Abstract:
An apparatus for breast and buttock modification is provided which includes first and second tubes that extend alongside each other, and each of which has a lumen. The apparatus also includes an inflatable balloon having a valve that is detachably coupled to a distal end of the second tube such that a portion of the distal end extends through the valve. The balloon is adapted to be introduced to a space in a body and inflated in the space in the body by fluid introduced through the valve through the second tube. And the second tube is detached from the inflated balloon to leave the inflated balloon positioned in the space in the body.

Description:
CROSS REFERENCE TO RELATED APPLICATION  
       [0001]     The present application is based upon and claims the benefit of priority of provisional application Ser. No. 60/638,565, filed on Jun. 23, 2004. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to methods and apparatuses for performing breast and buttock modifications, such as lifts and augmentations, percutaneously.  
       BACKGROUND OF THE INVENTION  
       [0003]     Breast augmentation, buttock augmentation, breast lifts and buttock lifts are typically performed surgically. More recently, breast augmentation has, for example, has performed with endoscopic guidance.  
         [0004]     It should be possible to reduce the risks and costs associated with breast and buttock modification by performing the procedures percutaneously, thereby.  
       SUMMARY OF THE INVENTION  
       [0005]     According to one aspect of the invention, an apparatus is provided that includes first and second tubes that extend alongside each other, and each of which has a lumen. The apparatus also includes an inflatable balloon having a valve that is detachably coupled to a distal end of the second tube such that a portion of the distal end of the second tube extends through the valve. The balloon is adapted to be introduced to a space in a body and inflated in the space in the body by fluid introduced through the valve through the second tube. And the second tube is detachable from the inflated balloon to leave the inflated balloon positioned in the space in the body.  
         [0006]     According to another aspect of the invention, an apparatus for lifting a breast is provided that includes a bone anchor adapted to be screwed into a rib, a tissue anchor including a plurality of barbs to be lodged in breast tissue, and a suture to connect the tissue anchor to the bone anchor. A length of the suture is set to a desired length to lift the breast by a desired amount.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0007]      FIGS. 1-6  show the placement and inflation of an inflatable balloon for performing breast augmentation;  
         [0008]      FIG. 7  is a diagram showing a catheter for introducing and inflating the inflatable balloon;  
         [0009]      FIG. 8  is a cross-sectional view along line I-I in  FIG. 7 ;  
         [0010]      FIGS. 9-11  show the placement of tissue and bone anchors to perform a breast lift; and  
         [0011]      FIG. 12  shows multiple tissue and bone anchor pairs implanted in a breast. 
     
    
     DETAILED DESCRIPTION  
       [0012]     To perform breast augmentation according to the present invention, an inflatable balloon is inserted percutaneously under the pectoral muscle using image guidance, and the balloon is inflated to augment the breast.  
         [0013]     More specifically, one technique of performing breast augmentation according to the present invention is shown in  FIGS. 1-6 .  
         [0014]     First, as shown in  FIG. 1 , a needle  2  such as a Seldinger needle, which includes a sharp stylet inside of a cannula, will be inserted into the breast  100  such that the tip of the needle  1  is posterior to the pectoral muscle  102 , but not posterior to the ribs  110 . The stylet will then be removed from the cannula  6  of the needle  1 .  
         [0015]     At this stage, fluid (indicated by hatching in  FIG. 2 ), which could include an anesthetic (e.g. lidocaine), may be introduced through the cannula  6  to enlarge a space  108  between the pectoral muscle  102  and the chest wall  104 , as shown in  FIG. 2 . Then, a guide wire  8  will be inserted through the cannula  6  to maintain an access track to the site  108  posterior to the pectoral muscle  102 , and the cannula  6  will be withdrawn, as shown in  FIG. 3 .  
         [0016]     If necessary, the track around the guide wire  8  can be increased in size using a dilator or series of dilators that are slid over the guide wire  8  to increase the size of the track in the tissue using a well-known technique. Once the track to the site  108  has a sufficient size, sheath  10  will be inserted as shown in  FIG. 4  through the dilated track to the site  108  posterior to the pectoral muscle.  
         [0017]     As shown in  FIG. 5 , a catheter  20  with a detachable balloon  22  will then be inserted over the guide wire  8  through the sheath  10  to the site  108 , and the balloon  22  will then be inflated to a desired size, using a desired fluid. Conventional fluids for inflating breast implants should be suitable for inflating the balloon  22 . Once the balloon  22  is sufficiently large, the balloon  22  will be detached and the catheter  20  will be withdrawn. The incision in the breast will then be closed, leaving an inflated implant, as shown by cross-hatching in  FIG. 6 .  
         [0018]     As shown in more detail in  FIGS. 7 and 8 , the catheter  20  may include a guide catheter  201  that is fed over the guide wire  8  to guide the tip of the catheter  20  to the site  108 , and a feeding catheter  202  through which the fluid is fed to the balloon  22 . The balloon  22  will be wrapped around the catheter  20  when it is introduced through the sheath  10 , and will be unfurled by being inflated. It may be necessary to rotate the catheter  20  to assist in unfurling the balloon  22  as the balloon  22  is inflated.  
         [0019]     The balloon  22  is not physically connected to the guide catheter  201 , and is coupled to the feeding catheter  202  by a self-sealing valve that closes when the feeding catheter is withdrawn from the balloon  22 . Self-sealing valves, for example valves that are formed from elastomeric materials, such as the valve coupling the balloon  22  and feeding catheter  202 , are well known in the art, for example for use in inflating balloons for blocking blood vessels with catheters that are detachable from the balloons. For example, self-sealing valves that are detachable balloons are described in U.S. Pat. No. 4,819,637 and U.S. Pat. No. 6,736,793, the entire contents of which are incorporated herein by reference.  
         [0020]     It may be beneficial for the feeding catheter  202  to be threaded into the valve portion of the balloon  22 , so that the feeding catheter is coupled securely to the balloon  22  while the tip of the feeding catheter  202  extends through the valve to be in position for inflating the balloon  22 .  
         [0021]     The breast augmentation technique described above may also be applied to buttock augmentation, in which case the balloon should be inserted sub-gluteally.  
         [0022]     With the percutaneous breast/buttock augmentation technique described above, the space  108  between the pectoral muscle  102  and the chest wall  104  might be enlarged using an inflatable balloon or series of inflatable balloons, instead of by filling the space  108  with fluid. In addition, catheter  20  and balloon  22  could possibly be inserted over the wire without the use of a sheath  10 . Still further, the balloon  22  could be connected to a sub-cutaneous inflation port that could be used to adjust the amount by which the balloon  22  is inflated. If the sub-cutaneous inflation port is used, the necessity of a feeding catheter  202  could be avoided, and the balloon could be deposited in the space  108  and inflated to a desired degree using the inflation port. Yet still further, it might be possible to avoid using the balloon by injecting a hydrogel into the space  108 .  
         [0023]     According to another aspect of the present invention, a breast lift may be performed by grasping tissue in the breast with a barbed needle and anchoring the barbed needle to a rib with a suture.  
         [0024]     As shown in  FIG. 9 , a trocar needle  302  will be inserted into the deep subcutaneous fat of breast  100 . A tissue anchor needle  304  will be inserted through the trocar  302 , and barbs  306  will then deployed from the end of the tissue anchor needle  304 , and the trocar  302  will then be removed ( FIG. 10 ). The tissue anchor needle  304  will have enough barbs  306  to securely grab the tissue, and the barbs  306  may expand from the needle  304  in all directions in an umbrella-like array. The tissue anchor needle  304  may have a structure similar to the Semi-Flex RITA Medical RF probes, although with an entirely flexible shaft. The tips of the barbs  306 , which may for example be made of nitinol, should not be so sharp that they cut through tissue to the extend that the needle  304  cannot be held in place by the barbs  306 .  
         [0025]     After (or before; order should make no difference in this technique) the tissue anchor needle  304  is positioned, a bone anchor  320  will be attached to a desired rib  110 . The bone anchor  320  has a shape similar to an eye screw, so that a suture can be attached to the bone anchor  320 . The bone anchor  320  is introduced to the rib  110  through a sheath that is positioned at the rib in the same way that the sheath  10  described above is positioned so that its distal tip is posterior to the pectoral muscle. That is, a track to the rib  110  is created with a needle and cannula or trocar needle, and the track is dilated and a sheath is inserted to allow access to the rib  110 . The bone anchor  320  will then be screwed into the rib  110  with conventional tools, and a suture  322  will be attached to the bone anchor and extend out of the breast  100 , as shown in  FIG. 11 .  
         [0026]     The suture  322  will be buried and connected to the flexible shaft (which could also be suture) of the tissue anchor needle  304  by tunneling from the position of the shaft of the tissue anchor needle  304  to the suture  322 , or vice versa. Tunneling is a well-known technique for creating a sub-cutaneous path. A tunneling device for creating a path for, for example, a catheter, is described in, for example US 2005/0215994.  
         [0027]     The tissue anchor needle  304  will then be attached to the suture  322  attached to the bone anchor, and distance from the barbed end of the tissue anchor needle  304  to the bone anchor will be adjusted to be a desired amount to lift the breast. See  FIG. 12 . The incisions in the breast will then be closed.  
         [0028]     It may be desirable to place multiple tissue anchor/bone anchor pairs in the breast, as shown in  FIG. 13 . In addition, it may be beneficial for the tissue anchor needle  304  to be coated with, for example, Dacron mesh, so that the tissue grows onto the tissue anchor. Still further, the barbs  306  could be fixed in the deployed position, without the need for a plunger to deploy them. In this case, it may be necessary to dilate the opening through which the tissue anchor needle is inserted, to account for the width of the anchor with the needles deployed.  
         [0029]     The procedure described above for performing a breast lift could also be used to perform a buttock lift, by securing the bone anchor to the pelvis.  
         [0030]     Presently preferred embodiments of the invention have been described in detail hereinabove. However, various modifications and additions can be made without departing from the spirit and scope of the invention. In particular, the breast and buttock augmentations described above could conceivably be used to augment or lift other parts of the body without departing from the spirit and scope of the present invention. Accordingly, the foregoing description is meant to be taken only by way of example and not to otherwise limit the scope of the present invention as defined in the appended claims.