Breast Prosthesis and Breast Augmentation Using the Breast Prosthesis

• US 20100114310A1
• Filed: 10/24/2006
• Published: 05/06/2010
• Est. Priority Date: 10/24/2006
• Status: Abandoned Application

• Current Assignee: Nobuyuki Masaki
• Original Assignee: Nobuyuki Masaki
• Inventors: Masaki, Nobuyuki
• Application Number:
  US12/443,127
• Publication Number:
  US 20100114310A1
• Time in Patent Office: Days
• US Class Current: 623/8
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants

Abstract

An outer bag in which a core is contained in a movable state is made of a non-assimilatable material to function as an outer artificial coating. The outer bag includes a sheet-shaped base and a large number of convexes (14, 15) and/or concaves 14 formed integrally with the sheet-shaped base and disposed on an outer surface of the sheet-shaped base. Therefore, there is no probability that a breast prosthesis implanted into an implantation-scheduled space in a chest is deformed due to capsular contracture to decrease its surface area. There is no probability that free movement of the breast becomes poor. Even though the construction is simple, a breast prosthesis having a good outer artificial coating can be provided.

Claims

1. A breast prosthesis comprising a core (2) and an outer bag (4) in which the core (2) is contained in a movable state, characterized in that

the outer bag (4) is made of a non-assimilatable material to function as an outer artificial coating;

the outer bag (4) comprises a large number of convexes (14, 15) and/or a large number of concaves formed integrally with a sheet-shaped base (13) of the outer bag (4) and disposed on an outer surface of the sheet-shaped base (13); and

the convexes (14, 15) and/or the concaves are constructed so as to function as engaging means for a fibrous coating to be formed on an outer surface of the outer bag (4).

2. The breast prosthesis according to claim 1, characterized in that the core (2) comprises an inner bag (3) and a core filling material (6) filling up the inner bag (3).

3. The breast prosthesis according to claim 2, characterized in that the core filling material (6) is a gel material and/or a compatible solution.

4. The breast prosthesis according to any of claims 1 to 3, characterized in that the space between an outer surface of the core (2) and an inner surface of the outer bag (4) is filled up with an outer filling material (7).

5. The breast prosthesis according to claim 4, characterized in that the outer filling material (7) is a gel material and/or a compatible solution.

6. The breast prosthesis according to any of claims 1 to 5, characterized in that each of the convexes and/or the concaves is a projection (14, 15) comprising a retaining portion (14b, 15c).

7. The breast prosthesis according to any of claims 1 to 5, characterized in that each of the convexes and/or the concaves is a projection (14) comprising a constricted portion.

8. The breast prosthesis according to claim 6, characterized in that the projection (14, 15) comprises a columnar portion (14a, 15a, 15b) formed on the outer surface of the outer bag (4) to protrude, and the retaining portion (14b, 15c) formed continuously from an end of the columnar portion (14a, 15a, 15b).

9. The breast prosthesis according to claim 8, characterized in that the projection (14, 15) is a single-pole type projection (14).

10. The breast prosthesis according to claim 8, characterized in that the projection (14, 15) is an arch type projection (15).

11. The breast prosthesis according to any of claims 1 to 5, characterized in that the convexes and/or the concaves are textured type convexes and/or concaves that make the outer surface of the sheet-shaped base (13) textured with fine irregularities.

12. The breast prosthesis according to any of claims 1 to 11, characterized in that a tube (5) is detachably attachable to the outer bag (4) so as to connect with the interior of the outer bag (4).

13. The breast prosthesis according to claim 12, characterized in that a valve is provided for the outer bag (4) to close a portion of the outer bag (4) to which the tube (5) was connected, for sealing the outer bag (4) when the tube (5) has been detached from the outer bag (4).

14. The breast prosthesis according to any of claims 1 to 13, characterized in that the convexes (14, 15) and/or the concaves are formed within a range of 50 to 100%, preferably 70 to 100%, more preferably 90 to 100% of the area of the outer surface of the sheet-shaped base (13).

15. The breast prosthesis according to any of claims 1 to 14, characterized in that a thickness (T₁) of the sheet-shaped base (13) is within a range of 0.1 to 2.5 mm, preferably 0.2 to 1.2 mm.

16. The breast prosthesis according to any of claims 8 to 10, characterized in that a length (L₁, L₂) of each columnar portion (14a, 15a, 15b) is within a range of 0.15 to 4 mm, preferably 0.3 to 2 mm.

17. The breast prosthesis according to any of claims 8 to 10 and 16, characterized in that the maximum length (L₂, L₆) of each columnar portion (14a, 15a, 15b) substantially parallel to the outer surface of the sheet-shaped base (13) is within a range of 0.05 to 2 mm, preferably 0.1 to 1 mm.

18. The breast prosthesis according to any of claims 6, 8 to 10, 16, and 17, characterized in that the maximum length (L₃, L₄, L₇, L₈) of each retaining portion (14b, 15c) substantially parallel and/or substantially perpendicular to the outer surface of the sheet-shaped base (13) is within a range of 0.1 to 3 mm, preferably 0.2 to 1.5 mm.

19. The breast prosthesis according to claim 9, characterized in that the interval (S₁) between a pair of neighboring columnar portions (14a) of the single-pole type projections (14) is within a range of 0.2 to 4 mm, preferably 0.4 to 2 mm.

20. The breast prosthesis according to claim 10, characterized in that the maximum length (L₉) of each retaining portion (14b, 15c)(15c) of the arch type projection (14, 15)(15) substantially perpendicular to a longitudinal axis of the retaining portion is within a range of 0.05 to 2 mm, preferably 0.1 to 1 mm.

21. The breast prosthesis according to claim 10 or 20, characterized in that the interval (S₂) between a pair of columnar portions (15a, 15b) of each arch type projection (15) is within a range of 0.075 to 3 mm, preferably 0.15 to 2 mm.

22. The breast prosthesis according to any of claims 10, 20, and 21, characterized in that the interval (S₃) between a pair of neighboring columnar portions (14a, 15a, 15b)(15a, 15b) of a pair of neighboring arch type projections (14, 15)(15) is within a range of 0.075 to 3 mm, preferably 0.15 to 2 mm.

23. The breast prosthesis according to any of claims 8 to 10, 16, 17, and 19 to 22, characterized in that the ratio of the length (L₁, L₅) of each columnar portion (14a, 15a, 15b) to the thickness (T₁) of the sheet-shaped base (13) is within a range of 0.3 to 6, preferably 0.6 to 3.

24. The breast prosthesis according to any of claims 8 to 10, 16, 17, and 19 to 23, characterized in that the ratio of the maximum length (L₂, L₆) of each columnar portion (14a, 15a, 15b) substantially parallel to the outer surface of the sheet-shaped base (13) to the thickness (T₁) of the sheet-shaped base (13) is within a range of 0.1 to 4, preferably 0.3 to 2.

25. The breast prosthesis according to any of claims 6, 8 to 10, and 16 to 24, characterized in that the ratio of the maximum length (L₃, L₄, L₇, L₈) of each retaining portion (14b, 15c) substantially parallel and/or substantially perpendicular to the outer surface of the sheet-shaped base (13) to the thickness (T₁) of the sheet-shaped base (13) is within a range of 0.2 to 6, preferably 0.4 to 3.

26. The breast prosthesis according to any of claims 7 to 10, 16, 17, and 19 to 25, characterized in that the ratio of the maximum length (L₂, L₆) of each columnar portion (14a, 15a, 15b) substantially parallel to the outer surface of the sheet-shaped base (13) to the length (L₅) of each columnar portion (14a, 15a, 15b) is within a range of 0.05 to 4, preferably 0.1 to 2.

27. The breast prosthesis according to any of claims 8 to 10, 16, 17, and 19 to 26, characterized in that the ratio of the maximum length (L₃, L₄, L₇, L₈) of each retaining portion (14b, 15c) substantially parallel and/or substantially perpendicular to the outer surface of the sheet-shaped base (13) to the length (L₁, L₅) of each columnar portion (14a, 15a, 15b) is within a range of 0.1 to 5, preferably 0.2 to 3.

28. The breast prosthesis according to any of claims 8 to 10, 16, 17, and 19 to 27, characterized in that the ratio of the maximum length (L₃, L₄, L₇, L₈) of each retaining portion (14b, 15c) substantially parallel and/or substantially perpendicular to the outer surface of the sheet-shaped base (13) to the maximum length (L₂, L₆) of each columnar portion (14a, 15a, 15b) substantially parallel to the outer surface of the sheet-shaped base (13) is within a range of 0.2 to 10, preferably 0.4 to 6.

29. The breast prosthesis according to any of claims 8 to 10, 16, 17, and 19 to 28, characterized in that each columnar portion (14a, 15a, 15b) has a substantially cylindrical column shape.

30. The breast prosthesis according to claim 9 or 19, characterized in that each retaining portion (14b) is substantially spherical.

31. The breast prosthesis according to claim 10, 20, or 21, characterized in that each retaining portion (15c) is substantially semi-ring-shaped as a whole, and its cross section is substantially circular.

32. The breast prosthesis according to claim 11, characterized in that the height and/or depth of each of the textured type convexes and/or concaves is within a range of 0.01 to 1 mm, preferably 0.05 to 0.5 mm.

33. The breast prosthesis according to claim 11 or 32, characterized in that the maximum length of each of the textured type convexes and/or concaves is within a range of 0.01 to 3 mm, preferably 0.05 to 1.5 mm.

34. The breast prosthesis according to any of claims 11, 32 and 33, characterized in that the number of textured type convexes and/or concaves per 1 cm is within a range of 4 to 400, preferably 8 to 200, more preferably 20 to 100.

35. The breast prosthesis according to claim 8, characterized in that single-pole type projections (14) and double-pole type projections (15) are provided together.

36. The breast prosthesis according to claim 8, characterized in that projections (14, 15) each having a retaining portion (14b, 15c) and projections each having no retaining portion are provided together as the projections.

37. The breast prosthesis according to any of claims 1 to 5, characterized in that the convexes and/or the concaves are projections each having no retaining portion (14b, 15c).

38. A method of breast augmentation to be applied to a chest (12) of a human body (11) using a breast prosthesis (1) comprising a core (2) and an outer bag (4) in which the core (2) is contained in a movable state, comprising:

(a) a step of first partially cutting the human body (11) to make an incised portion, and thereby forming an implantation-scheduled space (21) in the chest (12) for implanting the breast prosthesis (1);

(b) a step of then inserting the breast prosthesis (1) into the implantation-scheduled space (21); and

(c) a step of then stitching up the incised portion, characterized by using the breast prosthesis (1) in which;

(d) the outer bag (4) is made of a non-assimilatable material to function as an outer artificial coating;

(e) the outer bag (4) comprises a large number of convexes (14, 15) and/or a large number of concaves formed integrally with a sheet-shaped base (13) of the outer bag (4) and disposed on an outer surface of the sheet-shaped base (13); and

(f) the convexes (14, 15) and/or the concaves function as engaging means for a fibrous coating to be formed on an outer surface of the outer bag (4).

39. The method of breast augmentation according to claim 38, characterized in that each of the convexes and/or the concaves is a projection (14, 15) comprising a retaining portion (14b, 15c).

40. The method of breast augmentation according to claim 38 or 39, characterized by further comprising, between the step (b) and the step (c):

(g) a step of injecting an outer filling material (7) into the outer bag (4) through a tube (5).

41. The method of breast augmentation according to any of claims 38 to 40, characterized by further comprising, between the step (g) and the step (c):

(h) a step of discharging an adequate amount of outer filling material (7) from the outer bag (4) to the outside to adjust the shape of the breast of the human body (11).

42. The method of breast augmentation according to any of claims 38 to 41, characterized by further comprising, between the step (h) and the step (c):

(i) a step of detaching the tube (5) from the outer bag (4) and then closing the tube connection portion of the outer bag (4) with a valve.