Abstract:
A system for breast augmentation includes a plurality of microballoons. An injector can be provided for injecting microballoons into a breast through an incision in the breast. The microballoons can have a first dimension when in the injector and a second, larger dimension when in the breast. An injector and tissue dissector are also disclosed. The microballoons can also include a filling structure to permit the microballoons to be filled after insertion into the breast. A method for performing breast augmentation surgery and microballoons for use in the method are also disclosed.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application is a continuation-in-part of U.S. patent application Ser. No. 10/654,156, filed on Sep. 3, 2003, which is incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     This invention relates generally to surgical systems and methods, and more particularly to systems and methods for performing breast augmentation surgery.  
       BACKGROUND OF THE INVENTION  
       [0003]     Breast augmentation surgery is a cosmetic procedure in which a foreign substance is placed into or under the breast to alter the size and/or shape of the breasts. Breast augmentation surgery has been performed for many years according to many different procedures. Generally, these procedures have centered on the use of a single large sack comprised of a silicone elastomer shell that is filled with a silicone gel or saline solution to give the implant a more natural appearance and feel when implanted into the patient. Although this procedure is considered to be generally safer for the patient than prior procedures, it does have some associated complications. All implants can rupture, deflate or leak. Silicone-filled implants will thereby release this foreign substance into the body. Saline-filled implants are considered preferable in that breakage will release only a sterile saline solution into the body. There is concern, however, that the saline-filled implants could support the growth of fungus and certain bacteria. Rupture or leakage would then release these potentially harmful organisms into the patient&#39;s body.  
         [0004]     A significant complication that exists with both silicone-filled and saline-filled implants is that of capsular contracture. This is a condition in which abnormal scar tissue forms around the implant, resulting in a hard capsule that is abnormal in appearance and can be painful for the patient. It is a chronic condition for which there are few effective treatments that do not require additional surgery.  
       SUMMARY OF THE INVENTION  
       [0005]     A system for breast augmentation comprises a plurality of microballoons. An injector is provided for injecting the microballoons into a breast through an incision in the breast. The microballoons have a first dimension when held by the injector and a second, larger dimension when in the breast.  
         [0006]     The microballoons can comprise a flexible, substantially spherical shell defining an open interior. The open interior is filled with a sterile material such as silicone gel or saline solution. The flexible shell can be made of plastic or silicone. In a preferred embodiment, the microballoons have a diameter or largest dimension of between about 1 and about 50 mm. In another aspect, the microballoons have a diameter or largest dimension of between about 3 and about 30 mm. In still another aspect of the invention, the microballoons have a diameter or largest dimension of between about 5 and about 20 mm.  
         [0007]     The injector can be any suitable device for holding a microballoon in a first, compressed dimension and then releasing the microballoon into the breast. The microballoon will expand in the breast to the second, expanded dimension. It is also possible to fill or partially fill the microballoons after they have been placed into the breast by appropriate means such as valves or injection by syringe.  
         [0008]     In one aspect, the injector comprises a compression chamber for holding the microballoons in the first, compressed dimension. Structure can be provided for forcing the microballoon into the compression chamber. This structure can be vacuum structure. The vacuum structure can comprise an aperture for drawing a sufficient vacuum in the compression chamber to force the microballoon into the compression chamber. A funnel or other suitable structure can be provided for directing microballoons into the compression chamber under the force of the vacuum.  
         [0009]     The compression chamber can have an open end and releasing structure can be provided for forcing the microballoon through the open end. The releasing structure can comprise a plunger moveable through the compression chamber. The injector can have an elongated tubular member that is closed at a first end and has an opening at a second end that defines the open end. The tubular member has an open interior defining, at least in part, the compression chamber. The plunger can comprise a piston and an actuating structure. The piston is slidable within the compression chamber and the actuating structure extends through an aperture in the first end. Movement of the actuating structure through the aperture will cause the plunger to move through the compression chamber to force the microballoon through the open end.  
         [0010]     A tissue dissector can be provided with an elongated main body portion having a proximal end and a distal end. A pair of dissecting arms have first and second ends. The first ends are pivotally mounted to the distal end of the elongated main body portion. The dissecting arms have a first pivotal position in which the dissecting arms are substantially juxtaposed and a second pivotal position in which the dissecting arms are separated. A flexible dissecting member is connected between substantially the second ends of the dissecting arms. The dissecting member is in an extended, dissecting position when the dissecting arms are in the second pivotal position. Actuating structure is provided for moving the dissecting arms between at least the first and second pivotal positions.  
         [0011]     Tensioning structure can be provided for applying pressure to the flexible dissecting member at a position between the dissecting arms. The tensioning structure can extend through the main body portion. In one aspect, the tensioning structure is an elongated tensioning rod. Gripping structure can be provided for gripping and operating the tensioning rod.  
         [0012]     The actuating structure for the dissecting arms can be any suitable actuating structure. In one aspect, the actuating structure is a squeeze grip. Operation of the squeeze grip moves the dissecting arms from the first pivotal position to the second pivotal position. Biasing structure can be provided to return the dissecting arms to the first pivotal position.  
         [0013]     A method for performing breast augmentation surgery can include the step of making an incision under the breast. A subcutaneous pocket is made under the breast. A tissue dissector can be inserted through the incision and used to make the subcutaneous pocket under the breast. A plurality of microballoons are then placed into the subcutaneous pocket. A compressed microballoon can be provided with a microballoon injector. The injector holds the microballoon in the compressed condition and permits insertion into the subcutaneous pocket through the incision. The injector is inserted through the incision and the microballoon is released, whereby the microballoon assumes a second, larger dimension when in the subcutaneous pocket. The procedure is repeated until a plurality of the microballoons have been released into the subcutaneous pocket.  
         [0014]     The microballoons can include filling structure to permit the microballoons to be formed and then filled with the filling material. The filling structure can be a valve or a seal portion adapted to permit the injection of fluid through the filling portion. In one aspect, the unfilled microballoons are first inserted into the subcutaneous pocket and then filled. A positioning device can be provided to position the unfilled microballoons in the subcutaneous pocket, and a filling apparatus such as a syringe can be used to fill the microballoons with fluid when the microballoon has been positioned in the breast. In this manner, the microballoons can be inserted through a small-diameter incision in the breast.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]     There are shown in the drawings embodiments which are presently preferred, it being understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown, wherein:  
         [0016]      FIG. 1  is a side elevation of a tissue dissector according to the invention in a first configuration.  
         [0017]      FIG. 2  is a side elevation in a second configuration.  
         [0018]      FIG. 3 (A) is a side elevation of a microballoon according to the invention.  
         [0019]      FIG. 3 (B) is a cross-section of a microballoon according to the invention.  
         [0020]      FIG. 4  is a cross-section, partially in phantom, of a microballoon injector according to the invention.  
         [0021]      FIG. 5  is a cross-section, partially in phantom, illustrating a breast augmentation procedure according to the invention.  
         [0022]      FIG. 6  is a top plan view of an alternative embodiment of a tissue dissector according to the invention, in a first configuration.  
         [0023]      FIG. 7  is a top plan view of an alternative embodiment of a tissue dissector according to the invention, in a second configuration.  
         [0024]      FIG. 8  is a side elevation of a dissecting member, partially in phantom.  
         [0025]      FIG. 9  is a top plan view of a dissecting member, partially in phantom.  
         [0026]      FIG. 10  is an exploded perspective of a portion of a dissecting member, partially in phantom.  
         [0027]      FIG. 11  is a side elevation of a microballoon according to another aspect of the invention.  
         [0028]      FIG. 12  is a cross-section taken along line A-A in  FIG. 11 .  
         [0029]      FIG. 13  is a side elevation of a microballoon in an unfilled state.  
         [0030]      FIG. 14  is a side elevation, partially broken away and partially in phantom, illustrating the filling of microballoons according to one aspect of the invention.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0031]     There is shown in  FIGS. 1-2  a tissue dissector  10  according to the invention. The tissue dissector  10  has an elongated main body portion  12  having a proximal end  14  and a distal end  18 . A pair of dissecting arms  22  have first ends  26  and second ends  30 . The first ends  26  are pivotally mounted to the distal end  18  of the elongated main body portion  12 . The dissecting arms  22  have a first pivotal position ( FIG. 1 ) in which the dissecting arms  22  are substantially juxtaposed. In a second pivotal position shown in  FIG. 2 , the dissecting arms  22  are separated.  
         [0032]     A flexible dissecting member such as cable  34  is connected substantially between the second ends  30  of the dissecting arms  22 . The dissecting cable  34  is in a substantially taut and extended dissecting position when the dissecting arms  22  are in the second pivotal position shown in  FIG. 2 .  
         [0033]     Actuating structure can be provided for moving the dissecting arms  22  between at least the first and second pivotal positions. The actuating structure can be a squeeze grip  40  having a handle  44  and a movable grip lever  48 . Suitable linkage is provided such that movement of the grip lever  48  in the direction shown by the arrow will cause the dissecting arms  22  to move from the first pivotal position to the second pivotal position. A biasing such as spring  52  can be provided to cause the dissecting arms  22  to return to the first pivotal position when the grip lever  48  is released. Other actuating structure is possible.  
         [0034]     Movement of the dissecting arms  22  to the second pivotal position will cause the cable  34  to extend. The dissecting cable  34  can be placed under tension by appropriate tensioning structure. In one aspect, a moveable tensioning rod  56  is provided to contact the dissecting cable  34  and place the dissecting cable  34  under tension. The tensioning rod  56  can be elongated and positioned through a suitable channel in the elongated main body portion  12 . Gripping structure such as end  60  can be provided with which to manipulate the tensioning rod  56  to the extended position shown in  FIG. 2  where the dissecting cable  34  is placed under tension. The tensioning rod  56  can be retracted by movement of the end  60  away from the proximal end  14 . Other tensioning structure is possible.  
         [0035]     The tissue dissector is used to form a subcutaneous pocket under the breast. The dissecting arms  22  are kept in the first pivotal position shown in  FIG. 1  to insert the distal end  18  of the tissue dissector  10  through an incision under the breast. Only a small incision need be made due to the small cross-sectional area of the tissue dissector  10  when in the first pivotal position shown in  FIG. 1 . The actuating structure is then operated to open the dissecting arms  22  to the second pivotal position shown in  FIG. 2 . The tensioning structure is operated by movement of the tensioning rod  56  to the extended position, such that the dissecting cable  34  is substantially taut. The dissecting cable  34  is of a dimension such that, when taut, it will cut tissue under the breast to form a subcutaneous pocket.  
         [0036]     The open configuration shown in  FIG. 2 , while in the breast, permits the rapid formation of a subcutaneous pocket under the breast, with minimal motion of the tissue dissector. The dissecting arms  22  are then returned to the first pivotal position by a release of the grip lever  48  and return of the tensioning rod  56  to the initial positions, such that the tissue dissector  10  can easily be removed through the incision.  
         [0037]     There is shown in FIGS.  3 A-B, a microballoon  70  according to the invention. The microballoon  70  has a flexible exterior shell  74  defining an open interior that is filled by a material  78  that is either a fluid, a gel, or a gas. The microballoon  70  is thereby elastically deformable due to the flexible shell  74  and filled interior. The flexible shell  74  can be made from several suitable materials. In one embodiment, the flexible shell is made of silicone. Other polymeric materials can be used. The filling material  78  can be any suitable material, such as saline solution, hydrogen gas or air, or silicone gel. Additionally, solid or semi-solid microballoons  70  are possible as long as they are elastically deformable.  
         [0038]     The microballoons  70  are preferably spherical in shape, but can also be non-spherical. According to the invention, a plurality of the microballoons  70  are implanted into or under each breast and, accordingly, the dimensions of the microballoons  70  are much smaller than current breast implants. In a preferred embodiment, the microballoons have a diameter or largest dimension of between about 1 and about 50 mm. In another aspect, the microballoons have a diameter or largest dimension of between about 3 and about 30 mm. In still another aspect of the invention, the microballoons have a diameter or largest dimension of between about 5 and about 20 mm.  
         [0039]     An injector can be used to hold at least one microballoon  70  in a compressed position with a first, compressed dimension, and to release the microballoon when in the breast to permit the microballoon to expand to a second, larger dimension in the subcutaneous pocket. In this manner, the microballoon  70  can be inserted into the subcutaneous pocket through a smaller incision. One such injector  90  is shown in  FIGS. 4-5 . The structure for holding the microballoon  70  in a first, compressed dimension can be any suitable structure, but in one aspect is a compression chamber  94  into which the microballoon  70  is inserted. The microballoon  70  when inserted in the compression chamber  94  assumes an elongated, deformed shape (indicated by phantom lines  70 A in  FIG. 4 ). The extent of compression can vary. In the case of spherical microballoon  70 , it is preferable that the microballoon be compressed to 10-90% of the expanded diameter. In one aspect, the microballoon is compressed to about 50% of the expanded diameter.  
         [0040]     The injector  90  can be an elongated tubular member having a housing  100  and an open interior  104 . The compression chamber  94  can be formed in part by the housing  100 . The manner in which the microballoons  70  are loaded into the injector  90  can vary. A manipulator can be used to apply a mechanical force to the microballoons  70  to force them into the compression chamber  94 . In another aspect, a vacuum source is applied to a vacuum fitting  98  such that a sufficient force of vacuum is used to draw the microballoons  70  into the compression chamber  94 .  
         [0041]     Suitable structure can be utilized to guide the microballoons  70  through an opening  108  in the second end  106  of the housing  100 . Structure such as detachable funnel  112  can be provided to assist and direct the microballoon  70 B (dashed lines in  FIG. 4 ) into the opening  108 .  
         [0042]     Releasing structure is provided for releasing the microballoon  70  from the injector  90  into the subcutaneous pocket under a breast to permit the balloon to expand in the pocket to the second, expanded dimension. Any suitable structure can be used. In one aspect, a plunger  116  is movable within the open interior  104  of the housing  100 . An actuating structure  120  such as an elongated rod can extend through a suitable opening in the first end  102  of housing  100 . A head  124  can be provided to facilitate manipulation by hand.  
         [0043]     The microballoon is drawn into the injector  90  to the position shown by the microballoon  70 A using funnel  112 . In this position, the microballoon is in a first, compressed shape. The funnel  112  is then removed. The injector  90  is then inserted through the incision under the breast into the subcutaneous pocket  130  ( FIG. 5 ). The releasing structure such as plunger  116  is then manipulated as by actuating structure  120  to push the microballoon  70  into the subcutaneous pocket  130  as shown in  FIG. 5 . The microballoon will then expand to the second, expanded dimension.  
         [0044]     The number of microballoons  70  that are implanted into the breast can vary. In one aspect, the number varies from about 3 to about 1000. In another aspect, between about 50 and about 300 microballoons are implanted. The number will depend in part on the size of the patient, the amount of augmentation that is desired, and the shape and size of microballoons  70 . The microballoons  70  can be of the same size or different sizes.  
         [0045]     The plurality of microballoons  70  in the subcutaneous pocket  130  provides for a more natural shape and appearance. Addtionally, because the microballoons  70  are free to move slightly within the subcutaneous pocket  130 , it is believed that the likelihood of severe scarring will be reduced. Also, the microballoons  70  will more readily conform to the shape of the subcutaneous pocket  130  than does a larger implant.  
         [0046]     There is shown in  FIGS. 6-11 , an alternative embodiment of a tissue dissector according to the invention. The tissue dissector  150  has an elongated main body portion  154 , having a proximal end  158  and a distal end  162 . A pair of dissecting arms  166  have first ends  168  and second ends  172 . The first ends  168  are pivotally mounted to the distal end  162  of the elongated main body portion  154 . The dissecting arms  166  have a first pivotal position ( FIG. 6 ) in which the dissecting arms  166  are substantially juxtaposed. In a second pivotal position shown in  FIG. 7 , the dissecting arms  166  are separated.  
         [0047]     A flexible dissecting member  178  is connected substantially between the second ends  172  of the dissecting arms  166 . The dissecting member  178  is in an extended dissecting position when the dissecting arms  166  are in the second pivotal position shown in  FIG. 2 . Actuating structure such as the squeeze grip  180  having a handle  184  and a movable grip lever  188  can be provided. Suitable linkage can be provided such that movement of the grip lever  188  will cause the dissecting arms  166  to move from the first pivotal position to the second pivotal position. A biasing such as spring  192  can be provided to cause the dissecting arms  166  to return to the first pivotal position when the grip lever  188  is released. Other actuating structure is possible.  
         [0048]     The dissecting member  178  can be comprised of a number of links  194  connected to junction members  196 . The links  194  are engaged to the junction members  196  through appropriate pins  198  or other suitable structure. The pins  198  permit each link  194  to pivot relative to the junction members  196 . In this manner, the dissecting member  178  is flexible and can be positioned from the position shown in  FIG. 6  to the position shown in  FIG. 7 . A distal link  200  permits the adjoining links  194  to pivot to the juxtaposed position shown in  FIG. 6 .  
         [0049]     The dissecting member  178  must not flex toward the distal end  162  of the elongated main body portion  154  during the tissue dissection operation. The junction members  196  are constructed so as to restrict inward flexing of the dissecting member  178 . The structure to prevent this flexing can take various forms and embodiments. In the embodiments shown in  FIGS. 8-10 , the junction members  196  are provided with a stop  204 . Adjacent links  194  have protrusions  208  which engage the stop  204  to prevent the inward flexing of the dissecting member  178 . Similar protrusions  208  and stops  204  can be provided on other links  194  to prevent the inward flexing of the dissecting member  178 . Pins  198  or other suitable structure can be provided to pivotally engage the links  194  to the junction members  196 . Pins  198  can extend through suitable apertures  218 . A distal link  200  is constructed to permit positioning of the flexible member  178  in the juxtaposed and extended positions shown in  FIGS. 6-7 .  
         [0050]     An alternative aspect of the invention is shown in  FIGS. 11-14 . In this alternative embodiment, microballoons  300  are comprised of a flexible exterior shell  304  capable of receiving a filling material  308  that is either a fluid, a gel, or a gas. Filling structure  310  is provided for permitting the filling material  308  to enter into the microballoon  300 .  
         [0051]     The filling structure  310  can be any suitable structure. In one embodiment, the filling structure  310  is a valve. A suitable device can be provided to inject the filling material into the microballoon through the valve. In another embodiment, the filling structure  310  is a polymer plug. The polymer plug can be of any suitable size, such as 2 mm-10 mm. The polymer plug is made of a material which will permit the introduction of a filling syringe needle through the plug. This will permit the filling material  308  to be placed into the microballoon  300 .  
         [0052]     The microballoon  300  can be filled with the filling material  308  prior to placement into the breast. In this aspect, the microballoon can be placed into the subcutaneous pocket by the techniques described above. In another aspect, however, the microballoon  300  can be placed into the subcutaneous pocket in the unfilled state, and then filled with the filling material  308 . This will permit the microballoon  300  to be inserted into the breast through a smaller incision in the breast. A microballoon  300  in the unfilled state is shown in  FIG. 13 .  
         [0053]     The microballoon  300  with filling structure  310  can be placed into the subcutaneous pocket by any suitable method. In one aspect shown in  FIG. 14 , a positioning device  320  is utilized. The positioning device  320  can include an elongated housing with an open interior  334 . A suitable filling device such as syringe  344  can be utilized to fill the microballoon  300 . The filling needle  348  of the syringe  344  is positioned in the polymer plug of the filling structure  310 . A plug or stop  338  can be provided on the needle  348  to prevent the needle from passing too far into the microballoon  300 . The microballoon  300  and filling needle  344  are positioned in the open interior  334  and the positioning device  320  and inserted through the incision  326 . The syringe  344  is then manipulated, as by handle  350 , to inject the filling material  308  into the microballoon  300 , which will become too large to pass out of the incision  326  and therefore will be secured in the subcutaneous pocket. The process is repeated until a sufficient number of microballoons  300  have been placed into the breast cavity  340  to render the desired result, and the positioning device  320  is removed and the incision  326  is closed. Other insertion structure and methods are possible.  
         [0054]     The components of the invention are preferably made of surgical grade materials such as plastics and stainless steel. Various modifications will be apparent.  
         [0055]     This invention can be embodied in other forms without departing from the spirit or essential attributes thereof. Accordingly, reference should be had to the following claims, rather than to the foregoing specification, as indicating the scope of the invention.