way valve 48, in contrast, is oriented to cause inflation medium from a refill source 52 connected by a connecting tube 50 to flow back into the syringe barrel 126 when the plunger is retracted in order to draw the medium into the syringe. A needle 54 which is connectable to the tubing 50 is configured to be inserted into the source of saline or other inflation medium 52 so that the syringe maybe refilled between successive activations to deliver the inflation medium to the inflatable bladder 42. The controller 114 may be programmed to allow convenient refilling performed by the user. A cover 56 is provided to maintain sterility of the needle between successive uses. Another cover 57 is provided to cover and maintain sterility of the pump during use.
[0060] FIGS. 5A and 5B illustrate certain control and other features present on the driver assembly 112 of the systems of the present invention. A battery cover 62 can be removed to replace batteries as shown also in FIG. 4. A touch screen or other display 70 may be provided on the enclosure of the driver as a user interface. The display 70 may include, either virtually or mechanically, a power switch 72, a status light 74, a ready light 76, an incrementing key 78, a decrementing key 80, a run/stop key 82, and a syringe operation indicator 84.
[0061] The pump maybe removed and replaced on the top of the driver assembly 112. In particular, the pump is held in place by a securing strap 92. In the case of a syringe pump, the plunger 124 is engaged by a slot 90 in the carriage 122, as best seen in FIG. 6B. Similarly, the syringe barrel flange 88 is held in another slot 88, as best seen in FIG. 6A. The position of the plunger maybe monitored, when the top 57 is in place, with a travel indicator 86 on the display panel 70. The carriage 122 maybe released from the lead screw 120 by a carriage release button 94.
[0062] Referring now to FIG. 8, the inflation control system 100 of the present disclosure may be used by first connecting the catheter 40 to the pressure sensor 36 which in turn has been coupled to the driver 112, as described above. After making sure that the syringe 100 has a sufficient volume of inflation medium, the drive 112 may be turned on using switch 82 which may initiate the sequence of operations illustrated in FIG. 8. Initially, the pressure from sensor 36 is checked. If the pressure exceeds the high pressure threshold level PH, the driver may be stopped and an alert or alarm is raised since high pressure should not be present at this point in the protocol. Assuming that the initial pressure check is successful, the controller 114 may initiate power to the motor 118 in order to rotate the lead screw 120 which advances the carriage 122 which in turn drives the plunger 124 at a relatively low rate, typically the volumetric flow ranges set forth about. The pressure sensor 136 may monitor pressure while the syringe is delivering fluid, and the controller 114 may allow continued delivery for so long as the pressure does not exceed the high threshold value PH, again typically within the ranges set forth above. Assuming that no high pressure is detected, the syringe may be driven for a time sufficient to transfer the desired incremental volume Vi to the bladder 42. Typically, the volume may be from about 1 cc to 10 cc and it may take from 5 seconds to 60 seconds to complete the delivery.
[0063] If, however, the pressure sensor detects a pressure above the high threshold level PH, the controller may stop the pump and continue to monitor the pressure. For so long as the pressure remains above a low pressure threshold PL, which is typically 5 to 10 mmHg lower than the high pressure threshold PH, the pump may remain stopped. As soon as the pressure falls below this lower pressure threshold PL, the pump may be restarted and the inflation medium may continue to be delivered for so long as the pressure remains below the high pressure threshold PH. Pumping may continue until the entire incremental volume Vi has been delivered, at which time the pumping is stopped and not restarted until after the passage of a preselected time interval until the scheduled delivery of the successive incremental volumes Vi+1, i+2, ... , typically in the time ranges set forth above. Such successive incremental volume deliveries may continue until the total cumulative volume VT of inflation medium has been delivered to the inflatable bladder. Such total volume may take days or even weeks. In some instances, it may be desirable to divide the delivery of the total volume of inflation medium into stages, for example 2, 3, 4, 5, or even more stages, where the time between successive stages is greater than the normal time between the delivery of the incremental volumes.
[0064] FIGS. 9A-9B depict an illustration of an exemplary embodiment of a patient-wearable device, such as a (sports) bra-like jacket 200, wherein the external system components of the system 10 may be mounted on . The bra-like jacket 200 may have the general layout of a women’s sports bra and may further include the system components mounted on an interior surface thereof. The bra-like jacket may be similar in configuration to the vest 30 and include any combination of the system components therewith, such as the pump 12, the controller 14, the tissue expander or inflatable bladder 16, the connecting tube 18, the pressure sensor 20, the fluid supply 22 (e.g., a saline pouch), the port 24, armholes 32, the short connecting tube 34, the battery 35, and/or the connecting port 36. The bra-like jacket 200 may be configured to give the wearer the appearance of breasts to a casual observer, particularly when worn as an undergarment. The bra-like jacket 200 may be made of materials such as Spandex, Nylon, cotton, polyester, a combination thereof, or the like. The bra-like jacket 200 may contain pockets or other accommodations for holding the controller/pump, the container or pouch of inflation fluid or saline (e.g., 250 cc of saline), a controller board, the pressure sensor, tubing from the container to the pump, tubing from the pump to the tissue expander, and/or valves as appropriate for detaching the tissue expander from the pump controller, for example, when the wearer wants to take a shower, change clothing, or otherwise desires to take off the bra-like jacket 200. The controller board may comprise an electronic box containing a circuit board, pump, housing, battery, and other components.
[0065] FIGS. 10 and 11A-B depict an illustration of another exemplary embodiment of a patient-wearable device, such as a (sports) bra-like jacket 300, wherein the external system components of the system 10 may be mounted on. The bra-like jacket 300 may have the general layout of a women’s sports bra and may further include the system components mounted on an interior surface thereof. The bra-like jacket may be similar in configuration to the vest 30 and include any combination of the system components therewith, such as the pump 12, the controller 14, the tissue expander or inflatable bladder 16, the connecting tube 18, the pressure sensor 20, the fluid supply 22 (e.g., a saline pouch), the port 24, armholes 32, the short connecting tube 34, the battery 35, the connecting port 36, and/or a supply connecting tube 302 between the fluid supply 22 and the pump. The pump 12 may be disposed with the controller 14 in the same housing 304. The connecting tube 18 may connect to the tissue expander via a luer lock. The tissue expander end may comprise a sealed needleless connecter. The pump and controller housing 304 end may comprise an exposed male luer lock when disconnected. The tubing 302 between fluid supply 22 and the housing 304 (e.g., pump, controller) may comprise a needleless connection to said fluid supply 22. The tube 302 may be in fluid communication with fluid supply using a spike (e.g., see inlet 308 in FIGS. 12A-12B).
[0066] FIGS. 12A-12B depict an exemplary embodiment of a pump and controller housing as described herein. The pump may include an inlet (e.g., 308), to receive fluid from the fluid supply 22, and an outlet (e.g., 306), to deliver fluid to the tissue expander. The pump and controller housing 304 may comprise the pump 12, a circuit board (e.g., as part of the controller 14) for controlling the pump flow rate (e.g., based on the pressure sensor), a battery, and/or other components (as known in the art). The battery may be the same battery as referred to in the vest 30, or a different battery. As aforementioned, the pump may comprise a peristaltic pump or a syringe pump. The pump and controller housing 304 may have a length of about 1“ to about 3”, and a width of about 1“ to about 3”. The bra-like jacket may comprise a button on the pump / controller housing 304, or elsewhere on the system components, that is configured to pause operation of the pump.
[0067] The pump may be configured to be activated by using an activation device that is received by the circuit board of the controller, and/or received by the pump. The activation device may be a subscriber identification module (SIM) card or the like. Removing the activation device may prevent the pump from operating. A given activation device (e.g., SIM card) may be configured to be valid for a specified duration before becoming invalid, at which point the pump will be prevented from operating until the invalid activation device is replaced with a valid activation device. By limiting the duration of a activation device, use of the system for expanding tissue, as described herein, can be restricted so as to help prevent a user from continuously and indefinitely using said system. The activation device may be prescribed to be valid for about 1 day, about 1 week, about 2 weeks, about 1 month, or about 3 months after being first used with a pump and controller configuration (as described herein). The activation device may be prescribed to be valid for any duration from about 6 hours to about 6 months.
[0068] The bra-like jacket 300 may be configured to give the wearer the appearance of breasts to a casual observer, particularly when worn as an undergarment (e.g., see FIGS. 11A-11B). The bra-like jacket 300 may be made of materials such as Spandex, Nylon, cotton, polyester, a combination thereof, or the like. The bra-like jacket 300 may contain pockets or other accommodations for holding the controller/pump, the fluid supply (e.g., see FIG. 11B, reference character 303), a controller board, the pressure sensor, tubing from the fluid supply to the pump, tubing from the pump to the tissue expander, and/or valves as appropriate for detaching the tissue expander from the pump / controller, for example, when the wearer wants to take a shower, change clothing, or otherwise desires to take off the bra-like jacket 300. The fluid supply may be inserted and removed from a pocket of the bra-like jacket 300 via a Velcro® flap from the top of a pocket. The fluid supply may be a container or pouch of inflation fluid or saline. The container or pouch may be configured to hold about 100 cc, about 250 cc, about 500 cc of inflation fluid or saline. The container or pouch may weigh about 0.5 pound, about 1 pound, about 1.2 pounds, or about 1.5 pounds. The pump and controller housing may weight about 50 grams, about 80 grams, or about 100 grams. The controller board may comprise an electronic box containing a circuit board, pump, housing, battery, and other components.
[0069] For any wearable support described herein (e.g., FIG. 9A, FIG. 10), the expandable bladder (also referred to herein as a tissue expander) may be implanted in a subpectoral or subcutaneous pocket as described herein. In some cases, the inflatable bladder may be implanted submuscular, partially submuscular, or subcutaneously (with or without acellular dermal matrix, or a synthetic mesh) as described herein. The inflatable bladder implant may be connected to a controller, pump, pressure sensor, and fluid supply (e.g., a saline pouch) as described herein. For example, FIGS. 9A-9B shows the bra-like jacket 200 with a pump 12, a controller 14 coupled to the pump 12 for control thereof, a tissue expander 16 fluidically coupled to the pump 12, and a source of inflation medium or saline container or bag or pouch (e.g., fluid supply 22) also fluidically coupled to the pump 12. Similarly, FIG. 10 shows the bra-like jacket 300 with a pump 12 and controller 14 disposed with a housing 304, a tissue expander 16 fluidically coupled to the pump 12, and a source of inflation medium or saline container or bag or pouch (e.g., fluid supply 22) also fluidically coupled to the pump 12 The system components are depicted in dashed lines to represent their location as being beneath an exterior surface of the bra-like jacket 200 / 300 (e.g., within the bra-like jacket, on an interior surface of the bra-like jacket, and/or subcutaneous, such as the tissue expander). As described above, for any wearable device described herein (e.g., FIG. 9A, FIG. 10) the pump may be a reciprocating and/or rotary pump, such as a syringe pump or a peristaltic pump. For example, the pumps may be such as those available from Binaca Pumps of Temecula, CA. The pressure sensor 20 may be adapted to monitor pressure within the expandable bladder 16 (either directly or indirectly) on a substantially continuous basis as described herein. The pressure sensor 20 may be connected to the controller 14 which receives such pressure data. The controller 14 may be adapted for substantially continuous operation in response to pressure within the tissue expander as described herein. The controller 14 may thus be able to deliver saline to the tissue expander 16 when the pressure within the tissue expander 16 falls below a predetermined threshold as described herein, while also pausing delivery of the fluid when the pressure is above a higher set threshold or reaches a predetermined maximum volume as described herein. For example, a pressure threshold may be any pressure from about 5 mmHg to about 40 mmHg. The predetermined maximum volume may be any volume between about 150 cc to about 800 cc, including any volume from about 200 cc to about 600 cc. The pump may be able to deliver the fluid (e.g., inflation medium, saline) at a flow rate of about 0.5 ml/hr to about 3 ml/hr.
[0070] The components of the system external to the patient may be configured to sit within the bra-like jacket 200, 300 and mimic the appearance of a normal, healthy breast (or breasts) during use. For instance, the outward facing surface of the fluid source or container may be shaped to mimic the appearance of a normal, healthy breast, and the inward facing surface may be adapted to conform to the changing shape of the patient. As the fluid is moved from the fluid source 22 to the tissue expander 16, the tissue may expand and fill in the space within the bra-like jacket which was previously occupied by the fluid source. The fluid source 22 may incrementally and substantially continuously reduce in size as the tissue expander incrementally and substantially continuously expands the tissue. As such, the appearance of the bra-like system may remain substantially the same (e.g., as breasts) during the whole tissue expansion process. The outward facing surface of the fluid source or container 22 may be more rigid than the inward facing surface so as to maintain the external appearance and shape of the bra-like system as the system conforms to the expanded tissue of the patient. After a pre-determined maximum volume has been delivered to the tissue expander, for example over a period of 102 weeks, the tissue expander may be removed and a suitable permanent breast implant may be added to the expanded tissue pocket. By providing a system which can mimic the feel of a bra and look of a breast, patients may be better able to and/or be more comfortable performing routine, daily tasks without a feeling of loss (e.g., missing breast(s) or self-consciousness as the tissue expansion takes place).
[0071] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
