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CN-121971201-A - Breast implant wrap and related methods of limiting movement of a breast implant

CN121971201ACN 121971201 ACN121971201 ACN 121971201ACN-121971201-A

Abstract

The present invention relates to a breast implant wrap and related methods of limiting movement of a breast implant. Breast implant immobilization devices for breast reconstruction and breast augmentation are described herein. The new wrap is designed to avoid lateral displacement and bottoming of the breast implant, reduce capsular contraction and implant compression, eliminate skin dents and ripples caused by the breast implant, and reduce or eliminate palpability. The wrap is adapted to fold securely around the breast implant, limit relative movement between the wrap and the breast implant, and reduce wrinkles. Tissue ingrowth into the wrap limits movement of the wrap-breast implant assembly and thus the breast implant.

Inventors

  • Scandell Lim
  • Gehrman O. Hollopez
  • SIMON F. WILLIAMS

Assignees

  • 特法公司

Dates

Publication Date
20260505
Application Date
20201116
Priority Date
20191125

Claims (20)

  1. 1. A breast implant immobilization device for immobilizing a breast implant in a patient, comprising: a base portion, a cover portion, and a hinge region connecting the base portion to the cover portion; Wherein the implant fixture comprises a substantially planar two-dimensional first configuration, and A folded three-dimensional second configuration comprising a shape and size that at least partially covers the breast implant when the cover portion is wrapped around the anterior portion of the breast implant and secured to the base portion, and Wherein the cover portion has a greater elasticity than the base portion.
  2. 2. The device of claim 1, wherein the cover portion has an elasticity of 15% to 75%.
  3. 3. The device of claim 1, wherein the base portion has an elasticity of 5% to 25%.
  4. 4. The device of claim 1, wherein the base portion and cover portion comprise a plurality of apertures.
  5. 5. The device of claim 4, wherein the average diameter of the pores in the cover portion is less than the average diameter of the pores in the base portion.
  6. 6. The device of claim 1, further comprising one or more tabs for anchoring the device to the chest wall of the patient to prevent movement of the breast implant.
  7. 7. The device of claim 1, wherein the thickness of the cover portion is greater than the thickness of the base portion.
  8. 8. The device of claim 1, wherein the base portion is formed from a first mesh and the cover portion is formed from a second mesh, and wherein the second mesh is more elastic than the first mesh.
  9. 9. The device of claim 8, wherein the first and second webs are formed from fibers and the average diameter of the fibers forming the first web is greater than the average diameter of the fibers forming the second web.
  10. 10. The device of claim 1, further comprising a plurality of tabs and a plurality of slits, wherein each slit is adapted to receive one tab such that the cover portion can be pulled taut to eliminate wrinkles in the cover portion.
  11. 11. A breast implant immobilization device that restricts movement of a breast implant in a patient, comprising: A two-dimensional first configuration comprising a base portion, a cover portion, and a hinge region connecting the base portion to the cover portion, and A second three-dimensional configuration comprising a shape and size that at least partially covers the breast implant when the cover portion is wrapped around the anterior portion of the breast implant and secured to the base portion, and Wherein at least one of the base portion and the cover portion includes a plurality of apertures.
  12. 12. The device of claim 11, wherein the base portion is adapted to be placed in contact with the posterior portion of the breast implant and the cover portion is adapted to fold over the anterior portion of the breast implant.
  13. 13. The device of claim 11, further comprising one or more tabs for anchoring the device to the chest wall of the patient to prevent movement of the breast implant.
  14. 14. The device of claim 13, wherein at least one tab is in an elevated position when the device is implanted in a breast.
  15. 15. The device of claim 11, wherein the base portion or cover portion further comprises one or more tabs useful for securing the breast implant inside the fixation device.
  16. 16. The device of claim 11, wherein the base portion or cover portion further comprises one or more slits or openings operable to secure the breast implant inside the fixation device.
  17. 17. The device of claim 11, wherein the base portion or cover portion comprises one or more rounded portions or areas.
  18. 18. The device of claim 11, wherein when a breast implant is wrapped in the device and the device is implanted in the patient's breast with a base portion placed on the patient's chest wall and a cover portion placed under the patient's skin, the thickness of the cover portion of the device is sufficient to prevent the breast implant from being palpable or to hide any ripple or dent in the patient's skin.
  19. 19. The device of claim 11, wherein the cover portion has an elastic range selected from 15% to 75% and 30% to 65%, or the base portion has an elastic range selected from 5% to 25% or 8% to 20%.
  20. 20. The device of claim 11, wherein the elasticity of the cover portion increases from a region in contact with the top of the breast implant to a region in contact with the bottom of the breast implant when the breast implant is wrapped in the device and the device is implanted in a patient's breast.

Description

Breast implant wrap and related methods of limiting movement of a breast implant The application is a divisional application of Chinese patent application with the application date of 2020, 11-16, the application number of 202080093518.8 and the application name of 'breast implant wrap for limiting the movement of a breast implant and related method'. Technical Field The present invention relates generally to the field of surgery, and more particularly to implantable medical devices that limit movement of breast implants following breast reconstruction procedures, including augmented breast immobilization (augmentation mastopexy). Background Breast reconstruction following mastectomy has become an integral and significant part of the surgical treatment of breast cancer, providing both aesthetic and socioeconomic benefits to the patient. Today, nearly 65% of U.S. breast reconstruction surgical procedures use Tissue Expanders (TEs) that are temporarily implanted into the breast in the first step of the procedure to create a pocket for a permanent breast implant. Tissue expanders are now placed more frequently on top of the pectoral muscle (chest placement) than under the pectoral muscle in order to reduce postoperative pain. Once the pocket is created, the TE is removed and replaced with a permanent breast implant in a second step. However, in some patients, the pocket for the breast implant may be formed after mastectomy without use of TE. Breast implants may also be used in both breast augmentation and breast immobilization procedures to augment breast size. In the latter procedure, breast lifting is combined with breast augmentation. Most commonly, the breast implant is placed in a pocket under the breast tissue, but in some cases it is implanted under the chest wall. Breast implants vary in size, shape and surface texture. A variety of different sizes may allow the surgeon and patient to select from a range of elevations, heights, widths, and total volumes. In terms of shape, there are circular and anatomical implants, and the surface of the implant may be smooth, micro-textured or macro-textured. For example, siltex 1600 micro-textured breast implants have small openings (open-pore) with diameters of 70 to 150 μm and depths of 40 to 100 μm on the surface, while Biocell RTV large textured breast implants have larger openings with diameters of 600 to 800 μm and depths of 150 to 200 μm （Damino et al. Comparison of the capsular response to the Biocell RTV and Mentor 1600 Siltex breast implant surface texturing: a scanning electron microscopic study, Plastic and Reconstructive Surgery, 2001, 108(7), 2047-2052）. The texture of the breast implant was originally used as a method to limit the rotation and movement of the breast implant. However, recent studies using high resolution ultrasound have found that large textures are not sufficient to prevent breast implant rotation. For example ,Sieber et al.（Clinical evaluation of shaped gel breast implant rotation using high-resolution ultrasound, Aesthetic Surgery Journal, 2017, , volume 37 (3), volumes 290-296) have reported that the rotation rate of breast implants is 27% in patients implanted with anatomical breast implants made by Mentor and Allergan. Furthermore, it is surprising that 26% of the breast implants examined were rotated 45 ° or more from the neutral line. Sieber et al concluded that rotation of the breast implant occurred in 42% of patients. Balloon formation around the breast implant may prevent the breast implant from being held in place. Clearly, the patient does not want to find that their anatomic implant has rotated and that the thicker part of the implant is no longer located at the bottom of the breast, but rather at the sides of the breast or even at the top. Especially when the only way to solve the problem is by further surgery. The concern for using large textured anatomical breast implants is not limited to undesired rotation of the implant resulting in a suboptimal appearance of the breast. There is increasing evidence that the use of these implants has been linked to the severe increase in cases of anaplastic large cell lymphoma (ANAPLASTIC LARGE CELL lymphoma, ALCL) (rare peripheral T cell lymphomas) （Leberfinger et al., Breast-implant associated anaplastic large cell lymphoma: a systematic review, JAMA Surg. 2017, Dec 1;152(12), 1161-1168）., a mechanism that is thought to be underlying by chronic inflammation caused by the large texture of anatomical breast implants. Chronic inflammation is thought to in some cases trigger malignant transformation of T cells, leading to cancers of the immune system. Treatment of lymphomas involves removal of the patient's implant and the capsule surrounding the implant, and in more advanced cases, the patient may require further treatment, including radiation therapy, chemotherapy, and lymph node cleaning. As a result of the increasing number of breast implant-ALCL cases, the FDA has suggested pati