Medical devices to limit movement of breast implants

Abstract

Breast fixation devices for use in breast reconstruction and breast augmentation limit the rotation or movement of breast implants after implantation that results in an unnatural appearance of the breast. The breast fixation devices can include a thin-walled enclosure in the shape of a pouch. A breast implant is secured inside the pouch to limit movement by applying compression to the breast implants, or using a mating or interlocking mechanism between the pouch and breast implant. The pouches containing the breast implants are implanted in the breast. Tissue in-growth into the pouch limits movement of the pouch-breast implant assembly and thereby limits rotation, migration, and displacement of the breast implant. The pouches preferably comprise poly-4-hydroxybutyrate or copolymer thereof.

We claim: 
     
         1 . A breast implant fixation device to limit migration of a breast implant in a patient comprising:
 a pouch comprising a shape and size to at least partially cover the breast implant;   a plurality of pores for tissue to grow therein and secure the device to the patient;   wherein the pouch comprises a back area for placement on the chest wall of the patient, a front area opposite the back area, the front area comprising a front bottom for placement in the lower pole of the breast, a front top for placement in the upper pole of the breast, and a front intermediate-region for placement under the skin of the patient; and wherein at least a portion of the front area of the pouch is thicker than the back area of the pouch.   
     
     
         2 . The device of  claim 1 , wherein the thickness of the front area of the pouch is sufficient to prevent the breast implant from being palpable, or to hide any ripples or indentations in the skin of the patient, when a breast implant is placed in the pouch, and the pouch is implanted in the breast of the patient. 
     
     
         3 . The device of  claim 1 , wherein the front area of the pouch has an elasticity range of 30-65%, wherein the elasticity is measured as the percent increase in an area when an area is subject to deformation in ASTM burst method D6797-02 using a round ball. 
     
     
         4 . The device of  claim 1 , wherein the back area of the pouch has an elasticity range of 8-20%, wherein the elasticity is measured as the percent increase in an area when an area is subject to deformation in ASTM burst method D6797-02 using a round ball. 
     
     
         5 . The device of  claim 1 , wherein the pouch has at least one of the following thicknesses: a thickness of the front area of the pouch between 0.75-3 mm, and a thickness of the back area of the pouch between 0.2-0.4 mm. 
     
     
         6 . A breast implant fixation device to limit migration of a breast implant in a patient comprising:
 a pouch comprising a shape and size to at least partially cover the breast implant;   a plurality of pores for tissue to grow therein, securing the device to the patient anatomy;   wherein the pouch comprises a back area for placement on the chest wall of the patient, a front area opposite the back area, the front area comprising a front bottom for placement in the lower pole of the breast, a front top for placement in the upper pole of the breast, and a front intermediate-region for placement under the skin of the patient; and   wherein the back area has a different elasticity than the front area.   
     
     
         7 . The device of  claim 6 , wherein the front area of the pouch has an elasticity of 30-65%, wherein the elasticity is measured as the percent increase of the area when the area is subject to deformation in ASTM burst method D6797-02 using a round ball. 
     
     
         8 . The device of  claim 7 , wherein the back area of the pouch has an elasticity 8-20%, wherein the elasticity is measured as the percent increase of the area when the area is subject to deformation in ASTM burst method D6797-02 using a round ball. 
     
     
         9 . The device of  claim 6 , wherein the pouch is shaped to enclose a breast implant. 
     
     
         10 . The device of  claim 6 , wherein the pouch comprises at least one seam connecting the back area of the pouch with the front intermediate-region, front top or front bottom of the pouch. 
     
     
         11 . The device of  claim 6 , wherein the pouch has one or more of the following pore sizes: an average pore diameter in the back area of the pouch between 0.5 mm and 3 mm, an average pore diameter in the front bottom of the pouch between 0.5 mm and 1 mm, and an average pore diameter in the front top of the pouch between 0.1 mm and 1 mm. 
     
     
         12 . The device of  claim 6 , wherein the pouch comprises one or more of the following: a textile, woven textile, non-woven textile, monofilament mesh, or multifilament mesh. 
     
     
         13 . The device of  claim 12 , wherein the textile, woven textile, non-woven textile, monofilament mesh, or multifilament mesh has at least one of the following properties: (i) burst strength of 0.1 to 30 kgf/cm 2 ; (ii) suture pullout strength of 1 to 7 kgf; and (iii) areal density of 40 to 190 g/m 2 . 
     
     
         14 . The device of  claim 6 , wherein the back area of the pouch comprises a slit or opening to allow insertion of the breast implant into the pouch. 
     
     
         15 . The device of  claim 6 , wherein the pouch further comprises one or more of the following: a draw cord, a securing element to maintain the breast implant in fixed alignment with the pouch, and a slot or receptacle to engage a protuberance from a breast implant. 
     
     
         16 . The device of  claim 6 , wherein the pouch comprises a resorbable polymer. 
     
     
         17 . The device of  claim 6 , wherein the resorbable polymer is poly-4-hydroxybutyrate or copolymer thereof, or poly(butylene succinate) or copolymer thereof. 
     
     
         18 . The device of  claim 6 , wherein the pouch further comprises one or more of the following: an additive, bioactive agent, antibiotic, antimicrobial, autologous fat, fat lipoaspirate, injectable fat, adipose cells, fibroblast cells, stem cells, collagen, and hyaluronic acid. 
     
     
         19 . The device of  claim 6 , wherein an endotoxin content of the device is less than 20 endotoxin units, and the device is sterile. 
     
     
         20 . The device of  claim 6 , wherein the thickness of the front area of the pouch decreases from the upper pole to the lower pole. 
     
     
         21 . The device of  claim 6 , wherein the elasticity of the front area of the pouch increases from the upper pole to the lower pole. 
     
     
         22 . A method of making a pouch to limit movement of a breast implant in a patient comprising: forming a pouch in the shape of a breast implant and in a size to at least partially cover the breast implant, and carrying out the forming step such that a slit or opening is provided in a back area of the pouch to allow insertion of the breast implant. 
     
     
         23 . The method of  claim 22 , wherein the step of forming the pouch is performed by forming a front area comprising a front bottom for placement in the lower pole of the breast, a front top for placement in the upper pole of the breast, and a front intermediate-region for placement under the skin of the patient; and wherein the front area of the pouch is thicker than the back area of the pouch. 
     
     
         24 . The method of  claim 22 , wherein the step of forming the pouch is performed by forming a front area comprising a front bottom for placement in the lower pole of the breast, a front top for placement in the upper pole of the breast, and a front intermediate-region for placement under the skin of the patient; and
 wherein the pouch has one or more of the following elasticities: an elasticity of the front area of the pouch of 15-75%, and an elasticity of the back area of the pouch of 5-25%, wherein the elasticity is measured as the percent increase of the area when the area is subject to deformation in ASTM burst method D6797-02 using a round ball.   
     
     
         25 . The method of  claim 23 , wherein the step of forming the pouch is performed by forming the back area with a different elasticity than the front area. 
     
     
         26 . A method of implanting the device of  claim 1 , comprising:
 selecting the pouch;   placing a breast implant inside the pouch;   locating the pouch containing the breast implant in the breast of a patient, and   securing the pouch to the patient, and optionally, wherein the securing is performed by securing the pouch to the chest wall of the patient.