Tissue expander with integrated drainage and movable barrier membrane

Abstract

The present invention discloses a tissue expander with an integrated drainage member, the tissue expander comprising a shell having an opening and one or more drainage holes, and an injection port disposed in the opening of the shell and forming a fluid-tight seal with the shell. The injection port comprises a needle guard having a needle guard base with a top surface. The injection port comprises a movable barrier membrane covering the top surface of the needle guard base. The movable barrier membrane is movable between a first position and a second position, the first position being used to inflate and deflate the shell with a first fluid, and the second position being used to drain a second fluid from outside the shell. A magnet is coupled to the movable barrier membrane, and a compressible spring is connected to the magnet. When the movable barrier membrane moves from the first position to the second position, the compressible spring is compressed to store energy.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims the benefit of U.S. Provisional Patent Application No. 62 / 752,839, filed on October 30, 2018, and is related to U.S. Provisional Patent Application No. 62 / 752,813, filed on October 30, 2018, the disclosures of which are hereby incorporated by reference herein. Background Art Technical Field

[0003] The present patent application relates generally to implantable devices, and more particularly to tissue expanders with integrated drainage and fluid delivery components.

[0004] Description of Related Technology

[0005] Tissue expanders are devices that are implanted beneath the skin or muscle and then gradually inflated to stretch overlying tissue. Expanders are often used to create a pocket for receiving a permanent prosthesis, or to create increased skin surface area where new skin for grafting or reconstruction is contemplated.

[0006] Tissue expanders are typically formed from a silicone polymer shell. After implantation, a fluid (such as saline) is periodically injected into the tissue expander to cause it to expand over time. During the injection, the surrounding skin is allowed to stretch and grow to create an increased skin surface and an increased tissue pocket to accommodate the permanent implant. Typically, the tissue expander has an injection element through which fluid can be introduced into or withdrawn from the expander. One such injection element is an integrated port with a septum that can be pierced by a hypodermic needle for introducing fluid into or withdrawing fluid from the expander. Alternatively, the injection element can be a self-sealing area on the tissue expander that allows penetration by a hypodermic needle and self-closes after the needle has been withdrawn from the expander.

[0007] Conventional, commercially available tissue expanders have a single port for inflating and deflation of the housing of the tissue expander. They do not have a means for draining fluid (eg, a seroma) that forms around the exterior of the housing of the tissue expander after the tissue expander is implanted.

[0008] After surgery, patients are often placed with surgical drains to prevent blood and lymph from accumulating under the skin, allowing for faster recovery. Some patients are sent home with drains implanted in the body and connected to external reservoirs. Emptying these reservoirs can be traumatic because the patient must measure and empty the reservoir periodically (e.g., every morning). Many patients hate surgical drains and look forward to having them removed.

[0009] In view of the above problems, there is a need for a tissue expander with a single injection port that can be used to inflate and deflate the tissue expander and drain fluid that collects around the tissue expander after surgery. There is also a need for a tissue expander with a single injection port that can be used to inflate / deflate, drain fluid, and infuse fluid (e.g., antibiotic solution) around the exterior of an implanted tissue expander. In addition, there remains a need for a tissue expander that removes seroma fluid without requiring a drain that is attached to the patient 24 hours a day. Summary of the invention

[0010] In one embodiment, the tissue expander preferably has a single injection port that can be used to inflate and deflate the tissue expander and drain fluid that forms around the exterior of the tissue expander after the tissue expander is implanted. Having a single injection port allows the empty tissue expander to be more easily folded and have a smaller profile, which reduces the size of the incision required for implantation. In addition, having a single injection port advantageously reduces the overall metal content of the tissue expander, which helps with MRI visualization and patient radiation. In addition, having only one injection port (less metal content than a tissue expander with two injection ports) will reduce the overall weight of the tissue expander.

[0011] In one embodiment, the injection port advantageously includes a needle guard having a needle guard base and a needle guard edge protruding upward from the needle guard base. In one embodiment, the needle guard may be made of metal. In one embodiment, the needle guard may be made of a polymer material such as plastic. The injection port preferably includes a barrier membrane positioned in the needle guard. The barrier membrane divides the injection port into two different chambers, namely an inflation chamber and a drainage chamber, the inflation chamber being in fluid communication with one or more inflation / discharge ports for inflating and discharging the tissue expander, and the drainage chamber being in fluid communication with one or more drainage ports for draining fluid collected outside the tissue expander.

[0012] In one embodiment, the shape, size and configuration of the barrier membrane of the injection port form a space without blocking the inflation / deflating port of the tissue barrier. The drainage chamber is coupled to the drainage port and at least one drainage conduit (e.g., a tube) connected to at least one drainage hole formed in the housing of the tissue expander. In one embodiment, the drainage conduit advantageously includes a one-way check valve (e.g., a duckbill valve). In one embodiment, the one-way check valve allows fluid (e.g., a seroma) to be withdrawn from the tissue surrounding the tissue expander without the possibility of inadvertently delivering saline into the patient.

[0013] In one embodiment, a first conventional injection needle can be used to inflate and deflate the tissue expander with a fluid (e.g., a saline solution). In one embodiment, the first needle is a standard injection needle used for inflation and deflation of the tissue expander. In one embodiment, the first needle can be used to inject a solution (e.g., a saline solution) into the housing to increase the size of the tissue expander. The first needle can also be used to remove a solution from the housing to reduce the size of the tissue expander.

[0014] In one embodiment, a second specially designed needle, referred to as a drainage needle, can be used to drain fluid (e.g., seroma) that accumulates around the housing of the tissue expander after the tissue expander is implanted. In one embodiment, the second drainage needle is used only for drainage. The drainage needle advantageously includes a hollow cylindrical shaft made of medical grade material (e.g., stainless steel). In one embodiment, the distal end of the hollow cylindrical shaft is closed and has a sharp tip. The drainage needle preferably includes a side port formed in the side of the hollow needle shaft, which is spaced proximally from the sharp tip. The side port advantageously enables fluids such as seroma fluids to be drawn into the drainage needle. The distance between the side port opening and the sharp distal tip preferably positions the side port to communicate with the drainage chamber, as described in more detail herein.

[0015] In one embodiment, the tissue expander preferably includes an integrated drainage and infusion system. In one embodiment, the tissue expander advantageously has a single injection port that can be used to inflate and deflate the tissue expander, to drain fluid that accumulates around the tissue expander after surgery and tissue expander implantation, and to deliver fluid around the exterior of the housing after implantation.

[0016] In one embodiment, a tissue expander with an integrated drainage member preferably includes a housing having an opening and one or more drainage holes, and an injection port disposed in the opening of the housing and forming a fluid-tight seal with the housing, the injection port including a needle barrier having a needle barrier base with a top surface. In one embodiment, the injection port preferably includes a movable barrier membrane covering the top surface of the needle barrier base. In one embodiment, the movable barrier membrane is movable between a first position for inflating and deflation of the housing with a first fluid and a second position for draining a second fluid from outside the housing.

[0017] In one embodiment, the movable barrier membrane is constructed of a rigid material such as a hard plastic or elastomer. In one embodiment, the movable barrier membrane has a hardness rating of Shore D 0-80.

[0018] In one embodiment, a magnet is coupled to the movable barrier membrane. In one embodiment, a compressible spring is connected to the magnet. In one embodiment, when the movable barrier membrane moves from the first position to the second position, the compressible spring is compressed to store energy. The energy can be released to return the membrane to the first position.

[0019] In one embodiment, the needle may cover the injection port and the second magnet may be coupled to the needle. In one embodiment, the second magnet repels the first magnet coupled to the movable barrier to move the movable barrier from the first position to the second position.

[0020] In one embodiment, the tissue expander preferably includes an inflation port for inflating the housing with a first fluid, and a drainage port for draining a second fluid from outside the housing. In one embodiment, when the movable barrier membrane is in the first position, the inflation port is open and the drainage port is closed. In one embodiment, when the movable barrier membrane is in the second position, the inflation port is closed and the drainage port is open.

[0021] In one embodiment, the tissue expander preferably includes an injection port having a movable barrier membrane that divides the injection port into an inflation chamber for inflating and deflation of the tissue expander, and a drainage chamber for removing fluid that tends to collect around the implant after surgery. In one embodiment, the movable barrier membrane is connected to a magnet that is in turn coupled to a compressible spring. The barrier membrane is movable between a first extended position in which the connected spring is extended and a second retracted position in which the spring is compressed so that energy is stored in the spring.

[0022] In one embodiment, a first syringe with a needle is used to inflate and deflate the tissue expander. In one embodiment, a second syringe with a second needle contains a reverse polarity magnet to repel a magnet coupled to a movable membrane to block various openings. In the extended position, the movable barrier membrane blocks the drainage port, wherein a compression spring holds the movable barrier membrane in place (i.e., in the extended position). With the barrier membrane in the extended position, saline injection for inflation and deflation is achieved. The magnet mounted on the second syringe will repel the magnet coupled to the barrier membrane to push the movable barrier membrane downward, thereby allowing drainage via syringe aspiration.

[0023] In one embodiment, a tissue expander with an integrated drainage piece preferably includes a shell having an opening and one or more drainage holes, and an injection port disposed in the opening of the shell and forming a fluid-tight seal with the shell. In one embodiment, the injection port may include a needle barrier having a needle barrier base with a top surface and a barrier membrane covering the top surface of the needle barrier base. In one embodiment, the barrier membrane defines an inflation chamber located between the top surface of the needle guard base and the bottom surface of the barrier membrane, and a drainage chamber covering the top surface of the barrier membrane. In one embodiment, one or more inflation ports are in fluid communication with the inflation chamber for inflating and deflation of the shell with a first fluid. In one embodiment, a drainage conduit is in fluid communication with the drainage chamber and one or more drainage holes and extends between them to drain a second fluid from outside the shell.

[0024] In one embodiment, the first needle is used to inflate the shell, and the second needle is used to drain fluid from the outer periphery of the shell. In one embodiment, the first needle has an opening at the sharp distal end. In one embodiment, the first needle is suitable for insertion into the injection port so that the opening at the sharp distal end is aligned with the inflation chamber to selectively inflate and deflate the shell with a first fluid. In one embodiment, the second needle has a closed distal end and a side port proximally spaced from the closed distal end. The second needle is suitable for insertion into the injection port so that the side port of the second needle is aligned with the drainage chamber to drain the second fluid from the outside of the shell.

[0025] In one embodiment, the tissue expander may include an infusion chamber covering the top surface of the barrier membrane and separated from the drainage chamber, and an infusion conduit fluidly connected to the infusion chamber and at least one of the drainage holes and extending therebetween for delivering the infusion fluid to the outside of the shell.

[0026] Dip molding using a mandrel of appropriate size and shape can be used to form the shell, but other suitable methods such as injection molding or spraying can also be used. By dip molding, the mandrel is dipped into a silicone dispersion and then removed to allow partial curing and solvent evaporation. This process is usually repeated several times. Once the shell is formed, it is removed from the mandrel. The dip molding process forms a partial shell with an opening (e.g., a circular hole (patch hole)) on the back side. An injection port is installed, and the patch hole is then covered with a patch that seals the hole, thereby forming a complete fluid-impermeable shell. Silicone rubber or other similar biocompatible adhesives can be used to attach the patch to the partial shell. The complete shell can be unfilled or partially pre-filled. After the expander is implanted, the expander is filled with saline, gel, foam, or a combination of these materials or other suitable materials known in the art during surgery through the injection port to gradually increase the tissue expander to the desired size. Filling is usually performed through the injection port during multiple office visits.

[0027] In one embodiment, a tissue expander with an integrated drainage member preferably includes a housing having an injection port opening and one or more drainage holes, and an injection port disposed in the injection port opening of the housing, whereby the injection port forms a fluid-tight seal with the housing.

[0028] In one embodiment, the injection port advantageously includes a needle guard having a needle guard base with a top surface. In one embodiment, the injection port preferably has a movable barrier covering the top surface of the needle guard base. In one embodiment, the movable barrier is movable between a first position for inflating and deflation of the housing with a first fluid and a second position for draining a second fluid from outside the housing.

[0029] In one embodiment, the needle guard comprises a needle guard edge extending upwardly from the needle guard base.In one embodiment, the needle guard edge surrounds the outer periphery of the movable barrier membrane.

[0030] In one embodiment, the injection port preferably includes one or more inflation ports formed in the edge of the needle guard, the one or more inflation ports being configured to direct the first fluid into the housing to inflate the housing, and to remove the first fluid from the housing to deflate the housing.

[0031] In one embodiment, the injection port preferably includes at least one drainage port formed in the edge of the needle guard, which is fluidly connected to the one or more drainage holes of the shell for extracting the second fluid from the outside of the shell through the one or more drainage holes.

[0032] In one embodiment, the movable barrier membrane may have a membrane edge at the outer periphery of the movable barrier membrane. In one embodiment, when the movable barrier membrane is in a first position, the membrane edge closes the at least one drainage port and opens the one or more inflation ports, and when the movable barrier membrane is in a second position, the membrane edge opens the at least one drainage port and closes the one or more inflation ports.

[0033] In one embodiment, the needle guard base extends along a first axis and the needle guard edge extends along a second axis perpendicular to the first axis of the needle guard base. In one embodiment, when the movable barrier membrane moves between the first position and the second position, the movable barrier membrane including the membrane edge moves up and down relative to the needle guard base along the second axis perpendicular to the first axis of the needle guard base.

[0034] In one embodiment, the tissue expander may include a drainage conduit having a first end in fluid communication with the at least one drainage port and a second end in fluid communication with the one or more drainage holes formed in the housing to drain a second fluid from outside the housing.

[0035] In one embodiment, the tissue expander may include a magnet coupled to the movable barrier membrane, and a compressible spring connected to the magnet. In one embodiment, the compressible spring may be compressed to store energy when the movable barrier membrane moves from the first position to the second position.

[0036] In one embodiment, the magnet has an upper end connected to the underside of the movable barrier membrane and a lower end connected to the compressible spring.

[0037] In one embodiment, a needle may be inserted into the injection port to inflate the housing and / or drain fluid that has collected around the exterior of the housing.

[0038] In one embodiment, the second magnet is preferably coupled to the needle. In one embodiment, when the needle is inserted into the injection port, the second magnet advantageously repels the first magnet coupled to the movable barrier to move the movable barrier from the first position to the second position.

[0039] In one embodiment, a tissue expander with an integrated drainage member preferably includes a housing having an injection port opening and one or more drainage holes formed in the housing, and an injection port disposed in the injection port opening.

[0040] In one embodiment, the injection port preferably includes a needle guard having a needle guard base and a needle guard edge extending upwardly from the needle guard base.

[0041] In one embodiment, the injection port preferably has one or more inflation ports formed in the edge of the needle guard, the one or more inflation ports being in fluid communication with the interior region of the housing.

[0042] In one embodiment, the injection port preferably includes at least one drainage port formed in the edge of the needle guard, the at least one drainage port being in fluid communication with the one or more drainage holes formed in the housing.

[0043] In one embodiment, the tissue expander preferably includes a movable barrier membrane that covers the top surface of the needle guard base and is surrounded by the needle guard edge. In one embodiment, the movable barrier membrane is movable between a first position for closing the at least one drainage port and opening the one or more inflation ports, and a second position for opening the at least one drainage port and opening the one or more inflation ports.

[0044] In one embodiment, the movable barrier membrane advantageously has an outer periphery and a membrane edge located at the outer periphery of the movable barrier membrane.

[0045] In one embodiment, the needle guard base extends along a first axis, and the membrane edge of the movable barrier membrane extends along a second axis perpendicular to the first axis of the needle guard base. In one embodiment, when the movable barrier membrane moves between the first position and the second position, the movable barrier membrane including the membrane edge advantageously moves up and down relative to the needle guard base along the second axis perpendicular to the first axis of the needle guard base.

[0046] In one embodiment, when the movable barrier membrane is in the first position, the membrane edge closes the at least one drainage port and opens the one or more inflation ports, and when the movable barrier membrane is in the second position, the membrane edge opens the at least one drainage port and closes the one or more inflation ports.

[0047] In one embodiment, the one or more inflation ports formed in the edge of the needle guard are configured to direct a first fluid into the shell to inflate the shell and remove the first fluid from the shell to deflate the shell, and the at least one drainage port formed in the edge of the needle guard is fluidly connected to the one or more drainage holes formed in the shell to draw out a second fluid from outside the shell.

[0048] In one embodiment, the magnet may be coupled to the underside of the movable barrier membrane. In one embodiment, the compressible spring is advantageously connected to the magnet, whereby the compressible spring is compressed to store energy when the movable barrier membrane moves from the first position to the second position.

[0049] In one embodiment, the magnet has an upper end connected to the underside of the movable barrier membrane and a lower end connected to the compressible spring.

[0050] In one embodiment, the tissue expander may include a needle configured to be inserted into the injection port, and a second magnet coupled to the needle. In one embodiment, when the needle is inserted into the injection port, the second magnet repels the first magnet coupled to the movable barrier membrane to move the movable barrier from the first position to the second position.

[0051] In one embodiment, a tissue expander with an integrated drainage member preferably includes a housing having an injection port opening and one or more drainage holes formed in the housing, and an injection port disposed in the injection port opening.

[0052] In one embodiment, the injection port preferably includes a needle guard having a needle guard base extending along the first axis and a needle guard edge extending upwardly from the needle guard base.

[0053] In one embodiment, the injection port preferably comprises one or more inflation ports formed in the edge of the needle guard, the one or more inflation ports being in fluid communication with the interior region of the housing for introducing the first fluid into the housing.

[0054] In one embodiment, the injection port preferably includes at least one drainage port formed in the edge of the needle guard, and the at least one drainage port is connected to the one or more drainage holes formed in the shell for draining the second fluid from the outside of the shell through the one or more drainage holes.

[0055] In one embodiment, the tissue expander preferably includes a movable barrier film that covers the top surface of the needle guard base and is surrounded by the edge of the needle guard. In one embodiment, the movable barrier film is movable along a second axis perpendicular to the first axis of the needle guard base to move between a first position and a second position, the first position being used to close the at least one drainage port and open the one or more inflation ports, and the second position being used to open the at least one drainage port and close the one or more inflation ports.

[0056] In one embodiment, a magnet may be coupled to the movable barrier membrane, and a compressible spring is connected to the magnet. In one embodiment, a magnet is disposed between the movable barrier membrane and the compressible spring.

[0057] In one embodiment, the tissue expander may include a needle and a second magnet, the needle being configured to be inserted into an injection port, the second magnet being coupled to the needle, whereby when the needle is inserted into the injection port, the second magnet repels the first magnet coupled to the movable barrier to move the movable barrier from a first position to a second position.

[0058] In one embodiment, the movable barrier membrane preferably has an outer periphery and a membrane edge located at the outer periphery of the movable barrier membrane, the membrane edge extending along a second axis perpendicular to the first axis of the needle guard base. In one embodiment, when the movable barrier membrane is in the first position, the membrane edge closes the at least one drainage port and opens the one or more inflation ports, and when the movable barrier membrane is in the second position, the membrane edge opens the at least one drainage port and closes the one or more inflation ports.

[0059] In one embodiment, the tissue expander advantageously includes a drainage conduit having a first end in fluid communication with the at least one drainage port and a second end in fluid communication with the one or more drainage holes formed in the shell for draining a second fluid from outside the shell via the one or more drainage holes.

[0060] These and other preferred embodiments of the invention are described in more detail below. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] Figure 1A A perspective view of a tissue expander with an integrated drainage system according to one embodiment of the present patent application is shown.

[0062] Figure 1B Shows Figure 1A A side view of a tissue expander is shown.

[0063] Figure 2 A cross-sectional view of a tissue expander with an integrated drainage system according to one embodiment of the present patent application is shown.

[0064] Figure 3 Shows Figure 2 An enlarged view of the injection port of a tissue expander is shown.

[0065] Figure 4A Shows Figure 1A and Figure 1B A partial cross-sectional side view of a tissue expander is shown.

[0066] Figure 4B Shows Figure 1A and Figure 1B A partial cross-sectional top view of a tissue expander is shown.

[0067] Figure 5A The inner surface of a drainage manifold of an integrated drainage system of a tissue expander according to one embodiment of the present patent application is shown.

[0068] Figure 5B Shows Figure 5A The exterior surface of the drainage manifold is shown.

[0069] Fig. 6A According to one embodiment of the present patent application, Figure 5A and Figure 5B A perspective view of the drainage manifold with the drainage pieces assembled together.

[0070] Figure 6B Shows Fig. 6A A cross-sectional view of the guide member shown.

[0071] Figure 7 A method of inflating a tissue expander according to one embodiment of the present patent application is shown.

[0072] Fig. 8A A method of draining a tissue expander having an injection port and an integrated drainage system according to one embodiment of the present patent application is shown.

[0073] Figure 8B Shows Fig. 8A An enlarged view of the injection port of a tissue expander is shown.

[0074] Fig. 9 A cross-sectional view of a tissue expander with an integrated drainage member according to one embodiment of the present patent application is shown.

[0075] Fig. 10A A partial cross-sectional view of a tissue expander with an integrated drainage and infusion system according to one embodiment of the present patent application is shown.

[0076] Fig. 10B Shows Fig. 10A A side view of a tissue expander is shown.

[0077] Fig. 10C Shows Fig. 10A and Fig. 10B A cross-sectional side view of a tissue expander is shown.

[0078] Fig.11 An embodiment of the present patent application is shown. FIG. 10A to FIG. 10C The drainage catheter of the tissue expander is shown.

[0079] Fig.12 An embodiment of the present patent application is shown. FIG. 10A to FIG. 10C An infusion catheter for a tissue expander is shown.

[0080] Fig.13A An injection port of a tissue expander according to one embodiment of the present patent application is shown, the injection port having a movable membrane coupled to a magnetic element.

[0081] Fig. 13B Shows Fig.13AAnother view of the injection port is shown.

[0082] Fig.14A According to one embodiment of the present patent application, the use Fig.13A and Fig. 13B The injection port is the first step in the method of draining fluid from around the periphery of the tissue expander.

[0083] Fig. 14B According to one embodiment of the present patent application, the use Fig.13A and Fig. 13B The injection port is a second step of the method for draining fluid from around the periphery of the tissue expander.

[0084] Fig. 14C Shows Fig. 14B Another view of the injection port is shown.

[0085] Fig.15A A top view of a tissue expander with an integrated drainage system including drainage holes disposed on a top side of a housing according to one embodiment of the present patent application is shown.

[0086] Fig. 15B Shows Fig.15A A side perspective view of a tissue expander is shown.

[0087] Fig.16A A top perspective view of a tissue expander with an integrated drainage system including radially extending drainage holes according to one embodiment of the present patent application is shown.

[0088] Fig. 16B Shows Fig.16A A side view of a tissue expander is shown.

[0089] Fig.17 A schematic diagram of a tissue expander with an integrated drainage system according to one embodiment of the present patent application is shown.

[0090] Fig.18 A schematic diagram of a tissue expander according to one embodiment of the present patent application is shown, the tissue expander having an integrated system for drainage and infusion of fluids.

[0091] Fig.19 A schematic diagram of a tissue expander with an integrated inflation, drainage and infusion system according to one embodiment of the present patent application is shown.

[0092] Fig. 20 A tissue expander according to one embodiment of the present patent application is shown having a first injection port for drainage and infusion of fluid and a second injection port for inflating the tissue expander with a solution.

[0093] Fig.21 A system for creating a vacuum to drain fluid collected around a tissue expander according to one embodiment of the present patent application is shown.

[0094] Fig.22A An embodiment of the present patent application is shown. Figure 5A and Figure 5B A perspective view of the drainage manifold with the drainage pieces assembled together.

[0095] Fig. 22B Shows Fig.22A A cross-sectional view of the guide member shown. DETAILED DESCRIPTION

[0096] In one embodiment, see Figure 1A and Figure 1B , tissue expander 100 preferably includes a housing 102 and an injection port 104 located on the top side of the housing. Housing 102 may have any desired shape and any thickness suitable for the purpose of a particular tissue expander. Housing 100 may be formed of a biocompatible elastomeric material such as silicone.

[0097] In one embodiment, the tissue expander 100 preferably includes one or more stabilizing tabs 106 that can be used to secure the tissue expander 100 to the tissue. In one embodiment, sutures or surgical fasteners can be used to secure the one or more stabilizing tabs 106 to the patient's tissue. In one embodiment, the tissue expander 100 advantageously includes one or more drainage holes 108 disposed on the housing 102. The one or more drainage holes 108 can be used to drain fluid (e.g., seroma fluid) that may accumulate around the tissue expander 100 after surgical implantation.

[0098] In one embodiment, see Figure 2 and Figure 3 , the injection port 104 can be fixed to the opening present in the housing for sealing the housing 102. In one embodiment, the injection port 104 is assembled in the opening of the housing 102 at a position facing the patient's skin surface. The injection port can be formed of an elastomeric material. In one embodiment, the injection port 104 advantageously includes a septum area 110, which is preferably located at a central area of ​​the upper surface of the injection port 104 and / or the tissue expander 100. The septum area 110 is advantageously self-sealing to prevent fluid from leaking from the tissue expander 100 after the injection needle is removed from the injection port 104.

[0099] In one embodiment, the injection port 104 advantageously includes an outer flange 112 that overhangs the outer surface of the housing 102. In one embodiment, the injection port 104 advantageously includes a self-sealing safety patch 114 secured to the inner surface of the housing 102, whereby the housing is at least partially sandwiched between the flange 112 of the injection port and the self-sealing safety patch 114. The self-sealing safety patch preferably has a diameter greater than the flange 112 of the injection port 104, such that the safety patch extends beyond the outer perimeter of the flange 112.

[0100] In one embodiment, a mandrel of appropriate size and shape can be used to form the shell 102 of the tissue expander 100. In one embodiment, the shell 102 can be formed using a dip molding method, but other methods can also be used, including spraying the mandrel with a solution that forms the shell or injection molding. In the dip molding method, the mandrel is dipped into a silicone dispersion and then removed to allow partial curing and solvent evaporation. This dipping step is repeated several times. Once the shell is formed, it is removed from the mandrel. The dip molding process forms a partial shell with an opening (e.g., a circular hole (patch hole)). The injection port 104 and the safety patch 114 are installed to form a complete fluid-impermeable shell. The safety patch 114 can be attached to the inner surface of the shell 102 using silicone rubber or other similar biocompatible adhesives. The complete shell can be unfilled or partially pre-filled. After implantation of the tissue expander, the tissue expander 100 is filled with saline, gel, foam, or a combination of these materials or other suitable materials known in the art across the septal region 110 to gradually enlarge the tissue expander 100 to the desired size. This typically occurs over the course of multiple office visits.

[0101] In one embodiment, the injection port 104 advantageously includes a needle guard 116 having a needle guard base 118 and a needle guard edge 120 extending upwardly from the needle guard base 118. In one embodiment, the needle guard edge 120 completely surrounds the outer periphery of the needle guard base 118.

[0102] In one embodiment, the injection port 104 desirably includes a barrier membrane 122 that extends from one side of the needle guard edge 120 to an opposite side of the needle guard edge portion 120. In one embodiment, the barrier membrane 122 preferably covers the needle guard base 118 and is coextensive with a region of the needle guard base 118. The barrier member 122 preferably divides the injection port 104 into an inflation chamber 124 for introducing inflation solution into the housing 102 to expand the tissue expander and / or removing solution from the housing to deflate the tissue expander, and a drainage chamber 126 for draining fluid (e.g., seroma fluid) that may accumulate around the housing 102 of the tissue expander 100 after the tissue expander is implanted.

[0103] In one embodiment, the inflation chamber 124 is in fluid communication with housing inflation ports 128A, 128B that pass through lateral openings disposed in the needle guard edge 120. In one embodiment, an injection needle can be used to introduce a fluid (e.g., a saline solution) into the inflation chamber 124, which then flows through the inflation ports 128A, 128B for inflating the housing 102 with the solution. In one embodiment, an injection needle can be used to create a vacuum within the inflation chamber while removing fluid from the housing 102 to deflate the tissue expander 100.

[0104] In one embodiment, the drainage chamber 126 of the injection port 104 preferably includes a drainage port 130 that passes through an opening 132 formed in the needle guard edge 120 of the needle guard 116. In turn, the drainage port 130 is connected to a first end 134 of a drainage conduit 136. The drainage conduit 136 advantageously has a second end 138 coupled to the drainage member 140, which is in fluid communication with one or more drainage holes 108 formed in the housing 102.

[0105] In one embodiment, the first needle 142 is used to inflate and deflate the housing 102 of the tissue expander 100. The first needle 142 preferably has a sharp tip 144 and an opening 146 disposed at the sharp tip 144. In one embodiment, the sharp tip 144 of the first needle 142 passes through the septum 110 and the barrier membrane 122 such that the opening 146 at the distal tip 144 of the first needle 142 is aligned with the inflation chamber 124 of the injection port 104. Once the opening 146 of the first needle 142 is positioned within the inflation chamber 124, a fluid (e.g., saline solution) may pass through the needle opening 146, and the injected fluid subsequently flows into the inflation chamber 124, through the lateral openings in the needle guard edge 120, and through the inflation ports 128A, 128B for inflation of the housing 52 with the injected fluid. To deflate tissue expander 100 , fluid may be removed from the housing using first needle 142 by withdrawing the fluid through inflation ports 128A, 128B and into inflation chamber 124 , after which the fluid may be removed from housing 102 via first needle 142 .

[0106] In one embodiment, the second needle 148 can be used to drain fluid that has collected around the outer periphery of the tissue expander 100. In one embodiment, the second needle 148 has a sharp distal tip 150 and a side port 152 spaced proximally from the sharp distal tip 150. As will be described in greater detail herein, the side port 152 of the second needle enables fluid that has collected around the exterior of the housing to be drained and removed from the patient.

[0107] In one embodiment, see Figure 4A and Figure 4B The tissue expander 100 preferably includes a drainage manifold 154 that is aligned with and covers one or more drainage holes 108 disposed on the housing 102. In one embodiment, the second end 138 of the drainage conduit 136 is fixed to the drainage manifold port 156 for connecting the drainage conduit 136 to the drainage manifold 154.

[0108] In one embodiment, the drainage catheter 136 advantageously includes a one-way check valve 158 ( Figure 2 ), which allows the fluid passing through the drainage conduit to move in only one direction designated as DIR1, i.e., toward the drainage chamber 126 ( Figure 3 )sports.

[0109] In one embodiment, see Figure 5A and Figure 5B The drainage manifold 154 advantageously includes a drainage manifold port 156 protruding from an inner surface 158 of the drainage manifold 154. In one embodiment, the drainage manifold 154 preferably has an outer surface 160 surrounding a groove 162 that is suitable for receiving one or more drainage members 140 ( Figure 2 ), the one or more guide members are preferably connected to one or more guide holes 108 ( Figure 1A ) is aligned. The drainage manifold port 156 is advantageously in fluid communication with a groove 162 disposed at a front face 160 of the drainage manifold 154. In one embodiment, the outer surface 160 of the drainage manifold 154 is preferably fixed to the inner surface ( Figure 1A ) to form a watertight seal with the inner surface of the housing so as to separate the fluid used to inflate and deflate the housing from the fluid drained from the outside of the housing.

[0110] In one embodiment, one or more flow guides 140 ( Figure 2 ) is advantageously positioned within the groove 162 of the drainage manifold 154 to drain fluid from around the periphery of the tissue expander. In one embodiment, the drainage member is advantageously aligned with the drainage holes 108 ( Figure 1A ) to align.

[0111] In one embodiment, see Fig. 6A and Figure 6B , the flow guide 140 preferably has a core 166 with struts 168 that protrude from the core 166 along the longitudinal axis of the core. Each of the outer ends of the struts 168 has a corresponding overhang 170 that extends longitudinally throughout the entire length of the strut 168. In one embodiment, as Figure 6BAs shown, the overhangs 170 are arcuate members extending on either side of their respective struts 168. The overhangs 170 are sized to form a generally elliptical member at the perimeter of the drain 140 with small gaps between adjacent overhangs 170. Each of these gaps forms a longitudinal groove 172 that is parallel to the longitudinal axis of the core 166 and extends throughout the entire length of the drain 140. The core portion 166, struts 168, and overhangs 170 combine to form a plurality of channels or lumens 174 extending along the length of the drain 140. The longitudinal grooves 172 allow fluid communication between the respective lumens 174 and the wound.

[0112] In one embodiment, the drain 140 can be similar to the surgical drains disclosed in US Pat. No. 4,398,910 to Blake et al., the disclosure of which is hereby incorporated herein by reference.

[0113] In one embodiment, see Figure 7 To inflate the tissue expander 100, the sharp distal tip 144 of the first needle 142 passes through both the septum region 110 and the barrier membrane 122 of the injection port 104 until the opening 146 at the distal tip 144 of the inflation needle 142 is aligned with the inflation chamber 124 of the injection port. In one embodiment, a fluid (e.g., saline solution) is injected from the opening 146 at the distal tip 144 of the first needle 142, and the injected fluid then flows into the inflation chamber 124 and through the inflation ports 128A, 128B to inflate the housing 102 and expand the tissue expander 100. The distal tip 144 is advantageously stopped by the needle guard base 118 of the needle guard 116 to prevent the distal tip of the first needle from passing through the bottom of the injection port 104 and / or damaging the housing of the tissue expander. If the opening 146 at the distal end 144 of the first needle 142 is not properly aligned with the drainage chamber 126 of the injection port 104 and fluid is injected under pressure from the opening 146 of the first needle 142, the one-way check valve 158 ( Figure 2 ) will prevent fluid from passing through the drainage catheter and reaching the drainage piece 140 located at the second end 138 of the drainage catheter 136.

[0114] In one embodiment, see Fig. 8A and Figure 8B The body fluid collected around the shell 102 of the tissue expander 100 can be drained from one or more drainage openings 108 ( Figure 1A ) drainage. In one embodiment, the second needle 148 ( Figure 3) is used to drain fluid that has accumulated around the outer periphery of the housing 102. In one embodiment, the sharp distal tip 150 of the second needle 148 is advanced through the barrier membrane 122 until the sharp tip 150 abuts the top surface of the needle guard base 118 of the needle guard 116. When the sharp distal tip 150 of the second needle 148 engages the needle guard base 118, the side port 152 of the second needle 148 (which is spaced apart from the distal tip 150) is preferably aligned with the drainage chamber 126 of the injection port 104 covering the top surface of the barrier membrane 122. A vacuum can then be drawn through the second needle 148 for withdrawing fluid (e.g., a seroma) through the drainage conduit 136. The drainage conduit 136 preferably includes a one-way check valve 158 that enables the accumulated fluid to flow in only one direction (e.g., toward the injection port 104). The drained fluid preferably passes through the one-way check valve 158 , through the drainage port 130 , and into the drainage chamber 126 where the fluid is withdrawn through the side port 152 of the drainage needle 148 . Figure 8B The flow of the drained fluid is shown, where the drained fluid flows through the one-way check valve 158 , the first end 134 of the drainage conduit 136 , and the drainage chamber 126 and into the side port 152 of the second needle 148 to be removed from the housing 102 of the tissue expander 102 .

[0115] In one embodiment, see Fig. 9 , the tissue expander 200 has an integrated drainage member disposed therein for draining fluid and / or liquid accumulated around the periphery of the housing 202 of the tissue expander. In one embodiment, the tissue expander 200 preferably includes a drainage conduit 236 having a first end 234 coupled to the drainage port 230 of the injection port 204 and a second end 238 coupled to the drainage manifold 254, which is positioned adjacent to the drainage opening 208 disposed on the housing 202. In one embodiment, the integrated drainage member does not include the above Fig. 6A and Figure 6B Similar flow guide 140 ( Fig. 6A ). Instead, the integrated drainage member includes a sealed drainage cover 245 secured to an inner surface 258 of the drainage manifold 254. An outer surface 260 of the drainage manifold 254 is preferably secured to the inner surface 255 of the housing 202 to form a watertight seal between the inner surface of the housing and the outer surface of the drainage manifold 254 for separating the inflation fluid circulating inside the housing 202 from the liquid that accumulates around the housing 202 and is drained through the one or more drainage holes 208.

[0116] In one embodiment, see FIG. 10A to FIG. 10C, the tissue expander 300 preferably includes a housing 302, an injection port 304, a stabilizing tab 306, and a drainage and infusion port 308 disposed on the housing 302. In one embodiment, the tissue expander 300 advantageously includes a manifold 354, which is preferably used for both drainage and infusion and is positioned inside the housing 302 adjacent to the drainage and infusion port 308. In one embodiment, a drainage conduit 336A has a first end 334A coupled to the drainage and infusion chamber 326 of the injection port 304, and a second end 338A coupled to the drainage port 356A of the manifold 354. As will be described in more detail herein, the drainage conduit 336A advantageously includes a one-way check valve 358A that allows fluid drained through the hole 308 to flow from the second end 338A of the drainage conduit 336A to the first end 334A, but does not allow fluid to flow in the opposite direction from the first end 334A of the drainage conduit 336A to the second end 338A.

[0117] In one embodiment, the tissue expander 300 desirably includes an infusion conduit 336B having a first end 334B coupled to the drainage and infusion chamber 325 of the injection port 304 and a second end 338B coupled to an infusion port 356B disposed on the manifold 354. In one embodiment, a solution (e.g., a medical solution, an antibiotic) may pass through the infusion conduit 336B to be dispensed from the hole 308 formed in the housing 252. In one embodiment, the infusion conduit 336B desirably includes a one-way check valve 358B that allows the infusion solution to flow from the first end 334B of the infusion conduit 336B to the second end 338B of the infusion conduit 336B, but does not allow flow through the infusion conduit 336B in the opposite direction.

[0118] In one embodiment, see Fig. 10C and Fig.11 , the tissue expander 300 advantageously includes a drainage conduit 336A having a one-way check valve 358A that allows the drained fluid to flow from the second end 338A of the drainage conduit 336A to the first end 334A in a direction designed as DIR1, but not in an opposite direction designed as DIR2. In one embodiment, the manifold 354 is fixed to the second end 338A of the drainage conduit 336A. The drainage system advantageously includes one or more drainage members 340, which are located within the groove 362 of the manifold 354 and are located between the opening at the second end 338A of the drainage conduit 336A and the one or more holes 308 formed in the housing 302. The fluid drained through the one or more holes 308 passes through the one or more drainage members 340 and enters the drainage conduit 336A.

[0119] Fig.12A one-way check valve 358B is shown disposed in the infusion conduit 336B. The one-way check valve 358B allows infusion fluid to flow from the first end 284B to the second end 288B of the infusion conduit 286B in only one direction, designated DIR2, and not in the opposite direction, designated DIR1.

[0120] In one embodiment, see Fig.13A and Fig. 13B , the injection port 404 of the tissue expander 400 advantageously includes a movable barrier membrane 422 positioned inside a needle guard 416 having a needle guard base 418 and a needle guard edge 420 protruding upwardly from the needle guard base 418. The injection port 404 preferably includes a magnet 475 positioned on top of a compressible spring 485 that normally forces the movable barrier membrane 422 into the needle guard. Fig.13A and Fig. 13B In one embodiment, the movable barrier membrane 422 advantageously includes a membrane edge 425 that extends when the movable barrier membrane 422 is in the extended position. Fig.13A and Fig. 13B In the extended position shown, the edge of the membrane blocks the drain port 430. In one embodiment, the magnet 475 and the movable blocking membrane 422 are connected together and together in Fig.13A and Fig. 13B Extended position shown and Fig. 14B and Fig. 14C Movement between the compressed positions shown.

[0121] In one embodiment, the movable barrier membrane 422 is constructed of a rigid material such as a hard plastic or elastomer. In one embodiment, the movable barrier membrane has a hardness rating of Shore D 0-80.

[0122] In one embodiment, to inflate the housing of the tissue expander with a solution, an inflation needle 442 having a distal tip 444 with an opening 446 is preferably passed through the dome 410 of the injection port 404 until the distal tip 444 of the needle 442 abuts against the movable barrier membrane 422. The compression spring 485 is extended so that the magnet 475 and the movable barrier membrane 422 are in an extended position. When the solution is injected from the opening 446 at the distal tip 444 of the needle 442, the injected solution advantageously flows through the opening 435 in the bottom plate of the barrier membrane 422 and flows through the inflation port 428 for filling the housing of the tissue expander 400.

[0123] In one embodiment, see Fig.14A, the second magnet 495 may be positioned above the elongated shaft of the injection needle 442. The second magnet 495 may be positioned adjacent to the lower end of the syringe. The second magnet 495 preferably generates a magnetic field that repels the first magnet 475 located within the injection port 440. The repulsive force between the magnet 475 and the magnet 495 causes the movable barrier 422 to move to the Fig.14A In the compressed position shown, the barrier edge 422 of the barrier membrane 422 is then positioned below the opening of the drainage port 430 so that fluid that has accumulated around the periphery of the tissue expander can be drawn out through the drainage port. Fig.14A A dashed line P is shown indicating a possible insertion path of the needle 442 when the needle is inserted into the injection port 404 .

[0124] See also Fig. 14B and Fig. 14C , the second magnet 495 ( Fig. 14B ) repels the first magnet 475 in the injection port 404 to compress the spring 485 ( Fig. 14B ) and moves the movable barrier film 422 to the compressed position. The peripheral edge 425 of the movable barrier film 422 no longer blocks the drainage port 430, so that the drainage fluid can be drawn into the opening 446 at the sharp end 444 of the injection needle 442. Fig. 14B , Fig. 14C When in the lower compressed position shown, the compression spring 485 ( Fig. 14B ) is compressed. When the second magnet 495 ( Fig. 14B ) moves away from the injection port 404, stored in the compression spring 485 ( Fig. 14B ) will cause the movable barrier film 422 to return to Fig.13A , Fig. 13B When the movable barrier film 422 returns to the extended position Fig.13A , Fig. 13B In the extended position shown, the peripheral edge 425 of the movable barrier membrane 422 again blocks the drainage port 430 of the injection port 404 of the tissue expander 400 .

[0125] In one embodiment, the needle guard base 418 of the needle guard 416 extends along the first axis A1, and the membrane edge 425 of the movable barrier membrane 422 extends along the second axis A2 perpendicular to the first axis A1 defined by the needle guard base 418. In one embodiment, when the movable barrier membrane 422 moves and / or shifts between the first position and the second position to open and close the inflation port and the drainage port, the movable barrier membrane 422 including the membrane edge 425 moves up and down relative to the needle guard base 418 along the second axis A2 perpendicular to the first axis A1 of the needle guard base.

[0126] In one embodiment, the barrier edge 425 of the movable barrier membrane 422 defines an outer diameter OD1 of the movable barrier membrane 422 that matches the inner diameter ID1 defined by the needle guard edge 420, whereby the outer peripheral surface 427 of the barrier edge 425 engages the inner surface 421 of the needle guard edge 420 for guiding the movable barrier membrane relative to the needle guard 416 in the first position ( Fig.13A , Fig. 13B ) and the second position ( Fig. 14B , Fig. 14C ), the first position being used to inflate the housing and the second position being used to drain fluid gathered around the exterior of the housing. In one embodiment, the needle guard 416 is designed to remain stationary within the injection port 404, and the barrier membrane 422 is designed to move up and down along the second axis A2 to selectively open and close the corresponding inflation port 428 and drainage port 430. In one embodiment, the barrier edge 425 slides over the inner surface 421 of the needle guard edge 420 when moving between the first position and the second position.

[0127] In one embodiment, see Fig.15A , Fig. 15B , tissue expander 500 advantageously includes a housing 502 and an injection port 504. Tissue expander 500 advantageously includes a plurality of holes 508 formed in the top side of housing 502. A series of holes 508 can be used to drain fluids that accumulate around the exterior of housing 502 and / or infuse a medical solution through holes 508 and around the exterior of housing 502. In one embodiment, tissue expander 500 may include one or more drainage conduits and drains as disclosed herein. In one embodiment, tissue expander 500 may include one or more infusion conduits as disclosed herein. In one embodiment, tissue expander 500 may include a drainage conduit in communication with one or more of holes 508 and an infusion conduit in communication with one or more of holes 508.

[0128] In one embodiment, see Fig.16A , Fig. 16B , tissue expander 600 advantageously includes a housing 602 and an injection port 604. Tissue expander 600 advantageously includes a series of radially extending holes 608 that can be used to drain fluid that has accumulated around the exterior of housing 602 and / or to infuse fluid from the holes to flow around the exterior of housing 602.

[0129] In one embodiment, see Fig.17, the tissue expander 700 preferably includes a housing 702 and an injection port 704 positioned in an opening of the housing 702. In one embodiment, the housing 702 preferably has a drainage opening 708 formed therein, and a drainage conduit 736 extending between the drainage opening 708 and the injection port 704.

[0130] In one embodiment, the injection port 704 preferably includes an injection compartment 755. A first one-way check valve 758A is positioned between the first end 734 of the drainage conduit 736 and the injection compartment 755. Under vacuum, the first one-way check valve 758A opens to allow fluid to be drawn into the injection compartment 755, such as by using the needle 742. Under pressure, the first one-way check valve 758A remains closed.

[0131] In one embodiment, tissue expander 700 preferably includes a second one-way check valve 758B that enables an inflation fluid (e.g., saline solution) to be introduced into injection compartment 755 and flow through second one-way check valve 758B into the interior of housing 702 to inflate tissue expander 700. Second one-way check valve 758B opens under pressure and remains closed under vacuum. Thus, first one-way check valve 758A opens under vacuum and second one-way check valve 758B opens under pressure, such that first one-way check valve 758A and second one-way check valve 758B are not opened at the same time. In one embodiment, the same syringe / needle 742 can be used to deliver inflation fluid into injection compartment 755 in a forward stroke and to discharge drainage fluid from injection compartment 755 in a reverse stroke.

[0132] In one embodiment, the injection port 704 of the tissue expander 700 desirably includes a third one-way check valve 758C located between the injection compartment 755 and the interior area of ​​the housing 702. The third one-way check valve 758C desirably opens under vacuum, but has a highly restricted orifice 765 so that the third one-way check valve 758C under vacuum will drain some saline back into the injection compartment 755 for flushing the compartment and also venting the tissue expander 700.

[0133] In one embodiment, see Fig.18 , the tissue expander 750 advantageously includes a housing 802 and an injection port 804. The injection port 804 advantageously includes a first injection chamber 855A communicating with a first check valve 858A and a second check valve 858B and a second injection chamber 855B communicating with a third check valve 858C. The membrane 865 separates the first injection chamber 855A from the second injection chamber 855B. The distal end of the injection needle 852 can pass through the membrane to enter the second injection chamber 855B to inject fluid into the second injection chamber 855B or remove fluid from the second injection chamber 855B.

[0134] In one embodiment, the first check valve 858A is coupled to a drainage conduit 836A that is in communication with a drainage opening 808A formed in the housing 802. The second check valve 858B is advantageously in communication with an infusion conduit 836B that is coupled with an infusion opening 808B formed in the housing 802 of the tissue expander 800. Under vacuum, the first one-way check valve 858A opens in the first injection chamber 855A to drain fluid accumulated around the tissue expander through the drainage opening 808A and the drainage conduit 836A. The drained fluid can be removed from the first injection chamber 855A using a needle 842. Under pressure, the second one-way check valve 858B opens in the first injection compartment 855A to allow infusion fluid to pass through the infusion conduit 836B to the infusion opening 808B. In one embodiment, therefore, the same syringe 842 can be used to deliver fluid (e.g., antibiotic solution) via infusion conduit 836B during a forward stroke and can be used to discharge drainage fluid (e.g., seroma) via drainage conduit 836A and drainage opening 808A during a reverse stroke.

[0135] In one embodiment, the third valve 858C is located in the second injection chamber 855B. The third valve 858C can be used to inflate and deflate the housing 802 of the tissue expander 800. Under pressure, the fluid in the second injection chamber 855B passes through the third valve 858C to inflate the housing 802. Under vacuum, the fluid in the housing 802 is drawn through the third valve 858C into the second injection chamber 855B, where the fluid can be drawn using the needle 842.

[0136] In one embodiment, see Fig.19 , the tissue expander 900 includes a housing 902 having an injection port 904. The injection port advantageously includes a first injection chamber 955A in communication with the drainage catheter 936A and a second injection chamber 955B in communication with the infusion tube 936B. In one embodiment, a first membrane 965A separates the first injection chamber 955A and the second injection chamber 955B from each other. In one embodiment, the injection port 904 may include an injection area marker for locating and distinguishing the first injection chamber 955A and the second injection chamber 955B, as disclosed in the commonly assigned U.S. Patent 9,636,210 to Hristov et al., the disclosure of which is hereby incorporated herein by reference. The injection area marker may be made of a material having an ultrasonically detectable marker incorporated therein. In one embodiment, the marker may include a plurality of microcavities positioned relative to the first and second injection chambers of the injection port so that when detected ultrasonically, such detection includes the location of the first and second injection chambers.

[0137] The tissue expander 900 advantageously includes a first check valve 958A coupled to a first end of the drainage conduit 936A. The drainage conduit 936A is in turn coupled to a drainage hole 908A disposed in the housing 902. Under vacuum within the first injection chamber 955A, the first check valve 958A opens to allow fluid to be drawn through the drainage opening 908A, the drainage conduit 936A, and the first one-way check valve 958A into the first injection chamber 885A to draw fluid from the first injection chamber using the needle 892.

[0138] The second check valve 958B is disposed at a first end of the infusion conduit 936B. The infusion conduit 936B has a second end coupled to an infusion hole 908B formed in the housing 902. Under the pressure in the second injection chamber 955B, the second one-way check valve 958B opens to allow the fluid injected into the second injection chamber 955B to pass through the second valve 908B, through the infusion conduit 936B and out of the infusion hole 908B to infuse the fluid to the outer surface of the housing.

[0139] In one embodiment, the third injection chamber 855C can be used to introduce fluid into the housing 852 to expand the size of the tissue expander or to withdraw fluid from the housing 902 to reduce the size of the tissue expander 900 (i.e., venting). In one embodiment, the tissue expander 900 advantageously includes a third valve 958C coupled to the third injection chamber 955C. The second membrane 965B separates the first injection chamber 955A and the second injection chamber 955B from the third injection chamber 955C. The needle 942 can pass through the first and second membranes for selective access to each of the injection chambers 955A to the injection chamber 955C. Under pressure, the third check valve 908C opens to allow a solution, such as a saline solution, to flow through the valve 908C and into the housing 902 to inflate the tissue expander 900. Under vacuum, the third check valve 958C opens to withdraw fluid from the housing 902 into the third injection chamber 955C to reduce the size of the tissue expander.

[0140] In one embodiment, see Fig. 20, the tissue expander 1000 advantageously includes a housing 1002 having a first injection port 1004A and a second injection port 1004B fixed to the housing 1002. In one embodiment, the first injection port 1004A includes a first injection chamber 1055A in communication with a first check valve 1058A and a second check valve 1058B. In one embodiment, the tissue expander 1000 includes a first drainage conduit 1036A having a first end coupled to a drainage port in communication with the first check valve 1058A. The drainage conduit 1036A preferably includes a second end coupled to a drainage hole 1008A formed in the housing 1002 of the tissue expander 1000. In one embodiment, when a vacuum is drawn inside the first injection chamber 1055A, the first check valve 1058A opens to allow any fluid that has accumulated around the exterior of the tissue expander 1000 to be drawn out through the drainage holes 1008A, through the drainage conduit 1036A, through the open first check valve 1058A and into the first injection chamber to draw the fluid out of the first injection chamber 1055A using the needle 1042.

[0141] In one embodiment, the second check valve 1058B is disposed between the first injection chamber 1055A and the first end of the infusion conduit 1036B. The infusion conduit 1036B has a second end connected to an infusion hole 1008B disposed in the housing 1002 of the tissue expander 1000. In one embodiment, when pressure is provided inside the first injection chamber 1055A, the second check valve 1058B opens to allow the infusion fluid to flow through the infusion conduit 1036B through the second check valve 1058B and out of the infusion hole 1008B to bathe the outside of the housing 1002 with the infusion fluid.

[0142] In one embodiment, the second injection port 1004B of the tissue expander 1000 can be used to inflate and deflate the housing 1002 of the tissue expander 1000. In one embodiment, the second injection port 1004B advantageously includes a second injection chamber 1055B and a third valve 1058C that open under pressure and vacuum. In one embodiment, when the inflation fluid is injected into the second injection chamber 1055B via the needle 1042, the fluid opens the third check valve 1058C under pressure, and the fluid enters the interior area of ​​the housing 1002 to inflate the tissue expander 1000. When a vacuum is drawn in the second injection chamber 1055B, the third check valve 1058C opens to allow the fluid inside the housing 1002 to be drawn out into the second injection chamber 1055B to be removed from the housing 1002, thereby deflation of the tissue expander 1000.

[0143] Fig.21Various systems and devices are shown that can be used to create a vacuum to drain fluid that has accumulated around a tissue expander disclosed herein after the tissue expander has been implanted in a patient. The device can be coupled to a drainage catheter, injection chamber, and / or injection port disclosed herein for withdrawing any fluid that has accumulated around the exterior of the housing of the corresponding tissue expander. In one embodiment, the system for creating a vacuum preferably includes a compressible bulb 1115. In one embodiment, a vacuum can be created using a flexible, compressible reservoir 1125 that draws a substantially constant vacuum to allow for uniform and continuous removal of fluid from a surgical incision through a wound drainage catheter, such as the surgical fluid drain disclosed in U.S. Pat. No. 4,429,693 to Blake et al., the disclosure of which is hereby incorporated by reference herein. In one embodiment, a system having a metering container 1035 can be used to create a vacuum to allow for uniform and continuous removal of fluid from a surgical site.

[0144] In one embodiment, see Fig.22A , Fig. 22B , the flow guide 140' preferably has an elongated cylindrical core 166' with four struts 168' that radially protrude from the core 166' along the longitudinal axis of the core. The radial struts 168' are preferably of equal size and are spaced at equal angles relative to each other. Each of the outer ends of the radial struts 168' has a corresponding overhang 170' that extends longitudinally throughout the entire length of the radial strut 168'. In one embodiment, as Figure 6B As shown, the overhang 170' is a thin arc-shaped member extending an equal distance on either side of its corresponding radial strut 168'. Therefore, the overhang 170' and the corresponding radial strut 168' are combined to form four T-shaped members. The size of the overhang 170' is set to form a segmented circle at the periphery of the drainage member 140', wherein there is a small gap between adjacent overhangs 170'. Each of these gaps forms a longitudinal groove 172', which is parallel to the longitudinal axis of the core 166' and extends throughout the entire length of the drainage member 140'. The core portion 166', the radial strut 168' and the overhang 170' are combined to form a plurality of channels or lumens 174' extending along the length of the drainage member 140'. The longitudinal groove 172' allows the fluid between the corresponding lumen 174' and the wound to be communicated. In one embodiment, the width of the longitudinal groove 172' is approximately 0.05-0.2 times the outer diameter of the drain 140', which ensures adequate tissue contact in the drainage area while inhibiting tissue growth or debris such as clots from entering the lumen 174'.

[0145] After breast reconstruction surgery, patients will be placed with surgical drains to prevent blood and lymph from accumulating under the skin, allowing for faster recovery. Some patients are sent home with drains implanted in the body and connected to external reservoirs. Emptying these reservoirs can be traumatic because the patient must measure and empty the reservoir every morning. Patients cannot wait to have the drains removed. It would be very beneficial for patients to have a device for removing seroma fluid without having to attach the drains 24 hours a day.

[0146] Although the foregoing relates to embodiments of the present invention, other and further embodiments of the present invention may be devised without departing from the basic scope of the present invention, which is limited only by the scope of the following claims. For example, the present invention contemplates that any feature shown in any embodiment described herein or incorporated by reference herein may be combined with any feature shown in any other embodiment described herein or incorporated by reference herein and still fall within the scope of the present invention.

Claims

1. A tissue expander with an integrated drainage member, comprising: a housing having an injection port opening and one or more drainage holes; an injection port disposed in the injection port opening of the housing, wherein the injection port forms a fluid-tight seal with the housing; The injection port includes a needle guard having a needle guard base with a top surface; The injection port includes a movable barrier membrane covering the top surface of the needle guard base, wherein the movable barrier membrane is movable between a first position for inflating and deflating the housing with a first fluid and a second position for draining a second fluid from outside the housing; When a needle is inserted into the injection port, the movable barrier film is movable from the first position to the second position.

2. The tissue dilator of claim 1, wherein the needle guard includes a needle guard edge extending upwardly from the needle guard base, and wherein the needle guard edge surrounds an outer periphery of the movable barrier membrane.

3. The tissue expander according to claim 2, further comprising: one or more inflation ports formed in the needle guard edge and configured to direct the first fluid into the housing to inflate the housing and remove the first fluid from the housing to deflate the housing; At least one drainage port is formed in the needle guard edge and is in fluid communication with the one or more drainage holes of the housing for withdrawing the second fluid from outside the housing via the one or more drainage holes. 4 . The tissue expander according to claim 3 , wherein the movable barrier membrane has a membrane edge at an outer periphery of the movable barrier membrane.

5. The tissue expander of claim 4, wherein when the movable barrier membrane is in the first position, the membrane edge closes the at least one drainage port and opens the one or more inflation ports, and wherein when the movable barrier membrane is in the second position, the membrane edge opens the at least one drainage port and closes the one or more inflation ports.

6. A tissue expander according to claim 5, wherein the needle guard base extends along a first axis and the needle guard edge extends along a second axis perpendicular to the first axis of the needle guard base, and wherein when the movable barrier membrane moves between the first position and the second position, the movable barrier membrane including the membrane edge moves up and down relative to the needle guard base along the second axis perpendicular to the first axis of the needle guard base.

7. The tissue expander according to claim 3, further comprising a drainage conduit having a first end in fluid communication with the at least one drainage port and a second end in fluid communication with the one or more drainage holes formed in the shell to drain the second fluid from outside the shell.

8. The tissue expander according to claim 1, further comprising: a magnet coupled to the movable barrier membrane; A compressible spring is coupled to the magnet, wherein the compressible spring is compressible to store energy when the movable diaphragm moves from the first position to the second position.

9. The tissue expander of claim 8, wherein the magnet has an upper end coupled to the underside of the movable barrier membrane and a lower end coupled to the compressible spring.

10. The tissue expander according to claim 8, further comprising: the needle, the needle being configured to be inserted into the injection port; A second magnet is coupled to the needle, wherein when the needle is inserted into the injection port, the second magnet repels the magnet coupled to the movable barrier membrane to move the movable barrier membrane from the first position to the second position.

11. A tissue expander with an integrated drainage member, comprising: a housing having an injection port opening and one or more drainage holes formed in the housing; an injection port, the injection port being disposed in the injection port opening; The injection port includes a needle guard having a needle guard base and a needle guard edge, wherein the needle guard edge extends upward from the needle guard base; one or more inflation ports formed in the needle guard rim and in fluid communication with an interior region of the housing; at least one drainage port formed in the needle guard edge and in fluid communication with the one or more drainage holes formed in the housing; a movable barrier membrane covering a top surface of the needle guard base and surrounded by the needle guard edge, wherein the movable barrier membrane is movable between a first position for closing the at least one drainage port and opening the one or more inflation ports, and a second position for opening the at least one drainage port and closing the one or more inflation ports; When a needle is inserted into the injection port, the movable barrier film is movable from the first position to the second position.

12. The tissue expander of claim 11, wherein the movable barrier membrane has an outer periphery and a membrane edge located at the outer periphery of the movable barrier membrane.

13. A tissue expander according to claim 12, wherein the needle guard base extends along a first axis and the membrane edge of the movable barrier membrane extends along a second axis perpendicular to the first axis of the needle guard base, and wherein when the movable barrier membrane moves between the first position and the second position, the movable barrier membrane including the membrane edge moves up and down relative to the needle guard base along the second axis perpendicular to the first axis of the needle guard base.

14. The tissue expander of claim 13, wherein when the movable barrier membrane is in the first position, the membrane edge closes the at least one drainage port and opens the one or more inflation ports, and wherein when the movable barrier membrane is in the second position, the membrane edge opens the at least one drainage port and closes the one or more inflation ports.

15. The tissue expander of claim 11, wherein the one or more inflation ports formed in the edge of the needle guard are configured to direct a first fluid into the shell to inflate the shell and remove the first fluid from the shell to deflate the shell, and wherein the at least one drainage port formed in the edge of the needle guard is fluidly connected to the one or more drainage holes formed in the shell to withdraw a second fluid from the outside of the shell.

16. The tissue expander of claim 11, further comprising: a magnet coupled to an underside of the movable barrier membrane; A compressible spring is coupled to the magnet, wherein the compressible spring is compressed to store energy when the movable diaphragm moves from the first position to the second position.

17. The tissue expander of claim 16, wherein the magnet has an upper end coupled to the underside of the movable barrier membrane and a lower end coupled to the compressible spring.

18. The tissue expander of claim 17, further comprising: the needle, the needle being configured to be inserted into the injection port; A second magnet is coupled to the needle, wherein when the needle is inserted into the injection port, the second magnet repels the magnet coupled to the movable barrier membrane to move the movable barrier membrane from the first position to the second position.

19. A tissue expander with an integrated drainage member, comprising: a housing having an injection port opening and one or more drainage holes formed in the housing; an injection port, the injection port being disposed in the injection port opening; The injection port includes a needle guard having a needle guard base extending along a first axis and a needle guard edge extending upward from the needle guard base; one or more inflation ports formed in the needle guard rim and in fluid communication with an interior region of the housing for introducing a first fluid into the housing; at least one drainage port formed in the needle guard edge and in fluid communication with the one or more drainage holes formed in the housing for draining a second fluid from outside the housing via the one or more drainage holes; a movable barrier membrane covering the top surface of the needle guard base and surrounded by the needle guard edge, wherein the movable barrier membrane is movable along a second axis perpendicular to the first axis of the needle guard base between a first position for closing the at least one drainage port and opening the one or more inflation ports, and a second position for opening the at least one drainage port and closing the one or more inflation ports; a magnet coupled to the movable barrier membrane; a compressible spring coupled to the magnet, wherein the magnet is disposed between the movable diaphragm and the compressible spring; a needle configured to be inserted into the injection port; and A second magnet is coupled to the needle, wherein when the needle is inserted into the injection port, the second magnet repels the magnet coupled to the movable barrier membrane to move the movable barrier membrane from the first position to the second position.

20. The tissue expander of claim 19, wherein the movable barrier membrane has an outer periphery and a membrane edge located at the outer periphery of the movable barrier membrane, the membrane edge extending along the second axis perpendicular to the first axis of the needle guard base, wherein when the movable barrier membrane is in the first position, the membrane edge closes the at least one drainage port and opens the one or more inflation ports, and wherein when the movable barrier membrane is in the second position, the membrane edge opens the at least one drainage port and closes the one or more inflation ports.

21. The tissue expander according to claim 19, further comprising a drainage conduit having a first end in fluid communication with the at least one drainage port and a second end in fluid communication with the one or more drainage holes formed in the shell, for draining the second fluid from outside the shell through the one or more drainage holes.

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