Device for Removal of Implants and Associated Method of Use

In one aspect, an implant removal device for removal of ruptured silicone breast implants includes a hollow container having a middle portion disposed between a first end and a second end. The device also has a connector port coupled to the second end that is coupled to a suction device during use. The device also includes a nozzle coupled to the first end that is configured for placement against an incision of a patient for removing a ruptured breast implant from the patient. The middle portion of the hollow container defines one or more vent holes extending between an interior and exterior container surface with the one or more vent holes configured to reduce negative pressure within the hollow container when the suction device is activated during the removal process.

TECHNICAL FIELD

This disclosure is directed, in general, to a device used to remove implants from a patient, and typically to devices and methods for the removal of silicone breast implants.

BACKGROUND

The following discussion of the background is intended to facilitate an understanding of the present disclosure only. It should be appreciated that the discussion is not an acknowledgement or admission that any of the material referred to was part of the common general knowledge at the priority date of the application.

A breast implant is a prosthesis used to change the size, shape, and contour of a human breast. Breast implants are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation), to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction), or to correct congenital defects in the chest wall. They are also used in revision surgeries, which correct or improve the result of an original surgery.

Breast implants are available in many different forms. There are two types of breast implants approved for sale in the United States: saline-filled breast implants (i.e., saline breast implants), in which an implant shell is filled with sterile salt water, and silicone-filled breast implants (i.e., silicone breast implants), in which the implant shell is filled with a silicone gel.

Both types have a silicone outer shell. They vary in size, shell thickness, shell surface texture, and shape (contour).

Ruptured silicone breast implants can result after placement into the human body. A rupture is a tear or hole in the outer shell of the breast implant. When this occurs in a saline breast implant, it deflates, meaning the saltwater (saline) solution leaks from the shell. Silicone gel is thicker than saline, so when a silicone gel-filled implant ruptures, the gel may remain in the shell or in the scar tissue that forms around the implant (intracapsular rupture). Silicone gel that leaks outside the capsule surrounding the implant may travel (migrate) away from the breast.

The leaked silicone gel may cause lumps to form in the breast or in other tissue, most often the chest wall, armpit or arm. It may be difficult or impossible to remove silicone gel that has traveled to other parts of the body. Ruptured silicone breast implants can cause breast pain or changes in the contour or shape of the breast. Accordingly, the FDA (Food and Drug Administration of the United States) recommends removing both saline-filled and silicone gel-filled breast implants if they have ruptured.

In many instances, it is desirable to remove the ruptured silicone breast implant and leaking silicone gel. Removal after rupture is a time consuming, tedious and difficult process. Typically, such removal is performed by manual extraction utilizing surgical sponges.

The present disclosure provides a simple, efficient device and associated method to address this problem. The device of the present disclosure is also appropriate for the removal of other types of implants from a patient, including un-ruptured silicone breast implants, saline breast implants, and buttocks implants and the like that include an outer shell that is filled with saline or silicone gel or another filling material.

SUMMARY

According to an illustrative embodiment, a removal device for removing an implant by an operator is presented. The removal device includes a hollow container extending between a first end and a second end along a longitudinal axis. A middle portion is disposed between the first and second ends. The hollow container has an interior container surface and an opposing, exterior container surface with the interior container surface defining a volume for receiving and containing the implant. The removal device further includes a connector port coupled to the second end of the hollow container and adapted for connection to a suction device. A nozzle is coupled to the first end of the hollow container, extending away from the first end along a nozzle axis. The nozzle has an interior nozzle surface and terminates at a nozzle opening. The hollow container defines a set of vent holes extending between the interior and exterior container surfaces with the set of vent holes configured to reduce negative pressure within the hollow container when the suction device is activated.

According to another illustrative embodiment, a removal device for removing an implant is presented. The removal device includes a hollow container extending between a first end and a second end along a longitudinal axis. A middle portion is disposed between the first and second ends. The hollow container has an interior container surface defining a volume for receiving and containing the implant. The removal device further includes a connector port coupled to the second end of the hollow container and adapted for connection to a suction device. A nozzle, having a cylindrical body, is coupled to the first end of the hollow container, extending away from the first end along a nozzle axis. The nozzle has an interior nozzle surface and terminates at a nozzle opening. The nozzle axis is offset from the longitudinal axis such that the nozzle opening is offset from the middle portion of the hollow container along the longitudinal axis for aligning with the implant during a removal process. The hollow container further includes a first plurality of vent holes positioned through the middle portion and a second plurality of vent holes positioned through the middle portion on an opposing side from the first plurality of vent holes. The first and second plurality of vent holes are configured to reduce negative pressure within the hollow container when the suction device is activated.

According to another illustrative embodiment, a method for removing an implant through an incision in skin of a patient using a suction device and a removal device is presented. The removal device includes a hollow container extending between a first end and a second end along a longitudinal axis. A middle portion is disposed between the first and second ends. The hollow container further includes an interior container surface and an opposing, exterior container surface with the interior container surface defining a volume. A nozzle is coupled to the first end of the hollow container. The nozzle extends away from the first end, wherein the hollow container defines one or more vent holes extending between the interior and exterior container surfaces. The method comprises the steps of coupling the suction device to the second end, grasping the hollow container with one hand of the operator, and inserting the removal device within the incision such that the nozzle opening is in proximity to the implant. The method further comprises the steps of activating the suction device to create a negative pressure within the volume of the hollow container, and adjusting the negative pressure to a desired negative pressure within the volume of the hollow container by adjusting the position of the one hand of the operator to uncover, partially cover or fully cover the one or more vent holes, with the desired negative pressure being a negative pressure from a minimum negative pressure to a maximum negative pressure. The method further comprises the step of drawing the implant from the patient through the nozzle and into the volume of the hollow container at the desired negative pressure. Other embodiments are disclosed below.

DETAILED DESCRIPTION

In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the inventions, and it is understood that other embodiments may be utilized and that logical structural, mechanical, electrical, and chemical changes may be made without departing from the spirit or scope of the invention. To avoid detail not necessary to enable those skilled in the art to practice the invention, the description may omit certain information known to those skilled in the art. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present inventions are defined only by the claims. Unless otherwise indicated, as used throughout this document, “or” does not require mutual exclusivity.

With reference to the Figures, an implant removal device21for use in an implant removal system20is disclosed herein that is configured for the removal of an implant, and in particular silicone gel-filled implants, from a patient during a surgical procedure. The disclosure also describes the use of the implant removal device21for removing an implant (shown as80inFIGS.6and7below), and in particular a silicone gel filled implant such as a breast implant, but could also be used in the removal of other implants that include a shell (shown as82inFIGS.6and7below) and a gel or other filling material (shown as silicone gel84inFIGS.6and7below), such as a saline-filled implant, a buttocks implant, or the like. For ease of description, the description of the shell82and the gel84as used hereinafter, refers to any type of implant80that includes such components, including but not limited to silicone-filled implants80such as illustrated inFIGS.6and7.

Referring first toFIGS.1-5, the implant removal device21disclosed herein is in the form of a hollow container22having a middle portion24disposed between a first end26and a second end28. In certain embodiments, the hollow container22is generally bottle-shaped, with the middle portion24being substantially circular or oval-shaped in cross-section. However, in other embodiments, the hollow container22may be shaped different. By way of example, as opposed to being substantially circular or oval-shaped in cross-section, the middle section24may be rectangular or triangular in cross-section, with the respective shapes of the first end26and second end28modified so as to correspond to the shape of the modified middle portion24.

The middle portion24, first end26, and the second end28collectively have an interior container surface30, which further defines a volume32, and an exterior container surface30and the exterior container surface34defines a thickness of the hollow container22corresponding to the middle portion24, first end26, or the second end28. The volume32of the hollow container22should be sufficient to contain the entirety of the implant shell and silicone gel of the implant (respectively identified by reference numerals82,84and80inFIG.6) removed during the surgical procedure. For example, in certain embodiments, the volume32may be between 100 and 5000 cubic centimeters, such as 1000 cubic centimeters, although in further embodiments smaller and larger volumes are contemplated.

In the embodiments illustrated, a longitudinal axis25may also be defined within the volume32that extends generally parallel to the length L1of the middle portion24in a direction from the first end26to the second end28. In embodiments wherein the middle portion24is symmetrical in cross-section, the longitudinal axis25may further defined as extending on a line that is equidistant from the interior container surface30of the middle portion24.

To aid in gripping the exterior container surface34of the device21, a series of one or more protrusions or recesses (shown here as protrusions35) may be included on the exterior container surface34of the hollow container22, such as on one or more protrusions35or recesses on the exterior container surface34of the middle portion24, the first end26, and/or the second end28(shown inFIGS.1A,1B,2,6and7) as being included on the middle portion24).

A nozzle40is coupled to the first end26of the hollow container22which extends transversely in a direction away from the first end26and the second end28. The nozzle40is configured for interfacing with the implant80through the surgical incision90(seeFIG.6) of a patient95during the surgical procedure to remove the implant80. In certain embodiments, the positioning of the nozzle40is offset from the longitudinal axis25, as will be described further below.

The nozzle40includes an interior nozzle surface44that extends outwardly from, or otherwise transitions outwardly from, the interior container surface34of the first end26. In addition, the nozzle40includes an exterior nozzle surface46that extends outwardly from, or otherwise transitions outwardly away from, the exterior container surface34of the first end26.

The interior container surface44of the nozzle40extends away from the first end26and terminates at a nozzle opening50. The nozzle opening50functions as the inlet port for the receipt of the ruptured breast implant shell82and silicone gel84to the volume32of the hollow container22during the surgical procedure. The nozzle opening50is open to the volume32of the hollow container22. The size of the nozzle opening50may vary depending upon the ultimate end use of the implant removal device21. In particular, the size of the nozzle opening50may be enlarged or diminished in cases where larger amounts of material, including the ruptured breast implant80, shell82, or gel84, is desired to be removed from the patient95.

As noted above, in certain embodiments, the nozzle40is coupled to the first end26such that it is offset relative to the longitudinal axis25. In particular, the nozzle40defines a nozzle axis27extending in a direction away from the first end26, and preferably away and transverse to the first end26, and in a direction that is parallel to, and radially spaced from, the longitudinal axis25. With this configuration, the nozzle40is more easily positioned such that it may be located in closer proximity to the incision90along the skin of the patient95when the device21is used to remove the implant80during the implant removal process as compared with a nozzle40aligned along the longitudinal axis25.

In certain embodiments, in addition to the nozzle opening50being offset from the longitudinal axis, the nozzle40is spaced from an exterior container surface34of the middle portion24toward the longitudinal axis25.

In certain embodiments, the nozzle opening50includes at least one recessed portion52and at least one gripping portion56. In further embodiments, the nozzle opening50includes a plurality of recessed portions52and a plurality of gripping portion56, with each of the gripping portions56separated from each other by one of the respective pair of recessed portions52, and vice versa. In the embodiments shown inFIGS.1-7, the nozzle opening50includes a pair of recessed portions52and a pair of gripping portions56, with each of the pair of gripping portions56separated from each other by one of the respective pair of recessed portions52.

In certain embodiments, the gripping portions56define a terminal end surface48having an apex58, with the apex58of each of the gripping portions56spaced further away from the first end26than the recessed portions52.

Further, in certain embodiments, each of the recessed portions52are curved the gripping portions56to define a curved end surface57. In these embodiments, the recessed portions52have a vertex54between respective apexes58of the gripping portions56. The distance between the apex58of the gripping portions56and the vertex54of the recessed portions52define a depth D1of the recessed portions52.

When the implant removal device20is used to remove the implant80, as will be described in further detail below with respect to the removal of a ruptured breast implant as illustrated inFIG.6, the terminal end surface48corresponding to the apex58of each of the gripping portions56is brought into proximity with, and preferably brought into contact with, the shell82of the implant80, and functions to aid in holding or otherwise gripping the shell82of the implant80during the removal process. In order to aid in this function, it is preferable that the nozzle40, and in particular the gripping portions56of the nozzle opening50, is formed from a material and has dimension to have sufficient rigidity that they resist deformation when contacting the shell82(i.e., the curved gripping portions56in particular and the nozzle40in general do not bend or collapse when contacting the shell82), and in particular being pressed against the shell82, during the process of removing the implant80. Further, the nozzle40and nozzle opening50also resist deformation while contacting the shell82as described above while negative pressure is applied to the device21during the process of removing the implant80.

It has been surprisingly and unexpectedly discovered that this offset positioning of the nozzle40relative to the longitudinal axis25and along the nozzle axis27, in combination with the rigidity of the nozzle40, and particularly in combination with the inclusion of one or more gripping portions56on the nozzle40, provides a maximum efficiency in the removal of the implant shell82and silicone gel84of the implant80during the removal process, as will be described in further detail below.

In certain embodiments, such as shown in the Figures herein, the first end26and the nozzle40are a one-piece structure, with the one-piece structure being is coupled to, or otherwise secured to, the distinct middle portion24to form the hollow container22prior to use.

Stated another way, the nozzle40is integrally formed with the first end26as a one-piece structure which is distinct from the structure of the middle portion24and second end28.

In certain embodiments, the hollow container22includes a first cap29defining the first end26, with an outer peripheral end42of the first cap29being coupled to the middle portion24. In particular, the outer peripheral end42of the first cap29is positioned adjacent to, or is otherwise coupled or sealed to, a terminal end region31of the middle portion24. In embodiments described below, the first cap29is shown as being press fit and/or ultrasonically welded to the middle portion24.

In certain of these embodiments, as best shown inFIGS.1A,4, and5, the outer peripheral end42of the first cap29includes a ledge45extending transverse from a shoulder47. The ledge45and shoulder47are shaped such that the outer surface49of the ledge45is press fit against the interior container surface30of the terminal end region31of the middle portion24and wherein the inward surface51of the shoulder47is adjacent to the outer terminal surface33of the middle portion24.

In certain alternative embodiments (not shown), as opposed to press fitting the ledge45of the first cap29to the interior container surface30of the middle portion24, the exterior container surface34of the middle portion24may be press fit to an inner surface51of the ledge45of the first cap29, with the inward surface51of the shoulder47still being adjacent to the outer terminal surface33(but wherein the shoulder47extends inwardly instead of outwardly. In certain related embodiments, in order to permanently secure the first cap29to the middle portion24in these alternative embodiments, an ultrasonic welding process may be performed, or an adhesive may be included, between the outer surface49and interior container surface30(or in the alternative arrangement between the inner surface51and the exterior container surface34), and/or between the inward surface51and the outer terminal surface33to secure or otherwise affix the first cap29to the middle portion24if desired.

In another alternative embodiment of the first cap29as shown inFIG.1B, as opposed to a press fitting the outer peripheral end42of the first cap29to the middle portion24, an inward terminal surface55of the outer peripheral end42of the first cap29may simply be abutted to the outer terminal surface33of the outer terminal region31of the middle portion24and be secured thereto via ultrasonic welding or through the use of an adhesive.

In certain embodiments, a connector port60is coupled to the second end28of the hollow container22. The connector port60, as best shown inFIG.4A, includes a connector receiving region62that is adapted for connection to the suction device100. In particular, as further shown inFIG.5, the connector interior region62is adapted to receive an external portion102of the suction device100.

In certain embodiments, the connector interior region62has an internal opening63that is open to, and forms a portion of, the volume32of the hollow container22. The internal opening63of the connector interior region62is also open with an internal opening103of the suction device100when the suction device100is coupled to the connector port60, with the internal opening103defined within the external portion102. As such, when negative pressure is actuated from the suction device100, suction is created (shown as arrow200inFIG.6) through the internal opening103, the internal opening63, and into the volume32of the hollow container22that is then used that draw the implant80(including the shell82and gel84) through the nozzle opening50and into the volume32.

In certain embodiments, such as shown inFIGS.4and4A, the connector port60is integrally formed with the second end28. In these embodiments, the inner surface64of the connector receiving region62, which defines the internal opening63, extends outwardly from, or otherwise transitions outwardly from the interior container surface30of the second end28in an opposite direction from the middle portion24relative to the nozzle40. Similarly, the connector receiving region62includes an outer surface66that extends outwardly from, or otherwise transitions outwardly away from the exterior container surface34of the first end26. The outer surface66also includes a depressed region69that receives a corresponding flange107of the external portion102of the suction device100to secure the suction device100to the connector portion60.

The connector port60also defines a connector axis65. In particular, the connector axis65is defined within the internal opening63and is generally aligned parallel to the length of the inner surface64of the connector port60.

In certain embodiments, such as shown in the Figures, the connector axis65is parallel to the nozzle axis27. In further embodiments, the connector axis65is offset from the longitudinal axis25. Still further, in certain embodiments, the connector axis65is offset from the longitudinal axis25and is radially spaced from the nozzle axis27relative to the longitudinal axis25.

In still further embodiments, the connector port60is coupled to the second end28and extends in a direction transverse to the longitudinal axis25. In certain of these embodiments, the connector port60is coupled to the second end28and extends in a direction normal to the longitudinal axis25.

In still further embodiments, as opposed to being coupled to the second end28, the connector port60is coupled to the middle portion24and extends in a direction transverse to the longitudinal axis25. In certain of these embodiments, the connector port60is coupled to the middle portion24and extends in a direction normal to the longitudinal axis25.

In certain other embodiments, the connector port60is a separate structure that is coupled to the second end28. In certain of these embodiments, the outer surface66of the connector port60is coupled to the interior container surface30of the second end28, while in further alternative embodiments the inner surface64of the connector port60is coupled around the exterior container surface34of the second end28. In either of these embodiments, ultrasonic welding or an adhesive material may be introduced between the connector port60and the second end28to secure the connector port60to the first end28. In embodiments wherein the connector port60is coupled to the middle portion24and is a separate structure from the middle portion24, a similar kind of coupling and securing via ultrasonic welding or through an adhesive can occur.

In certain embodiments, the hollow container includes a second cap70defining the second end28. In these embodiments, the second cap70is integrally formed with the middle portion24as a one-piece structure, such s best shown inFIGS.4and5.

Alternatively, the second cap70may be coupled to another terminal end surface (not shown) of the middle portion24in a manner like the connection of the first cap29to the terminal end region31of the middle portion24as described above.

The hollow container22, in certain embodiments, is formed from a material having physical properties, particularly in terms of leakage prevention, durability and strength, appropriate for the temporary acceptance of the shell82, any silicone gel84, and associated medical waste from the patient95. Preferably, the hollow container22is transparent such that a doctor can confirm the acceptance of the breast implant shell82, any silicone gel84, and associated medical waste from the patient95during the surgical procedure. In certain embodiments, however, the separate first end26(including the nozzle40) may be formed from an opaque material, such as an opaque plastic material. Still further, as noted above, the material used in the nozzle40should have sufficient rigidity to maintain its shape when pressed against the shell82of the implant80during the removal process. Yet still further, it is desirable that the material used in forming the hollow container22has sufficient rigidity and strength to withstand collapsing upon the introduction of negative pressure, in the range of 150-500 mm Hg (mercury), during the removal process. Even still further, it is desirable that such material retain their physical properties, including transparency, after a sterilization process such as through e-beam sterilization.

Illustrative materials for forming the hollow container22, or any component thereof (such as the nozzle40), include, but are not limited, thermoplastic materials such as polycarbonate. In certain embodiments, the materials for each separate piece of the hollow container22are formed from the same illustrative material, while in other embodiments the separate pieces may be formed of different materials, or slightly different formulations of the same general thermoplastic material. For example, in embodiments, wherein the first end26is formed from an opaque material, while the middle portion24and second end28are formed from a transparent material, the difference in such materials could simply occur by adjusting the formulations to include additives (such as including a fillers or pigments in the first end26that are not present, or present in differing amounts, in the middle portion24or second end28). Alternatively, the polymer composition of the thermoplastic materials may be different (such as through the use of a polycarbonate material in one instance and a polyurethane in another instance, or alternatively wherein the generally polycarbonate material is modified in some other manner (such as through changes in number average molecular weights or by modifying the structure to include additional chemical groups). Other materials, such as thermosetting polymeric materials or glass, may also form one or more of the separate components of the hollow container22.

In certain embodiments, a coating layer110is applied to the interior nozzle surface44of the nozzle40. The coating layer110is in the form of a low friction coating layer110formed from a low friction material, in which the outer surface112(shown inFIG.5) of the coating layer110, opposite the interior nozzle surface44, has lower surface friction than the corresponding surface friction of the interior nozzle surface44. In certain embodiments, in addition to forming a low surface friction outer surface, the coating material also is hydrophilic coating, which is believed to provide the outer surface layer with an increased amount of lubricity.

The lower surface friction properties of the outer surface112of the coating layer110, alone or in combination with the increase in hydrophilicity, aids in preventing the implant80and any associated residual medical waste (such as blood, tissue, water etc.) from a patient from adhering onto the outer surface112during use of implant removal device21in removing the implant80as compared with an uncoated interior nozzle surface44, thereby increasing the efficiency of the implant removal process.

In still further embodiments, in addition to having the lower surface friction properties, the outer surface112of the coating layer110may also provide increased durability properties, or enhanced durability properties, as compared with devices21not include such a coating layer110. Further, the coating layers110provided have sufficient bonding strength to the interior nozzle surface44such that they are not removed, delaminated, or otherwise degrade during the implant removal process.

Illustrative, non-limiting coating compositions used to form the coating layer110include low friction, hydrophilic coating compositions sold under the tradename Serene™, commercially available from Surmodics, Inc. of Eden Prairie, Minnesota and hydrophobic coating compositions sold under the tradename Hydak®, commercially available from Biocoat, Inc., of Horsham, Pennsylvania. However, other coating compositions for forming layers110having specific properties or combination of properties are also contemplated.

In even further embodiments, a flexible diaphragm may be provided that is positioned at the interface between the hollow container22and the suction device100, or within the interior of the hollow container22at a position near, along or adjacent to the connector port60, to separate the volume32of the hollow container25from the suction device100. The flexible diaphragm functions to limit contamination of the suction device100from the removed implant80during use, the flexible diaphragm also prevents the introduction of cross contamination into the volume32of the hollow container22, and into the patient95via the volume32of the hollow container22, from the outside environment. When included, the flexible diaphragm does not adversely impact the generation of negative pressure from the suction device100within the volume32of the hollow container22.

The present invention also is directed to an implant removal system20, including the afore-mentioned implant removal device21, and an associated method which is used in a surgical procedure to remove a ruptured silicone breast implant80from a patient95. In the implant removal system20, as shown inFIG.6, the implant removal device21is coupled to a suction device100, such as a wall suction device100coupled to and extending from a wall140within an operating room150which when actuated provides negative pressure, in the range of 150-500 mm Hg, within the volume32of the hollow container22and through the nozzle opening50sufficient to facilitate the removal of the shell82and silicone gel84from the patient95.

The suction device100is conventional in nature and is of the type found in hospital or medical settings to provide a vacuum source for surgical procedures. The suction device100may be mounted in an operating room150of a medical facility, or alternatively may be mobile.

In particular, as best shown inFIG.6, during the surgical procedure for removal on an implant, here shown as ruptured silicone breast implant80, a small incision90is made in the skin of a patient95in order to access the ruptured implant80.

The device21, which has been sterilized before use such as through e-beam sterilization as described above, is then brought into proximity with the incision90and is utilized to remove the implant80. More particularly, the device21is positioned on the surface of the skin near the incision90between the ends of the incision90, with the nozzle opening50positioned in close proximity to the skin of the patient95for easier insertion. The nozzle40is then inserted within the small incision90in the skin and brought into proximity to the implant80. The size of the small incision90is preferably roughly equal to the cross-sectional width to the nozzle40such that the nozzle40is surrounded bye the tissue and skin of the patient95after insertion, although the size could be larger if desired based on the preference of the doctor.

Preferably, during the insertion process, the gripping portions156are brought into pressing contact with the shell82of the implant80. As noted above, the rigidity of the nozzle40and the gripping portions156allows the device21to maintain its internal position within the incision90of the patient20during the implant removal process.

The suction device100is coupled to the connector port60either prior to the insertion of the nozzle40or after the insertion of the nozzle40. Typically this is accomplished by inserting the external portion102of the suction device100into the connector receiving portion62and securing the flange107into the depressed portion107of the outer surface66. The suction device100is then actuated, thereby creating negative pressure (i.e., vacuum suction) within the volume32of the hollow container22(shown by arrow200inFIG.6) sufficient to draw out the breast implant shell82and cohesive silicone gel84through the nozzle opening50of the device21and into the volume32of the hollow container22. As illustrated inFIG.6, a portion of the silicone gel84has been removed to the volume32, while the majority of the gel84contained in the shell82still remains in the patient95, such as immediately after actuation. As noted above, in certain embodiments, such negative pressure may be between 150 and 500 mm Hg. If needed, the negative pressure of the suction device100may be increased or decreased relative to the desired range. Because the middle portion24of the device21is transparent, the doctor can observe and confirm the introduction of the shell82and silicone gel84in the volume32of the hollow container22during the removal process as the negative pressure is actuated.

Upon confirmation, typically visual confirmation by the doctor, that a desired amount of the implant shell82and silicone gel84has been removed from the patient95and is visible through the transparent middle portion24in the volume32, the suction device100is turned off, and the device21is removed from the incision90, as shown inFIG.7. The suction device100is then disconnected from the connector port60. Any residual silicone gel84or shell82of the implant80that was not removed by the device21can be removed from the patient through the use of surgical sponges or other known manual extraction surgical techniques.

The device21, including the extravagated silicone gel84and shell82contained within the volume32of the hollow container22as best illustrated inFIG.7, may be disposed of as medical waste. Alternatively, such materials may be removed from the device21, and the device21can be cleaned, sterilized, and reused as desired.

The disclosed devices differ from what currently exists. For example, there is no implant removal device21available which is able to be sterilized prior to use and will assist in removal of an implant80(or the shell or gel), such as a ruptured breast implant, as is described herein. This invention is an improvement on what currently exists. The device removes the vast majority of the extravagated silicone and the shell and traps it into an easily disposed unit which substantially expedite the process as well as limits contamination.

While the device21is ideally suited for the removal of silicone breast implants, and in particular ruptured silicone breast implants, the device21is also appropriate for use, in the method described above, for removal of other types of implants having a shell and material contained within a shell (such as silicone gel, saline, or some other filling material).

Referring now toFIGS.8A-17, an illustrative embodiment of an implant removal device121for use in an implant removal system120will be described in more detail. The implant removal device121and the implant removal system120are similar to the implant removal device21and the implant removal system20described above with reference to FIGS.1A-7. However, the implant removal device121and implant removal system120include additional features that will be described in detail below.

The implant removal device121and implant removal system120are configured for the removal of the same types of implants from the same type of surgical sites as those described above with reference toFIGS.1A-7. Thus, the same reference numerals for the implant80, the shell82, the gel84, the surgical incision90and the patient95are used with reference toFIGS.8A-17.

Referring primarily toFIGS.8A-12, with occasional reference toFIGS.13-17, the implant removal device121includes a hollow container122having a middle portion124disposed between a first end126and a second end128. In certain embodiments, the hollow container122is generally bottle-shaped, with the middle portion124being substantially circular or oval-shaped in cross-section. However, in other embodiments, the hollow container122may have other shapes like those described above with reference to the implant removal device21ofFIGS.1A-7.

The middle portion124, the first end126, and the second end128collectively have an interior container surface130, which further defines a volume132, and an exterior container surface134opposite the interior container surface130. The distance between the interior container surface130and the exterior container surface134defines a thickness of the hollow container122. The volume132of the hollow container122should be sufficient to contain the entirety of the implant shell82and the silicone gel84of the implant80removed during the surgical procedure. For example, in certain embodiments, the volume132may be between 100 and 5000 cubic centimeters. In some embodiments the volume132is 1000 cubic centimeters. In yet other embodiments, smaller and larger volumes are contemplated should a less common size implant be removed.

In the embodiments illustrated, a longitudinal axis125may also be defined within the volume132that extends generally parallel to the length L1of the middle portion124in a direction from the first end126to the second end128. In embodiments wherein the middle portion124is symmetrical in cross-section, the longitudinal axis125may be further defined as extending on a line that is equidistant within the interior container surface130of the middle portion124.

To aid in gripping the exterior container surface134of the device121, a series of one or more protrusions or recesses (shown here as protrusions135) may be included on the exterior container surface134of the hollow container122. The protrusions135may be located on the middle portion124, the first end126, and/or the second end128of the exterior container surface134.

Referring now toFIGS.8A-17, the middle portion124of the hollow container122can be further defined as including a top side136, a bottom side137, a first side138, and a second side139(which is opposite the first side138), with the first side138and the second side139each connecting the top side136to the bottom side137. In one embodiment, a first set of vent holes111is formed in the first side138, such that the first set of vent holes111extend between the interior container surface130and the exterior container surface134. In another embodiment, a second set of vent holes113is formed in the second side139, such that the second set of vent holes113extend between the interior surface container130and the exterior surface container134. In yet another embodiment, the first and second sides138,139have their respective set of vent holes111,113formed therethrough. The open vent holes allow gas to pas therethrough between the exterior and interior. It should be appreciated that a set of vent holes may include one or more vent holes. In some aspects, the set of vent holes may include 1, 2, 3, 4, 5, 6, or more holes. As will be described below, the first and second set of vent holes111or113are configured to reduce negative pressure within the hollow container122when the suction device100is activated during a removal procedure (seeFIGS.13-17). Negative pressure may be used to refer to reduced pressure from ambient.

In the embodiments illustrated, the first set of vent holes111(seeFIGS.8A,8B,9, and13-17) is positioned on the first side138of the middle portion124of the hollow container122, while the second set of vent holes113(seeFIGS.8A,8B,11,12, and16) is positioned on the second side139of the middle portion124of the hollow container122.

The number, size, shape, and positioning of the first set of vent holes111on the first side138of the middle portion124of the hollow container122may vary, but preferably are configured in such a manner that each of the first set of vent holes111may be fully covered, partially covered, or uncovered by one or more fingers (collectively and individually labelled as reference numeral205) on one hand200of an operator, and more preferably by one finger205such as the index finger210on the one hand200of the operator, when utilizing the device121during a removal process.

Similarly, the number, size, shape, and positioning of the second set of vent holes113on the second side139of the middle portion124of the hollow container122may vary, but preferably are configured in such a manner that each of the first set of vent holes113may be fully covered, partially covered, or uncovered by a thumb220on the one hand200of an operator when utilizing the device121during a removal process. As intended herein, the fingers205and thumb220are on the same hand (i.e., either the right hand or the left hand, shown as the right hand200inFIGS.14-17).

A nozzle140is coupled to the first end126of the hollow container122which extends transversely in a direction away from the first end126and the second end128. The nozzle140is configured for interfacing with the implant80through the surgical incision90(seeFIG.14) of a patient95during the surgical procedure to remove the implant80. In certain embodiments, the positioning of the nozzle140is offset from the longitudinal axis125, as will be described further below.

The nozzle140includes an interior nozzle surface144that extends outwardly from, or otherwise transitions outwardly from, the interior container surface130of the first end126. In addition, the nozzle140includes an exterior nozzle surface146that extends outwardly from, or otherwise transitions outwardly away from, the exterior container surface134of the first end126.

The interior container surface144of the nozzle140extends away from the first end126and terminates at a nozzle opening50. The nozzle opening50functions as the inlet port for the receipt of the ruptured breast implant shell82and silicone gel84to the volume132of the hollow container122during the surgical procedure. The nozzle opening50is open to the volume132of the hollow container122. The size of the nozzle opening50may vary depending upon the ultimate end use of the implant removal device121. In particular, the size of the nozzle opening50may be enlarged or diminished in cases where larger amounts of material, including the ruptured breast implant80, shell82, or gel84, is desired to be removed from the patient95.

As noted above, in certain embodiments, the nozzle140is coupled to the first end126such that it is offset relative to the longitudinal axis125. In particular, the nozzle140defines a nozzle axis127extending in a direction away from the first end126, and preferably away and transverse to the first end126, and in a direction that is parallel to, and radially spaced from, the longitudinal axis125. With this configuration, the nozzle140is more easily positioned such that it may be located in closer proximity to the incision90along the skin of the patient95when the device121is used to remove the implant80during the implant removal process as compared with a nozzle140aligned along the longitudinal axis125.

In certain embodiments, in addition to the nozzle opening50being offset from the longitudinal axis, the nozzle140is spaced from an exterior container surface134of the middle portion124toward the longitudinal axis125.

In certain embodiments, the nozzle opening50includes at least one recessed portion152and at least one gripping portion156. In further embodiments, the nozzle opening50includes a plurality of recessed portions152and a plurality of gripping portion156, with each of the gripping portions156separated from each other by one of the respective pair of recessed portions152, and vice versa. In the embodiments shown in the Figures, the nozzle opening50includes a pair of recessed portions152and a pair of gripping portions156, with each of the pair of gripping portions156separated from each other by one of the respective pair of recessed portions152.

In certain embodiments, the gripping portions156define a terminal end surface148having an apex158, with the apex158of each of the gripping portions156spaced further away from the first end126than the recessed portions152.

Further, in certain embodiments, each of the recessed portions152are curved so as to define a curved end surface157. In these embodiments, the recessed portions152have a vertex154between a respective apexes158of the gripping portions156. The distance between the apex158of the gripping portions156and the vertex154of the recessed portions152define a depth D1(seeFIG.11) of the recessed portions152.

When the implant removal device120is used to remove the implant80, as will be described in further detail below with respect to the removal of a ruptured breast implant as illustrated inFIGS.14-17, the terminal end surface148corresponding to the apex158of each of the gripping portions156is brought into proximity with, and preferably brought into contact with, the shell82of the implant80, and functions to aid in holding or otherwise gripping the shell82of the implant80during the removal process. In order to aid in this function, it is preferable that the nozzle140, and in particular the gripping portions156of the nozzle opening50, is formed from a material and has dimension to have sufficient rigidity that they resist deformation when contacting the shell82(i.e., the curved gripping portions156in particular and the nozzle140in general do not bend or collapse when contacting the shell82), and in particular being pressed against the shell82, during the process of removing the implant80. Further, the nozzle140and nozzle opening50also resist deformation while contacting the shell82as described above while negative pressure is applied to the device121during the process of removing the implant80.

It has been surprisingly and unexpectedly discovered that this offset positioning of the nozzle140relative to the longitudinal axis125and along the nozzle axis127, in combination with the rigidity of the nozzle140, and particularly in combination with the inclusion of one or more gripping portions156on the nozzle140, provides a maximum efficiency in the removal of the implant shell82and silicone gel84of the implant80during the removal process, as will be described in further detail below.

In certain embodiments, such as shown in the Figures herein, the first end126and the nozzle140are a one-piece structure, with the one-piece structure being coupled to, or otherwise secured to, the distinct middle portion124to form the hollow container122prior to use. Stated another way, the nozzle140is integrally formed with the first end126as a one-piece structure which is distinct from the structure of the middle portion124and second end128.

In certain embodiments, the hollow container122includes a first cap129defining the first end126, with an outer peripheral end142of the first cap129being coupled to the middle portion124. In particular, the outer peripheral end142of the first cap129is positioned adjacent to, or is otherwise coupled or sealed to, a terminal end region131of the middle portion124. In embodiments described below, the first cap129is shown as being press fit and/or ultrasonically welded to the middle portion124.

In certain of these embodiments, as best shown inFIGS.8A,11and12, the outer peripheral end142of the first cap129includes a ledge145extending transverse from a shoulder147. The ledge145and shoulder147are shaped such that the outer surface149of the ledge145is press fit against the interior container surface130of the terminal end region131of the middle portion124and wherein the inward surface151of the shoulder147is adjacent to the outer terminal surface133of the middle portion124.

In certain alternative embodiments, as opposed to press fitting the ledge145of the first cap129to the interior container surface130of the middle portion124, the exterior container surface134of the middle portion124may be press fit to an inner surface151of the ledge145of the first cap129, with the inward surface151of the shoulder147still being adjacent to the outer terminal surface133but wherein the shoulder147extends inwardly instead of outwardly. In certain related embodiments, in order to permanently secure the first cap129to the middle portion124, an ultrasonic welding process may be performed, or an adhesive may be included, between the outer surface149and interior container surface130(or in the alternative arrangement between the inner surface151and the exterior container surface134), and/or between the inward surface151and the outer terminal surface133to secure or otherwise affix the first cap129to the middle portion124if desired.

In another alternative embodiment of the first cap129as shown inFIG.8B, as opposed to a press fitting the outer peripheral end142of the first cap129to the middle portion124, an inward terminal surface155of the outer peripheral end142of the first cap129may simply be abutted to the outer terminal surface133of the outer terminal region131of the middle portion124and be secured thereto via ultrasonic welding or through the use of an adhesive.

In certain embodiments, a connector port160is coupled to the second end128of the hollow container122. The connector port160, as best shown inFIG.11A, includes a connector receiving region162that is adapted for connection to the suction device100. In particular, as further shown inFIG.12, the connector interior region162is adapted to receive an external portion102of the suction device100.

In certain embodiments, the connector interior region162defines an internal opening163that is open to, and forms a portion of, the volume132of the hollow container122. The internal opening163of the connector interior region162is also open with an internal opening103of the suction device100when the suction device100is coupled to the connector port160, with the internal opening103defined within the external portion102. As such, when negative pressure is actuated (i.e., the suction device100is activated) from the suction device100, suction is created (shown as arrow200inFIG.13) through the internal opening103, the internal opening163, and into the volume132of the hollow container122that is then used that draw the implant80(including the shell82and gel84) through the nozzle opening50and into the volume132.

In certain embodiments, such as shown inFIGS.11and11A, the connector port160is integrally formed with the second end128. In these embodiments, the inner surface164of the connector receiving region162, which defines the internal opening163, extends outwardly from, or otherwise transitions outwardly from the interior container surface130of the second end128in an opposite direction from the middle portion124relative to the nozzle140. Similarly, the connector receiving region162includes an outer surface166that extends outwardly from, or otherwise transitions outwardly away from the exterior container surface134of the first end126. The outer surface166also includes a depressed region169that receives a corresponding flange107of the external portion102of the suction device100to secure the suction device100to the connector portion160.

The connector port160also defines a connector axis165. In particular, the connector axis165is defined within the internal opening163and is generally aligned parallel to the length of the inner surface164of the connector port160.

In certain embodiments, the connector axis165is parallel to the nozzle axis127(seeFIG.8B). In further embodiments, the connector axis165is offset from the longitudinal axis125. Still further, in certain embodiments, the connector axis165is offset from the longitudinal axis125and is radially spaced from the nozzle axis127relative to the longitudinal axis125.

In still further embodiments, the connector port160is coupled to the second end128and extends in a direction transverse to the longitudinal axis125. In certain of these embodiments, the connector port160is coupled to the second end128and extends in a direction normal to the longitudinal axis125.

In still further embodiments, as opposed to being coupled to the second end128, the connector port160is coupled to the middle portion124and extends in a direction transverse to the longitudinal axis125. In certain of these embodiments, the connector port160is coupled to the middle portion124and extends in a direction normal to the longitudinal axis125.

In certain other embodiments, the connector port160is a separate structure that is coupled to the second end128. In certain of these embodiments, the outer surface166of the connector port160is coupled to the interior container surface130of the second end128, while in further alternative embodiments the inner surface164of the connector port160is coupled around the exterior container surface134of the second end128. In either of these embodiments, ultrasonic welding or an adhesive material may be introduced between the connector port160and the second end128to secure the connector port160to the first end128. In embodiments wherein the connector port160is coupled to the middle portion124and is a separate structure from the middle portion124, a similar kind of coupling and securing via ultrasonic welding or through an adhesive can occur.

In certain embodiments, the hollow container122includes a second cap170defining the second end128. In these embodiments, the second cap170is integrally formed with the middle portion124as a one-piece structure, such as best shown inFIGS.11and12.

Alternatively, the second cap170may be coupled to another terminal end surface (not shown) of the middle portion124in a manner similar to the connection of the first cap129to the terminal end region131of the middle portion124as described above.

The hollow container122, in certain embodiments, is formed from a material having physical properties, particularly in terms of leakage prevention, durability and strength, appropriate for the temporary acceptance of the shell82, any silicone gel84, and associated medical waste from the patient95. Preferably, the hollow container122is transparent such that a doctor can confirm the acceptance of the breast implant shell82, any silicone gel84, and associated medical waste from the patient95during the surgical procedure. In certain embodiments, however, the separate first end126(including the nozzle140) may be formed from an opaque material, such as an opaque plastic material. Still further, as noted above, the material used in the nozzle140should have sufficient rigidity to maintain its shape when pressed against the shell82of the implant80during the removal process. Yet still further, it is desirable that the material used in forming the hollow container122has sufficient rigidity and strength to withstand collapsing upon the introduction of negative pressure, in the range of 150-500 mm Hg (mercury), and more preferably from 300 to 500 mm Hg during the removal process. Even still further, it is desirable that such material retain their physical properties, including transparency, after a sterilization process such as through e-beam sterilization.

Illustrative materials for forming the hollow container122, or any component thereof (such as the nozzle140), include, but are not limited, thermoplastic materials such as polycarbonate. In certain embodiments, the materials for each separate piece of the hollow container122are formed from the same illustrative material, while in other embodiments the separate pieces may be formed of different materials, or slightly different formulations of the same general thermoplastic material. For example, in embodiments, wherein the first end126is formed from an opaque material, while the middle portion124and second end128are formed from a transparent material, the difference in such materials could simply occur by adjusting the formulations to include additives (such as including a fillers or pigments in the first end126that are not present, or present in differing amounts, in the middle portion124or second end128). Alternatively, the polymer composition of the thermoplastic materials may be different (such as through the use of a polycarbonate material in one instance and a polyurethane in another instance, or alternatively wherein the polycarbonate material is modified in some other manner (such as through changes in number average molecular weights or by modifying the structure to include additional chemical groups). Other materials, such as thermosetting polymeric materials or glass, may also form one or more of the separate components of the hollow container122.

In certain embodiments, the coating layer110(same as the coating layer110described above with reference toFIGS.8-14) is applied to the interior nozzle surface144of the nozzle140. The coating layer110is in the form of a low friction coating layer110formed from a low friction material, in which the outer surface112(shown inFIG.12) of the coating layer110, opposite the interior nozzle surface144, has lower surface friction than the corresponding surface friction of the interior nozzle surface144. In certain embodiments, in addition to forming a low surface friction outer surface, the coating material also is a hydrophilic coating, which is believed to provide the outer surface layer with an increased amount of lubricity.

The lower surface friction properties of the outer surface112of the coating layer110, alone or in combination with the increase in hydrophilicity, aids in preventing the implant80and any associated residual medical waste (such as blood, tissue, water etc.) from a patient from adhering onto the outer surface112during use of implant removal device121in removing the implant80as compared with an uncoated interior nozzle surface144, thereby increasing the efficiency of the implant removal process.

In still further embodiments, in addition to having the lower surface friction properties, the outer surface112of the coating layer110may also provide increased durability properties, or enhanced durability properties, as compared with devices121not include such a coating layer110. Further, the coating layers110provided have sufficient bonding strength to the interior nozzle surface144such that they are not removed, delaminated, or otherwise degrade during the implant removal process.

Illustrative, non-limiting coating compositions used to form the coating layer110include low friction, hydrophilic coating compositions sold under the tradename Serene™, commercially available from Surmodics, Inc. of Eden Prairie, Minnesota and hydrophobic coating compositions sold under the tradename Hydak®, commercially available from Biocoat, Inc., of Horsham, Pennsylvania. However, other coating compositions for forming layers110having specific properties or combination of properties are also contemplated and could be used in combination with, or in the alternative to, the coating compositions described above if necessary or desired.

In even further embodiments, a flexible diaphragm may be provided that is positioned at the interface between the hollow container122and the suction device100, or within the interior of the hollow container122at a position near, along or adjacent to the connector port160, to separate the volume132of the hollow container125from the suction device100. The flexible diaphragm functions to limit contamination of the suction device100from the removed implant80during use, the flexible diaphragm also prevents the introduction of cross contamination into the volume132of the hollow container122, and into the patient95via the volume132of the hollow container122, from the outside environment. When included, the flexible diaphragm does not adversely impact the generation of negative pressure from the suction device100within the volume132of the hollow container122.

Referring now primarily toFIGS.13-17, with continued reference toFIGS.8A-12, the present disclosure also is directed to an implant removal system120, including the afore-mentioned implant removal device121, and an associated method which is used in a surgical procedure to remove a ruptured silicone breast implant80from a patient95. In the implant removal system120, as shown inFIG.13, the implant removal device121is coupled to a suction device100, such as a wall suction device100coupled to and extending from a wall140within an operating room150that when actuated provides negative pressure, in the range of 150-500 mm Hg, within the volume132of the hollow container122and through the nozzle opening50sufficient to facilitate the removal of the shell82and silicone gel84from the patient95.

The suction device100is conventional in nature and is of the type found in hospital or medical settings to provide a vacuum source for surgical procedures. The suction device100may be mounted in an operating room150of a medical facility, or alternatively may be mobile.

The subject disclosure is also directed to an associated method for removal a surgical implant80from a patient95, as shown inFIGS.14-17.

In particular, as best shown inFIGS.14,15and17, during the surgical procedure for removal on an implant80, here shown as a ruptured silicone breast implant80, a small incision90is made in the skin of a patient95in order to access the ruptured implant80.

The device121, which has been inspected and sterilized before use such as through e-beam sterilization as described above and preferably after the nozzle140has been briefly dipped into a basin of sterile solution, is then brought into proximity with the incision90and is utilized to remove the implant80. The device121is positioned on the surface of the skin near the incision90between the ends of the incision90, with the nozzle opening50positioned in closest proximity to the skin of the patient95for easier insertion. The nozzle140is then inserted within the small incision90in the skin and brought into proximity to the implant80. The size of the small incision90is preferably roughly equal to the cross-sectional width of the nozzle140such that the nozzle140is surrounded by the tissue and skin of the patient95after insertion, although the size could be larger if desired based on the preference of the doctor.

As shown clearly inFIG.14, preferably, during the insertion process, the gripping portions156are brought into pressing contact with the shell82of the implant80such that the nozzle140is sealed to the implant80. As noted above, the rigidity of the nozzle140and the gripping portions156allows the device121to maintain its internal position within the incision90of the patient120during the implant removal process.

The suction device100is coupled to the connector port160either prior to the insertion of the nozzle140or after the insertion of the nozzle140. Typically, this is accomplished by inserting the external portion102of the suction device100into the connector receiving portion162and securing the flange107into the depressed portion169of the outer surface166.

The suction device100is then actuated (i.e., activated), thereby creating negative pressure (i.e., vacuum suction/reduced pressure) within the volume132of the hollow container122(shown by arrow200inFIG.14) sufficient to draw out the breast implant shell82and cohesive silicone gel84through the nozzle opening50of the device121and into the volume132of the hollow container122. As illustrated inFIG.15andFIG.16, a portion of the silicone gel84has been removed to the volume132, while the majority of the gel84contained in the shell82still remains in the patient95, such as immediately after actuation. As noted above, in certain embodiments, such negative pressure may be between 150 and 500 mm Hg as defined by the system120as defined primarily by wall suction device100. Because the middle portion124of the device121is transparent, the doctor can observe and confirm the introduction of the shell82and silicone gel84in the volume132of the hollow container122during the removal process.

Upon confirmation, typically visual confirmation by the doctor, that a desired amount of the implant shell82and silicone gel84has been removed from the patient95and is visible through the transparent middle portion124in the volume132, the suction device100is turned off (i.e., deactivated) and the negative pressure is relieved fully, and the device121is removed from the incision90, as shown inFIG.17. The suction device100is then disconnected from the connector port160. Any residual silicone gel84or shell82of the implant80that was not removed by the device121can then be removed from the patient through the use of surgical sponges or other known manual extraction surgical techniques.

If needed, the negative pressure of the suction device100may be increased or decreased relative to a desired range of negative pressure by covering or uncovering the first and/or second set of vent holes111,113, as described and illustrated inFIGS.14-17, for safely removing the implant80while minimizing damage to the tissue of the patient95.

In particular, the negative pressure of the suction device100may be defined as varying between a maximum negative pressure when the nozzle140is sealed against the implant80and wherein each of the first and second set of vent holes111,113present are covered by the one hand200of the operator and a minimum negative pressure when the nozzle140is sealed against the implant80and wherein each of the first and second vent holes111,113present are uncovered by the one hand200of the operator. A desired negative pressure for removing the implant80may thus be defined as a being a negative pressure that ranges from the maximum negative pressure to the minimum negative pressure, and includes pressures between the maximum negative pressure and the minimum negative pressure when one or more, but less than all, of the first or second set of vent holes111,113are either partially or fully uncovered (i.e., at least one of the first or second set of vent holes111or113is at least partially covered and at least one of the first or second set of vent holes111or113is at least partially uncovered).

Accordingly, to precisely control the negative pressure utilized to remove of the implant80, the following procedure may be utilized. For ease of description, the removal device system ofFIG.13is utilized in the description ofFIGS.14-17below.

In particular, the nozzle140is inserted within the small incision90in the skin and brought into proximity and preferably into sealing contact to the implant80prior to activating the wall suction device100. The operator holding the hollow container122with the one hand200uncovers each of the first set of vent holes111present on the first side138of the middle portion124by moving the fingers205, such as the index finger210, to uncover each of vent holes111. In addition, the operator holding the hollow container122with the same one hand200uncovers each of the second set of vent holes113present on the second side139of the middle portion124by moving the thumb to uncover each of vent holes113. With the vent holes111,113preferably uncovered, the wall device100is then activated, creating the minimum negative pressure (during use) in the hollow container200. If the negative pressure is sufficient, the implant80will be sucked into the cavity132of the hollow container122through the nozzle opening50.

If the negative pressure is not sufficient to remove the implant80, the operator may cover one or more the first set of vent holes111using one or more of the fingers205and/or cover one or more of the second set of vent holes113using the thumb225on the one hand to increase the pressure.

For example, the user may uncover one or more, but not all, of the first set of vent holes111on the first side138of the middle portion124of the hollow container122(such as covering two of the five vent holes111present using the index finger210as shown in the embodimentFIG.14) to increase the negative pressure to a desired negative pressure between the minimum negative pressure and the maximum negative pressure.

Alternatively, as shown inFIG.15, the operator may cover all of the first set of vent holes111present on the first side138using one or more of the fingers205(such as the index finger210as shown inFIG.15) to increase the negative pressure to a desired negative pressure greater than the minimum negative pressure. Assuming that the same number of the second set of vent holes113are covered by the thumb225on the one hand200on the opposing side inFIGS.14and15(not shown), the negative pressure in the hollow container122inFIG.15is greater therefore than the negative pressure in the hollow container122ofFIG.14. If all of the second set of vent holes113are covered by the thumb225(or in embodiments wherein there are no vent holes113), the negative pressure inFIG.15is the maximum negative pressure for the system120.

Still further, and in another alternative as shown inFIG.16, the operator may cover one or more of the second set of vent holes113using the thumb225(shown inFIG.16as covering all five of the second set of vent holes113) to increase the negative pressure to a desired negative pressure greater than the minimum negative pressure. Assuming that the same number of the first set of vent holes111are covered by the fingers205on the one hand200on the opposing side as illustrated inFIG.14or inFIG.15(not shown), the negative pressure in the hollow container122inFIG.16is greater therefore than the negative pressure in the hollow container122ofFIG.14and greater than the negative pressure in the hollow container122ofFIG.15. If all of the first set of vent holes111are covered by the fingers (or in embodiments wherein there are no vent holes111), the negative pressure inFIG.16is the maximum negative pressure for the system120.

In instances where sealing contact with the implant80is lost, the operator may uncover the first set of vent holes111and/or the second set of vent holes113and reposition the device121and resume the removal process. Still further, to stop the suction process at any time, operator may uncover the first set of vent holes111and/or the second set of vent holes113, deactivate the wall suction device100, and remove the device from the incision at any time.

Once the implant80has been removed, the operator removes the device121from the incision90of the patient95and deactivates the suction device100. Preferably, the suction device100is deactivated prior to removal. Even still further, in certain embodiments, it is preferable to uncover one or more of the first set of vent holes111(seeFIG.17) and/or the one or more of the second set of vent holes113prior to the removal of the device121from the incision, and in certain instances prior to the deactivation of the suction device100.

The device121, including the extravagated silicone gel84and shell82contained within the volume132of the hollow container122as best illustrated inFIG.17, may be disposed of as medical waste. Alternatively, such materials may be removed from the device121, and the device121can be cleaned, sterilized, and reused as desired.

While the device121is ideally suited for the removal of silicone breast implants, and in particular ruptured silicone breast implants, the device121is also appropriate for use, in the method described above, for removal of other types of implants having a shell and material contained within a shell (such as silicone gel, saline, or some other filling material). In addition, the device121is contemplated for use in removing objects that are not implants. By way of non-limiting examples, such objects could include the removal of other substances or objects from an animal or objects from a structure, particularly objects sized and having the flexibility to be drawn through the nozzle opening140and into the hollow container122at the negative pressures contemplated herein.

Although the present invention and its advantages have been disclosed in the context of certain illustrative, non-limiting embodiments, it should be understood that various changes, substitutions, permutations, and alterations can be made without departing from the scope of the invention as defined by the claims. It will be appreciated that any feature that is described in a connection to any one embodiment may also be applicable to any other embodiment.