Medical device for breast reconstruction

Abstract

Medical device made of biomaterial, for implant-based breast reconstruction, having a flat original shape of plane geometry, with sections, which sutured together define the front part, lateral, upper and lower of a box element, at least one of the aforesaid sections having at least one appendix adapted to define the rear part of the box element, said box element being adapted to wrap and contain integrally a breast prosthesis, said box element being configured to be interposed between the subcutaneous layer and the pectoralis major muscle and being suturable to the latter.

Claims

1. A medical device for breast reconstruction, comprising: a box element having a front part, lateral parts, an upper part, a lower part, and a rear part so as to be configured to enclose or contain integrally a breast prosthesis, said box element being configured to be interposed between the skin and the pectoralis major muscle and being configured to be sutured to said pectoralis major muscle; wherein the box element is formed from a single flat sheet; wherein the single flat sheet comprises a plurality of sections; and wherein, when the plurality of sections are folded and joined together, the sheet defines the front part, the lateral parts, the upper part, the lower part, and the rear part of the box element.

2. The device of claim 1, wherein the box element is made of biomaterial.

3. A combination of a medical device for breast reconstruction and of a breast prosthesis, wherein the medical device comprises a box element enclosing or containing integrally the breast prosthesis, said box element being configured to be interposed between the skin and the pectoralis major muscle and being configured to be sutured to said pectoralis major muscle; wherein the box element has a front part, lateral parts, an upper part, a lower part, and a rear part; wherein the box element is formed from a single flat sheet; wherein the single flat sheet comprises a plurality of sections; and wherein, when the plurality of sections are folded and joined together, the sheet defines the front part, the lateral parts, the upper part, the lower part, and the rear part of the box element.

4. The combination of claim 3, wherein the box element is made of biomaterial.

5. A method for breast reconstruction, comprising: preparing a single flat sheet having a plurality of sections; preparing a breast prosthesis; folding and joining the plurality of sections of the single flat sheet to define a box element configured to contain the breast prosthesis, wherein the plurality of sections of the sheet define a front part, lateral parts, an upper part, a lower part, and a rear part of the box element when the plurality of sections are joined together; enclosing the breast prosthesis into the box element; interposing the box element containing the breast prosthesis between the skin and the pectoralis major muscle; and suturing the box element to the pectoralis major muscle.

6. The method of claim 5, comprising: enclosing completely the breast prosthesis into the box element.

7. The method of claim 5, wherein the flat sheet is made of biomaterial.

8. The device of claim 1, wherein said sections are joined together through sutures.

9. The combination of claim 3, wherein said sections are joined together through sutures.

10. The method of claim 5, wherein said sections are joined together by sewing.

11. The device of claim 1, wherein, when the sections are folded and joined together, sides of the sections are adjoined.

12. The combination of claim 3, wherein, when the sections are folded and joined together, sides of the sections are adjoined.

13. The method of claim 5, wherein sides of the sections are adjoined and then joined together.

Description

(1) Further characteristics and advantages of the invention will become apparent from the detailed description of a specific, but not exclusive, embodiment, illustrated only by way of a non-limitative example in the accompanying drawings, in which:

(2) FIG. 1 shows the device in the arrangement in plan;

(3) FIG. 2 shows the device partially assembled to assume a conformed box;

(4) FIG. 3 illustrates the positioning of the device within a breast implant;

(5) FIG. 4 illustrates APPLIANCE assembled to make up the correct form for the breast implant;

(6) FIG. 5 shows the device referred to in the previous figure in a three-quarter view perspective;

(7) FIG. 6 shows the device before it is placed in between the skin and the pectoralis major muscle;

(8) FIG. 7 shows the device sutured to the pectoralis major muscle; and

(9) FIG. 8 illustrates a different form that the device assumes in the arrangement in plan.

(10) In the realisations that follow, individual characteristics, given in relation to specific examples, may actually be interchanged with others (different characteristics that exist in other examples of realization).

(11) Also note that if during the procedure of registration a patent is found to have already in place any part of the device to which this patent refers, then this claim should be considered with disclaimer to previously patented claims.

(12) With reference to the above figures, a medical device is indicated with the number (1), that is used in breast reconstruction and which is constituted by a box element obtained from a flat sheet (2), made with a biomaterial, divided in two or more sections (3).

(13) In the particular realisation illustrated in FIG. 1, the device (1) the plane sheet (2) is cut in order to define three distinct sectors (3) each of which comprises a substantially triangular shape with concentric vertices, which thus define a central zone (4) flat it can possibly be drilled, and first bases (5) are slightly arched.

(14) The sections (3), are obtained in such a way that they can be folded by combining the respective first sides (6) and adjoining so that, once joined together by such sutures (7), define a containment structure (20) for a breast implant (8).

(15) The sections (3), once pushed together and sewn at the respective first sides (6) define adjacent the front end (9), lateral (10a, 10b), upper (11) and lower (12) of a box element (13).

(16) At least one of the two sections (3), and specifically the lower one of which a particular realization is illustrated in FIG. 1, presents two appendages (14a, 14b) projecting from the base (5), substantially equal to each other and are arranged approximately symmetrically to a longitudinal central axis (15) of the above section (3).

(17) Each of the said appendages (14a, 14b) has a substantially triangular shape with a linear second side (16) and a third substantially arched side (18).

(18) Once the breast prosthesis (inserted 8) corresponds with the structure of containment (20) obtained by sewing the sections (3) and then the second sides (16), adjacent to them, are sewn together by with one or more points of suture as seen in the illustrations (7) are sewn as well as the first bases (5) with the appendages (14a, 14b), as shown in FIG. 5.

(19) The appendices (14a, 14b) are such as to define the rear part (19) of said box element (13) so that it completely encloses the breast prosthesis (8).

(20) The said box element (13) is then interposed between the skin and the pectoralis major muscle (21) and is then suturable to the latter, as shown in FIGS. 6 and 7.

(21) The flat sheet (2) is made of biomaterial, such as for example, the one known by the trademark “VYPRO” of the company Ethicon Products, or with the trademark “VYCRILL” distributed by the company Johnson & Johnson, or a polypropylene coupled to “Vycrill”, or obtained through the use of suture thread of vegetable origin (such as flax or cotton) or synthetic (such as polyamides, polyester, polypropylene) or of mineral origin (steel), or biomaterial such as a synthetic mesh or network of the type known the brand “Tiloop BRA.”

(22) Said flat sheet (2) in fact constitutes a scaffold for the fixing to the pectoralis major muscle (21) of the box (13) and is adapted to ensure the continuing stability over time of the anatomical shape even when subjected to the force of gravity.

(23) In practice it has been observed that the invention has achieved the intended aim and purposes mentioned above. Having obtained a medical device in the application of which does not compromise the functionality of the pectoralis major muscle, preventing any muscle damage between the medial part of the clavicle, the sternum, cartilage of the first six/seven ribs, the external oblique aponeurosis (medially), and the ridge below the greater tuberosity of the humerus (laterally).

(24) The said device allows the maintenance of the movement of the pectoralis major muscle, avoiding the need for rehabilitation therapies, thus eliminating the costs associated with this disability.

(25) The device also allows the achievement of a drastic reduction in postoperative pain, eliminates the risk of the muscle contracture; the muscle allows the maintenance of the stock in case of revision, requires less surgical time and reduced complexity of the operation given that the lack of dislocation of the prosthetic material is dynamic and static, and also of a reduction in bleeding.

(26) Therefore a superior aesthetic result in both the short and long term.

(27) In essence, the device is advantageous for the patient from various points of view, given that psychologically the patient is less affected given the rapidity of the intervention that can take place at a single time and with a simplified technique that, by eliminating the procedure of loosening the muscle, may take place more quickly, with less bleeding and decrease of blood loss and serous, with a lower risk during and after surgery; also physiologically the patient will not suffer any loss of movement due to resection/disconnection of the pectoral muscles and not clinically suffer pain to the same intensity and extent of previous surgical techniques and the recovery time will be significantly reduced, reducing the effect of the work life of the patient due to a more rapid reintegration into the workplace.

(28) It will be possible to perform the same physical activities which are not recommended in the absence of said device and maintaining a high quality of life in normal daily tasks.

(29) Anatomically, the pectoralis major muscle remains intact and its complete structure will not be affected and will eventually be available for a subsequent surgical operation that may involve muscle fascia.

(30) The materials used and the dimensions that constitute the individual components of the invention may be more pertinent according to the specific requirements.

(31) The various means of performing certain different functions certainly need not coexist only in the illustrated realisation, but may be per se present in many embodiments, also not illustrated.

(32) FIG. 8 is shown as a flat sheet (102) divided into two sections (103) arranged opposite one another and present, each having a substantially triangular shape with concentric vertices, that define a flat central area (104) which may possibly be perforated, and first bases (105), curved to various extents.

(33) The sections (103) are formed so that they can be folded by combining the respective first sides (106) adjacent that, once joined together by such sutures, define a containment structure for a breast implant.

(34) In correspondence of the lower septum (103) projects, substantially in correspondence of its longitudinal central axis (115), an appendice (114) that has a shape substantially linear radiused to the third sides (118a, 118b) each having an end portion which substantially arched is connected to the first base (105) of the septum (103) bottom.

(35) Corresponding with the vertex in which converge the first sides (106) of the two baffles (103) which are advantageously formed from the cut (122) shaped eyelet.

(36) Although this solution allows the obtainment of a containment structure for a breast implant which, thanks to the presence of the appendix (114) allows a box-like structure to be attained, which is then interposed between the skin and the pectoralis major muscle and the pectoralis major muscle suture is stretched.

(37) The characteristics indicated as advantageous, convenient or similar may also be omitted or be replaced with equivalents.