KR20190018448A - Asymmetric dual proximal end insertion bellows - Google Patents

Abstract

The present invention relates to an apparatus and method for inserting implant inserts into a patient pocket. The device has three openings including an implant opening, a large proximal opening, and a small proximal opening. The device prevents infection; Facilitates insertion and placement; Reduce complications. In use, the bellows are disposed through the patient incision while allowing the bellows to be manipulated to force the implant into the patient ' s surgical pocket. The bellows are then rotated so that the distal end becomes the proximal end and is inserted into the second incision while allowing the bellows to be manipulated to force the implant into the second pocket.

Description

Asymmetric dual proximal end insertion bellows

Cross-references to related applications

Priority is claimed on June 11, 2016, which claims priority to Provisional Application Serial No. 62 / 348,338 entitled " Opposing Proximal Insertion Ends Implant Devices, " filed June 10, Filed on even date herewith, the disclosure of which is hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION Field

The present invention relates to an apparatus and a method for safely inserting two prostheses into a human body.

The present invention is a useful new device for enhancing breast implant surgical procedures to improve surgical sterility.

Breast implants are manufactured implants used in cosmetic and reconstructive surgery. Breast implants are gelatinous with an external casing or membrane containing a fluid such as saline or silicone.

Currently, only about 30 percent (30%) of the breast implant procedures use an insertion device. The insertion device improves both the surgical and patient outcomes. Without the insertion device, the surgeon forms an incision, creates a pocket for the implant, retracts the incision, and then manually pushes the insertion into the pocket.

Unlike silicone inserts, the saline insert is inserted into the pocket in an empty configuration. Once placed in the pocket, the surgeon takes an additional step of filling the membrane with saline solution using a tube.

The incision is made in one of four places: the armpit, the breast fold, the navel, or around the shoulder. Except for the umbilicus insertion, one incision is made for each insert. The incision of the patient is preferably as short as possible. The shorter incisions are less disgusting. The purpose of shorter incisions is easier to achieve with saline implants. Saline implants are relatively easy to insert through short incisions, as the bladder is not filled and thus is small in size as it passes through the incision. For these inflatable inserts, the surgeon does not like the cigar and pushes it through the incision into the pocket. In contrast, silicone inserts are pre-filled resulting in more difficult and complication-sensitive operations. For these pre-filled inserts, the procedure requires a larger incision length. By using the insertion device, the surgeon can ensure that the incision is not stretched during the operation.

After the initial incisions, the surgeon incises the pathway through the tissue to the desired destination of the implant. Once such a path is created, a pocket is created for the insert at the epidermis or deeply of the pectoralis muscle. The pockets can be formed in one of two places below the breast: subglandular (between breast tissue and pectoralis major) or subpectoral (below pectoralis major). Immediately behind the wired line and placing the implant in front of the muscle. Place the implant partially under the pectoralis major muscle. Due to the structure of the pectoral muscles, some of the inserts are not covered by the muscles.

Secondary surgery is common to patients with breast implants. In particular, patients with breast implants can change their placement (from the underarm to the pectoralis muscle or vice versa), correct the detectable folding of the insert, and remove the ruptured insert; Infection, bleeding, breast pain, contracted scar tissue and fluid collection around the implant may require surgery. These additional surgeries have risks due to anesthesia, infection and bleeding. The overall complication rate is about 20% for silicone gel breast augmentation with most re-surgery associated with implant rupture (leakage), bleeding or capsular contracture.

Cellulitis, a skin-based infection, occurs in 2% to 4% of patients, and some surgeons report that they result from much higher proportions and bacteria normally present on the skin in general. Symptoms of infection include fever, pain, swelling and redness. To reduce infection, surgeons provide one dose of antibiotic before surgery and use an antibiotic solution on the wound prior to implant placement. The antibiotic solution can be applied as a lubricant to allow for easier insertion of the insert into the pocket. However, surgeons can further reduce the rate of infection by preventing the implant from touching the patient ' s skin.

The insert insert devices known so far suffer from a number of disadvantages:

1. Require the surgeon to adjust the size of the insertion device in the middle of the surgery to match the two different insert sizes.

2. Dependent on accurately sized trimming by the surgeon.

The implant company and the insertion device company have no control over the surgeon.

If the surgeon does not properly modify the device, dangerous damage pressure can be applied to the insert during the insertion process.

3. The distal end of the device is large enough for the insert to inadvertently slide out of the device causing skin bacteria to transit to the insert.

4. The high cost of current insert devices encourages reuse, despite manufacturer's recommendations.

The present invention, meeting the stated needs, relates to a system and method for inserting two implants into a patient with maximum sterility. The method allows the surgeon to use two different sized inserts with a single device, each proximal end of the device receiving a different sized insert.

Thus, in addition to the objects and advantages of the system for breast implant insertion devices described above, several objects and advantages of the present invention include:

a) providing the device with two proximal ends sized for inserts of different sizes;

b) provide a means for further improving asepticity;

c) providing an apparatus for a procedure using two differently sized inserts;

d) provide a simplified insertion method;

e) providing means for reducing anesthesia time;

f) providing a device that does not need to be trimmed by a surgeon;

g) providing a single device fitted to all sizes of inserts;

h) to provide easier manipulation of the insert.

Further objects and advantages of the present invention will become apparent from the review of the drawings and the following description of the drawings.

From the above description, a number of advantages become apparent for the " asymmetric dual proximal end insertion bellows ". The present invention provides all of the following benefits to the participating parties including manufacturers, patients and surgeons:

a) allow manufacturers to ship single size bellows for all implant sizes;

b) allows a lower risk of complications of the patient;

c) allow doctors to prevent gross infection by using the proximal end twice, causing contamination, infection and / or spherical build-up by the skin bacteria;

d) allowing doctors to remove the step of trimming the insertion device;

e) allowing doctors to remove damage to the insert during the insertion process;

f) Allow doctors a simplified insertion process;

g) Increasing the rate of insertion surgery.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention. In the drawings:
Figure 1: Upper side perspective view of an asymmetric bellow.
Figure 2: Bottom view of asymmetric bellows.
Figure 3: Upper side perspective view of the unassembled, asymmetric bellows.
Figure 4a: Plan view of an asymmetric bellows with folds along adjacent edges.
4b: a top view of an asymmetric bellows illustrating the folding of the sealing folds;
Figure 4c: Plan view of the asymmetric bellows of an internal tab disposed through the implant opening.
Figure 4d: Plan view of the asymmetric bellows of the outer tab folded over the implant opening.
Figure 5: A front perspective view of an asymmetric bellow in which the insert is inserted through the implant opening.
Figure 6 is a side elevation view of adding a lubricant to the small proximal end of the asymmetric bellows.
7a: a right side perspective view of an asymmetric bellows in which a large proximal end is inserted into the right incision of a patient;
7b: a left perspective view of a rotated asymmetric bellows into which a small proximal end is inserted into the left incision of the patient;
Key Terms
Distal: The furthest part from the point of attachment to the body.
Child: Closer to feet.
Side: A position that is substantially located on any side of the longitudinal position of the patient's supine position.
Longitudinal: The longitudinal or longest direction associated with the patient's supine position.
Proximal: The closest part to the point of attachment to the body.
Upper: closer to the head of the body.

Detailed description of the drawings

BRIEF DESCRIPTION OF THE DRAWINGS Reference will now be made to the drawings,

1 To  2

Figures 1-2 illustrate the individual elements of the assembled asymmetric dual proximal end insertion bellows 40.

Reference is now made to Fig. 1, which is a top perspective view of an asymmetric bellows 40 made of sheet material such as plastic or flexible, surgical nylon. Plastics can be reinforced or reinforced with fibers. The asymmetric bellows 40 may be transparent or translucent in color to allow observation of the implant 30 moving from the bellows 40 to the patient pocket 24. [

The bellows 40 has three openings: a small proximal opening 42 for inserting a smaller range of inserts into the incision 20; A large proximal opening 44 for inserting a larger range of implants into a patient's incision 20; And an implant opening 54 surrounded by an outer tab 50 and an inner tab 52 for inserting the implant 30 into the asymmetric bellows device 40. Each end 42, 44 is considered proximal because the device 40 is rotated during surgery so that each end 42, 44 is sequentially inserted into the patient's left and right openings 20. Figure 1 shows an inner tab 52 that is pushed through the implant opening 54 to prevent the insert from passing beyond the bellows device 40 and preventing the outer tab 50 from folding over the implant opening 54 Respectively. The outer tab 50 may be folded in place by friction or may be attached by glue, adhesive, thermal bond, surgical tape, or other coupling mechanism. While bellows tab 50 and bellows tab 52 initially illustrate the exterior of bellows 40 and the implant opening 54 that surrounds the bellows 40, Will be provided to the surgeon with both tabs 50,52. Although the preferred embodiment shows taps 50 and 52 of different sizes to distinguish the outer tab 50 and the inner tab 52, the tabs 50 and 52 may be the same size.

The asymmetric bellows 40 is assembled using seal tucks 56 that include two (2) tap side sealing jaws 57 and one (1) adjacent side sealing jaws 58. In a preferred embodiment, the assembly may be performed prior to packaging. In an alternative embodiment, the sealing jaws 56 are sealed to the basefold 46 by the surgical team of the patient 10. Reference is made to Fig. 4b for a further example of assembly using sealing jaws 56. Fig.

The bellows 40 prevents the breast implant 32 from touching the patient's dermal tissue 28 and prevents damage to the insert 32 during insertion of the insert 32. The asymmetric bellows 40 may be manufactured to accommodate any breast insert 32 shape, volume, and diameter. Each proximal end 42,44 will be sized to deliver a different range of insert 32 sizes. The manufacturer may also require or suggest two specific cuts 20 lengths to allow insertion of the insert through the bellows 40 into the incision 20. [ The features relieve the surgeon's burden of attempting to make shorter incisions 20.

While the preferred embodiment of the asymmetric dual proximal end insertion bellows has each end 42, 44 used in a single operation, the manufacturer may choose to ship a single asymmetric device 40 for surgery with inserts of the same size . In this latter embodiment, the surgeon will use one proximal end 42, 44 for insertion of the two inserts 32.

Figure 2 shows a bottom view of the manufactured version of the bellows 40 when the bellows 48 is folded over the base fold 46 along an adjoining seam and three sealing jaws 56 are attached . The manufactured bellows 40 includes an initial fold 48 that is partially sealed on the periphery to the base fold 46 so that it can be used to secure the small proximal opening 42, the large proximal opening 44, the bellows prosthesis opening 54, The bellows outer tab 50 and the bellows inner tab 52 are left. The large proximal end 44 is parallel to, and larger than, the small proximal end 42 of the device 40.

3 To  4d

Reference is now made to Fig. 3, which is an illustration showing a perspective view of an unassembled bellows device 40. Fig. The asymmetric bellows 40 configuration includes two simple, convex, irregular hexagonal folds 46, 48 with opposing implant insertion taps 50, 52. In a preferred embodiment, the taps 50, 52 are positioned opposite the center of the proximal sides of the bellow 40 produced. The taps 50,52 may also be located at any location on the side opposite the assembled adjacent sides. 3 to 4D, the base folds 46 extend along the first folds 48 along either edge opposite the tabbed sides of the folds 46,48. In the preferred embodiment, Lt; / RTI > In the second embodiment, the initial folds 48 and the basefolds 46 are fabricated separately and will be assembled together later on.

In a preferred embodiment, the bellows 40 will be folded along the adjacent edges and be made of three sealing jaws 56 as follows:

a. The proximal end of the initial fold 48 from the abutment to the proximal end 42, 44;

b. A tab-side edge of the initial fold (48) from the outer tab (50) to the smaller proximal end (42);

c. The tab-side edge of the initial fold (48) from the outer tab (50) to the larger proximal end (44).

The bellows 40 will be fabricated with separate initial folds 48 and base folds 46 stacked against each other and assembled into four sealing jaws 56 along with:

a. A proximal side edge of the initial fold 48 from the proximal portion to the small proximal end 42;

b. A proximal side edge of the initial fold 48 from the proximal portion to the larger proximal end 44;

c. A tab-side edge of the initial fold (48) from the outer tab (50) to the smaller proximal end (42);

d. The tab-side edge of the initial fold (48) from the outer tab (50) to the larger proximal end (44).

The bellows seal jaw 56 may be folded over the opposing folds 46,48 and attached by glue, adhesive, thermal bond, surgical tape or other coupling mechanism.

The sealing jaws 56 may be seamed along the edges to join the initial folds 48 and the base folds 46 with glue, adhesive, thermal bond, surgical tape or other bonding mechanism. Can be replaced.

4A-4D illustrate an assembly of asymmetric bellows 40. 4A, the pattern is folded along the adjacent edge so that the base folds 48 and the initial folds 46 overlap on top of each other with the taps 50, 52 pointing in the same direction.

4B, the sealing jaws 56 are folded over the opposing folds 46,48 and sealed to the opposing folds 46,48 with any desired manufacturing sealing technique.

With the breast implant 32 in place in the asymmetric bellows 40, the inner tab 52 is pushed through the implant opening 54 in Figure 4c. The inner tab 52 prevents the insert 32 from being inadvertently released through the implant opening 54 during surgery.

4D, the outer tab 50 can be pushed onto the top surface of the opposing folds 46,48, with the inner tab 52 in the implant opening 54. [ The outer tab 50 may be sealed to the opposed folds 46,48 with a surgical tape, heat seal, glue, or other type of seals. The bonded seal 50 opposes the implant opening 54 and bonds the initial fold 48 and the base fold 46 together.

5 To  7b

As illustrated in FIG. 5, in a preferred embodiment, a liquid lubricant 60 surrounds the breast insert 32 within the bellows 40. A coating of surgical lubricant 60 may be used on the inner surface of the asymmetric bellows 40. Alternatively, the bellows device 40 may have a coating that is wetted when wetted. In another alternative, the implant 30 may have a smooth surface, such as a surgical lubricant 60. The surgeon may also have the option of applying a lubricant 60 to the implant 30 immediately prior to insertion into the asymmetric bellows 40. Lubricant 60 may also act as an antibiotic solution.

After lubrication, the breast implant 32 is inserted into the bellows device 40 by a surgeon and a nurse. To do so, the nurse opens the bellows prosthesis opening 54 by separating the taps 50, 52, and the surgeon slides the implant 30 through the bellows prosthesis opening 54. The team will then fold the inner tab 52 into the bellows prosthesis opening 54 to prevent the breast implant 32 from moving back out of the opening 54. The outer tab 50 may be left over or folded over the opposing folds 46,48. If desired, the outer tab 50 may be sealed to the opposing folds 46,48. In a preferred embodiment, inserting the implant 30 into the bellows device 40 will be completed prior to inserting the retractor 70 into the patient incision 20. However, the surgeon may perform this step while the bellows 40 is inserted into the incision 20.

In Figure 6, the surgical team inserts the lubricant 60 into the opposed openings 42,44 of the openings 42,44 which are inserted into the incisions 20 of the patient. The liquid lubricant 60 surrounds the breast insert 32 within the bellows 40. The antibiotic solution may be used as the lubricant 60.

FIG. 7A shows a patient 10 being positioned in a supine position before the incision 20 is made in the patient's dermal tissue 28. FIG. In the figure, the incision 20 is cut at the lower breast 22 crease. With the incision 20 open, the surgeon then forms a pocket 24 in one of the following two positions beneath the breast 22: under the wrist (breast 22 tissue And between the chest muscles) or below the pectoralis major (below the chest muscles). The pockets 24 are sized to coincide with the implant 30. By operating the retractor handle 72, the retractor handle proximal end 74 and the retractor proximal lip 76 retract the incision 20 and into the incision 20 to retain the incision 20 in the open state .

The retractor (70) assembly includes a centrally located handle (72), a retractor handle proximal end (74), and a retractor handle proximal end lip (76). Retractor 70 may have a variety of shapes and sizes to match specific application or surgical preferences. The handle 72 of the retractor 70 is bent or angled on the ends with respect to the middle portion. The proximal end (74) of the retractor (70) has an angled lip (76) with respect to the end (74). The retractor 70 is made of a metal such as stainless steel, but may also be made of surgical plastic.

The retractor proximal end 74 is configured and arranged to be inserted through the incision 20 into the pocket 24 of the patient 10. The proximal end lip 76 assists in retaining the proximal end 74 of the retractor 70 to the skin tissue 28 wrist of the patient 10.

The retractor 70 extends laterally from the asymmetric bellows 40 so that it does not interfere with the surgeon operating the bellows 40 and the proximal ends and proximal end lips 76 of the retractor 74 are spaced apart from the incision 20 And is positioned below the skin tissue 28 and is moved to retract the incision 20. The proximal ends 42,44 of the bellows 40 can be lubricated with the lubricant 60 and inserted into the open cutout 20.

The asymmetric bellows 40 is compressed and / or twisted to force the implant 30 toward the proximal end 42, 44 of the bellows device 40 and into the pocket 24, . The implant 30 is deformed to fit through the proximal opening 44.

The retractor 70 is removed from the incision 20 prior to the bellows 40 when the implant 30 is positioned within the pocket 24. [ Then, the incision 20 is closed.

Finally, in Figure 7b, which shows the left side of the patient, the retractor 70 is inserted into the second breast 22 incision 20 and moved to retract the incision 20. The asymmetric bellows 40 is then rotated so that the new proximal end 42,44 is introduced into the incision 20 of the second breast 22. [ These second proximal ends 42,44 may be lubricated with lubricant 60 and inserted into open cut 20.

The asymmetric bellows 40 may be squeezed and / or compressed to urge the implant 30 toward the second proximal end 42, 44 of the bellows device 40 and into the pocket 24, Twisted. The implant 30 is deformed to fit through the second proximal opening 42,44.

The retractor 70 is removed from the second incision 20 prior to the bellows 40 when the implant 30 is positioned within the pocket 24. Then, the incision 20 is closed.

When the asymmetric bellows 40 are designed for reuse, they are subjected to sterilization procedures. If the bellows 40 are designed for disposable use, they are discarded. The advantage of the asymmetric bellows 40 and method is that the minimal breast inserts 32 are fit through the small proximal opening 42 and a larger range of inserts 32 are inserted properly through the large proximal opening 44 The insert 32 and the proximal openings 42,44 can be sized appropriately during manufacture relative to each other. This allows appropriate pressure to be applied to each of the ranges of inserts 32 as they are deformed through the proximal ends 42,44.

The insert 32 may be compromised if the insert 32 is misapplied. Possible mishandling may be caused by excessive stresses or pressures, such as the insert 32 may be caused by attempting to squeeze the insert 32 through too small a proximal end, Folding of the cohesive silicone gel, and internal cracking of the cohesive silicone gel. The surgeon may make incisions 20 in the patient 10 that are too small for the insert 32 so that too much force is required to squeeze the insert 32 into the pocket 24. With such a bellow device 40, the insert 32 is protected from damage by the provision of a suitable cut-out length and an appropriately sized proximal end 44. The main complication of the inserts 32 is spherical formation, which is believed to be due to sub-clinical infection. The asymptomatic infection pushes the insert 32 through the skin incision 20 and exposes the natural skin 28 bacteria (still present after appropriate skin 28 preparations) It is most likely to be caused by dragging into the pocket 24. Use of such an apparatus 40 prevents the insert 32 from coming into contact with the skin preparation 28 during the insertion process.

While this disclosure and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the present disclosure as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the specific embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. Those skilled in the art will readily appreciate from the disclosure that processes, machines, fabrication, material compositions, means, methods, and methods for performing presently or later developments that perform substantially the same functions or achieve substantially the same results as the corresponding embodiments described herein Methods, or steps described in connection with the embodiments disclosed herein may be utilized in accordance with the present disclosure. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.

In the foregoing description, and in the following claims, method steps and / or actions are described in a particular order for purposes of illustration. It should be understood that, in alternative embodiments, method steps and / or actions may be performed in a different order than described. Additionally, the methods described above may be embodied in one or more machine-readable media, e.g., disk drives, thumb drives, or machine-executable instructions stored on CD-ROMs. The instructions may be used to cause a machine (e.g., a computer processor) programmed with instructions to perform the method. Alternatively, the methods may be performed by a combination of hardware and software. Although illustrative and presently preferred embodiments of the invention have been described in detail herein, it will be apparent to those skilled in the art that the inventive concepts may be variously embodied and utilized in various different ways and that the appended claims include all such modifications, Quot; is intended to be interpreted as < / RTI >

Benefits, other advantages, and solutions to problems have been described herein with regard to specific embodiments. It should be understood, however, that any element (s) that may cause or may cause any benefit, advantage, solution, or solution to occur, any or all of the advantages, And should not be construed as critical, essential, or essential features or elements of the claims. As used herein, the terms " comprises, " " comprising, " or any other variation thereof, may refer to a process, method, article, or apparatus that comprises a list of elements, Quot; is intended to cover a non-exclusive inclusion, either explicitly listed or non-exclusive of any method, article, or apparatus.

Benefits

From the above description, a number of advantages become apparent for the " asymmetric dual proximal end insertion bellows ". The present invention provides all of the following benefits to the participating parties including manufacturers, patients and surgeons:

a) allow manufacturers to ship single size bellows for all implant sizes;

b) allows a lower risk of complications of the patient;

c) allow doctors to prevent gross infection by using the proximal end twice, causing contamination, infection and / or spherical build-up by the skin bacteria;

d) allowing doctors to remove the step of trimming the insertion device;

e) allowing doctors to remove damage to the insert during the insertion process;

f) Allow doctors a simplified insertion process;

g) Increasing the rate of insertion surgery.

10 patients
20 incision of the patient, opening
22 patients breast
24 Patient's pockets
28 The skin tissue of the patient
30 Implants
32 Breast implants, inserts
40 Bellows, bellows, asymmetric bellows
42 Small proximal end, small proximal opening
44 Large proximal end, large proximal opening
46 Base Fold
48 Initial Fold
50 External tabs
52 Internal tabs
54 implant opening
56 Sealing tucks
57 tap side sealing jaw
58 Adjacent Sealing Chin
60 Lubricant
70 Retractor
72 Retractor Handle
74 Retractor Handle Proximal End
76 Retractor proximal end lips

Claims (3)

An apparatus for inserting a prosthesis into a surgical pocket through an incision,
a. Breast Implants;
b. A bellow including a bellow implant, a small proximal opening allowing a minimal range of breast implants to exit and a large proximal opening roll allowing a maximum range of breast implants to exit, said implant opening being surrounded by tabs, The bellows being semi-rigid and constructed and arranged to receive the breast implant through the implant opening, the bellows being assembled with the tap side sealing jaws and the adjacent side sealing jaws;
c. Wherein the retractor has a proximal end adjacent the bellows proximal opening and configured and arranged to fasten an edge of a surgical pocket opening, the proximal end being secured with respect to the proximal end of the bellows, Comprising a device. An apparatus for inserting a prosthesis into a surgical pocket through an incision,
A bellows formed of two simple, convex, irregular hexagonal folds with opposed taps;
An initial fold adjacent the base folds along the sides facing the taps;
An initial fold that is folded over the basefold along an adjacent edge;
An adjacent sealing jaw from the proximal portion to the proximal end;
A tab-side sealing jaw from the proximal portion to a small proximal end;
And a tab-side sealing jaw from the proximal portion to the small proximal end,
Whereby the asymmetric bellows are formed with a bellows implant opening, and two proximal openings. An apparatus for inserting a prosthesis into a surgical pocket through an incision,
A simple, convex, irregular hexagonal base fold with tabs;
A simple, convex, irregular hexagonal initial fold with tabs;
A first folded sheet stacked on said initial fold;
An adjacent sealing jaw from the proximal portion to the smaller proximal end;
An adjacent sealing jaw from the proximal portion to the small proximal end;
A tab-side sealing jaw from the proximal portion to the small proximal end;
And a tab-side sealing jaw from the proximal portion to the small proximal end,
Whereby the asymmetric bellows are formed with a bellows implant opening, and two proximal openings.

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