Patent Application
20200008923
Implant delivery devices have multiple orifices, or a slot or seam, one through which the implant is placed into the delivery device and one through which the implant is then inserted into the patient. Multiple orifices and/or other slots or seams complicate the device and procedure and increase the chance of handling, loading, and implant delivery errors.
The physical handling of implants is also believed to increase infection risk to the patient, and therefore devices that reduce or even eliminate handling of the implant prior to delivery would be preferred to reduce the risk of patient injury.
A simpler solution with a single opening, that reduces or eliminates the physical handling of implants prior to insertion, and that is easier to use, would be desirable.
According to an aspect, an implant delivery device includes a body portion and an implant delivery portion. The body portion includes a first sidewall, a second sidewall, and a closed end. The implant delivery portion is disposed opposite to the closed end. The implant delivery portions include a first sidewall, a second sidewall, and an orifice. The first sidewall is angled with respect to the first sidewall of the body portion, and the second sidewall is angled with respect to the second sidewall of the body portion.
The closed end may include an end wall bonded to at least one face of the body portion.
The closed end may include a bond between at least one face of the body portion.
The body portion may include a lay flat tube. The thermal bond may include a bond closing the lay flat tube.
The implant delivery portion may be configured to invert such that the orifice is disposed inside the body portion.
The implant delivery portion may be configured to receive an implant while in an inverted configuration such that the implant is disposed inside the body portion.
The implant delivery portion may be configured to return to a not inverted configuration while an implant is disposed in the body portion. In the not inverted configuration, the orifice may not be disposed inside the body portion.
An interior surface of the implant delivery portion may include a friction reducing coating.
The friction reducing coating may be hydrophilic.
An interior surface of the implant delivery portion may include an antimicrobial treatment.
The orifice may be an only opening of the implant delivery device.
According to another aspect, an implant delivery device includes a first closed sidewall, a second closed sidewall, a third closed sidewall, and an open end. The second closed sidewall is disposed opposite the first closed sidewall. The third closed sidewall is disposed between the first closed sidewall and the second closed sidewall. The open end is disposed opposite the third closed sidewall and disposed between the first closed sidewall and the second closed sidewall. A face of the implant delivery device disposed between the first closed sidewall and the second closed sidewall is configured to fold such that a cross-sectional area of the open end is reduced.
The face of the implant delivery device may include an indicia. The indicia may extend from proximal a corner of the first closed sidewall and the open end toward the second closed sidewall.
The indicia may include a crease.
The face may include a protruding tab.
The indicia may extend at approximately a 45 degree angle with respect to the open end.
The device may include a second indicia extending from the first indicia towards the open end.
According to another aspect, a method of manufacturing an implant delivery device includes: providing a section of lay flat tubing; inverting the lay flat tubing to arrange the lay flat tubing in an inverted configuration; applying a friction reducing treatment to the inverted lay flat tubing; inverting the lay flat tubing to arrange the lay flat tubing in a not inverted configuration; and sealing an end of the section of lay flat tubing.
The lay flat tubing may include a thermoplastic material, and sealing the end of the section of lay flat tubing includes thermally bonding the thermoplastic material.
In a not inverted configuration, an interior surface of the lay flat tubing may be textured.
The applying the friction reducing treatment may include dipping the inverted lay flat tubing in a lubricious material.
The method may include curing the lubricious material before the inverting the lay flat tubing to arrange the lay flat tubing in a not inverted configuration.
The lubricious material may be hydrophilic.
According to another aspect, a method of inserting an implant includes: providing an implant delivery device, the device including: a first closed sidewall, a second closed sidewall disposed opposite the first closed sidewall, a third closed sidewall disposed between the first closed sidewall and the second closed sidewall, and an open end disposed opposite the third closed sidewall and disposed between the first closed sidewall and the second closed sidewall; inserting the implant into the implant delivery device through the open end; folding the first closed sidewall towards the second closed sidewall to reduce a cross sectional area of an orifice provided by the open end; and applying a force to the implant delivery device to cause the implant to move towards and through the orifice.
The method may include folding the second closed sidewall towards the first closed sidewall to reduce a cross sectional area of the orifice.
The method may include removing a corner formed by the open end and the second closed side wall.
The removing may include cutting.
An interior surface of the implant delivery device may include a friction reducing treatment.
The friction reducing treatment may include a hydrophilic coating.
The method may include hydrating the friction reducing treatment.
For a better understanding of the aforementioned embodiments as well as additional embodiments thereof, reference should be made to the Detailed Description below, in conjunction with the following drawings in which like reference numerals refer to corresponding parts throughout the figures.
Reference will now be made in detail to embodiments, examples of which are illustrated in the accompanying drawings and figures. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be apparent to one of ordinary skill in the art that the invention may be practiced without these specific details. In other instances, well-known methods, procedures, components, circuits and networks have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.
The implant delivery device 10 includes a single orifice 24 at one end (e.g., at the end of the sidewalls 20 and 22, and a closed end 26 at the opposite end of the implant delivery device 10. An end wall 28 may be bonded to the body portion 12 by a thermal weld, glue, tape, or other securement at the bonding region 30. In some embodiments, all sides of the implant delivery device 10 may be sealed. An exemplary advantage of such an embodiment is the maintenance of sterile conditions inside the implant delivery device. The surgeon may cut the implant delivery device to form the orifice.
The body portion 12 of the device 10 may be generally cylindrical with a single orifice 24 at one end of the delivery portion 14 having a reduced width relative to the body portion 12. The single orifice 24 can be used for placing the implant into the insertion device 10 and for delivering the implant into the patient. The closed end 26 of the implant delivery device may prevent the implant from slipping out of the insertion device 10 prior to insertion into the patient, limit or avoid contamination from entering the device 10 and reaching the implant, and house the implant while lubrication (e.g., saline or betadine) is applied to the implant or the inner surface of the implant delivery device. An exemplary advantage of the single opening is that it holds the contents of the lubrication (or other hydration) making the application of the lubrication or hydration easier, less messy, use a smaller quantity of lubrication or hydration and be more effective.
In some embodiments, the region 30 includes a flexible elastomer in place of the closed end 26. The flexible elastomer may be stretched to allow the implant to fit through and then return to its original size. In this manner, the implant can be securely loaded into the implant delivery device in cases where the orifice 24 is smaller than the implant.
In some embodiments, the implant delivery device 10 is pre-loaded with an implant for insertion into the patient, for example, in a manufacturing clean room to provide the least amount of contamination possible. The implant delivery device 10 and pre-loaded implant can be packaged in sterile packaging in preparation for delivery to the patient. For use, the implant delivery device 10 and pre-inserted implant can be removed from sterile packaging, and, in some embodiments, the lubricious coating can be hydrated if required. By being pre-loaded in the implant delivery device (e.g., by the manufacturer in some embodiments), the implant may be provided to the surgeon ready for delivery to the patient in a sterile state. In such an embodiment, the implant delivery device 10 with the implant disposed in the body 12 may together be disposed in a box or packaging such as shipping packaging that protects the combined device 10 and implant for transit.
The incision site may be slightly smaller than a width of the orifice 24. The orifice 24 may be inserted slightly into the site such that the side walls 20 and 22 extend into the surgical opening (e.g., 1 cm). When the implant is then deployed into the surgical site, as discussed in more detail below, the delivery may be touchless as the surgeon will not have directly touched the implant nor will the implant have come into contact with any external surface of the patient or environment.
In an embodiment, the implant is a breast implant, such as a silicone gel type implant (which may be an elastomer silicone shell enclosing a silicone gel). Other implant types, such as a saline implant, other composite filler type implants or tissue expander can also be used with the implant delivery device 10.
The implant can be placed inside the implant delivery device 10 through the single orifice 24 of the implant delivery device. The orifice 24 and other device dimensions can be sized according to the intended implant such that the end use is not required to make adjustments or modifications such as cuts, stretching, or additions or deletions.
In some embodiments, the implant delivery device is constructed of a material and structure that can be sterilized and/or is sterilizable. Sterilization methods include, but are not limited to, ethylene oxide sterilization, chlorine dioxide sterilization, hydrogen peroxide sterilization, gamma ray sterilization, electron beam sterilization, wet heat sterilization, dry heat sterilization, or a combination thereof. In embodiments where the implant is pre-loaded with the implant delivery device, the implant delivery device may be made of materials that can be usable at least once after being subjected to the sterilization method applied to the implant.
In some embodiments, at least a portion of the implant delivery device 10 includes a material that is at least partially transparent or translucent. The transparent or semi-transparent portions of the implant delivery device 10 may allow a surgeon to view the position of an enclosed implant and/or the position or motion of the implant during manipulation. This may be particularly advantageous in the case of a shaped implant to facilitate the delivery of the implant in the desired orientation. For example, at least a portion of the implant delivery device 10 may include transparent or translucent polymer film to allow a surgeon to view at least a portion of the implant.
In some embodiments, the implant delivery device 10 may be constructed of a flexible or semi flexible polymer or copolymer material. For example, the implant delivery device 10 may include one or more of polyethylene, polypropylene, polytetrafluoroethylene, polycarbonate, polyethylene terephthalate, fluoropolymer, ethylene vinyl acetate, polyvinylchloride, polyvinylchloride and silicon. The material may be provided as a film and bonded along a seam to provide the generically cylindrical shape of the body portion 12. The material may also be provided by a lay flat tube that may limit or avoid the need for seams. An advantage of a lay flat tube is that manufacturing steps for bonding a vertical seam may be limited or avoided thereby increasing yields and decreasing manufacturing costs. The lay flat tube may also limit or reduce the number of seams thereby reducing possible weak points and increasing the strength of the device 10. Preferably, the device 10 will not fail or yield under forces that may be exerted on the device by a surgeon.
In some embodiments, one or more of the internal surfaces of the implant delivery device 10 may be fabricated or treated to provide a low friction coefficient. This may be achieved through the use of a lubricious coating. A lubricious coating or surface may include a coating or surface of an object having slipperiness, low friction and/or smoothness. This description is exemplary in nature and a lubricious coating or surface is not defined by or limited thereto. For example, in some embodiments, at least a portion of at least one or more of the internal surfaces of the implant delivery device 10 can be lubricious. The lubricity may be achieved with or without a coating on the material of the implant delivery device 10. The lubricity may be provided or enhanced by a hydrophilic coating or a hydrophobic coating. In some embodiments, the lubricity includes a combination of the lubricious nature of the material (for example forming the walls) of the implant delivery device 10, and a coating on the material of the implant delivery device 10.
The size and/or shape of the implant delivery device 10 may be different based on surgeon requirements and/or patient requirements. For example, the single orifice 24 may have different sizes and dimensions, including angled or straight sides. The body portion 12 for holding the implant can also have different sizes and dimensions, including flat, curved or other shaped sealed ends. Some non-limiting embodiments are shown in
In the non-limiting embodiments show in
The implant may be loaded into the sealed-end chamber provided by the body portion 142 by being passed through the inverted delivery portion 144 and through the orifice 146 by the surgeon. The implant delivery device 140 can then be turned such that gravity pulls the implant towards the orifice 142 causing the inverted delivery portion 144 revert to its not inverted configuration. The delivery portion 144 may also be manually manipulated to the not inverted configuration.
With reference to
At this stage, the orifice 166 is inserted into the surgical site. Preferably, the incision in the surgical site is slightly smaller than a width of the orifice 166 such that orifice 166 can be securely placed into the surgical site to limit exposure of the implant 170 to the exterior environment of the surface of the skin, which may have bacteria and other undesirable contamination. Flexibility of the implant and/or the material of the implant delivery device 160 allows the implant to pass through the orifice 166 with the application of a gentle force as described next. It will be appreciated that the implant delivery device 166 may also be used to deliver the implant to the patient without inserting the orifice 166 into the surgical site.
The implant delivery device 200 may include tabs 210 and 212 to facilitate opening the open end 208 (as shown in
The implant delivery device 200 may include indicia 214 and 216 for fold lines. In addition to or in place of the indicia, the implant delivery device may be creased along the lines 214 and 216. The indicia or creases may extend from one or both upper corners of the closed end 202 to the open end 208. The indicia or creases are angled such that at the open end 208, their width is less than a width of the open end 208.
With reference to
In some embodiments, at least a portion of the implant delivery device 200 includes a material that is at least partially transparent or translucent. The transparent or semi-transparent portions of the implant delivery device 200 may allow a surgeon to view the position of an enclosed implant and/or the position or motion of the implant during manipulation. This may be particularly advantageous in the case of a shaped implant to facilitate the delivery of the implant in the desired orientation. For example, at least a portion of the implant delivery device 200 may include transparent or translucent polymer film to allow a surgeon to view at least a portion of the implant.
In some embodiments, the implant delivery device 200 may be constructed of a flexible or semi flexible polymer or copolymer material. For example, the implant delivery device 200 may include one or more of polyethylene, polypropylene, polytetrafluoroethylene, polycarbonate, polyethylene terephthalate, fluoropolymer, ethylene vinyl acetate, polyvinylchloride, and silicon. The material may be provided as a film and bonded along a seam to provide the generically cylindrical shape. The material may also be provided by a lay flat tube that may limit or avoid the need for seams. As noted above, an advantage of a lay flat tube is that manufacturing steps for bonding a vertical seam may be limited or avoided thereby increase yields and decreasing manufacturing costs. The lay flat tube may also limit or reduce the number of seams thereby reducing possible weak points and increasing the strength of the device 200. Preferably, the device 200 will not fail or yield under forces that may be exerted on the device by a surgeon.
In some embodiments, one or more of the internal surfaces of the implant delivery device 200 may be fabricated or treated to provide a low friction coefficient. This may be achieved through the use of a lubricious coating. A lubricious coating or surface may include a coating or surface of an object having slipperiness, low friction and/or smoothness. This description is exemplary in nature and a lubricious coating or surface is not defined by or limited thereto. For example, in some embodiments, at least a portion of at least one or more of the internal surfaces of the implant delivery device 200 can be lubricious. The lubricity may be achieved with or without a coating on the material of the implant delivery device 200. The lubricity may be provided or enhanced by a hydrophilic coating or a hydrophobic coating. In some embodiments, the lubricity includes a combination of the lubricious nature of the material (for example forming the walls) of the implant delivery device 200, and a coating on the material of the implant delivery device 200.
The size and/or shape of the implant delivery device 200 may be different based on surgeon requirements and/or patient requirements. For example, the open end 208 may have different sizes and dimensions, and the sides 204, 206 may be straight or angled.
The implant delivery device 240 includes indicia 250 for a fold line. The indicia 250 preferably extends from a corner of the open end 248 diagonally, for example at 45 degrees, to an opposite side of the delivery device 240. In addition to or in place of the indicia 250, the implant delivery device may be creased along the lines 250.
The implant delivery device 240 may also include one or more indicia 252a-252e extending from the indicia 250 to the open end 248. In the flat configuration, the indicia 252a-252e are approximately vertical. The indicia 252a-252e may also be angled to approximate an isosceles triangle for symmetry at the insertion end after folding.
Referring to
At 320, the bulk material is shaped into shape of the implant delivery device. In the case of lay flat tubing, a rotating hot knife apparatus may both cut the bulk lay flat tubing 314 to size as well as perform thermal welding of one end of the implant delivery device to close one end and leave one end open. A die cutting operation may be used in place of or addition to a rotating hot knife apparatus. In some embodiments, the end of the implant delivery device is not bonded until later in the process such as after the re-inversion. If film sheets are used for bulk material or other shaping such as applying angled seams, securing layers of film sheets and other shaping may be performed in this step.
At 330, the cut and shaped material is turned inside out. In the case of lay flat tubing, the ridges 316 may now be exposed on an exterior.
At 340, the inverted material may be dipped in a treatment. The treatment may be, for example, a lubricious coating as discussed above. Applying the lubricious coating may include preparing a liquid form of the coating if the coating is not already liquid. The coating material may be dissolved in a solvent such as alcohol or water. After dipping, the coating may be cured by drying, heating, exposure to ultra violet light, and the like. Once cured, the coating may be covalently bonded to the bulk material of the device such that subsequent exposure to liquid does not fully remove the coating from the bulk material. For example, the coating may include Serene ® available from Surmodics, ComfortCoat® available from DSM, ISurGlide® available from ISurTec®, Lubricent® available from Harland Medical Systems, Hydak® available from Biocoat and parylene. It will be appreciated that coatings applied with or without solvents and other delivery methods to apply the coating may be used. For example, the coating may be sprayed on, rolled on, poured on, and so forth. The coating may also be applied selectively, for example by masking off areas of the device prior to dipping, stamping on the coating material, using a slot die application process, roll coating, or applying the coating material through an aperture screen. Examples of patterns include dots, a checkerboard pattern and vertical stripes extending from the open end to the closed end of the device. The coating may also be selectively applied to regions of the device, for example starting from proximal orifice end and extending partially but not completely to an opposite end of the device. The selective application of the coating material may reduce the cost of the device while still reducing the coefficient of friction to provide desirable performance.
Once the coating is cured, at 350, the devices may be inverted again to be placed back in a not inverted configuration. At this step, a shipping protection sheet may optionally be added inside the device to limit contact and sticking between the coated interior surfaces of the device. At 360, the devices may be packaged for shipment. In some embodiments, this includes disposing an implant inside the device and sterilizing the device.
It will be appreciated that in some embodiments, the inversion of the material may be performed before the shaping and coating. For example, the section of bulk material may be inverted and both ends of the section of material (e.g., the lay flat tube), be sealed to prevent entry of the lubricious material. After dip coating, one or both seals may be cut off, the material re-inverted, and then sealed (and in some embodiments shaped). Portions of the inverted material may be masked off before dip coating or the coating may be applied by a selective process such as spraying to limit the application of coating material where seals will be formed to improve the strength of the seal at those locations.
It will also be appreciated that in place of or in addition to a lubricious coating, other treatments may also be provided. For example, an antimicrobial treatment may be applied to one or more surfaces of the implant delivery device.
It will be appreciated by those skilled in the art that while particular embodiments and examples, have been described above, the disclosure is not necessarily so limited, and that numerous other embodiments, examples, uses, modifications and departures from the embodiments, examples and uses are intended to be encompassed by the description and figures and the appended claims. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of the present disclosure. Any benefits, advantages, or solutions to problems that are described herein with regard to specific embodiments are not intended to be construed as a critical, required, or essential feature or element of any or all the claims.
The title, abstract, background, and headings are provided in compliance with regulations and/or for the convenience of the reader. They include no admissions as to the scope and content of prior art and no limitations applicable to all disclosed embodiments.
This application claims priority to U.S. Provisional Application No. 62/695,540, filed Jul. 9, 2018, the contents of which are incorporated herein by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62695540 | Jul 2018 | US |
