Patent Description:
Breast implants, also known as breast prostheses, have been successfully utilized since the <NUM>'s. The implants consist of an outer elastomeric shell and a fill material. In most implants, the fill material is a silicone polymer. From time to time, it may become necessary to remove a breast implant. The most often encountered reason for doing so is a malfunction of the implant, for example, a leak of the silicone fill material outside of the outer shell.

As time progresses, the outer elastomer shell of some breast implants may deteriorate allowing the fill material to leak out. This process is commonly known as gel bleed. In other circumstances, a frank disruption of the outer elastomeric shell occurs leading to direct leakage of the fill material. Other circumstances can also be indications for implant removal including, but not limited to, capsular contracture, implant malposition, a patient's desire for size change, and/or a patient's desire for implant removal.

Regardless of the indication for removal, actually removing the breast implant from the scar pocket, commonly known as a capsule, which naturally forms and surrounds the breast implant can present a technical and often time-consuming challenge in the operating room. More specifically, the breast implant must be brought out through a small opening in the scar pocket and skin and, preferably, removed intact. Grasping the implant digitally or with an instrument such as a clamp can lead to, or enlarge, an existing tear in the outer elastomeric shell of the implant. This is particularly true in cases of ruptured or leaking implants where the outer shell can be extremely fragile and/or partially or fully disintegrated. In such cases, removal of a ruptured or leaking breast implant and leaked material can require significant amounts of operating room time to complete.

The difficulty of removal is exacerbated by the fill material, which is commonly a silicone polymer and has a tendency to adhere to everything including, for example, breast tissue, skin, surgeon's gloves, and/or surgical instruments. As such, the silicone polymer fill material is difficult to work with and contain and requires a significant effort to clean from breast tissue and surgical instruments. Further complicating matters, fill material or gel left within the breast pocket can lead to granuloma formation which can create palpable and visible irregularities.

Accordingly, a need exists for a device and related method of efficiently removing an intact or a ruptured breast implant while containing the fill material.

Further prior art can be found in<NPL>. Also, related art can be found in <CIT>.

In accordance with the purposes and benefits described herein, a device for removing a breast implant from a patient is disclosed having the features of independent claim <NUM>. Dependent claims disclose embodiments.

In an embodiment of this disclosure, the step of applying a positive air pressure to the housing includes connecting an air line to a connector attached to the housing.

In yet another possible embodiment, the method further includes the step of assembling first and second portions of the housing.

In another possible embodiment, the housing defines an interior chamber for receiving the breast implant.

In yet another possible embodiment, the housing includes a proximal portion defining the orifice.

In still another possible embodiment, the housing includes a suction port.

In yet still another possible embodiment, the step of applying suction to the housing sufficient to draw the breast implant through the orifice includes the step of connecting in-wall suction to the suction port.

In one other possible embodiment, the step of applying suction to the housing sufficient to draw the breast implant through the orifice includes the step of connecting one of a vacuum pump, a syringe, or a hand operated pump to the suction port.

In another possible embodiment, the suction port is positioned on a distal portion of the housing.

In yet one other possible embodiment, the suction port is positioned on a distal end of the housing.

In another possible embodiment, the suction port extends from a distal end of the housing.

In yet another possible embodiment, the suction port is a barbed connector.

In still another possible embodiment, the step of connecting in-wall suction to the suction port includes connecting tubing between the in-wall suction and the suction port.

In yet still another possible embodiment, the step of connecting one of a vacuum pump, a syringe, and a hand operated pump a vacuum pump to the suction port includes connecting tubing between the one of the vacuum pump, the syringe, and the hand operated pump and the suction port.

In one other possible embodiment, the step of connecting one of a vacuum pump, a syringe, and a hand operated pump to the suction port includes connecting tubing between the one of the vacuum pump, the syringe, and the hand operated pump and the barbed connector.

In another possible embodiment, the step of exposing the breast implant includes the step of making an incision through the patient's skin.

In yet another possible embodiment, the step of exposing the breast implant includes the step of making an incision through a capsule at least partially surrounding the breast implant.

In one other possible embodiment, the housing includes a ring.

In another possible embodiment, the ring extends from the housing.

In yet another possible embodiment, the ring includes a rounded inner edge defining the orifice of the housing.

In still another possible embodiment, the ring includes an outer lip.

In yet still another possible embodiment, the step of positioning an orifice of a housing in contact with the breast implant includes positioning the ring in contact with the breast implant.

In one other possible embodiment, the step of exposing the breast implant includes the step of making an incision through the patient's skin, and wherein the step of positioning the ring in contact with the breast implant includes the step of inserting the ring through the incision in the patient's skin.

In another possible embodiment, the step of positioning the ring in contact with the breast implant includes the step of positioning the ring such that edges created by the incision in the patient's skin rest behind the ring during removal of the breast implant.

In yet one other possible embodiment, the step of exposing the breast implant includes the step of making an incision through the patient's skin and a capsule at least partially surrounding the breast implant, and wherein the step of positioning the ring in contact with the breast implant includes the step of inserting the ring through the incisions in the patient's skin and the capsule.

In another possible embodiment, the step of positioning the ring in contact with the breast implant includes the step of positioning the ring such that edges created by the incision in the capsule rest behind the ring during removal of the breast implant.

In yet another possible embodiment, the ring is integrally formed with the housing.

In yet still another possible embodiment, the step of assembling first and second portions of the housing.

In one other possible embodiment, the method further includes the step of performing a partial capsulectomy.

In another possible embodiment, the step of performing a partial capsulectomy occurs prior to removal of the breast implant.

In yet one other possible embodiment, the method further includes the step of performing a total capsulectomy.

In another possible embodiment, the step of performing a total capsulectomy occurs prior to removal of the breast implant.

In yet another possible embodiment, the step of applying suction to the housing sufficient to draw the breast implant through the orifice includes the step of applying suction to the housing sufficient to draw the breast implant and the capsule through the orifice.

In yet still another possible embodiment, the method further includes the step of disposing of the breast implant into a waste receptacle.

In yet still another possible embodiment, the method further includes the step of disposing of the housing, including the removed breast implant, into a waste receptacle.

In another possible embodiment, the housing includes a ring.

In yet another possible embodiment, the ring is fixed in position.

In yet still another possible embodiment, the ring extends from the housing.

In one other possible embodiment, a neck is formed between the ring and the proximal portion of the housing.

In another possible embodiment, the neck extends the ring and the orifice away from the distal portion of the housing.

In yet one other possible embodiment, the ring includes a rounded inner edge defining the orifice of the housing.

In another possible embodiment, the ring includes an outer lip.

In yet still another possible embodiment, the suction port extends from the distal portion of the housing.

In one other possible embodiment, the proximal portion and the distal portion are separable.

In another possible embodiment, the proximal portion and the distal portion are halves.

In yet one other possible embodiment, the proximal portion and the distal portion are frustoconically shaped.

In yet still another possible embodiment, the proximal portion and the distal portion are shaped to accommodate nesting one within the other when not in use.

In one other possible embodiment, the suction port extends through the orifice when the distal and proximal portions are in a nested position.

In another possible embodiment, the proximal portion and the distal portion are threaded for connecting the proximal portion and the distal portion.

In yet one other possible embodiment, the device further includes one of a vacuum pump, a syringe, and a hand operated pump.

In another possible embodiment, the device further includes tubing for connecting the one of the vacuum pump, the syringe, and the hand operated pump to the suction port.

In yet another possible embodiment, the device further includes at least one grip.

In yet still another possible embodiment, the at least one grip is a detent formed in the housing.

In one other possible embodiment, the at least one grip is elevated.

In another possible embodiment, the elevated grip is a rubber material.

In another possible embodiment, the ring is fixed in position.

In yet another possible embodiment, the ring extends from the housing.

In yet still another possible embodiment, a neck is formed between the ring and the proximal portion of the housing.

In one other possible embodiment, the neck extends the ring away from the distal portion of the housing.

In another possible embodiment, the ring includes a rounded inner edge defining the orifice.

In yet one other possible embodiment, the ring includes an outer lip.

In still yet another possible embodiment, the ring is integrally formed with the housing.

In one other possible embodiment, the suction port extends from the distal portion of the housing.

In another possible embodiment, the proximal portion and the distal portion are separable.

In yet another possible embodiment, the proximal portion and the distal portion are halves.

In another possible embodiment, the proximal portion and the distal portion are frustoconically shaped.

In yet one other possible embodiment, the proximal portion and the distal portion are shaped to accommodate nesting one within the other when not in use.

In yet still another possible embodiment, the suction port extends at least partially through the ring when the distal and proximal portions are in a nested position.

In one other possible embodiment, the proximal portion and the distal portion are threaded for connecting the proximal portion and the distal portion.

In another possible embodiment, the device further includes one of a vacuum pump, a syringe, and a hand operated pump.

In still another possible embodiment, the device further includes tubing for connecting the one of the vacuum pump, the syringe, and the hand operated pump to the suction port.

In yet still another possible embodiment, the device further includes at least one grip.

In still another possible embodiment, the at least one grip is a detent formed in the housing.

In one other possible embodiment, the at least one grip is elevated. In another, the elevated grip is a rubber material.

In the following description, there are shown and described several preferred embodiments of a device for removing a breast implant and related methods of removing a breast implant of a patient. As it should be realized, the devices and methods are capable of other, different embodiments and their several details are capable of modification in various, obvious aspects all without departing from the methods and devices as set forth and described in the following claims. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not as restrictive.

The accompanying drawing figures incorporated herein and forming a part of the disclosure, illustrate several aspects of the invention and together with the description serve to explain certain principles thereof. In the drawing figures:.

Reference will now be made in detail to the present preferred embodiments of the device and related methods for removing breast implants, examples of which are illustrated in the accompanying drawing figures, wherein like numerals are used to represent like elements.

Reference is now made to <FIG> which illustrates a device <NUM> for removing a breast implant (I) from a patient. The breast implant may be removed intact or when leaking fill material. References to breast implants within this specification refer to the breast implant including the outer elastomeric shell and the fill material, whether the shell is intact or the fill material has leaked out of the shell, and/or a capsule which naturally foms at least partially around breast implants. In other words, a reference to contacting the breast implant (I) includes contacting the fill material if leaked out, the outer shell, and/or the capsule.

The device <NUM> consists of a first, proximal portion <NUM> and a second, distal portion <NUM> which together form a housing. In the described embodiment, the proximal and distal portions are generally halves which are separable. Each portion <NUM>, <NUM> consists primarily of a solid wall <NUM>, <NUM> and together define an interior chamber for receiving the breast implant (I). Other embodiments of the device <NUM>, however, may include a unitary housing wherein the proximal and distal portions are not separable.

Each of the proximal and distal portions <NUM>, <NUM> are generally frustoconical in shape, in the described embodiment, and join together to form the housing along base ends <NUM>, <NUM>. Of course, other shapes (e.g., round, oval, oblong, conical, at least partially cylindrical, etc.) may be utilized. Overall, any shape may be utilized, and the shape of the proximal and distal portions <NUM>, <NUM> should be selected to accommodate the volume of the breast implant (I) and provide sufficient mechanical strength to avoid a collapse of the device <NUM> under vacuum pressure which is the driving force for removal or extraction of the breast implant.

The total volume of the interior chamber, adding both proximal and distal portions <NUM>, <NUM> together, should be sufficient to remove large-sized breast implants. In other words, the volume of the chamber is at least <NUM> cc capacity or greater, in the described embodiment, to accommodate the removal of large-sized breast implants. Of course, other embodiments may utilize smaller chamber volumes and/or specifically sized chamber volumes on a patient to patient basis.

As shown in <FIG> and <FIG>, the proximal portion <NUM> of the housing defines an orifice, designated reference numeral <NUM>, through which the breast implant (I) passes during removal. More specifically, the orifice <NUM> is positioned in contact with the breast implant (I) during the removal process such that a seal is formed between the housing and the breast implant sufficient to allow vacuum pressure to draw the breast implant from the patient and into the housing.

In the described embodiment, the housing includes an integrally formed ring <NUM> that is fixed in position and extends from the proximal portion <NUM> of the housing. In this position, best shown in <FIG>, a neck <NUM> is formed between the ring <NUM> and the proximal portion <NUM> of the housing such that the neck extends the ring and the orifice <NUM> away from the distal portion <NUM> of the housing.

As shown, the described ring <NUM> includes a rounded inner edge <NUM> that defines the orifice <NUM> in one embodiment. Other embodiments may not utilize a ring and the proximal portion itself may define the orifice. The rolled inner edge <NUM> provides a substantially smooth and mechanically advantageous ingress for the breast implant (I) being removed. The ring <NUM>, including the rolled inner edge <NUM>, may be made of a lubricious material or a medical lubricant may be applied thereto to limit friction between the breast implant (I), possibly leaked/leaking fill material (M), and the rolled inner edge as the implant passes through the orifice <NUM> during the removal process.

The described ring <NUM> also includes a flared, rounded, or rolled outer lip <NUM> as shown in <FIG> and <FIG>. The outer lip <NUM> helps to assist with a smooth insertion into an incision in the patient's skin (D) and, possibly, a capsulotomy incision. Further, the outer lip <NUM> assists with retention of the device <NUM> within the incision(s) and maintains edges of incision(s) in an open position when the ring/orifice <NUM> is positioned in contact with the breast implant (<NUM>) during removal. In other words, the ring <NUM> is inserted through the incision(s) and positioned such that the ring is contacting the breast implant (I). In this position, the incision edges extend around the outer lip <NUM> and rest behind the ring <NUM> which is generally adjacent the neck <NUM>. While the ring <NUM> and defined orifice are described as round in one embodiment, the orifice and/or ring may take essentially any shape including, for example, oval or oblong.

As shown in <FIG> and <FIG>, a suction port <NUM> extends from the distal portion <NUM> of the housing in the described embodiment. The suction port <NUM>, however, may be positioned in any location on the housing. The suction port <NUM> is a nipple or barbed connector, in the described embodiment, designed to receive tubing connected to a suction source <NUM> (e.g., a vacuum pump, a syringe, and/or a hand operated pump). Various other connectors may be used to connect the device <NUM> to a suction source as is known in the art. In the described embodiment, the suction source <NUM> is a vacuum pump. Operating rooms typically provide a suction source which may be a vacuum pump located in a remote area or within the operating room itself. In some instances, portable vacuum pumps, syringes, or even hand operated pumps may be supplied with the device <NUM> for utilization in operating rooms which are void of a suitable suction source. In each instance, however, the device <NUM> is connected to the suction source <NUM> utilizing tubing <NUM> as shown in <FIG>.

At a distal end <NUM> of the distal half <NUM>, shown in <FIG> and <FIG>, a nipple or barbed connector <NUM> receives a hose (not shown) to provide vacuum pressure for use in removal and/or forced air for use in the insertion process. Vacuum and air sources and/or hoses are universally available for surgical procedures in operating rooms. In alternate embodiments, a tube or hose may extend from the housing with the connector attached thereto for mating with a vacuum/fluid hose or vacuum/fluid source connector.

As shown in <FIG> and noted above, the proximal and distal portions <NUM>, <NUM> are separable and generally frustroconical in shape in the described embodiment. This shape, and others, accommodate nesting of the portions one within the other when not in use. In one embodiment, the suction port <NUM> extends through the orifice <NUM> when the distal and proximal portions are in the nested position. Nesting the portions in general is particularly useful for packaging the preoperative device <NUM>. Of course, other shapes may be utilized so long as they provide sufficient mechanical rigidity under vacuum pressure or the device may be a unitary structure as described above.

As further shown, the proximal portion <NUM> and the distal portion <NUM> are connected by a simple threaded mechanism. The connection between the two portions <NUM>, <NUM> provided by the mechanism is air tight in order to maintain vacuum pressure and also prevent leaking of any silicone polymer fill material received within the device <NUM>. More specifically, a distal end <NUM> of the proximal portion <NUM> has a screw thread <NUM> that combines with a mating screw thread <NUM> of the distal portion <NUM> forming the connection. Of course, other types of mechanical connections may be utilized in lieu of the threaded mechanism in alternate embodiments such as, but not limited to, press fit connections, friction fit connections, butt connections with a separate connection ring, or a compression band. Further, gaskets or O rings may be utilized in all such embodiments to ensure an air tight seal or the above-described unitary design may be utilized.

As an added convenience, one or more grips <NUM> may be provided on one or both of the proximal and distal portions <NUM>, <NUM> to assist the user in assembly and disassembly thereof. As best shown in <FIG> and <FIG>, the grips <NUM> may be detents formed in the one or both portions <NUM>, <NUM>. While shown as generally oval in shape in the described embodiment, the grips <NUM> may take any shape sufficient to provide improved gripping of the portions <NUM>, <NUM> during use and/or assembly/disassembly. Even more, the grips may be elevated (not shown) extending above an outer surface of the housing. The elevated grips may be made of a rubber or like material and may provide a rigid and/or a tacky feel for the user. Of course, other types and numbers of grips may be utilized in alternate embodiments.

As noted above, a device <NUM> may be a unitary structure as shown in <FIG>. In other words, the device <NUM> may be a single piece unit thereby eliminating threaded mechanism <NUM> between the proximal and distal portions <NUM>, <NUM> of the earlier described device <NUM>. The alternate device <NUM> similarly includes proximal and distal portions <NUM>, <NUM> which define an interior chamber, and generally includes walls, <NUM>, <NUM>, a defined orifice <NUM>, a suction port <NUM>, and a ring <NUM> in at least the described embodiment. Other than the unitary nature of the housing, the device <NUM> is the same as the above described embodiment and alternative embodiments thereof. Even more, the unitary device <NUM> is intended for disposal after a single use.

In all embodiments, caps (not shown) may be provided to seal off the proximal opening and/or distal suction port prior to and/or post operation. In addition, the devices <NUM>, <NUM> may be created using materials suitable for biohazardous waste disposal.

The method of removing a breast implant (I) of a patient referred to above in describing devices used therein includes the steps of exposing the breast implant, positioning an orifice of the device in contact with the breast implant, and applying suction to the device sufficient to draw the breast implant through the orifice. The method is further described with reference to an embodiment of the device <NUM> described above.

The device <NUM> is supplied in a sterile condition. The user first assembles the two portions <NUM>, <NUM> of the device <NUM> together using the threaded mechanism <NUM>. Once together, the device <NUM> is ready for use. Surgically, a capsule (C) which naturally forms at least partially around the breast implant (I) is exposed via incisions through skin (S), breast tissue (T), and muscle depending on the placement of the breast implant. If a partial or total capsulectomy procedure is to be completed, the desired steps may be performed prior to or after removal of the breast implant (I).

As part of the described removal process, a capsulotomy incision is created in the capsule (C) thereby directly exposing the breast implant (I). The capsulotomy incision is necessarily sized large enough to admit the ring <NUM> in the described method. This allows for direct contact between the device <NUM> and the breast implant (I) which necessarily includes the outer shell (S) and/or fill material (M) if the outer shell of the breast implant (I) has dissolved or is disrupted. In other words, the orifice <NUM> of the device <NUM> is positioned in contact with the breast implant.

In the described method, the ring <NUM> defines the orifice and is positioned in contact with the breast implant (I) by inserting the ring through the incision in the patient's skin (D) and capsule (C). In alternate methods, the capsule (C) may not be breached and the ring <NUM> may be inserted through the incision in the patient's skin (D) and positioned in contact with the capsule.

With the ring <NUM> inserted through the incision in the patient's skin (D) and capsule (C) and positioned in contact with the breast implant (I), the outer lip <NUM> of the ring <NUM> assists with retention of the device <NUM> within the incision(s) and maintains edges of the incision(s) in an open position. In other words, edges created by the incision in the patient's skin (D) extend around the outer lip <NUM> and rest behind the ring <NUM> during removal of the breast implant (I). Again, if an incision is made in the capsule (C), then edges of the capsule incision likewise rest behind the ring <NUM>. Even more specifically, edges of the incision(s) rest in a recess behind the ring <NUM> which is generally adjacent the neck <NUM>.

Subsequent to inserting the ring <NUM> and positioning the orifice <NUM> in contact with the breast implant (I), a suction source <NUM> is connected to the suction port <NUM>. As described above, the suction port <NUM> may be a nipple or barbed connector <NUM>, for example, which is positioned at the distal end of the distal portion <NUM> of the device <NUM> in the described embodiment. In the described embodiment, tubing <NUM> is utilized to connect the suction port <NUM> to the suction source <NUM>. Again, the suction source <NUM> may be a vacuum pump <NUM> provided with the device <NUM> or located in an operating room or in a basement of a building wherein the operating room is located. In alternative embodiments, a syringe or hand operated vacuum source may be utilized as the suction source. In other words, a suction source may be provided with the device or an existing suction source may be utilized by connecting the device thereto.

Once connected, the suction source <NUM> is initiated applying suction to the housing sufficient to draw the breast implant (I) through the orifice. In other words, the suction source <NUM> is initiated drawing air out of the internal chamber of the device <NUM> through the tubing <NUM>. The negative pressure created by the vacuum draws the implant (<NUM>) through the orifice <NUM> in the ring <NUM> or proximal portion <NUM> and into the internal chamber of the device (<NUM>). For reference, the breast implant (I) being removed will move along a proximal to distal direction during the removal process.

The natural cohesivity of the implant (I) including its outer shell (S) and fill material (M) ensure that the entire implant, including any leaked fill material or gel, is drawn into the interior chamber of the housing. In addition, if the capsule (C) has been fully mobilized from its surrounding soft tissue attachments prior to removal of the implant (I), the capsule typically accompanies the breast implant (<NUM>) into the interior chamber. In other words, the suction applied to the housing is sufficient to draw the breast implant (I) and the capsule (C) through the orifice. It should be noted that the suction source <NUM> can be connected to the suction port <NUM> prior to insertion of the ring <NUM> and/or positioning of the orifice in contact with the breast implant (I). Similarly, the suction source <NUM> may be initiated at any time throughout the process.

If the user desires to inspect the breast implant (I) now contained in the interior chamber of the device <NUM>, then the proximal and distal portions <NUM>, <NUM> may be separated opening the device and granting access to the breast implant. If the breast implant (I) is intact, it may be removed from the interior chamber for further inspection and/or disposal into a suitable biohazardous waste receptacle <NUM>. The two portions <NUM>, <NUM> of the device <NUM> may then be reassembled, and the same device may be used to remove a contralateral breast implant, if desired.

In the event the breast implant (I) is ruptured or there has been substantial gel bleed, it is recommended not to remove the breast implant from the interior chamber as doing so may expose the operative field to the sticky polymer fill material (M) or gel. Rather, the breast implant (I) and device <NUM> may be disposed of within the biohazardous waste receptacle <NUM> with or without caps applied to the ring <NUM> and/or distal suction port <NUM> as desired to seal the breast implant (I) within the interior chamber. A new removal device <NUM> may be used for extraction of the contralateral breast implant. In the event the one-piece alternate embodiment of the device <NUM> is utilized, it is preferable to use one removal device <NUM> per breast implant (I). In this scenario, the breast implant (I) resident in the interior chamber of the device <NUM> may not be taken out for inspection or otherwise.

The foregoing has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the embodiments to the precise form disclosed. Obvious modifications and variations are possible in light of the above teachings. For instance, the integrally formed ring that is fixed in position and extends from the proximal portion of the housing may not be integrally formed. The ring and a neck section extending therefrom may be attached to the proximal portion <NUM> of the device <NUM>. For example, the ring and neck section may be screwed into the proximal portion <NUM> such that removal is possible. In this manner, the ring may extend any desired distance from the proximal portion <NUM> subject only to the length of the neck.

Claim 1:
A device (<NUM>) for removing a breast implant from a patient, comprising:
a housing defining an interior chamber for receiving the breast implant, the housing having distal and proximal portions (<NUM>, <NUM>), and a suction port (<NUM>), characterized by: a ring (<NUM>) attached to the proximal portion (<NUM>), and the ring having a rounded inner edge (<NUM>) defining an orifice (<NUM>) through which the breast implant passes during removal, wherein the orifice (<NUM>) is defined such that a seal is formed between the ring (<NUM>) and the breast implant during removal of the breast implant.