CN109561892A - Bellows is inserted into asymmetric double proximal end - Google Patents

Abstract

A kind of device and method for prothesis implant body to be inserted into patient's depression.The device has three openings including prosthese opening, big proximal openings and small proximal openings.The device can prevent from infecting；Simplify insertion and places；And reduce complication.In use, bellows is placed by patient incision, while allowing to operate bellows to make in the operation depression of prosthese push-in patient.Then rotation bellows makes distal end become proximal end and be inserted into the second notch, while allowing to operate bellows so that prosthese to be pushed into the second depression.

Description

Bellows is inserted into asymmetric double proximal end

Cross reference to related applications

It is proposed that priority is wanted based on the non-provisional application sequence number 15/179,983 submitted on June 11st, 2016 in the application It asks, entitled " the Opposing Proximal Insertion Ends which on June 10th, 2016 submits The priority of the U.S.Provisional Serial 62/348,338 of Implant Devices ", the disclosure of which are whole by reference It is incorporated into herein.

Technical field

The present invention relates to the apparatus and method that two prostheses are securely inserted into human body.

Background technique

The present invention be it is a kind of for promoting breast implant surgery program to improve the useful and novel of the aseptic of operation Device.

Breast implant is a kind of manufacture prosthese for cosmetics and reconstruction operations.Breast implant be it is gelatinous, It include the liquid of such as salt water or silica gel in its shell or film.

Insertion equipment is used in current only about 30% breast implant surgery.Insertion equipment improves operation and patient Effect.In the case where being not inserted into equipment, surgeon can do notch, generate the depression for implantation, and retraction notch is simultaneously subsequent Implantation material is pushed into depression manually.

Different from silica gel implant object, saline implant is inserted into depression with empty shape.Once being placed in depression, surgery doctor It is raw to carry out additional step, saline solution is filled into film using pipe.

Notch carries out in four places: around armpit, breast fold, navel or mammary areola.In addition to navel is inserted into, each implantation Object needs a notch.The shorter the notch of patient the better.The shorter notch the less ugly.This shortens the target of notch Saline implant is easier to realize.Saline implant is relatively easily inserted through chopped mouth, because pouch is not filled simultaneously And so that size is smaller when it passes through notch.For these expandable implantation materials, implantation material is rolled into cigar by surgeon Appearance and push it into across to notch and enter depression.In contrast, silica gel implant object is pre-filled, so that operation is more It is difficult and be easy to appear complication.For these pre-filled implantation materials, operation needs bigger incision length.By using slotting Enter equipment, surgeon may insure that notch will not be stretched in the course of surgery.

After initial notch, surgeon's dissection reaches the path of the required destination of implantation material by tissue.Once That coordinates measurement just generates depression for the surface of pectoralis major or deep layer implantation material.Depression can be in inframammary following two One of place of position is formed: under body of gland (between breast tissue and pectoralis major) or under pectoralis major (below pectoralis major).Body of gland It is lower by prosthese be directly placed at behind mammary gland and muscle before.Implantation material is partially disposed in below pectoralis major under pectoralis major. Due to the structure of pectoralis major, a part of implantation material is not covered by muscle.

For the patient of breast implantation, second operation is very common.In particular, the patient of breast implantation can need hand Art corrects apparent implantation material and folds, remove rupture to change the position (under body of gland to pectoralis major under or vice versa) of implantation material Implantation material；Infection, bleeding, mastodynia are treated, the cicatricial tissue formed around implantation material is reduced and is reduced around implantation material Hydrops.Due to anesthesia, infection and bleeding, there are risks for these traditional operations.The whole complication hair enlarged the bosom for Silica hydrogel Raw rate is about 20%, wherein most of operations again are related with implantation material rupture (leakage), bleeding or pouch contracture.

Cellulitis is a kind of infection based on skin, and some of them surgeon in the patient of 2%-4% occurs The incidence of report is much higher, and this is typical from the bacterium being prevalent on skin.The symptom of infection include fever, Pain, swelling and general red.In order to reduce infection, surgeon injects the antibiotic of dose before surgery, and in implantation position It is preceding to use antibiotic solution in wound.Antibiotic solution can be used as lubricant and double, so that implantation material is easier to be inserted into depression In.But surgeon can further decrease the incidence of infection by preventing implantation material from contacting the skin of patient.

So far, it is known that implantation equipment have following disadvantage:

1. needing surgeon to adjust the size of insertion equipment during surgery, with implantation material size phases different from two Match.

2. leaning on surgeon, correctly size is trimmed.Implantation material company and insertion equipment company are unable to control surgery doctor It is raw.If surgeon does not suitably change equipment, unsafe damage pressure will be applied to implantation material in implantation process.

3. the distal end of equipment is sufficiently large to insert, so that implantation material can accidentally skid off equipment, cause skin thin Bacterium is transmitted in implantation material.

4. high-cost implantation equipment has encouraged to reuse instantly although manufacturer is not recommended.

Summary of the invention

One invention for meeting the demand is the system by two prostheses to be inserted into patient under maximum germ-free condition With method.This method allows surgeon to use two different size of implantation materials and individual equipment, and wherein each of equipment is close End receives different size of implantation material.

Objects and advantages

Therefore, other than the objects and advantages of the above-mentioned system for breast implant insertion equipment, the present invention also has Following target and advantage:

A) a kind of equipment of tool there are two proximal end is provided, which is sized for different size of implantation material；

B) a kind of device is provided to further increase aseptic；

C) a kind of equipment is provided, the program for two different size implantation materials uses；

D) a kind of insertion method of simplification is provided；

E) a kind of device is provided to reduce anesthesia duration；

F) a kind of equipment not needing surgeon's trimming is provided；

G) a kind of single equipment of implantation material being suitble to all sizes is provided；

H) more simply implant procedure is provided.

In consideration of the drawings with subsequent Detailed description of the invention, other objects and advantages of the present invention be will become obvious.

Detailed description of the invention

It included in this specification and constitutes part thereof of attached drawing and shows the embodiment of the present invention, and with specification one It rises for explaining the principle of the present invention.In the accompanying drawings:

Fig. 1: the top perspective of asymmetric bellows.

Fig. 2: the bottom view of asymmetric bellows.

Fig. 3: the top perspective of unassembled asymmetric bellows.

Fig. 4 A: the top view of asymmetric bellows, wherein being folded along neighboring edge.

Fig. 4 B: the top view of asymmetric bellows shows the folding in sealed folded portion.

Fig. 4 C: the top view of asymmetric bellows, internal tab are disposed through prosthese opening.

Fig. 4 D: the top view of asymmetric bellows, external tabs are folded in prosthese opening.

Fig. 5: there is the isometric front view of the asymmetric bellows for the implantation material for being inserted through prosthese opening.

Fig. 6: lubricant is added to the end perspective view of the small proximal end of asymmetric bellows.

Fig. 7 A: there is the right perspective view of the asymmetric bellows of the big proximal end for the right cut mouth for being inserted into patient.

Fig. 7 B: there is the left perspective view of the asymmetric bellows of the small proximal end for the left cut mouth for being inserted into patient.

Key Term

Distally: the farthest part from tie point to body

Lower part: closer to foot

Laterally: being located substantially on the position of any side of the lengthwise position of patient lies supine position

It is longitudinal: supine position lengthwise or longest direction relative to patient

Proximal end: the forefield from tie point to body

Top: closer to the head of body

Appended drawing reference

10 patients

The notch of 20 patients, opening

The breast of 22 patients

The depression of 24 patients

The skin histology of 28 patients

30 prostheses

32 breast implants, implantation material

40 bellows devices, bellows, asymmetric bellows

42 small proximal ends, small proximal openings

44 big proximal ends, big proximal openings

46 basic folding parts

48 initial fold portions

50 external tabs

52 internal tabs

54 prostheses opening

56 sealing rings

57 tab side seal circles

58 adjacent side seal circles

60 lubricants

70 retractors

72 retractor handles

74 retractor handle proximal ends

76 retractor proximal end lips

Specific embodiment

With reference to attached drawing, wherein the identical element of identical digital representation.

Attached drawing 1-2

Fig. 1-2 identifies the discrete component of the asymmetric double proximal end insertion bellows 40 of assembling.

Referring now to Figure 1, the top-side perspective view of i.e. asymmetrical bellows 40, the bellows is by such as plastics or soft The flaky material of the nylon of soft surgical grade is made.Plastics can use fiber reinforced or enhancing.Asymmetric bellows 40 can be Transparent or translucent, color allows to observe prosthese 30 and is moved in patient's depression 24 from bellows 40.

There are three openings for the bellows 40 tool: small proximal openings 42 are cut for being inserted into a series of lesser inserts On mouth 20；A series of big proximal openings 44, for biggish inserts to be inserted into the notch 20 of patient；And it is prominent by outside The prosthese opening 54 that piece 50 and internal tab 52 surround, for prosthese 30 to be inserted into asymmetric bellows device 40.It is each End 42,44 is considered as proximal end, because equipment 40 is rotation during surgery, so that every one end 42,44 is continuously inserted into trouble In the left and right opening 20 of person.Fig. 1 shows push-in across the internal tab 52 of prosthese opening 54 and is folded in prosthese opening 54 On external tabs 50, which prevents implantation material from passing through the outside of bellows device 40.External tabs 50 can lead to It crosses friction and folds and be secured in position or pass through glue, adhesive, thermal bonding, operation band or the attachment of other coupled connection mechanisms.Although Fig. 1 Two tabs 50,52 for folding into operating position are shown, but bellows external tabs 50 and bellows interior tab 52 will most It is just presented to surgeon, two of them tab 50,52 is located at the outside of bellows 40 and around prosthese opening 54.Although it is preferred that Implementation is illustrated different size of tab 50,52 so that internal tab 52 is different from external tabs 50, but tab 50,52 can To be that size is identical.

Asymmetric bellows 40 is assembled using sealing ring 56, which includes two tab side seal circles 57 and one Adjacent side seal circle 58.In a preferred embodiment, which can complete before packing.In an alternate embodiment of the invention, it seals Circle 56 is sealed on basic folding part 46 by the medical surgery team of patient 10.Other about the assembling for using sealing ring 56 are said It is bright, B referring to fig. 4.

Bellows 40 prevents breast implant 32 from contacting the skin histology 28 of patient, and prevents the insertion in implantation material 32 Implantation material 32 is destroyed in the process.Asymmetric bellows 40 can be manufactured to accommodate the implantation of the breast of any shape, volume and diameter Object 32.Each proximal end 42,44 is sized and dimensioned to convey 32 size of implantation material of different range.Manufacturer can also need or It is recommended that two 20 length of particular skin notch are to allow that implantation material is inserted into notch 20 by bellows 40.This specification mitigates Surgeon makes great efforts to shorten the burden of notch 20.

Although asymmetric double proximal end be inserted into bellows preferred embodiment have every one end 42 used in single operation, 44, manufacturer can choose the single asymmetric device 40 of shipment, the operation for same size implantation material.In this subsequent reality It applies in example, surgeon uses a proximal end 42,44, for being inserted into two implantation materials 32.

It is folded on basic folding part 46 along contiguous seal part once Fig. 2 shows bellows folding parts 48 and bonds three A sealing ring 56, the bottom view of the version of bellows 40.The bellows 40 of manufacture includes that part is sealed in basic folding part The 46 outer initial fold portion 48 placed, so that it leaves small proximal openings 42, big proximal openings 44, bellows prosthese opening 54, bellows external tabs 50 and bellows interior tab 52.Big proximal end 44 is parallel to and is greater than the small proximal end 42 of equipment 40.

Attached drawing 3-4D

Fig. 3 is turned to, illustration describes the perspective view of unassembled bellows device 40.The composition packet of asymmetric bellows 40 Include two simple, protrusion, irregular hexagon folding parts 46,48 and opposite prosthese insertion tab 50,52.Preferred Embodiment in, tab 50,52 is located at center and opposite with the adjoining side of the bellows of manufacture 40.Tab 50,52 may be used also To be located at any position on opposite sides of the adjoining side of assembling.As shown in Fig. 3-4D, in a preferred embodiment, basis is folded Portion 46 manufacture at along any edge opposite with the protrusion side of folding part 46,48 against initial fold portion 48.Implement second In example, initial fold portion 48 and basic folding part 46 manufacture respectively, and assemble in the subsequent stage.

In a preferred embodiment, bellows 40 is folded along adjacent edge and is manufactured along following three sealing rings 56:

A) from adjacency section to proximal end 42,44 initial fold portion 48 adjoining side edge；

B) from external tabs 50 to the tab side edge in the initial fold portion 48 of small proximal end 42；

C) from external tabs 50 to the tab side edge in the initial fold portion 48 of big proximal end 44；

In a second embodiment, bellows 40 is manufactured by the initial fold portion 48 separated and basic folding part 46, mutual heap It folds and is assembled along following 4 sealing rings 56:

A) from adjacency section to the adjoining side edge in the initial fold portion 48 of small proximal end 42；

B) from adjacency section to the adjoining side edge in the initial fold portion 48 of big proximal end 44；

C) from external tabs 50 to the tab side edge in the initial fold portion 48 of small proximal end 42；

D) from external tabs 50 to the tab side edge in the initial fold portion 48 of big proximal end 44；

Corrugated pipe sealing ring 56 can be folded in portion 46,48 folded against, and pass through glue, adhesive, thermal bonding, hand Art band or the attachment of other coupled connection mechanisms.

In another embodiment, sealing ring 56 can be replaced with the simple seam along edge, with glue, adhesive, heat Bonding, operation band or other coupled connection mechanism combination initial fold portions 48 and basic folding part 46.

Fig. 4 A to 4D shows the assembling of asymmetric bellows 40.In Figure 4 A, the adjacent edge fold in pattern edge, thus Basic folding part 48 and initial fold portion 46 are stacked with, and wherein tab 50,52 is directed toward identical direction.

Then in figure 4b, sealing ring 56 is folded on opposite folding part 46,48, and utilizes any ideal manufacture Sealing technique is sealed to opposite folding part 46,48.

In Fig. 4 C, as breast insert 32 is located in asymmetric bellows 40, internal tab 52 is pushed into across vacation Body opening 54.Internal tab 52 prevents implantation material 32 in the course of surgery unintentionally by 54 pop-up of prosthese opening.

In fig. 4d, using the internal tab 52 in prosthese opening 54, external tabs 50 can shift onto portion 46 folded against, 48 top surface.External tabs 50 can be sealed to opposite folding with the sealant of operation band, hot-seal, Instant cement or other forms In folded portion 46,48.Sealing element 50 and the prosthese opening 54 of bonding is opposite and is connected to initial fold portion 48 and basic folding part 46 On.

Attached drawing 5-7B

As shown in Figure 5, in a preferred embodiment, fluid lubricant 60 surrounds the breast implant 32 of bellows 40. The coating of operation lubricant 60 can be on the inner surface of asymmetric bellows 40.As an alternative, bellows device 40 Coating can be set, which becomes smooth after humidity.In another alternative solution, prosthese 30 can be set smooth Surface, such as operation lubricant 60.Before being inserted into asymmetric bellows 40, surgeon is also an option that lubricant 60 It is applied directly on prosthese 30.Lubricant 60 is also used as antiseptic solution.

After lubrication, breast implant 32 is inserted into bellows device 40 by surgeon and nurse.In order to accomplish this A bit, nurse opens bellows prosthese opening 54 by separation tab 50,52, and surgeon slides through prosthese 330 Bellows prosthese opening 54.Then group folds into internal tab 52 in bellows prosthese opening 54 to prevent breast implant 32 remove opening 54.External tabs 50 can keep expansion or folding in portion 46,48 folded against.If desired, external tabs 50 can be sealed on opposite folding part 46,48.In a preferred embodiment, retractor 70 is being inserted into patient incision 20 Before, it completes for prosthese 30 to be inserted into bellows device 40.However, surgeon can be inserted into notch 20 in bellows 40 The step for Shi Zhihang.

In Fig. 6, lubricant 60 is inserted in the opposite of the opening 42,44 in the notch 20 for being inserted into patient by medical surgery team In opening 42,44.Fluid lubricant 60 surrounds the breast implant 32 in bellows device 40.Lubrication can be used in antiseptic solution Agent 60.

Fig. 7 A is shown do notch 20 in the skin histology 28 of patient before, patient 10 is in the position lain on the back.Attached In figure, notch 20 is cut at folding line under breast 22.With the incision of notch 20, then surgeon is following under breast 22 Depression 24 is formed in one of them of two positions: (chest is big (between the tissue of breast 22 and pectoralis major) or under pectoralis major under body of gland Below flesh).The size of depression 24 matches with prosthese 30.By operating retractor handle 72, retractor handle proximal end 74 and lead It opens device nearside lip 76 to be inserted into notch 20, so that notch 20 retracts and notch 20 is kept to open.

70 component of retractor includes centrally located handle 72, retractor handle proximal end 74 and retractor handle proximal end lip 76.Retractor 70 can have different shapes and sizes to match specific application or surgeon's preference.Retractor 70 Handle 72 is bent or is at an angle of relative to middle section in end.The proximal end 74 of retractor 70 has angled relative to end 74 Lip 76.Retractor 70 is made of metal (such as stainless steel), it is also possible to be manufactured with surgery plastics.

Retractor proximal end 74 is constructed and arranges, to be inserted into the depression 24 of patient 10 by notch 20.Proximal end lip 76 Facilitate under the skin histology 28 that the proximal end 74 of retractor 70 is maintained to patient 10.

Retractor 70 is laterally extended from asymmetric bellows 40, so as not to interfere the surgeon of manipulation bellows 40, The proximal end of middle retractor 74 and proximal end lip 76 are inserted into notch 20, and are located under skin histology 28 and are moved to retraction notch At 20.The proximal end 42,44 of bellows 40 can lubricate with lubricator 60 and be inserted into open notch 20.

The asymmetric bellows 40 for squeezing and/or reversing 20 distal side of notch, pushes prosthese 30 to bellows device 40 Proximal end 42,44 simultaneously enters in depression 24.Make the deformation of prosthese 30 to fit through proximal openings 44.

Once prosthese 30 is located in depression 24, retractor 70 is removed from notch 20, then removes bellows 40.Then it seals Notch 20.

Finally, showing the left side of patient in figure 7b, retractor 70 is inserted into the notch 20 of the second breast 22 and movement To at retraction notch 20.Then asymmetrical bellows 40, to introduce new proximal end at the notch 20 of the second breast 22 42,44.This second proximal end 42,44 can lubricate with lubricator 60 and be inserted into open notch 20.

The asymmetric bellows 40 for squeezing and/or reversing 20 distal side of notch, pushes prosthese 30 to bellows device 40 Second proximal end 42,44 simultaneously enters in depression 24.Make the deformation of prosthese 30 to fit through the second proximal openings 42,44.

Once prosthese 30 is located in depression 24, retractor 70 is removed from the second notch 20, then removes bellows 40.Then Seal notch 20.

If asymmetric bellows 40 is designed to reuse, to pass through sterilizing program.If bellows 40 designs At disposable, it is handled.The advantage of asymmetric bellows 40 and method be implantation material 32 and distal openings 42, 44 during manufacturing can relative to each other size it is suitable, so that the smallest breast implant 32 will fit through small proximal openings 42, And large range of implantation material 32 will be appropriately interposed through big proximal openings 44.Pass through proximal end when these are implanted into composition deformations 42,44 when, allow for suitable pressure to be applied in the implantation material 32 of each range.

If 32 misoperation of implantation material, implantation material 32 will be damaged.Possible improper operation includes making implantation material 32 Improperly stress or pressure are born, such as too small proximal end 42, the external silicon rubber of folding may be passed through by attempting extruding implantation material 32 The internal rupture of the Silica hydrogel of rubber shell, bonding.The notch 20 that surgeon may do on patient 10 is too small to implantation material 32, and Therefore need too big power that implantation material 32 is expressed in depression 24.Using this bellows device 40, implantation material 32 is by mentioning Damage is protecteded from for enough skin incision length and appropriately sized proximal end 44.The major complications of implantation material 32 are The capsule contracture due to caused by subclinical infection.Subclinical infection most probable is by being pushed through skin incision for implantation material 32 20,28 bacterium of natural skin (suitable skin 28 prepare then still remain) is dragged in created in operation for implantation material 32 Caused by depression 24.Prevent implantation material 32 from contacting during insertion with skin histology 28 using this equipment 40.

Although the disclosure and its advantage is described in detail, it should be understood that do not departing from by appended claims In the case where in the spirit and scope of the present disclosure of restriction, it can carry out various modifications, replace and change herein.And this Shen Range please is not intended to be limited to the spy of process, machine described in this specification, manufacture, material composition, device, method and steps Determine embodiment.One ordinarily skilled in the art will readily appreciate that present disclosure is existing or disclosure, the process, machine developed later Device, manufacture, material composition, device, method or step execute substantially the same function or reach basically same structure.Because It can use corresponding embodiment described herein according to the disclosure.Therefore, appended claims are intended within its scope include this Class process, machine, manufacture, material composition, device, method or step.

In description and claims below before, for ease of description, method and step and/or operation are by spy Fixed sequence description.It should be understood that in an alternate embodiment of the invention, method and step and/or operation can be by different from being retouched The sequence stated carries out.In addition, the above method may be embodied in be stored in one or more machine readable medias (disc driver, Thumb actuator or CR-ROM) on machine can be in operational order.The instruction may be used in the machine (example of the instruction programming Such as, computer processor) execute this method.Optionally, this method can be executed by the combination of software and hardware.Although this Illustrative and currently preferred embodiments of the invention are described in detail in text, it should be appreciated that, idea of the invention can Otherwise differently to implement and use, and appended claims are intended to be interpreted as including such modification, in addition to Other than being limited by the prior art.

There have been described herein interests, other advantages and the solution to the problem about specific embodiment.However, should Advantage, related interests, the specific solution of problem and any any interests, advantage or solution of may cause occur Or the one or more elements become readily apparent from should not be construed as the key of any or all claim of the invention, necessity Or essential characteristic or element.As it is used herein, term " including (comprises, comprising) " or its it is any its What his variant was intended to cover nonexclusion includes, such as the process, method, article or the device that are made of a series of elements can wrap Including the process, method, article or device is other elements obviously list or intrinsic.

Advantage

In from the description above, the lot of advantages of " bellows is inserted into asymmetric double proximal end " becomes obvious.The present invention is packet It includes manufacturer, patient or surgical participant and provides all new interests:

A) implantation material of all sizes of manufacturer is made to provide the bellows of single size；

B) making the complication risk of patient reduces；

C) make doctor prevent from leading to the pollution of the skin bacterium of infection and/or capsule contracture, use the serious sense of proximal end twice Dye；

D) doctor is made to eliminate the step of trimming to insertion equipment；

E) doctor is made to eliminate the damage in insertion process to implantation material；

F) doctor is made to use simplified insertion process；

G) speed of implantation material insertion operation is improved.

Claims (3)

1. a kind of for prosthese to be inserted into the device of operation depression by notch, comprising:

A. breast implant；

B. bellows, the bellows include that bellows prosthese opening, the small proximal end that allows the smallest breast implant to exit are opened Mouth and the big proximal openings for allowing maximum breast implant to exit, the prosthese opening surrounded by tab, the bellows is semihard Property and construct and arrange to receive breast implant, the bellows and tab side seal circle and adjacent side by prosthese opening Sealing ring fits together；

C. retractor equipment, the retractor have proximal end, and the proximal end is adjacent with bellows proximal openings and constructs and arranges At the edge that engaging operation depression is open, the proximal end is fixed with respect to the proximal end of bellows.

2. a kind of device that prosthese is inserted into operation depression by notch, comprising: it is simple, convex to form two with opposite tab The bellows of hexagon folding part rise, irregular；The initial fold adjacent along the side of opposite tab and basic folding part Portion；The initial fold portion of basic folding part is folded into along neighboring edge；Adjacent side sealing ring from adjacency section to proximal end；From adjoining Tab side seal circle of the portion to small proximal end；

The asymmetric bellows with bellows prosthese opening and two proximal openings is consequently formed.

3. a kind of device that prosthese is inserted into operation depression by notch, comprising: simple, raised, no with tab The basic folding part of the hexagon of rule；The initial fold portion of simple, raised, irregular hexagon with tab； It is stacked on the first folding part in initial fold portion；From adjacency section to the adjacent side sealing ring of small proximal end；From adjacency section to small close The adjacent side sealing ring at end；Tab side seal circle from adjacency section to small proximal end；From adjacency section to the tab side seal of small proximal end Circle；

The asymmetric bellows with bellows prosthese opening and two proximal openings is consequently formed.