CN209154106U - Light-duty breast prosthesis - Google Patents

Abstract

The utility model provides a kind of light-duty breast prosthesis, including soft shell；Wherein, the inner surface of the soft shell and/or outer surface are formed with recess and/or protrusion for mitigating breast prosthesis weight, the recess and/or protrusion are in array or spiral distribution in the inner surface of soft shell and/or outer surface, and the flexible utricule being supported to shell is preferably arranged inside the shell.The utility model additionally provides another light-duty breast prosthesis comprising flexible utricule and porous support structure, the utricule have outer layer coating and internal layer coating, which is located in the internal layer coating and supports.The specific gravity of the utility model breast prosthesis is more than or equal to 0.5 and is less than or equal to 0.95, has the advantages that specific gravity is small, light-weight.

Description

Light-duty breast prosthesis

Technical field

The utility model relates to a kind of breast prosthesis, especially a kind of light-duty breast prosthesis with smaller specific gravity.

Background technique

Existing breast prosthesis generally includes the soft shell made of organic silicon rubber elastomer and as filler Silicon gel or physiological saline.The specific gravity of these fillers is usually 1 or so, close with the specific gravity of natural breast tissue.

Chinese patent literature CN2925415Y discloses a kind of breast prosthetic implant, including the shell on bottom cover and bottom cover, outside Shell includes five layers, is successively from the inner to the outer: the first silastic-layer, interior barrier separation layer, the second silastic-layer, micropore weavy grain Shape flocked layer and stabilized zone.Wherein, interior barrier separation layer is the separation layer for adding xylene solvent to constitute by silicon rubber, plays antiseepage Effect thoroughly, can utmostly prevent the outside disperse of low-molecular material in Silica hydrogel.

Chinese patent literature CN202446296U discloses one kind and enlarges the bosom with prosthese, which is cystic structures, it includes Expanded PTFE shell and Medical silicone gels internal layer are provided with osculum on the expanded PTFE shell；The osculum passes through Sewing sealing.Wherein, using polytetrafluoroethylene (PTFE) as raw material, successively by processes systems such as preforming, pushing, roll-in, stretching and sizings The polytetrafluoroethylsheet sheet with a thickness of 0.1-0.5mm is obtained, mold is processed into bag-like capsule shell；Then, using Medical silicone gels pair Above-mentioned shell is filled, and shape according to needed for it suitably increases the content of Silica hydrogel, finally sutures and breast prosthesis is made.

Chinese patent literature CN100469336C discloses a kind of anti-seepage freeze gel breast prosthesis, and the breast prosthesis is by outer Capsule and its subsequent capping plate and the silicone gel filler among external capsule and capping plate form, and external capsule has multilayered structure, And wherein there are 2-5 layers to contain barrier material.Specifically, the barrier material category organosiloxane series, it is specially fluorine-containing Or the impervious material of the polysiloxane containing phenyl.Capping plate, which is suppressed or is poured by layer high molecule material, to be made, the high score Sub- material is identical as external capsule；Cover board and utricule adhesive seal.

Chinese patent literature CN100469336C also discloses a kind of production method of anti-seepage freeze gel breast prosthesis, example Such as the production method of round smooth surface antiseep artificial breast prosthesis: (1) cryogenic vulcanization type polysiloxanes and chloroplatinic acid being made into A material B material is made into polysiloxanes and containing hydrogen silicone oil, 5% solution is made by 1: 1 mixing with petroleum ether dissolution respectively, select round mold Be poured, 80 DEG C cryogenic vulcanization 3 hours, pour the second layer again after solidification is cooling, pour 4 layers altogether, wherein in be added 10% in 2 layers Permeability-reducing admixture, after all casting solidification after, it is spare that utricule is made in cooling and demolding；(2) above-mentioned polysiloxanes A material and B material are pressed 1 : 1 proportion after be kneaded repeatedly on kneading machine, with flat plate mold hot pressing (120 DEG C × 10 minutes) form, then in (1) added with prevent The silicone rubber solution of penetration enhancer is poured two layers, spare as capping plate after vulcanization；(3) by capping plate and utricule silicone rubber adhesive Bonding；(4) addition type polysiloxane A material, B material are tuned into Silica hydrogel material by 1: 0.8 proportion；(5) above-mentioned silicon is coagulated with syringe Glue quantitative filling enters in the good utricule of above-mentioned sealing, and 60 DEG C of baking ovens of injection port adhesive seal postposition, which vulcanize 36 hours, to be become Frozen glue shape；(6) above-mentioned semi-finished product are through Co60 irradiation sterilization, examine it is qualified then at.

Chinese patent literature CN201147386Y then discloses a kind of breast prosthesis of no dispensing mouth, including external capsule and bottom Lid connects envelope part with external capsule on bottom cover and is equipped with a gum-injecting port, and external capsule corresponding with gum-injecting port is equipped with weak spot；On bottom cover Coated with glue preparative layer.The production of the breast prosthesis includes: 1, firstly, choose the bottom cover using intermediate not reserved gum-injecting port, There are a weak spot (its thickness are in 0.3mm or so) at edge (outer ring), and its thickness needs reach centre (inner ring) 1.2mm More than, and the thickness of edge (outer ring) needs to reach 0.6mm or more.2, it then, is covered using ring shape mixed sheet When, a small gap is left, is the former weak spot reserved in the center in this gap, gets an injecting glue with needle point in this point Mouthful.3, it will carefully link together at bottom cover and external capsule bottom opening.4, it is appropriate then again to dry external capsule at a certain temperature Time vulcanizes rubber compound.5, the injection for carrying out gel from side gum-injecting port again, after reaching certain required fullness degree, It is put into baking oven vulcanization appropriate time, is taken out.6, after cooling, upper few to its bottom cover member (inner ring) with glue is kneaded using shell Bottom cover surface is completely covered in amount feed liquid, carries out second time, needs in total three to four times again after solvent vapors away naturally, can make Last bottom cover is integrated (no noticeable steps), and intensity is available to be further increased.

For up to the purpose of shaping, breast prosthesis usually has biggish volume, this also means that its weight is also heavier, such as It is even higher up to 500 grams.The non-human autologous tissue as implantation material, the breast prosthesis of such weight may cause a variety of ask The generation of topic.Such as: it is excessive to lower pleat pressure, blood circulation is influenced, leads to that lower pleat rupture easily occurs；Back, shoulder, neck are negative Weight is long-term to be increased, and pain and deformation are caused；The weight bearing of entire breast is big, is also easy to produce breast tenesmus, is easy to produce nipple after tenesmus With mammary areola change in location, surgical effect is influenced, second operation probability is caused to increase.

Summary of the invention

In view of the deficiencies of the prior art, the main purpose of the utility model is to provide a kind of with smaller specific gravity and mitigation weight The breast prosthesis of amount.

In order to achieve the above-mentioned main objectives, the first aspect of the utility model provides a kind of light-duty breast prosthesis, including Be formed as the soft shell that udder shape is imitated such as water-drop-shaped or hemispherical；Wherein, the inner surface and/or appearance of the shell Face is formed with recess and/or protrusion for mitigating breast prosthesis weight, the recess and/or the raised inner surface in soft shell And/or outer surface is in array or spiral distribution.

In above-mentioned technical proposal, depending on the needs of shaping and surgical effect, dented space (multiple arrays or helical form point Be similarly formed dented space between the protrusion of cloth) volume can account for about the 10% to 50% of breast prosthesis volume, such as greatly About 20%, 30%, 40%, 50%, so that breast prosthesis has the weight of lesser specific gravity and mitigation.

In above-mentioned technical proposal, a part of breast prosthesis volume is occupied by dented space to realize the light weight of breast prosthesis Change.The light-weighted advantage of breast prosthesis is: mitigating breast prosthesis to the pressure of lower pleat, lowers breast prosthesis rupture and wind occurs Danger；Postoperative breast prosthesis is relatively low to shaping person's back, shoulder, neck pressure, alleviates or eliminate pain and deformation；Entire breast Downward pressure lowers, and has attenuating by a relatively large margin to the tenesmus of postoperative breast, extends the shaping effect retention time.

In addition, tissue can be grown into the dented space for be formed in outer surface of outer cover after breast prosthesis implantation, Enhance the binding force between breast prosthesis and tissue, breast prosthesis is effectively prevent to slide or shift.

A kind of specific embodiment according to the present utility model, soft shell include coating layer and are formed in coating layer The porous network bracket of inside and or outside, porous network bracket are composed porous with the hole array by forming recess Network structure.

In above-mentioned technical proposal, porous network bracket could be configured such that soft shell can be under non-external force (under such as non-tactile state) keeps predetermined shape, such to be advantageous in that, the shape of breast prosthesis is by including porous network branch The shell of frame and be maintained, to greatly reduce the specific gravity and weight of breast prosthesis.In order to preferably keep breast prosthesis Shape, the inner side and outer side of coating layer is preferably each formed with porous network bracket.

In above-mentioned technical proposal, porous network bracket can have such as polygon, circle, ellipse it is various rule or Irregular array mesh.Porous network bracket has and is composed of hexagonal hole as a preferred implementation manner, Porous network structure, this porous network bracket has preferable structural stability, so as to preferably keep breast prosthesis Shape.

In above-mentioned technical proposal, physiological saline can also be filled inside the shell, so that breast prosthesis more preferably keeps pre- Shape shape.

Another specific embodiment according to the present utility model, concave shape become blind hole structure, which is distributed in The inner surface of shell and/or outer surface.Wherein, the cross section of blind hole can be formed as such as polygon, circle, ellipse Various rules or non-regular shape.

Yet another embodiment according to the present utility model, concave shape become the ring-type of helical groove or array distribution Groove.Preferably, the inner surface and the outer surface of soft shell is each formed with groove, and the groove of the groove of inner surface and outer surface It is arranged alternately.

In the utility model, breast prosthesis preferably includes to be located in shell and to the flexible utricule that shell is supported, with The stability of breast prosthesis shape is improved, and obtains sense of touch more true to nature.Wherein, flexible utricule can be used physiological saline or have Machine Silica hydrogel is as filler.In the utility model, have the shell of recess and/or protrusion can be by organic silicon rubber material system Standby to form, this shell generally can not prevent the silicon gel of flow morphology to be percolated well, therefore when the utility model When breast prosthesis uses silicon gel as filler, need for silicon gel to be first filled to the soft of impermeable ability Property pouch in, then obtained flexible utricule is placed into shell again.

In above-mentioned technical proposal, depending on the needs of shaping and surgical effect, the volume of flexible utricule can account for breast vacation About the 20% to 80% of body volume, such as about 20%, 30%, 40%, 50%, 60% or 70%.

In the utility model, shell can be formed as an entirety or be formed by multiple portions seal combination.As one kind Specific embodiment, shell include for example formed as approximately hemispheric first shell and for example formed as generally circular second The outer peripheral edge portion of shell, first shell and second shell is tightly connected.Wherein it is possible to be realized in the form of such as heat-sealing It is tightly connected.

In the utility model, for the preparation convenient for breast prosthesis, first shell and second shell can by injection molding or Die pressing is integrally formed.For example, the coating layer of first shell can be formed as with the porous network bracket of its inside and or outside One, the coating layer of second shell can be formed as one with the porous network bracket of its inside and or outside.

In the utility model, can only first shell and second shell inner surface or outer surface depressions and/or Protrusion.But as a preferred implementation manner, the inner and outer surfaces of first shell and second shell be each formed with recess and/or it is convex It rises, so as to more reduce the specific gravity and weight of breast prosthesis.

In order to realize that above-mentioned main purpose, the another aspect of the utility model provide a kind of light-duty breast prosthesis, wrap Include flexible utricule and porous support structure；Wherein, which has outer layer coating and internal layer coating, and porous support structure is located at interior Inside layer coating and internal layer coating is supported.

In above-mentioned technical proposal, depending on the needs of shaping and surgical effect, the volume of porous support structure (including its The volume of body and its inner space) can account for about the 20% to 80% of breast prosthesis volume, such as about 20%, 30%, 40%, 50%, 60% or 70%.

In above-mentioned technical proposal, porous support structure can using any physiological harmlessness, low chemical reactivity it is porous Material, such as the metal support network with shape memory function or porous organic rubber silica gel material.

In the utility model, the specific gravity of breast prosthesis may be controlled to be more than or equal to 0.5 less than or equal to 0.95, preferably greatly It is less than or equal to 0.9 in being equal to 0.6, is more preferably higher than equal to 0.65 and is less than or equal to 0.85.

It is with reference to the accompanying drawing and specific real in order to more clearly illustrate the purpose of this utility model, technical solution and advantage Applying mode, the utility model is described in further detail.

Detailed description of the invention

Fig. 1 is the perspective view of the utility model breast prosthesis embodiment 1；

Fig. 2 is the structural exploded view of the utility model breast prosthesis embodiment 1；

Fig. 3 is the three-dimensional cutaway view of the utility model breast prosthesis embodiment 1；

Fig. 4 is the structural exploded view of the utility model breast prosthesis embodiment 2；

Fig. 5 is the three-dimensional cutaway view of the utility model breast prosthesis embodiment 2；

Fig. 6 is the structural schematic diagram of the utility model breast prosthesis embodiment 3；

Fig. 7 is the perspective view of the utility model breast prosthesis embodiment 4；

Fig. 8 is the cross-sectional view of the utility model breast prosthesis embodiment 4；

Fig. 9 is the perspective view of the utility model breast prosthesis embodiment 5；

Figure 10 is the cross-sectional view of the utility model breast prosthesis embodiment 5；

Figure 11 is the perspective view of the utility model breast prosthesis embodiment 6；

Figure 12 is the cross-sectional view of the utility model breast prosthesis embodiment 6.

Specific embodiment

Embodiment 1

Fig. 1-3 shows the structure of the utility model breast prosthesis embodiment 1.Referring to Fig. 1 and 2, the breast of the present embodiment Prosthese includes the soft shell as composed by approximately hemispheric first shell 11 and generally circular second shell 12, and first The outer peripheral edge portion of the coating layer 121 of the coating layer 111 and second shell of shell 11 seals connection.First shell 11 and The material of two shells 12 can be organic silicon rubber.

Referring to Fig. 3, the inner and outer surfaces of the center portion 112 of the first coating layer 111 are respectively formed with the first porous network branch Frame 113 and 114, the inner and outer surfaces of the center portion 122 of the second coating layer 121 are respectively formed with the second porous network bracket 123 With 124.Porous network bracket 113,114,123 and 124 has the porous network knot as made of hexagonal hole array combination Structure, and it is constructed so that soft shell can keep predetermined shape under non-external force.In the present embodiment, porous network bracket 113,114,123 and 124 thickness can be respectively 0.5 millimeter to 0.8 millimeter, and the specific gravity control of breast prosthesis is about 0.5。

The first porous network bracket 113 and 114 of the first coating layer 111 and its inner surface and the outer surface by injection molding or Die pressing is integrally formed, and the second coating layer 121 and the second porous network bracket 123 and 124 of its inner surface and the outer surface are same It is integrally formed by injection molding or die pressing.

It is readily appreciated that, it, can be only in the first coating layer and the second coating layer in the other embodiments of the utility model Inner surface or outer surface form porous network bracket.

Embodiment 2

Fig. 4-5 shows the structure of the utility model breast prosthesis embodiment 2.Referring to fig. 4-5, the breast of the present embodiment is false Body includes the soft shell as composed by approximately hemispheric first shell 21 and generally circular second shell 22, flexible outer Flexible utricule 23 is placed in shell.The volume of flexible utricule 23 accounts about the 50% of breast prosthesis volume, in can fill life Manage the silicon gel of salt water or flow morphology.In the present embodiment, the specific gravity of breast prosthesis is about 0.75.

The outer peripheral edge portion of the coating layer 221 of the coating layer 211 and second shell of first shell 21 seals connection.First Shell 21 has the structure for being similar to first shell 11 in embodiment 1, and second shell 22, which has, is similar to second shell in embodiment 1 The structure of body 12.In addition, by being placed with the flexible utricule 23 played a supporting role to shell inside the shell in this present embodiment, because This porous network bracket may not necessarily be configured so that soft shell can keep predetermined shape under non-external force.

Embodiment 3

Fig. 6 is the structural schematic diagram of the utility model breast prosthesis embodiment 3.Referring to Fig. 6, the breast prosthesis of the present embodiment Flexible utricule 31 and porous support structure 32 including limiting breast prosthesis shape, flexible utricule 31 have outer layer coating 311 With internal layer coating 312, porous support structure 32 is located at 312 inside of internal layer coating and is supported to internal layer coating 312.Outer layer packet Sealing accommodation space is formed between film 311 and internal layer coating 312, wherein the organosilicon of physiological saline or flow morphology can be used Rubber is as filler.Porous support structure 32 is molded by organic silicon rubber material, is had similar to more in embodiment 1 The porous network structure of pore network bracket.In the present embodiment, the volume of porous support structure 32 (including itself and its are internal empty Between volume) account for about the 50% of breast prosthesis volume, the specific gravity of breast prosthesis is about 0.8.

Embodiment 4

Fig. 7-8 shows the structure of the utility model breast prosthesis embodiment 4.Referring to Fig. 7-8, the breast of the present embodiment is false Body includes the soft shell as composed by approximately hemispheric first shell 41 and generally circular second shell 42, flexible outer Flexible utricule 43 is placed in shell.The volume of flexible utricule 43 accounts about the 70% of breast prosthesis volume, in can fill life Manage the silicon gel of salt water or flow morphology.In the present embodiment, the specific gravity of breast prosthesis is about 0.85.

First shell 41 and second shell 42 outer peripheral edge portion seals connection.The outer surface shape of first shell 41 At the groove 411 for having spiral distribution, inner surface is formed with the groove 412 of spiral distribution, and groove 411 and 412 is alternately set It sets.The outer surface of second shell 42 is formed with the groove 421 of spiral distribution, and inner surface is formed with the groove of spiral distribution 422, groove 421 and 422 is equally arranged alternately.

It is readily appreciated that, in the other embodiments of the utility model, first shell 41 and second shell 42 inner surface And/or outer surface forms the annular recess of array distribution, can also equally achieve the effect that reduce breast prosthesis specific gravity and weight.

Embodiment 5

Fig. 9-10 shows the structure of the utility model breast prosthesis embodiment 5.Referring to Fig. 9-10, the breast of the present embodiment Prosthese includes the soft shell as composed by approximately hemispheric first shell 51 and generally circular second shell 52, flexible Flexible utricule 53 is placed in shell.The volume of flexible utricule 53 accounts about the 50% of breast prosthesis volume, in can fill The silicon gel of physiological saline or flow morphology.In the present embodiment, the specific gravity of breast prosthesis is about 0.7.

First shell 51 and second shell 52 outer peripheral edge portion seals connection.The appearance mask of first shell 51 There is the regular hexagon blind hole 511 of array distribution, inner surface has the regular hexagon blind hole 512 and 513 of array distribution, blind hole 512 Depth be greater than blind hole 513 depth；Wherein, blind hole 512 and 513 is arranged alternately, and blind hole 513 and 511 is separately positioned on At the relative position of one shell, 51 inner and outer surfaces.The outer surface of second shell 52 has the regular hexagon blind hole of array distribution 521, inner surface has the regular hexagon blind hole 522 and 523 of array distribution, and the depth of blind hole 522 is greater than the depth of blind hole 523； Wherein, blind hole 522 and 523 is arranged alternately, and blind hole 523 and 521 item is separately positioned on the opposite of 52 inner and outer surfaces of second shell At position.

Embodiment 6

Figure 11-12 shows the structure of the utility model breast prosthesis embodiment 6.Referring to Figure 11-12, the cream of the present embodiment Room prosthese includes the soft shell as composed by approximately hemispheric first shell 61 and generally circular second shell 62, flexible Flexible utricule 63 is placed in shell.The volume of flexible utricule 63 accounts about the 70% of breast prosthesis volume, in can fill The silicon gel of physiological saline or flow morphology.In the present embodiment, the specific gravity of breast prosthesis is about 0.85.

The heat-sealing connection of the outer peripheral edge portion of first shell 61 and second shell 62.The outer surface of first shell 61 has battle array The regular hexagon blind hole 611 of column distribution, inner surface have the regular hexagon blind hole 612 of array distribution, and blind hole 611 and 612 replaces Setting.The regular hexagon blind hole 621 with array distribution of 62 outer surface of second shell, inner surface have positive the six of array distribution Side shape blind hole 622, blind hole 621 and 622 are arranged alternately.

Embodiment 7

The present embodiment the difference from embodiment 1 is that: physiological saline is filled in soft shell as filler.

Although the utility model is disclosed above with specific embodiment, it is not intended to limit the utility model the model of implementation It encloses.Any those skilled in the art improve in the invention scope for not departing from the utility model when can make a little, I.e. all same improvement done according to the utility model, should be the protection scope of the utility model and are covered.

Claims (8)

1. a kind of light-duty breast prosthesis, including soft shell, it is characterised in that: the inner surface and/or appearance of the soft shell Face is formed with recess and/or protrusion for mitigating the breast prosthesis weight, and the recess and/or protrusion are described flexible outer The inner surface of shell and/or outer surface are in array or spiral distribution.

2. light-duty breast prosthesis as described in claim 1, it is characterised in that: the soft shell includes coating layer and formation In the porous network bracket of the inside and or outside of the coating layer, the porous network bracket has by forming the recess The porous network structure that is composed of hole array.

3. light-duty breast prosthesis as described in claim 1, it is characterised in that: the concave shape becomes blind hole structure, described blind Hole array is distributed in inner surface and/or the outer surface of the shell.

4. light-duty breast prosthesis as described in claim 1, it is characterised in that: the concave shape becomes helical groove or array The annular recess of distribution.

5. light-duty breast prosthesis as claimed in claim 4, it is characterised in that: the inner surface and the outer surface of the soft shell is equal It is formed with the groove, and the groove of the inner surface and the groove of the outer surface are arranged alternately.

6. light-duty breast prosthesis as described in claim 1, it is characterised in that: further include being located in the shell and to described outer The volume of the flexible utricule that shell is supported, the flexibility utricule accounts for the 20% to 80% of the breast prosthesis volume.

7. light-duty breast prosthesis as described in claim 1, it is characterised in that: the shell includes first shell and second shell The outer peripheral edge portion of body, the first shell and the second shell is tightly connected.

8. light-duty breast prosthesis as described in any one of claim 1 to 7, it is characterised in that: the ratio of the breast prosthesis is great It is less than or equal to 0.95 in being equal to 0.5.