Breast implant removal devices and related methods

Abstract

The present invention relates to a device for removing breast implants, filler material, and / or capsules from a patient. The device includes a housing having a proximal portion and a distal portion. The distal and proximal portions together define an internal chamber that receives the breast implant, filler material, and / or capsule. A rigid ring secured to the proximal portion deforms and guides the breast implant, filler material, and / or capsule toward an entrance to the internal chamber. The funnel has an internal diameter that tapers toward the distal end of the funnel, where the internal diameter is smallest. The removal device further includes a suction port, and the proximal and distal portions of the housing each occupy at least 25% of the total volume of the internal chamber. In another embodiment, the ring is replaced with a flared end of the housing, which serves the same or similar function.

Description

[Technical Field]

[0001] This application claims priority to U.S. Patent Application No. 17 / 991,283, filed November 21, 2022, which is incorporated herein by reference in its entirety.

[0002] The present invention relates generally to breast prostheses or implants, and more particularly to devices for use in removing breast implants. [Background technology]

[0003] Breast implants, also known as breast prostheses, have been used successfully since the 1960s. The implant consists of an outer elastic shell and a filler material. In most implants, the filler material is a silicone polymer. Occasionally, breast implants need to be removed. The most common reason for this removal is implant malfunction, such as leakage of the silicone filler material from the outer shell.

[0004] Over time, degradation of the outer elastic shell of some breast implants can result in leakage of filler material. This degradation process is commonly known as gel bleed. In other cases, the outer elastic shell may clearly rupture, resulting in direct leakage of filler material. There are other circumstances in which implant removal is indicated, including, but not limited to, capsular contracture, implant displacement, patient requests for resizing, and / or patient requests for implant removal.

[0005] Regardless of the indication for removal, the actual removal of a breast implant from the scar pocket, known as the capsule, that forms and surrounds it is a technically challenging and time-consuming procedure in the operating room. More specifically, the breast implant must be released through the scar pocket and a small opening in the skin, and it must be removed intact. Grasping the implant with fingers or using instruments such as clamps to grasp the implant can cause or amplify tears in the implant's outer elastic shell. This is particularly true for dehiscence or leaking implants, which occur when the outer shell is extremely fragile and / or partially or completely broken. In such cases, removal of a dehiscence or leaking breast implant or leaked filler material requires a significant amount of operating room time to complete.

[0006] The challenge of removal is further exacerbated by the filler material, which is usually a silicone polymer that tends to stick to everything, including breast tissue, skin, surgical gloves, and / or surgical instruments. The silicone filler itself is difficult to handle and encapsulate, and requires considerable effort to keep it clean from breast tissue and surgical instruments. Further complicating matters is the formation of filler or gel remaining in the breast pocket, which can lead to the formation of palpable, visible granulomas.

[0007] In one attempt to solve the problems associated with removing leaking or dehiscenced breast implants, a 1-liter saline bottle is used as a housing to receive the removed implant. Specifically, a breach smaller than the bottle's neck is created in the breast capsule. The neck is passed through the skin breach and placed over the capsule breach. A vacuum is then applied to the opposite end of the bottle. The vacuum pressure draws the breast implant, including any loose fill material from the dehiscenced or leaking breast implant, into the bottle through these breaches. Following implant removal, a sponge is packed into the pocket within the capsule to facilitate capsule removal, thus facilitating the capsulorhexis procedure.

[0008] While this relatively crude device is often sufficient to remove breast implants and loose filler material, if present, several challenges remain. First, positioning the bottle neck over a smaller tear poses challenges for the user in creating and maintaining a vacuum seal. Even when the initial seal is successfully created, it is easily broken during removal, primarily due to the lack of restraints on the bottle neck or edge, resulting in unpredictable movement.

[0009] In other words, the bottle neck is not secured within any of the lacerations, allowing the neck to move freely during the procedure. This movement can be caused by the user, the forces associated with the vacuum created within the bottle, and / or the retention forces created by the implant contacting the capsule lacerations, and possibly the skin lacerations. Because the capsules are often inelastic and sometimes calcified, they can become hard and brittle, and the capsule lacerations may not open sufficiently to allow the breast implant and filler material to simply be expelled.

[0010] Vial movement is further exacerbated by the collapsible nature of the vial's sidewall, which makes it difficult to grasp the vial during the procedure. This can result in the need for multiple attempts to remove the breast implant due to reasons including leaked filler and its potential spread into the treatment area. Depending on the size of the patient's skin tear, unless an excessive tear is utilized, uncontrolled expulsion of the implant can occur, potentially causing further tearing of the tear. Furthermore, maintaining an initial seal becomes even more difficult. These compounding issues can lead to inconsistent results and, in some cases, unnecessary patient harm.

[0011] Yet another attempt to solve the problems associated with removing leaking or dehiscenced breast implants involves an implant removal device disclosed in U.S. Patent Application Publication No. 2020 / 0281626, inventors Bateman et al. In the Bateman device, a nozzle is coupled to a hollow container. The nozzle has a fixed-diameter neck extending from the container and includes a plurality of recessed gripping portions that contact the implant. These recessed gripping portions function to help hold or grasp the implant during removal. Like the neck, the hollow container itself maintains a constant diameter throughout, and frictional forces generated by contact with the container and neck slow the progress of the implant during removal. While the Bateman device functions to remove the implant, several drawbacks arise due to the deceleration forces generated by the fixed-diameter neck and, therefore, the fixed-diameter container.

[0012] Therefore, a need remains for devices and related methods that can efficiently and consistently remove intact breast implants, dehiscenced or leaking breast implants and leaked filler, intact breast implants and capsules, and / or dehiscenced or leaking breast implants, leaked filler, and capsules without further harming the patient. Minimizing the deceleration forces experienced by the implant during the removal procedure by utilizing a varying diameter meets these challenges. The ability to remove the breast implant from the device following removal from the patient would have the advantage of allowing the removed implant to be inspected, any markings identified, and its volume / capacity determined. [Prior art documents] [Patent documents]

[0013] [Patent Document 1] U.S. Patent Application Publication No. 2020 / 0281626 Summary of the Invention

[0014] In accordance with the objects and advantages described herein, the present invention provides a device for removing breast implants, filler material, and / or capsules from a patient. The device has a proximal portion and a distal portion. The distal portion and proximal portion together define an internal chamber that receives the breast implant, filler material, and / or capsule. A rigid ring affixed to the proximal portion defines a funnel that deforms the breast implant, filler material, and / or capsule and guides it toward the entrance of the internal chamber. The funnel has an internal diameter that tapers toward the distal end of the funnel, where the internal diameter is smallest. The device further includes a suction port.

[0015] In yet another possible embodiment, the inner diameter of the proximal portion of the housing increases from the entrance to the internal chamber to the distal end of the proximal portion of the housing.

[0016] In yet another possible embodiment, the inner diameter of the distal portion of the housing decreases from the proximal end of the distal portion of the housing to the distal end of the distal portion of the housing.

[0017] In another possible embodiment, the inner diameter of the distal end of the proximal portion of the housing and the inner diameter of the proximal end of the distal portion of the housing are the same.

[0018] In yet another possible embodiment, the proximal and distal portions of the housing are separable and are separated by a connecting portion having substantially the same inner diameter from the proximal end to the distal end of the central portion.

[0019] In yet another possible embodiment, the smallest inner diameter of the proximal portion of the housing is substantially the same as the smallest inner diameter of the funnel and increases from the proximal end of the proximal portion to the distal end of the proximal portion.

[0020] In another possible embodiment, the proximal and distal portions of the housing each occupy at least 25% of the total volume of the interior chamber.

[0021] In another embodiment, a device for removing breast implants, filler material, and / or capsules from a patient has a housing comprising a proximal portion and a distal portion that together define an internal chamber for receiving the breast implant, filler material, and / or capsules, a ring attached to the proximal portion that defines a funnel for directing the breast implant, filler material, and / or capsules toward an entrance to the internal chamber, and a suction port. In this embodiment, the inner diameter of the distal portion of the housing decreases from the proximal end to the distal end of the distal portion of the housing.

[0022] In another possible embodiment, the inner diameter of the distal end of the proximal portion of the housing and the inner diameter of the proximal end of the distal portion of the housing are the same.

[0023] In yet another possible embodiment, the proximal and distal portions of the housing are separable and are separated by a connecting portion having a substantially uniform inner diameter.

[0024] In yet another possible embodiment, the smallest inner diameter of the proximal portion of the housing is substantially the same as the smallest inner diameter of the funnel, increasing from the proximal end of the proximal portion to the distal end of the proximal portion.

[0025] In another possible embodiment, the proximal and distal portions each occupy at least 25% of the total volume of the internal chamber.

[0026] Yet another embodiment of the present invention relates to a device for removing breast implants, filler material, and / or capsules from a patient. The device includes a housing having a proximal portion and a distal portion separated by a central portion, which together form an internal chamber for receiving the total volume of the breast implant, filler material, and / or capsules. In this embodiment, the proximal portion and the distal portion of the housing each occupy at least 25% of the total volume of the internal chamber. A ring is attached to the proximal portion, which forms a funnel with a decreasing internal diameter toward the entrance of the housing, guiding the breast implant, filler material, and / or capsules. The device further includes a suction port.

[0027] In another possible embodiment, the inner diameter of the proximal portion of the housing increases from the entrance to the central portion of the housing.

[0028] In yet another possible embodiment, the inner diameter of the distal portion of the housing decreases from a central portion of the housing toward the distal end of the distal portion of the housing.

[0029] In yet another possible embodiment, the inner diameter of the distal end of the proximal portion of the housing and the inner diameter of the proximal end of the distal portion of the housing are the same.

[0030] In another possible embodiment, the proximal and distal portions of the housing are separable, and the inner diameter of the distal end of the proximal portion of the housing and the inner diameter of the proximal end of the distal portion of the housing are substantially the same as the inner diameter of the central portion of the housing.

[0031] In yet another possible embodiment, the smallest inner diameter of the proximal portion of the housing is substantially the same as the smallest inner diameter of the funnel and increases from the proximal end of the proximal portion of the housing to the distal end of the proximal portion of the housing.

[0032] In yet another possible embodiment, the flat surface forms a central portion of the housing.

[0033] In yet another possible embodiment, the inner diameter of the distal portion of the housing decreases from a central portion of the housing toward the distal end of the distal portion of the housing.

[0034] The following description, with reference to the drawings, describes several preferred embodiments of a device for removing breast implants, fillers, and / or capsules and an associated method for removing breast implants and fillers. It should be noted that the device and method are capable of other different embodiments and that the details thereof are susceptible to various modifications and variations, all of which are obvious without departing from the methods and devices as claimed and disclosed. Accordingly, the accompanying drawings and description are intended to be illustrative and not limiting. [Brief explanation of the drawings]

[0035] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and provide a description below illustrating some principles of the invention. [Figure 1] FIG. 1 is a perspective view of an apparatus for removing breast implants, fillers, and / or capsules from a patient. [Figure 2]FIG. 2 is a perspective view of the end of the device for removing breast implants, fillers, and / or capsules, showing the ring forming the funnel attached or secured to the end of the proximal portion of the housing. [Figure 3] FIG. 3 is a perspective side view of a breast implant, filler, and / or capsule removal device in a partially disassembled state. [Figure 4] FIG. 4 is a partial cross-sectional view of the proximal portion of the housing showing the funnel formed by the ring and the inlet of the housing. [Figure 5] FIG. 5 is a cross-sectional view of a breast implant, filler, and / or capsule removal device showing the ring contacting the intact breast implant during the initial stage of the implant removal procedure. [Figure 6] FIG. 6 is a perspective view showing the first and second portions of the breast implant, filler, and / or capsule removal device in a nested position. [Figure 7] FIG. 7 is a perspective view of another embodiment of an integrated breast implant, filler, and / or decapsulation device. [Figure 8A] FIG. 8A is a partial cross-sectional view of the proximal portion of the housing showing the funnel formed by the large flared end of the proximal portion of the housing. [Figure 8B] FIG. 8B is a partial cross-sectional view of the proximal portion of the housing showing the funnel formed by the flared end of the proximal portion of the housing. [Figure 9] FIG. 9 is a perspective side view of another embodiment of a device for removing a breast implant, filler material, and / or capsule in a partially disassembled state. DETAILED DESCRIPTION OF THE INVENTION

[0036] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A preferred embodiment of an apparatus and associated method for removing breast implants, fillers, and / or capsules from a patient is described in detail below, examples of which are illustrated in the accompanying drawings, in which like reference numerals refer to like elements.

[0037] Reference is now made to FIG. 1, which illustrates an apparatus 10 for removing a breast implant from a patient. Breast implants can be removed intact or with or without a capsule that naturally forms at least partially around the breast implant upon leakage of filler material. Breast implants herein refer to breast implants having an outer resilient shell and filler material, where the shell may be intact or the filler material may have leaked from the shell and / or capsule. In other words, when referring to contacting the breast implant, it means contacting the filler material, outer shell, and / or capsule, if there is leakage, unless otherwise specified.

[0038] The device 10 comprises a first proximal portion 12 and a second distal portion 14, which together form a housing. In this embodiment, the proximal and distal portions are two separable parts. Each portion 12, 14 primarily comprises a solid wall 16, 18 of varying diameter, which together define an internal chamber for receiving the breast implant. However, other embodiments of the device 10 may utilize a one-piece housing in which the proximal and distal portions are inseparable, as described below.

[0039] In this embodiment, the proximal and distal portions 12, 14 each have a generally frustoconical shape and join to form a generally biconical housing. Of course, other shapes (e.g., circular, oval, rectangular, conical, at least partially cylindrical, etc.) can also be used, and the portions can have different shapes. Generally, any shape can be used, but the shapes of the proximal and distal portions 12, 14 should be selected to accommodate the volume of the breast implant, stabilize the shape of the device 10 under vacuum pressure, and provide sufficient mechanical strength to prevent collapse. In other words, a solid wall, regardless of shape, has sufficient strength and / or rigidity to prevent collapse under vacuum pressure, which is the driving force required to remove or extract a breast implant.

[0040] The total volume of the internal chamber, including the proximal and distal portions 12, 14, must be sufficient to allow for the removal of large breast implants. In other words, in the embodiments described herein, the volume of the internal chamber is at least 600 cc or greater to accommodate the removal of large breast implants. Of course, other embodiments may use smaller chamber volumes and / or chamber volumes of specific sizes on a patient-by-patient basis. In yet another embodiment, the proximal and distal portions 12, 14 each comprise at least 25% of the total volume of the internal chamber.

[0041] As best seen in FIG. 4 , the housing includes an integrally formed ring 26 that, in the embodiments described herein, is attached to, fixed in position relative to, and / or extends from the proximal portion 12 of the inner housing. More specifically, ring 26 includes a funnel (generally designated by reference numeral 28) that deforms and guides the breast implant, filler material, and / or capsule toward the entrance to the internal chamber through which the breast implant passes during removal. As shown, the inner diameter of funnel 28 tapers toward, and is smallest at, the distal end of the funnel. In other words, funnel 28 terminates at its distal end in a plane perpendicular to and intersecting ring 26, as indicated by line A.

[0042] Ring 26 also defines an entrance where proximal end 30 of housing proximal portion 12 meets the ring substantially defined by the second plane, as shown by line B in Figure 4. This entrance is defined by the housing / ring 26 at proximal end 30 of proximal portion 12 where the inner diameter of the proximal portion is smallest. Between the distal end of funnel 28 (line A) and the entrance (line B), the inner diameter of ring 26 continues to change, becoming larger in this embodiment.

[0043] As can perhaps be seen from the best mode illustrated in Figure 5, the inner diameter of the proximal housing portion 12 increases from the proximal end 30 to the distal end 20 of the proximal housing portion. This increasing diameter limits the amount of deceleration force acting on the breast implant during the removal procedure. Conversely, the inner diameter of the distal housing portion 14 decreases from its widest point adjacent the connecting portion 40 (which in some embodiments is the proximal end 22 of the distal housing portion 14) to the distal end 24 of the distal housing portion. In the distal housing portion 14, this decreasing inner diameter increases the deceleration force generated by the breast implant's contact with the housing, providing a braking function that slows the breast implant during the removal procedure.

[0044] As further shown, the ring 26 is positioned to contact the breast implant (I) during the removal procedure, creating a seal between the ring and the breast implant and sufficient vacuum pressure to draw the breast implant from the patient into the housing through the dehiscence, funnel, and entry port. In effect, the ring 26 acts as a retractor within the skin and / or capsule dehiscence. This positioning helps maintain the initial seal formed between the ring 26 and the breast implant (I) and protects the implant from unwanted tearing within the device 10 as it passes through the dehiscence(s).

[0045] In other words, the rigidity of the ring 26 and funnel 28 guides the breast implant (I) into the entrance and through it to enter and deform the device 10. The implant or capsule cannot be pulled into the dehiscence without deforming. Depending on the patient, the capsule may calcify over time, becoming hard and brittle, or may become thick and inelastic, limiting the resilience of the capsule dehiscence and its ability to accommodate the entry of a breast implant. By placing the ring 26 within the capsule dehiscence, capsule resilience is not an issue.

[0046] As shown, the ring 26 in one embodiment includes a funnel 28. The first thing the funnel 28 encounters is the breast implant (I). In other embodiments, such as those shown in FIGS. 8A and 8B, a ring may not be used, and the proximal portion of the housing itself may form the funnel and entrance. In all embodiments, the funnel provides a substantially smooth and structurally advantageous entry or suction port for the breast implant (I) being removed. In practice, the ring and funnel may be formed of a lubricious material, or a medical lubricant may be added thereto to limit friction caused by contact with the breast implant (I), and potentially any leaked / leaking filler material (M), as the breast implant passes through the ring / funnel during removal.

[0047] The ring 26 also has a flared, rounded, or rolled outer lip 32, as shown in FIGS. 1, 3, and 4. This outer lip 32 facilitates smooth insertion through the dehiscence and capsulotomy dehiscence in the patient's skin (D), as shown in FIG. 5. Furthermore, the outer lip 32 also aids in retention of the device 10 within the dehiscence(s), maintaining the edges of the dehiscence(s) in an open position when the ring 26 is positioned in contact with the breast implant (I) upon removal. In other words, the ring 26 penetrates and rests within the dehiscence, remaining in contact with the shell (S) of the breast implant (I) in this embodiment. Alternatively, the ring 26 may contact the capsule (C) of the breast implant (I). In this position, the edge(s) of the dehiscence extend around the outer lip 32 and generally rest around or behind the ring 26 adjacent the proximal housing portion 12. Although ring 26 is described as being circular in one embodiment, the ring can be essentially any shape, such as oval, rectangular, etc. Additionally, outer lip 32 can have a flat portion adjacent proximal portion 12 in another embodiment to further help maintain device 10 in place.

[0048] As shown in FIGS. 1 and 3 , in the above-described embodiment, the suction port 34 extends from the distal portion 14 of the housing. However, the suction port 34 can be located anywhere on the housing. In this embodiment, the suction port 34 can be a nipple or barbed connector configured to receive tubing connected to a suction source 36 (e.g., a vacuum pump, a syringe, and / or a hand pump). As is known, various other connectors can be used to connect the device 10 to a suction source. In this embodiment, the suction source 36 is a vacuum pump. Operating rooms typically include a suction source, such as a vacuum pump, either remotely or within the operating room itself. In some embodiments, the device 10 can be equipped with a portable vacuum pump, syringe, or even a hand pump for use in operating rooms lacking a suitable suction source. In another embodiment, the tubing or hose can extend from the housing with a connector that can engage a vacuum / fluid hose or a vacuum / fluid source connector. As shown in FIG. 1 , the device 10 is connected to the suction source 36 using tubing 38.

[0049] As shown and described above, in this embodiment, the proximal and distal sections 12, 14 are separable and generally have a biconical or frustoconical shape. These and other shapes can be nested or stacked with one another when not in use, as shown in FIG. 6 . In this embodiment, when the proximal and distal sections are in the nested position, the suction port 34 extends into the ring 26. This generally nested configuration of the sections is particularly advantageous for packaging the pre-surgical device 10. Of course, other shapes can be used as long as they have sufficient mechanical rigidity to avoid collapse under vacuum pressure, and the device can also have a one-piece structure as described above. Furthermore, the distal and proximal sections can be designed to insert a spacer between them during shipping, so that the suction port 34 is inserted into but does not extend into the ring 26, or they can be designed not to extend into the ring at all.

[0050] 1 and 3, the proximal and distal housing portions 12, 14 are separable and are separated by a connecting portion, generally designated 40. In this embodiment, the inner diameter of connecting portion 40 is substantially the same from the proximal end to the distal end. Furthermore, the inner diameters of the distal end 20 of the proximal housing portion 12 and the proximal end 22 of the distal housing portion 14 are generally the same, and are also generally the same as the inner diameter of the central housing portion 40.

[0051] As shown in FIG. 3 , the two housing sections 12, 14 are connected by a friction fit connection utilizing an O-ring 42 in the illustrated embodiment. This O-ring connection is sufficient to maintain vacuum pressure and prevent leakage of the silicone polymer filler material received within the device 10. More specifically, the distal portion 48 of the central section 40 has a gland 44 that supports the O-ring 42 in a sealing assembly. The gland 44 holds the O-ring 42 in place and accommodates deformations necessary for proper function. The proximal portion 50 of the central section 40 receives and connects to the O-ring 42 / gland 44 sealing assembly of the distal section 48, allowing the proximal and distal sections 12, 14 to be drawn together upon application of vacuum pressure. A stop ring 52 provides a contact surface against the end of the proximal section 50 when fully engaged. Of course, in other embodiments, other types of mechanical connections can be used in place of the O-ring sealing device described above, including, but not limited to, press-fit connections, threaded mechanisms, butt connections with separate connecting rings, compression bands, and the like, any of which is sufficient to maintain the two sections 12, 14 in substantially parallel alignment and ensure a good seal.

[0052] As an added advantage, one or more grips 46 may be provided on one or both of the proximal and distal portions 12, 14 to facilitate user assembly and disassembly. As best shown in Figures 3 and 5, the grips 46 may be elevated ridges extending radially along the outer surface of the distal portion 14. Of course, the height, length, and number of ridges may be varied to improve grip of the proximal and distal portions 12, 14 during use and / or assembly / disassembly. Of course, other types and numbers of grips may be used in alternative embodiments.

[0053] As noted above, the device 54 can be of one-piece construction, as shown in FIG. 7 . In other words, the device 54 can be constructed as a single, integral unit, eliminating the need for a central or connecting portion 40 between the proximal and distal portions 12, 14 of the device 10 described above. Alternatively, the central portion 40 can be defined by a flat surface, designated by reference numeral 56. Another embodiment of the device 54 includes a proximal portion 58 and a distal portion 60 defining an internal chamber, and includes solid walls 62, 64, a ring 66, a suction port 68, and a funnel 70, at least as in the previous embodiment. Other than the unity of the housing, the device 54 is essentially the same as the previous embodiment and its alternatives, except that the distal end 72 of the proximal portion 58 and the proximal end 74 of the distal portion 60 are essentially the same and meet at the flat surface 56. Furthermore, the one-piece device 54 is intended to be disposed of after a single use.

[0054] In all embodiments, caps (not shown) may be provided to seal the proximal opening and / or distal suction port before and after the procedure. Additionally, the devices 10, 54 may be constructed using materials suitable for biohazardous waste disposal.

[0055] A method of using the device described above for use in removing a patient's breast implant (I) in accordance with the present invention includes exposing the breast implant, positioning the ring of the device so that it contacts the breast implant, and applying sufficient suction to withdraw the breast implant through the funnel and port. This method will be further described with reference to one embodiment of the device 10 described above.

[0056] The device 10 is provided in a sterile / aseptic / sterile condition. First, the user assembles the two portions 12, 14 of the device 10 using the O-ring 42 and gland 44 sealing assembly. After assembly, the device 10 is ready for use. Surgically, a naturally forming capsule (C) at least partially surrounds the breast implant (I), exposing the skin (D), breast tissue (T), and muscle dehiscence (collectively referred to as the skin dehiscence) depending on the placement of the breast implant. Once the partial or full capsulectomy is complete, desired procedures can be performed before or after removal of the breast implant (I). In such a procedure, the capsule or partial capsule, along with the breast implant (I), is typically placed within the device 10, as described below.

[0057] As part of the removal process, a capsulectomy incision is made in the capsule (C) to directly expose the breast implant (I). The size of the capsulectomy incision must be large enough to accommodate the ring 26 in the described method. This necessarily places the device 10 in direct contact with the breast implant (I), including its outer shell (S) and / or filler material (M), if the outer shell of the breast implant (I) has already deteriorated or broken down. More specifically, the ring 26 of the device 10 is positioned to contact the breast implant.

[0058] In the above-described method, the ring 26 forms or defines a funnel 28, and the ring 26 contacts the breast implant (I) by inserting the ring into the dehiscence in the capsule (C), breast tissue (T), and patient's skin (D). When the ring 26 is inserted into the dehiscence in the patient's skin (D) and capsule (C) and contacts the breast implant (I), the outer lip 32 of the ring 26 holds the device 10 within the dehiscence(s) and acts as a retractor by maintaining the edges of the dehiscence(s) in an open position. In other words, the edge formed by the dehiscence in the patient's skin (D) extends around the outer lip 32 and is posterior to the ring 26 upon removal of the breast implant (I). Similarly, when a dehiscence forms in the capsule (C), the edge of the capsule dehiscence is generally posterior to the ring 26 adjacent the proximal end of the housing 12.

[0059] Following insertion of the ring 26 and contact of the funnel 28 with the breast implant (I), a suction source 36 is connected to the suction port 34. As noted above, the suction port 34 can be a nipple or barbed connector located at the distal end of the distal portion 14 of the device 10. In the illustrated embodiment, tubing 38 is utilized to connect the suction port 34 to the suction source 36. Similarly, the suction source 36 can be a vacuum pump 36 located on the device 10 or in the operating room or basement of the building in which the operating room is located. In alternative embodiments, the suction source can be a syringe or a manual vacuum source. In other words, the device can be provided with a suction source, or an existing suction source can be utilized and connected to it.

[0060] Once connected, the suction source 36 is activated to apply sufficient suction to the housing to draw the breast implant (I) through the funnel 28 and inlet. In other words, the suction source 36 is activated to draw air from the interior chamber of the device 10 through the tubing 38. The negative pressure created by the vacuum draws the implant (I) through the funnel 28 and inlet into the interior chamber of the device (10). For reference, the breast implant (I) being removed moves from a proximal to a distal direction during the removal process.

[0061] The inherent adhesiveness of the implant (I) with its outer shell (S) and filler material (M) ensures that the entire implant, including any leaked filler or gel, is drawn into the housing's internal chamber. Furthermore, if the capsule (C) is completely displaced from its surrounding soft tissue attachments prior to removal of the breast implant (I), the capsule will typically accompany the implant into the internal chamber. In other words, suction applied to the housing is sufficient to draw the breast implant (I) and capsule (C) into the funnel 28 and entrance. In this process, the capsule (C) is not ruptured, and the ring 26 can be inserted into the dehiscence in the patient's skin (D) and placed in contact with the capsule.

[0062] It should be noted that the suction source 36 can be connected to the suction port 34 prior to the insertion of the ring 26 and / or prior to contact of the ring 26 with the breast implant (I) or capsule (C). Likewise, the suction source 36 can be activated at any point throughout the process.

[0063] If it is desired to inspect the breast implant (I) held by suction in the internal chamber of the device 10, the proximal and distal portions 12, 14 can be separated, the device opened, and the breast implant accessed. If the breast implant (I) is intact, it can be removed from the internal chamber for further inspection and / or disposed of in a suitable biohazard waste disposal container. The two portions 12, 14 of the device 10 can then be reassembled, and this same device can be used again to remove the contralateral breast implant, if desired.

[0064] If the breast implant (I) breaks or has already experienced substantial gel bleed, it is recommended that it not be removed from the breast implant's internal chamber, as this would expose the surgical field to the sticky polymer filler (M) or gel. Rather, the breast implant (I) and device 10 should be disposed of in a biohazardous waste disposal container, with or without a cap attached to the ring 26 and / or distal suction port 34, if it is desired to keep the breast implant (I) sealed within the internal chamber. A new removal device 10 can be used to extract the contralateral breast implant. If an alternative, integrated embodiment of the device 54 is utilized, it is preferred to use one removal device 54 per breast implant (I). In this case, the breast implant (I) within the internal chamber of the device 54 should not be removed for purposes such as examination.

[0065] The foregoing description 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 example, if a partial or complete capsulectomy is to be completed, the desired procedure can be performed before or after removal of the breast implant (I). Furthermore, the device can be sized to accommodate two breast implants, eliminating the need to remove the first implant prior to removal of the contralateral implant or the need to utilize two devices. Additionally, the integral ring that secures the device in place and extends from the proximal portion of the housing need not be integrally formed.

[0066] In yet another embodiment, the planes indicated by lines A and B above may be the same plane or coplanar because ring 26 is integrally molded with housing proximal portion 12. In other words, the smallest inner diameter of housing proximal portion 12 may be set to be substantially equal to the smallest inner diameter of funnel 28, or the inner diameter of the proximal portion may be set to increase from proximal end 30 of the proximal portion to distal end 20 of the proximal portion.

[0067] Yet another embodiment utilizes the end of the proximal portion itself without the use of a ring. In such an embodiment, these ends perform the same or similar functions as the ring 26 of the previous embodiment. As shown in FIG. 8A, the end 76 extending from the proximal portion 78 has a significant outward flare, forming a funnel 80 and an entrance. This funnel 80 tapers (has a gradually decreasing inner diameter) toward the distal end of the funnel, with the smallest inner diameter at the distal end. Similarly, the entrance is formed by the distal end 76 of the proximal portion 78, which has the smallest inner diameter. The funnel 80 provides a substantially smooth and mechanically advantageous entrance for the breast implant (I) during removal. The flared end 76 also helps to retain the device within the dehiscence(s) and maintain the dehiscence(s) in an open position when the proximal portion 78 is in contact with the breast implant (I) during removal. In other words, the proximal portion 78 is inserted into the dehiscence(s) and positioned so that the flared end 76 contacts the breast implant (I) and acts as a retractor. In this position, the edges of the dehiscence extend around the flared end 76 and are positioned around or behind and generally adjacent to the proximal portion 78 of the housing.

[0068] Similarly, as shown in FIG. 8B, the end 82 extending from the proximal portion 84, albeit with a somewhat smaller outward flare, still defines the funnel 86 and entrance. The funnel 86 has an inner diameter that tapers toward the distal end of the funnel, where the inner diameter is smallest. Similarly, the entrance is defined by the end 82 of the proximal portion 84, where the inner diameter is smallest. The funnel 86 provides a substantially smooth and mechanically advantageous entrance for the breast implant (I) during removal. The flared end 82 also serves to retain the device within the dehiscence(s) and to maintain the dehiscence(s) in an open position when the proximal portion 84 is in contact with the breast implant (I) during removal. In other words, the proximal portion 84 is inserted into the dehiscence(s), with the flared end 82 positioned to contact the breast implant (I) and function as a retractor. In this position, the edges of the split extend around flared end 82 and are located around or behind, and generally adjacent, proximal portion 84 of the housing. In each of the embodiments shown in Figures 8A and 8B, the device and its components may be configured the same as either device 10 or device 54 described above, or as device 90 described below.

[0069] 9, the two portions 92, 94 of the housing of the device 90 are connected by a threaded interlock in the manner described. The threaded connection is sufficient to maintain vacuum pressure and also to prevent leakage of any silicone polymer filler received within the device 90. More specifically, the proximal portion 98 of the central portion 100 has threads 102 that engage with corresponding threads 104 on the distal portion 106 of the central portion 100, forming a connection that draws the proximal and distal portions 92, 94 together upon application of vacuum pressure.

[0070] As an added advantage, one or more grips 108 may be provided on one or both of the proximal and distal portions 92 and 94 to facilitate user assembly and disassembly. While shown as generally oval in the alternative embodiments described above, the grips 108 may take any shape sufficient to improve grip on the portions 92 and 94 during use / assembly / disassembly. Additionally, the grips may be taller (not shown) so as to extend above the exterior surface of the housing. The raised grips may be formed of rubber or the like and may provide a firm and / or sticky feel to the user.

[0071] All such modifications and variations are intended to be within the scope of the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled. [Explanation of symbols]

[0072] 10, 54, 90 devices 100 center part 102 threads 12, 50, 58, 78, 84, 92, 98 Proximal part 14, 48, 60, 94 distal portion 16, 18, 62, 64 solid wall 20, 21, 24, 72 distal end 22, 30, 74 proximal end 26, 66 rings 28, 70, 80, 86 funnel 32 outer lip 34, 68 Suction port 36 Suction source 38 Piping 40 Central or connecting part 42 O-ring 44 Grand 46, 108 Grip 52 Stop ring 56, A, B plane 76, 82 End (C) Capsule (D) Skin (I) Breast implants (M) Filler (S) Shell (T) Brainstorming Organization

Claims

1. 1. A device for removing breast implants, fillers, and / or capsules from a patient, comprising: a housing having a proximal portion and a distal portion that together define an internal chamber for receiving said breast implant, filler material, and / or capsule; a rigid ring secured to the proximal portion defining a funnel that deforms and directs the breast implant, filler material, and / or capsule toward the entrance of the internal chamber, the funnel having an inner diameter that gradually decreases toward the distal end of the funnel where the inner diameter is smallest; and suction port, The device characterized in that

2. 10. The device for removing a breast implant, filler material, and / or capsule from a patient of claim 1, wherein an inner diameter of the proximal portion of the housing increases from the entrance to the internal chamber toward the distal end of the proximal portion of the housing.

3. 3. The device for removing a breast implant, filler material, and / or capsule from a patient according to claim 1 or 2, wherein the inner diameter of the distal portion of the housing decreases from the proximal end of the distal portion of the housing to the distal end of the distal portion of the housing.

4. 4. The device for removing a breast implant, filler material, and / or capsule from a patient of claim 3, wherein the inner diameter of the distal end of the proximal portion of the housing and the inner diameter of the proximal end of the distal portion of the housing are the same.

5. 5. The device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 1 to 4, wherein the proximal and distal portions of the housing are separable and separated by a connecting portion having approximately the same inner diameter from the proximal end to the distal end of the central portion.

6. 10. The device for removing a breast implant, filler material, and / or capsule from a patient of claim 1, wherein the smallest inner diameter of the proximal portion of the housing is approximately the same as the smallest inner diameter of the funnel and increases from the proximal end of the proximal portion to the distal end of the proximal portion.

7. 7. The device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 1 to 6, wherein the proximal and distal portions of the housing each occupy at least 25% of the total volume of the internal chamber.

8. 8. The device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 1 to 7, wherein the inner diameter of the ring increases between the inner diameter of the proximal end of the housing at the inlet and the inner diameter of the funnel at its distal end.

9. 8. The device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 1 to 7, wherein the inner diameter of the ring varies between the inner diameter of the proximal portion of the housing at the inlet and the inner diameter of the funnel at its distal end.

10. 1. A device for removing breast implants, fillers, and / or capsules from a patient, comprising: a housing having a proximal portion and a distal portion that together define an internal chamber for receiving said breast implant, filler material, and / or capsule; a ring attached to the proximal portion and defining a funnel that directs the breast implant, filler material, and / or capsule toward the entrance of the internal chamber; and a suction port; The inner diameter of the distal portion of the housing decreases from the proximal end to the distal end of the distal portion of the housing. The device characterized in that

11. 11. The device for removing a breast implant, filler material, and / or capsule from a patient of claim 10, wherein the inner diameter of the distal end of the proximal portion of the housing is the same as the inner diameter of the proximal end of the distal portion of the housing.

12. 12. The device for removing a breast implant, filler material, and / or capsule from a patient according to claim 10 or 11, wherein the proximal and distal portions of the housing are separable and separated by a connecting portion having a substantially uniform inner diameter.

13. 13. The device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 10 to 12, wherein the smallest inner diameter of the proximal portion of the housing is approximately the same as the smallest inner diameter of the funnel and increases from the proximal end of the proximal portion to the distal end of the proximal portion.

14. 14. The device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 10 to 13, wherein each of the proximal and distal portions occupies at least 25% of the total volume of the internal chamber.

15. 15. A device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 10 to 14, wherein the inner diameter of the funnel gradually decreases towards the distal end of the funnel where the inner diameter is smallest.

16. 16. A device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 10 to 15, wherein the inner diameter of the ring increases between the inner diameter of the proximal portion of the housing at the inlet and the inner diameter of the funnel at its distal end.

17. 16. A device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 10 to 15, wherein the inner diameter of the ring varies between the inner diameter of the proximal portion of the housing at the inlet and the inner diameter of the funnel at its distal end.

18. 1. A device for removing breast implants, fillers, and / or capsules from a patient, comprising: a housing having proximal and distal portions separated by a central portion and together defining an internal chamber having a total volume for receiving the breast implant, filler material, and / or capsule, wherein each of the proximal and distal portions of the housing occupies at least 25% of the total volume of the internal chamber; a ring attached to the proximal portion, the ring defining a funnel having a narrowing inner diameter for directing the breast implant, filler material, and / or capsule toward the inlet of the housing; and suction port, The device characterized in that

19. 20. The device for removing a breast implant, filler material, and / or capsule from a patient of claim 18, wherein the inner diameter of the proximal portion of the housing increases from the entrance of the housing to the central portion of the housing.

20. 20. The device for removing a breast implant, filler material, and / or capsule from a patient of claim 18 or 19, wherein the inner diameter of the distal portion of the housing increases from the proximal end of the distal portion of the housing to the distal end of the distal portion of the housing.

21. 21. The device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 18 to 20, wherein the inner diameter of the distal end of the proximal portion of the housing is the same as the inner diameter of the proximal end of the distal portion of the housing.

22. 22. The device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 18 to 21, wherein the proximal and distal portions of the housing are separable, and the inner diameter of the distal end of the proximal portion of the housing and the inner diameter of the proximal end of the distal portion of the housing are approximately the same as the inner diameter of the central portion of the housing.

23. 23. The device for removing a breast implant, filler material, and / or capsule from a patient of any one of claims 18 to 22, wherein the smallest inner diameter of the proximal portion of the housing is approximately the same as the smallest inner diameter of the funnel and increases from the proximal end of the proximal portion of the housing to the distal end of the proximal portion of the housing.

24. 24. An apparatus for removing a breast implant, filler material and / or capsule from a patient according to any one of claims 18 to 23, wherein a flat surface forms the central portion of the housing.

25. 25. The device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 18 to 24, wherein the inner diameter of the distal portion of the housing increases from the central portion of the housing to the distal end of the distal portion of the housing.

26. 26. A device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 18 to 25, wherein the inner diameter of the funnel gradually decreases towards the distal end of the funnel where the inner diameter is smallest.

27. 27. The device for removing a breast implant, filler material, and / or capsule from a patient of claim 26, wherein the inner diameter of the proximal portion of the housing increases from the entrance to the internal chamber to the distal end of the proximal portion of the housing.

28. 28. The device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 18 to 27, wherein the inner diameter of the distal end of the proximal portion of the housing is the same as the inner diameter of the proximal end of the distal portion of the housing.

29. 29. The device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 18 to 28, wherein the proximal and distal portions of the housing are separable and are separated by a connecting portion having a substantially uniform inner diameter.

30. 30. The device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 18 to 29, wherein the smallest inner diameter of the proximal portion of the housing is approximately the same as the smallest inner diameter of the funnel.

31. 31. A device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 18 to 30, wherein the inner diameter of the ring increases between the inner diameter of the proximal portion of the housing at the inlet and the inner diameter of the funnel at its distal end.

32. 31. A device for removing a breast implant, filler material, and / or capsule from a patient according to any one of claims 18 to 30, wherein the inner diameter of the ring varies between the inner diameter of the proximal portion of the housing at the inlet and the inner diameter of the funnel at its distal end.

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