Artificial breast prosthesis delivery device

The breast implant delivery device with vertical grooves on its inner surface addresses the high injection force issue, enhancing surgical efficiency and safety by reducing friction and stress concentration.

WO2025143982A1PCT designated stage expired Publication Date: 2025-07-03OSSTEMIMPLANT CO LTD
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Patent Information

Application Number
PCT/KR2024/096608
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-12-29
Filing Date
2024-11-18
Publication Date
2025-07-03

AI Technical Summary

Technical Problem

Existing breast implant delivery devices with tapered structures require a large injection force, which can lead to adverse effects and increased surgical time and risk of infection due to the need for a large incision.

Method used

A breast implant delivery device with a tapered body featuring vertical grooves on its inner surface, arranged radially and with varying groove spacings and depths, reduces friction and distributes stress, thereby minimizing the required injection force.

Benefits of technology

The device significantly reduces the injection force needed for implantation by distributing stress and reducing friction, thus minimizing surgical trauma and recovery time.

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Abstract

One embodiment of the present invention provides an artificial breast prosthesis delivery device comprising: a tapered body in which a breast implant is accommodated, and the width of which becomes narrower from one side to the other side; and a plurality of vertical grooves recessed in the inner surface of the body, extending from one side to the other side, and radially spaced apart from each other.
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Description

Artificial breast implant delivery device

[0001] The present invention relates to an artificial breast implant delivery device.

[0002] During breast augmentation surgery, the skin tissue is incised to implant the implant into the body. However, if the skin tissue is incised too large during the surgery, not only will the skin tissue at the incision site be damaged, but scarring and post-operative discomfort may also occur.

[0003] Accordingly, the tapered breast implant delivery device (T) of Fig. 1, which can minimize the incision area during implantation, is gaining popularity. Since the implant (B) can be implanted into the body through a narrowing structure, implantation is possible through a minimal incision, and has the advantage of a reduced risk of infection and a shorter surgical time and recovery time.

[0004] However, due to the structure of the tapered breast implant delivery device (T), a large injection force is required for the implant (B) to pass through the narrow opening (T1), and there is concern that adverse effects may occur if this injection force is applied to the implant.

[0005] Accordingly, Keller Medical INC. has developed the Keller funnel (U.S. Patent No. 8,211,173), which has a tapered structure whose inner surface is made smooth through chemical treatment to facilitate easy sliding from the large end to the small end.

[0006] However, because the Keller funnel also has a tapered structure, there is a limitation in that a large injection force is still required when implanting the prosthesis.

[0007] [Prior Art Literature]

[0008] [Patent Document]

[0009] U.S. Patent No. 8,211,173 (registered on July 3, 2012)

[0010] The present invention is intended to solve the problems of the prior art described above, and an object of the present invention is to provide an artificial breast implant delivery device having a tapered structure that can reduce the injection force required when injecting the implant.

[0011] One aspect of the present invention provides an artificial breast implant delivery device, comprising a tapered body having a breast implant accommodated therein and having a width that becomes narrower from one side to the other, and a plurality of vertical grooves formed by being sunken into the inner surface of the body, extending from one side to the other, and arranged radially spaced apart from each other.

[0012] In one embodiment, the groove spacing between the vertical grooves and adjacent vertical grooves may become narrower from one side to the other.

[0013] In one embodiment, the groove spacing at one end of the vertical groove may be 0.15 mm or more and 100 mm or less, and the groove spacing at the other end of the vertical groove may be 0.025 mm or more and 50 mm or less.

[0014] In one embodiment, the depth of the vertical groove may be 0.01 mm or more and 0.15 mm or less.

[0015] In one embodiment, the length of the vertical groove may be 100 mm or more and 400 mm or less.

[0016] In one embodiment, the vertical grooves may be arranged at equal intervals from adjacent vertical grooves.

[0017] In one embodiment, the body may be formed of an elastic material.

[0018] In one embodiment, a hydrophilic functional group may be formed on the inner surface of the body.

[0019] In one embodiment, the inner surface of the body may be coated with a lubricant.

[0020] In one embodiment, the body may be formed as a hollow structure, with a first opening at one end being larger than a second opening at the other end.

[0021] According to one aspect of the present invention, friction is reduced and stress is concentrated on the narrow opening side by the vertical groove formed on the inner surface of the artificial breast implant delivery device, so that the injection force required when injecting the implant can be reduced.

[0022] The effects of the present invention are not limited to the effects described above, and should be understood to include all effects that can be inferred from the detailed description of the present invention or the composition of the invention described in the claims.

[0023] FIG. 1 relates to a conventional tapered artificial breast implant delivery device.

[0024] FIG. 2 is a schematic drawing of an artificial breast implant delivery device according to one embodiment of the present invention.

[0025] Figure 3 is a schematic cross-sectional view of an artificial breast implant delivery device with the other end removed.

[0026] FIG. 4 is a schematic drawing of a portion of a cross-sectional view of the artificial breast implant delivery device of FIG. 2.

[0027] Figures 5 to 7 are graphs showing the results of measuring the injection force of an artificial breast prosthesis delivery device according to examples and comparative examples of the present specification.

[0028] Hereinafter, the present invention will be described with reference to the attached drawings. However, the present invention can be implemented in various different forms and is therefore not limited to the embodiments described herein. In the drawings, irrelevant parts have been omitted for clarity of description, and similar parts have been designated with similar reference numerals throughout the specification.

[0029] Throughout the specification, when a part is said to be "connected" to another part, this includes not only "directly connected" but also "indirectly connected" with other elements intervening. Furthermore, when a part is said to "include" a component, this does not exclude other components, but rather implies that the other components may be included, unless otherwise specifically stated.

[0030] Terms containing ordinal numbers, such as "first" or "second," used herein may be used to describe various components or steps, but such components or steps are not limited by the ordinal numbers. Terms containing ordinal numbers should be interpreted only to distinguish one component or step from other components or steps.

[0031] When a range of numerical values ​​is described herein, unless a specific range is otherwise specified, the values ​​have the precision of the provided significant figures according to standard rules in chemistry for significant figures. For example, the number 10 includes a range of 5.0 to 14.9, and the number 10.0 includes a range of 9.50 to 10.49. Hereinafter, embodiments of the present invention will be described in detail with reference to the attached drawings.

[0032] FIG. 2 is a schematic drawing of an artificial breast implant delivery device according to one embodiment of the present invention.

[0033] An artificial breast implant delivery device (1) according to one embodiment of the present invention is configured to deliver an artificial breast implant to a surgical pocket. Here, the surgical pocket refers to an incision site such as the patient's armpit or under the breast.

[0034] Referring to FIG. 2, an artificial breast implant delivery device (1) according to one embodiment of the present invention includes a body (10) and a vertical groove (20).

[0035] In detail, the body (10) is formed so that the width of the body (10) becomes narrower as it goes toward the other end (12), and a first opening (11) is formed at one end into which a prosthesis is inserted. The pointed other end (12) of the body (10) may be cut off during a prosthesis implantation surgery. In this case, a second opening (13) through which the prosthesis can be discharged may be formed at the other end of the body (10), and the second opening (13) is formed to be smaller than the first opening (11).

[0036] For example, the body (10) may be tapered, conical, or funnel-shaped. Alternatively, the body (10) may be a pyramid. However, the present invention is not limited thereto, and the body (10) may be provided as a hollow structure in which one opening (11) is larger than the other opening (13). In this way, the body (10) may be applied with various shapes in which the width becomes narrower from one side to the other.

[0037] Due to the tapered structure of the body (10), when the surgeon applies a load to the body (10), the prosthesis can slide along the narrowing inner surface of the body (10) and be moved into the surgical pocket.

[0038] The body (10) may be made of an elastic material. For example, the body (10) may be made of a flexible and transparent material such as PVC (polyvinyl chloride), polyethylene, polyester, or polyurethane. Alternatively, the body (10) may be made of a soft material that can be easily crumpled, such as vinyl or thin fabric.

[0039] In one embodiment, the inner surface of the body (10) may be hydrophilic coated.

[0040] In one embodiment, the inner surface of the body (10) may be coated with a material having a hydrophilic functional group such as HA (Hyaluronic acid), cellulose, glycerol, ethylene glycol, sulfonic acid, etc.

[0041] In one embodiment, the inner surface of the body (10) may be coated with a hydrophilic lubricant such as Celluloue, Hyaluronic acid, propylene glycol, Glyerol, 4,4'-Diaminostibene-2,2'-disulfonic acid (DASDA), 2'-deoxyadenosine 5'-monophosphate (DAP), 2'-deozycytidine 5'-monophosphate (DCP), N-Tris(hydroxymentyl)methyl-3-aminopropanesulfonic acid, etc.

[0042] As a result, the frictional force on the inner surface of the body (10) is reduced, so that when the operator applies pressure to the body (10), the prosthesis can slide along the inner surface of the body (10) and be moved into the surgical pocket.

[0043] Figure 3 is a schematic cross-sectional view of an artificial breast implant delivery device with the other end removed.

[0044] Referring to Fig. 3, a vertical groove (20) is formed by being sunken to a certain depth into the inner surface of the body (10), and is formed by extending from one side of the body (10) to the other side, that is, in the direction in which the prosthesis is injected or in the direction in which a load is applied.

[0045] Here, if the groove is formed in a horizontal direction perpendicular to the injection direction of the prosthesis, the load is distributed along the groove, so the effect of the load being transferred from the first opening (11) to the second opening (13), i.e., the stress concentration is reduced, and rather, only the frictional force is increased by the groove, so that the load required for implantation of the prosthesis may increase.

[0046] A plurality of vertical grooves (20) may be formed along the circumference of the body (10), and may be arranged horizontally spaced apart from each other. Specifically, a plurality of vertical grooves (20) may be formed radially spaced at equal intervals based on the center of the body (10). That is, the groove spacing may be formed uniformly along the circumference of the body (10).

[0047] The groove spacing, which is the horizontal distance between a vertical groove (20) and an adjacent vertical groove (20), can be formed to become narrower from one side to the other.

[0048] FIG. 4 is a schematic drawing of a portion of a cross-sectional view of the artificial breast implant delivery device of FIG. 2.

[0049] Referring to FIGS. 2 and 4, the groove spacing (d1) on the side of the first opening (11), that is, the groove spacing (d1) at one end (21) of the vertical groove (20), may be formed to be 0.15 mm or more and 100 mm or less, and the groove spacing (d2) on the side of the second opening (13), that is, the groove spacing (d2) at the other end (22) of the vertical groove (20), may be formed to be 0.025 mm or more and 50 mm or less. Here, the groove spacing (d1) on the side of the first opening (11) may be formed to be greater than the groove spacing (d2) on the side of the second opening (13).

[0050] If the groove spacing (d1) of one end (21) of the vertical groove (20) is less than 0.15 mm or the groove spacing (d2) at the other end (22) of the vertical groove (20) is less than 0.025 mm, the strength of the body (10) may be weakened and may tear. In addition, if the groove spacing (d1) of one end (21) of the vertical groove (20) exceeds 100 mm or the groove spacing (d2) at the other end (22) of the vertical groove (20) exceeds 50 mm, the surface area reduction is slight, the stress concentration is reduced, and the injection force reduction effect does not appear.

[0051] In one embodiment, the depth (d3) of the vertical groove (20) can be formed to be 0.01 mm or more and 0.15 mm or less.

[0052] If the depth (d3) of the vertical groove (20) is less than 0.01 mm, the vertical groove (20) may spread out and disappear when a load is applied, thereby eliminating the stress concentration effect. If the depth (d3) of the vertical groove (20) exceeds 0.15 mm, the prosthesis may be introduced between the vertical grooves (20), thereby increasing the contact area between the body (10) and the prosthesis, thereby increasing the frictional force, thereby hindering stress concentration.

[0053] In one embodiment, the length (d4) of the vertical groove (20) can be formed to be 100 mm or more and 400 mm or less.

[0054] Hereinafter, the embodiments of this specification will be described in more detail. However, the experimental results below represent only representative experimental results among the above embodiments, and the scope and content of this specification cannot be interpreted as being reduced or limited by the embodiments, etc. The effects of each of the various implementation examples of this specification that are not explicitly presented below will be specifically described in the relevant sections.

[0055] The artificial breast implant delivery devices of Examples 1 to 6 were all manufactured using the same elastic material, and the length of the vertical grooves was formed to be 250 mm, but the groove spacing at one end of the vertical grooves, the groove spacing at the other end, or the depth were manufactured to be different from each other, as shown in Table 1 below.

[0056] The same type of hydrophilic lubricant was uniformly applied to the inner surface of the artificial breast implant delivery device of Examples 2 to 6.

[0057] The artificial breast implant delivery device of Comparative Example 1 was manufactured in the same manner as Example 1, except for the vertical groove.

[0058] The artificial breast implant delivery device of Comparative Example 2 was manufactured in the same manner as Example 2, except for the vertical groove.

[0059]

[0060] Division Vertical groove One end groove spacing (mm) Vertical groove Other end groove spacing (mm) Vertical groove depth (mm) Hydrophilic lubricant application Example 150 200.15 X Example 2 100 400.01 O Example 350 200.01 O Example 40 150.025 0.01 O Example 550 200.08 O Example 650 200.15 O Comparative Example 1 --- X Comparative Example 2 --- O

[0061] Experimental Example 1: Measurement of injection force with and without vertical grooves

[0062] In order to show the effect of reducing injection force depending on the presence or absence of a vertical groove, the injection force was measured in the artificial breast implant delivery devices of Comparative Example 1 and Example 1, and the results are shown in Fig. 5 and Table 2.

[0063] Specifically, using a universal material testing machine from INSTRON, the maximum load applied to the universal material testing machine when the prosthesis was injected from the first opening to the second opening at a constant speed (100 mm / min) in the artificial breast prosthesis delivery device was measured as the injection force.

[0064] Distinctive Input (N) Comparison Example 1200 Example 1180

[0065] Referring to FIG. 5 and Table 2, it was confirmed that the artificial breast implant delivery device with vertical grooves of Example 1 reduced the injection force required for injection of the implant by approximately 10% compared to the artificial breast implant delivery device without vertical grooves of Comparative Example 1.

[0066] Experimental Example 2: Measurement of injection force according to the spacing of vertical grooves

[0067] In order to show the effect of reducing injection force according to the spacing of the vertical grooves, the injection force was measured in the same manner as in Experimental Example 1 in the artificial breast implant delivery devices of Comparative Example 2 and Examples 2 to 4, and the results are shown in Fig. 6 and Table 3.

[0068] Distinctive Input (N) Comparison Example 2110 Example 289 Example 387 Example 486

[0069] Referring to FIG. 6 and Table 3, it was confirmed that the artificial breast implant delivery devices having vertical grooves of Examples 2 to 4 had a reduced injection force of about 20% compared to the artificial breast implant delivery device without vertical grooves of Comparative Example 2, and furthermore, the injection force decreased as the gap between the vertical grooves decreased. For reference, when the gap between the grooves at one end of the vertical grooves was less than 0.15 mm or the gap between the grooves at the other end of the vertical grooves was less than 0.025 mm, the strength of the body weakened and it tore. In addition, when the gap between the grooves at one end of the vertical grooves exceeded 100 mm or the gap between the grooves at the other end of the vertical grooves exceeded 50 mm, the surface area reduction was slight, the stress concentration was reduced, and the injection force reduction effect did not appear.

[0070]

[0071] Experimental Example 3: Measurement of injection force according to the depth of the vertical groove

[0072] In order to show the effect of reducing injection force according to the depth of the vertical groove, the injection force was measured in the same manner as in Experimental Example 1 in the artificial breast implant delivery devices of Comparative Example 2 and Examples 3, 5, and 6, and the results are shown in Fig. 7 and Table 4.

[0073] Distinctive Input (N) Comparison Example 2110 Example 387 Example 586 Example 685

[0074] Referring to FIG. 7 and Table 4, it was confirmed that the artificial breast implant delivery devices with vertical grooves of Examples 3, 5, and 6 had a reduced injection force of about 20% compared to the artificial breast implant delivery device without vertical grooves of Comparative Example 2, and furthermore, the injection force decreased as the depth of the vertical grooves increased. For reference, when the depth of the vertical grooves was less than 0.01 mm, the vertical grooves spread out and disappeared when a load was applied, so the stress concentration was reduced and the injection force reduction effect did not appear. In addition, when the depth of the vertical grooves exceeded 0.15 mm, the implant was introduced between the vertical grooves, so the contact area between the body and the implant increased, which increased the frictional force, so the stress concentration was reduced and the injection force reduction effect did not appear.

[0075] That is, according to the artificial breast prosthesis delivery device according to one embodiment of the present invention, friction is reduced by the vertical groove formed on the inner surface of the artificial breast prosthesis delivery device, and stress is concentrated on the narrow opening side, so that the injection force required when injecting the prosthesis can be reduced.

[0076] The foregoing description of the present invention is for illustrative purposes only, and those skilled in the art will readily appreciate that the present invention can be readily modified into other specific forms without altering the technical spirit or essential characteristics of the present invention. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive. For example, each component described as a single entity may be implemented in a distributed manner, and similarly, components described as distributed may be implemented in a combined manner.

[0077] The scope of the present invention is indicated by the claims set forth below, and all changes or modifications derived from the meaning and scope of the claims and their equivalent concepts should be interpreted as being included in the scope of the present invention.

[0078]

[0079] [Explanation of symbols]

[0080] 1 Artificial breast implant delivery device

[0081] 10 bodies

[0082] 20 vertical grooves

Claims

1. A tapered body that accommodates a breast implant inside and becomes narrower from one side to the other; and An artificial breast prosthesis delivery device comprising a plurality of vertical grooves formed by being sunken into the inner surface of the body, extending from one side to the other, and arranged radially spaced from one another.

2. In paragraph 1, An artificial breast implant delivery device, wherein the groove spacing between the vertical grooves and adjacent vertical grooves becomes narrower from one side to the other.

3. In paragraph 2, The groove spacing at one end of the above vertical groove is 0.15 mm or more and 100 mm or less, An artificial breast prosthesis delivery device, wherein the groove spacing at the other end of the vertical groove is 0.025 mm or more and 50 mm or less.

4. In paragraph 1, An artificial breast implant delivery device, wherein the depth of the vertical groove is 0.01 mm or more and 0.15 mm or less.

5. In paragraph 1, An artificial breast implant delivery device, wherein the length of the vertical groove is 100 mm or more and 400 mm or less.

6. In paragraph 1, An artificial breast implant delivery device, wherein the vertical grooves are arranged at equal intervals with adjacent vertical grooves.

7. In paragraph 1, An artificial breast implant delivery device, wherein the body is formed of an elastic material.

8. In paragraph 1, An artificial breast implant delivery device, wherein a hydrophilic functional group is formed on the inner surface of the body.

9. In paragraph 1, An artificial breast implant delivery device, wherein the inner surface of the body is coated with a lubricant.

10. In paragraph 1, An artificial breast implant delivery device, wherein the body is a hollow structure, and a first opening at one end is formed to be larger than a second opening at the other end.

Citation Information

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