CONTAINER DEVICE FOR BREAST PROSTHESIS FOR RECONSTRUCTIVE BREAST SURGERY

Abstract

Medical device for breast reconstruction for containing or integrating a breast implant, the device being designed for placement between the skin and the pectoralis major muscle and is configured to be sutured to the pectoralis major muscle. The device includes a container body having a half shell and a flat appendage joined continuously to a portion of the base of the half shell.

Claims

1. Medical device for breast reconstruction for containing or integrating a breast prosthesis (4), said device being designed for placement between the skin and the pectoralis major muscle, able to be sutured to the pectoralis major muscle, comprised by a container body (1; 1.1) which is comprised by a half shell (2) having a hollow dome shape, its internal surface is substantially complementary form to the external surface of the breast prosthesis (4) to be contained or integrated, and a flat appendage (3), wherein the device comprises: an open configuration wherein the half shell (2) is associated and joined with the flat appendage (3) continuously and without a continuous solution to a portion of a base of said half shell (2), in said open configuration said flat appendage (3) extending outwards in respect to said portion of the base of said half shell (2), and a closed configuration wherein a perimeter of the appendage (3) is sutured to a perimeter of the base of the half shell (2) to obtain a container device for the breast prosthesis (4).

2. The medical device according to claim 1, wherein the half shell (2) and the flat appendage (3) together form the container body (1.1) with a flat base corresponding to a coupling surface of the appendage (3) to the half shell (2).

3. The medical device according to claim 1, wherein the surface area of the appendage (3) is greater than or equal to the area of the base of the half shell (2).

4. The medical device according to claim 1, wherein the appendage (3) has a circular shape.

5. The medical device according to claim 1, wherein the appendage (3) has an oval shape.

6. The medical device according to claim 1, wherein the medical device is made in bio-material.

7. The medical device according to claim 1, wherein in said open configuration said flat appendage (3), that extends outwards in respect to said portion of the base of said half shell (2), is coplanar to said portion of the base of said half shell (2).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Additional characteristics and advantages of the device described as the invention are evident in the following detailed description, made with reference to the attached drawings, referring to the commonly adopted form for implementation, but not imperative and not restrictive with regard to the invention, in which the product demonstrates a configuration with half shell and flat base.

[0053] FIG. 1 demonstrates a side view of the container device in an open configuration;

[0054] FIG. 2 demonstrates an upper and lower view of the container device in an open configuration;

[0055] FIG. 3 demonstrates the container device in a close configuration containing a breast prosthesis; and

[0056] FIG. 4 demonstrates the container device and positioning of the breast prosthesis.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0057] With reference to the attached Figures, the container device that is the object of this patent application in an open configuration (1) is composed of a half shell (2) in a substantially complementary form to the external surface of a breast prosthesis (4) and a flat appendage (3) associated without a continuous solution to a portion of the base of the half shell (2).

[0058] According to the invention that is the object of this patent application, the external surface of the half shell (2) and the external surface of the appendage (3) together form the container body in the closed configuration, said container body (1.1) with a flat base in correspondence to the coupling plane of the appendage (3) to the half shell (2).

[0059] According to the invention in the object of this patent application, the surface of the appendage (3) is greater than or equal to the area of the base of the half shell (2).

[0060] As demonstrated in FIGS. 3 and 4, once the breast prosthesis is inserted (4), the perimeter of the appendage (3) is sutured to the perimeter of the base of the half shell (2) to obtain the container device in the closed configuration (1.1).

[0061] Subsequently, to overlap the appendage (3) on the half shell (2) to obtain a container (1.1) with a flat base to contain or containing or integrating a breast prosthesis (4), where said container (1.1) can be inserted between the skin and the pectoralis major muscle and sutured to the latter.

[0062] In a preferential but not exclusive form, the half shell (2) has a hollow spherical dome shape, joined continuously to the appendage (3) defining the base of the same dome.

[0063] In a preferential but not exclusive form, the surface of the appendage (3) is circular.

[0064] In a preferential but not exclusive form, the surface of the appendage (3) is oval.

[0065] Independently of the preferential but not exclusive forms, once the breast prosthesis (4) is inserted into the half shell (2), the border that constitutes the perimeter of the appendage (3) is sutured to the lower border of the half shell (2), constituting the perimeter of the base of the half shell (2) itself, therefore obtaining a container device (1.1) that completely encloses said breast prosthesis inside of it (4), which is then sutured to the pectoralis major muscle.

[0066] The flat base of the container device (1.1) constitutes a platform for attaching the half shell (2) to the pectoralis major muscle, and for guaranteeing stability over time of the anatomical form, also when subjected to the force of gravity.

[0067] In practice, it was observed that the invention reached the aforesaid objectives and purpose, having obtained a medical device that can be used in applications and not compromising the functionality of the pectoralis major muscle, preventing any muscular injury between the median part and the clavicle, sternum, cartilage of the first six/seven ribs, external oblique muscle (median) and crest below the greater tuberosity of the humerus (lateral).

[0068] The aforesaid device allows maintaining movement of the pectoralis major muscle, avoiding the need for rehabilitation therapy and eliminating costs associated with this disability.

[0069] The device also results in a drastic reduction in post-operative pain, eliminating the risk of muscle contraction, the muscle allows maintaining the stock in the case of a revision, and requires less surgery time and less complexity in the operation, given that no prosthetic materials are dislocated, being dynamic and static, and with less bleeding.

[0070] Said device drastically reduces the risk of capsular contraction caused by contact between the silicone and the surrounding tissues, and the risk of requiring another operation to remove the capsule due to the occurrence of a new type of tumor: ALCL.

[0071] The result is a superior aesthetic effect, both in the short and long-term.

[0072] Another advantage of this invention, which also exceeds patent EP2903563, is the drastic reduction in operating times. The device that is the object of this patent application, consisting of a flexible contained composed of a concave cup inside of which the breast prosthesis is housed and then subsequently closed to create a single body that does not require placement through the suturing of various septa. The decrease in maneuvers also decreases the risk of infection. In the place of the sixteen/eighteen suture stitches necessary for packaging a device with several septa, only three or four stitches are necessary for completing the union between the base to the dome.

[0073] The operating times are also reduced by 30 minutes, influencing the overall reduction of 25% in the time necessary for the surgery, with certain positive impacts in the reduction of post-operative complications.

[0074] The appendage (3) is united continuously to the half shell (2) so that three stitches are sufficient for inserting the flexible container holding the silicone prosthesis.

[0075] The complete enclosure, also in the back, of the prosthesis through the invention constituted of biological matrix (ECM) prevents contact between the silicone and the surrounding tissues, with the certain advantage of not activating the anti-inflammatory response that is typically enacted by foreign matter when tissue and synthetic material make contact.

[0076] In short, the device is beneficial for the patient from these points of view, given that psychologically speaking the patient benefits from the rapid operation in only one sitting, with a simplified technique, which eliminates the need to maneuver muscles, can be carried out in a much quicker time span, with less bleeding and a reduction in loss of blood and plasma, with a lowered risk both during and following the operation, also from a physiological standpoint, the patient will not be subjected to any loss of movement caused by the resection/disconnection of the pectoral muscles and will not be subjected to the same level and extension of clinical pain as in the previous surgical procedure, and the recovery time will be significantly reduced, improving the professional life of the patient with a more rapid return to the workplace.

[0077] It will be possible for the patient to carry out the same physical activities as without said device, maintaining a high quality of life in their daily activities.

[0078] Anatomically speaking, the pectoralis major muscle remains intact and its structure is maintained complete, and it will not be involved in the procedure and left for any subsequent operations that could involve the muscle fascia.

[0079] The materials used and the dimensions that constitute the single components of the invention may be selected based on specific requirements.

[0080] The various means for implementing different functions certainly must not co-exist only in the illustrated form, but can also take on many different forms not illustrated here.

[0081] The features indicated as beneficial, convenient, or similar can also be omitted or substituted with equivalents.