This invention is related to a reusable apparatus and method for the delivery of a soft flexible prosthetic implant such as a silicone breast implant into the surgical pocket and also having the option for packaging the implant within the delivery apparatus, in sterile condition, for use without having to transfer the implant into a separate apparatus for implantation, thereby providing a contamination free path for implantation or for providing a reusable, re-serializable delivery device apparatus to deliver a soft flexible prosthetic implant.
Silicone implants and other soft and flexible implants are placed within body tissue for both physical augmentations for aesthetic appearance and or for therapeutic purposes. In most instances the surgeon creates an incision on the body surface through which the implant is introduced either manually or using a delivery apparatus. When it is introduced manually, considerable handling of the implant takes place which exposes the implant to mechanical damage and or contamination. Implant failure post implantation due to mechanical damage and infections due to excessive handling contamination are well documented in the literature. During the last decade several devices have been developed to prevent or minimize these procedure failures due to damage or infections.
One of the most common devices known as Keller Funnel as described in U.S. Pat. No. 8,211,173 B2 is an example of such a delivery apparatus. The Keller funnel is essentially a flat flexible plastic cone, similar to a cake decorating cone, with a distal open end for the delivery of the implant and a large proximal opening to introduce the implant into the lay flat cone. Once the implant is placed in the flexible plastic cone and some lubricant is added, the surgeon squeezes the proximal end of the plastic cone in order to extrude the implant out from the cone's distal end. Most surgeons will have to use considerable effort and both hands to squeeze the implant out of the Keller funnel and requiring considerable effort. In order to minimize this effort, surgeons will cut open the distal end to increase the size of the distal opening and thereby reducing the effort needed to extrude out the implant.
One of the biggest drawbacks encountered during delivery of an implant using the Keller funnel is that the implant needs to be oriented appropriately in the delivery apparatus. While the funnel is substantially flat and the implant is bun like in nature, once the circularly shaped implant is placed within it, the implant takes a symmetrical spherical shape and hence loses its bun like shape and the intended orientation that is very important for the appropriate placement of the implant in the pocket. To prevent this from happening the surgeon has to be extra conscious in orienting the cone and in lining up the implant with the surgical pocket during the delivery process, which rather complicated and often ineffective.
Another disadvantage of the Keller Funnel is that when the implant is placed inside the delivery envelope, it takes a conical shape and therefore when the implant is delivered the proximal end of the implant tends to fold inwards forming a crease which can cause structural damage to the silicone envelop of the implant. This type of trauma to the implant wall can lead to implant failure, infection and or capsular contracture.
In a typical breast augmentation procedure the surgeon creates a small incision in the periareolar, inframammary or transaxillary regions. The size of the incision depends on the size and volume of the implant been implanted. It is preferred that the incision is as small as possible to prevent a large scar on the skin surface. Through the incision, surgeon creates an appropriate pocket into which the implant will be placed. The incision is always linear and the pocket created is typically two dimensional in nature. Breast implants are typically circular in nature and are “bun” shaped having a thickness of 1-2 cm and the bottom side is flat in nature while the top side has a convex surface. The implant therefore must be appropriately oriented so that the implant sits parallel to the floor of the pocket created by the surgeon. If the implant is not properly oriented the appearance of the breast augmentation will not have the natural appearance. The design in the Keller Funnel fails to provide the surgeon the ability to properly orient the implant such that it sits parallel to the floor of the pocket created by the surgeon.
Another disadvantage of the flexible cone type delivery methods is that the distal opening of the funnel can tear under pressure. Often reinforcements for the distal opening are proposed as in U.S. Pat. No. 8,211,173.
The present invention is a delivery apparatus and method for a reusable implant delivery apparatus which is constructed from metal or durable polymer that can be cleaned and reserialized.
Another objective of the present invention is to provide a means to package the implant in the delivery apparatus in sterile condition so that it can be delivered to the surgical pocket without having to transfer the implant to a separate delivery apparatus, thereby eliminating handling and contamination.
Therefore present invention provides a design such that the implant can be sterilized in the delivery apparatus which has appropriate openings for sterilization gases to flow in and also has openings in the apparatus to introduce fluids prior to its use, either for lubrication and washing the implant as needed or to provide hydraulic pressure within it during extrusion of the implant.
A delivery device is provided such that the implant can be delivered with proper orientation and with minimum force. Thereby the fluid filled implants of different volumes can be extruded out through an appropriate delivery spout into the surgical pocket without using surgeon's fingers to push it through the skin opening.
A universal delivery device is provided that is capable of delivering implants of different sizes from different manufacturers into a surgical pocket when the implant is not packaged with the delivery device.
The proposed device and the packaging method enables appropriate orientation of the implant and at the same time requires a lesser delivery force to extrude the implant out of the delivery device. It also can be provided in a sterile form with the implant where no transfer is needed from the package to an additional delivery device and hence minimizing any contamination or without an implant where the surgeon can select an implant of his/her choice. Also provided are the openings for adding lubricants and or washing solutions that may be desired by the attending surgeon.
As the delivery apparatus has a generally a rectangular shape and a conical distal portion that guides the implant into the surgical pocket will prevent the implant from folding and causing structural damage to the silicone envelop of the implant encountered by the current state of the art delivery apparatus.
The delivery device in the present invention is generally rigid in nature and is designed to maintain its rectangular shape without significant deformation to its character. The materials used for the construction can be stainless steel, molded Nylon, molded polycarbonate, molded Polyethylene Terephthalate (PET) or similar polymer material and can be made by molding, vacuum forming or 3D printing using rigid or semi-rigid clear or opaque plastics.
Many variations of the present invention are possible and the description herein is meant to disclose and discuss the general principles associated with the invention and other variations can be developed by one knowledgeable in the state of the art. Various details are left out for clarity which is part and parcel of the present invention.
The breast implant as discussed earlier is generally bun shaped having a circular nature and a smaller height as compared to its diameter as shown in
In any given situation the volume of the implant is constant. For example the implant from the above table having a volume of 475 cc has a diameter of 14.8 cm and a projection (height) of 4.2 cm. When this is placed in a conical delivery device as shown in
475 cc=V=⅓πr2h= 1/12πd2h (1)
As shown in
P=F·h/3V (2)
Or P is proportional to h/3
Now referring to
475cc=V=L·W·h=A·h (3)
where A=L·W
By rearranging the equation (3) above;
Area=A=V/h
Therefore Pressure generated P=F/A=F·h/V (4)
Or P is proportional to h
From this analysis it is quite evident that the pressure generated from a constant force (F) to extrude the implant out from a conical shape for a given volume is three times smaller than for a rectangular delivery device designed to deliver an implant of the same volume.
The delivery device has the shape of a rectangular cross section also enables to surgeon to orient the implant appropriately so that the flat bottom is parallel to the direction of the surgical incision. As such when the implant is delivered it would orient itself in the same plane as the surgical incision and hence in a plane more parallel to the chest wall. Therefor no attention is needed by the surgeon to be especially careful of the orientation of the implant after delivery which saves time and additional manipulations post implantation.
There are ports to introduce lubricants and fluids for rinsing while providing means for sterilization gases to enter and exit freely during the sterilization process. The vent feature provided will allow the surgeon to vent any air out of the system and thereby enhance the pressurization needed to extrude the implant, as any air present would simply compress without providing enhanced traction for the implant.
The description herein describes an embodiment representing and functioning to achieve the objectives set forth in the invention and is not the only form a device can be constructed and utilized. The description sets forth the function and the design features of the various components and the method of operation of the proposed Sterile Packaging Method and an Implant Delivery Apparatus and variations can be achieved by anyone with similar skills with various other embodiments of similar function.
The diagram in
When the implant delivery apparatus is provided without an implant (
The implant (100) can be supplied sterile within the delivery device (400) as shown in