U.S. patent application number 13/802457 was filed with the patent office on 2014-03-13 for apparatus and process for delivering a silicone prosthesis into a surgical pocket.
This patent application is currently assigned to KELLER MEDICAL, INC.. The applicant listed for this patent is KELLER MEDICAL, INC.. Invention is credited to Kevin Keller, Judy Jones Senn.
Application Number | 20140074236 13/802457 |
Document ID | / |
Family ID | 40939536 |
Filed Date | 2014-03-13 |
United States Patent
Application |
20140074236 |
Kind Code |
A1 |
Keller; Kevin ; et
al. |
March 13, 2014 |
Apparatus And Process For Delivering A Silicone Prosthesis Into A
Surgical Pocket
Abstract
A tapered sleeve is provided that includes a lubricating coating
on an inner surface. An implant (e.g., a pre-filled silicon breast
implant) is introduced into a large end of the sleeve and extruded
into a surgical pocket of minimal access incision size through a
small-sized end of the apparatus.
Inventors: |
Keller; Kevin; (Greenville,
SC) ; Senn; Judy Jones; (Spartanburg, SC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KELLER MEDICAL, INC. |
Stuart |
FL |
US |
|
|
Assignee: |
KELLER MEDICAL, INC.
Stuart
FL
|
Family ID: |
40939536 |
Appl. No.: |
13/802457 |
Filed: |
March 13, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13372196 |
Feb 13, 2012 |
8550090 |
|
|
13802457 |
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|
12228072 |
Dec 7, 2007 |
8211173 |
|
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13372196 |
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Current U.S.
Class: |
623/8 |
Current CPC
Class: |
A61F 2/12 20130101 |
Class at
Publication: |
623/8 |
International
Class: |
A61F 2/12 20060101
A61F002/12 |
Claims
1-12. (canceled)
13. A breast implant delivery apparatus for inserting a breast
implant into a surgical pocket, comprising: a flexible sleeve
having a proximal opening and a distal opening, the proximal
opening being sized to receive a breast implant into an interior of
the sleeve and being larger than the distal opening, wherein the
flexible sleeve comprises a dry lubricant on the interior of the
flexible sleeve that can be activated by a user, and wherein the
flexible sleeve can be manually manipulated to force the breast
implant along a length of the interior of the flexible sleeve and
through the distal opening.
14. The breast implant delivery apparatus of claim 13, wherein the
flexible sleeve is tapered from the proximal opening to the distal
opening.
15. The breast implant delivery apparatus of claim 13, wherein the
dry lubricant can be activated by the user by being moistened.
16. The breast implant delivery apparatus of claim 13, wherein the
proximal opening is at the termination of the apparatus.
17. The breast implant delivery apparatus of claim 13, wherein the
flexible sleeve has indicia for cutting the sleeve to a different
dimension.
18. The breast implant delivery apparatus of claim 13, further
comprising the breast implant.
19. The breast implant delivery apparatus of claim 18, wherein a
lubricant is present on an exterior of the breast implant.
20. The breast implant delivery apparatus of claim 13, wherein the
breast implant is a pre-filled breast implant.
21. The breast implant delivery apparatus of claim 20, wherein the
breast implant is a pre-filled silicone breast implant.
22. The breast implant delivery apparatus of claim 13, further
comprising a liner.
23. The breast implant delivery apparatus of claim 13, wherein the
flexible sleeve is in a flattened configuration.
24. A breast implant delivery apparatus for inserting a breast
implant into a surgical pocket, comprising: a flexible sleeve
having a proximal opening and a distal opening, the proximal
opening being sized to receive a breast implant into an interior of
the sleeve and being larger than the distal opening, wherein the
flexible sleeve comprises a powdered lubricant on the interior of
the flexible sleeve that can be activated by a user, and wherein
the flexible sleeve can be manually manipulated to force the breast
implant along a length of the interior of the flexible sleeve and
through the distal opening.
25. The breast implant delivery apparatus of claim 24, wherein the
flexible sleeve is tapered from the proximal opening to the distal
opening.
26. The breast implant delivery apparatus of claim 24, wherein the
powdered lubricant can be activated by the user by being
moistened.
27. The breast implant delivery apparatus of claim 24, wherein the
proximal opening is at the termination of the apparatus.
28. The breast implant delivery apparatus of claim 24, wherein the
flexible sleeve has indicia for cutting the sleeve to a different
dimension.
29. The breast implant delivery apparatus of claim 24, further
comprising the breast implant.
30. The breast implant delivery apparatus of claim 29, wherein a
lubricant is present on an exterior of the breast implant.
31. The breast implant delivery apparatus of claim 24, wherein the
breast implant is a pre-filled breast implant.
32. The breast implant delivery apparatus of claim 31, wherein the
breast implant is a pre-filled silicone breast implant.
33. The breast implant delivery apparatus of claim 24, further
comprising a liner.
34. The breast implant delivery apparatus of claim 24, wherein the
flexible sleeve is in a flattened configuration.
Description
RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/372,196, filed Feb. 13, 2012, which is a
continuation of U.S. patent application Ser. No. 12/228,072, filed
Dec. 7, 2007, each of which is incorporated herein by reference in
its entirety. Non-provisional application Ser. No. 12/228,072 is a
conversion of provisional application Ser. No. 61/005,777, filed
Dec. 7, 2007, done by way of a petition under 37 CFR 1.53(c)(3)
granted on Feb. 19, 2009. This application claims the benefit of
the Dec. 7, 2007 filing date.
FIELD OF INVENTION
[0002] This invention is directed to a delivery apparatus for
facilitating the insertion of a silicone implant, such as a breast
prosthesis, into a surgically developed pocket.
BACKGROUND OF THE INVENTION
[0003] This invention relates to the placement of silicone implants
within a patient's body. Silicone implants have been in worldwide
use for a number of years. While marketing of the implants was
halted within the United States for over 15 years, the use of
silicone implants has resumed within the United States. One problem
with silicone implants is that the implants are provided in a
filled condition and must be inserted into a surgical pocket. As a
result, traditional surgical approaches require the use of larger
incisions in comparison to saline implants which can be inserted
through small incisions which are later filled in situ with
saline.
[0004] While many patients prefer the more natural qualities of
silicone, patients remain apprehensive because of the larger
incisions and possibility for visible scars which result from
silicone implants.
[0005] An additional concern with the use of silicone implants is
that the longevity and integrity of the implants can be compromised
by the conventional insertion process. A typical insertion process
involves hand manipulation by the surgeon of the implant in order
to insert it into the surgical pocket. Studies have shown that
implant failures are often associated with an area of minor damage
to the outer surface of the implant. The damaged areas are believed
to correlate to excessive pressure applied by hand manipulation of
the implant and/or damage associated with a "nick" of the implant
surface by a "touching" injury such as a fingernail or insertion
that damages the implant.
[0006] An additional consideration with respect to silicone
implants involves the amount of time required to insert the
implants. A traditional hand manipulation of an implant into a
surgical pocket can take between 10 to 20 minutes per implant for
even a highly skilled surgical practitioner. Typically, hand
manipulation of an implant requires the use of a larger incision
and would be done with a saline implant. The amount of time
required has a direct bearing on the expense of the procedure, the
surgical expense reflecting the surgeon's time, the support staff
within the operating room, and the amount of time allocated for the
surgical procedure. Accordingly, any improvements to reduce the
time required for implantation of the silicone implant will have
significant cost savings with respect to the surgical
procedure.
[0007] Accordingly, there remains room for improvement and
variation within the art.
SUMMARY OF THE INVENTION
[0008] It is one aspect of at least one of the present embodiments
to provide an apparatus and a process for facilitating the delivery
of a silicone implant into a surgically developed pocket.
[0009] It is a further aspect of at least one embodiment of the
present invention to provide for an apparatus and process for
facilitating the placement of a filled silicone implant into a
surgical pocket through a surgical incision that is too small for a
manual insertion of an implant.
[0010] It is a further aspect of at least one of the present
embodiments to provide for an apparatus and process that allows
insertion of a silicone implant through a sleeve defining a small
diameter outlet into a patient without direct hand manipulation of
the implant.
[0011] It is yet a further and more particular aspect of at least
one aspect of at least one of the present embodiments to provide
for a process and apparatus that allows for a "touchless" insertion
of a silicone implant into a surgical pocket.
[0012] These and other features, aspects, and advantages of the
present invention will become better understood with reference to
the following description and appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] A fully enabling disclosure of the present invention,
including the best mode thereof to one of ordinary skill in the
art, is set forth more particularly in the remainder of the
specification, including reference to the accompanying
drawings.
[0014] FIG. 1 is a perspective view of a prosthetic insertion
sleeve along with a silicone prosthesis.
[0015] FIG. 2 is a picture of the insertion sleeve with the
silicone implant positioned within the sleeve and showing further
hand manipulation of the implant via the sleeve.
[0016] FIG. 3 is a view similar to FIG. 2 showing additional
manipulation of the prosthesis through the sleeve and illustrating
a portion of the prosthesis exiting a tapered end of the
sleeve.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0017] Reference will now be made in detail to the embodiments of
the invention, one or more examples of which are set forth below.
Each example is provided by way of explanation of the invention,
not limitation of the invention. In fact, it will be apparent to
those skilled in the art that various modifications and variations
can be made in the present invention without departing from the
scope or spirit of the invention. For instance, features
illustrated or described as part of one embodiment can be used on
another embodiment to yield a still further embodiment. Thus, it is
intended that the present invention cover such modifications and
variations as come within the scope of the appended claims and
their equivalents. Other objects, features, and aspects of the
present invention are disclosed in the following detailed
description. It is to be understood by one of ordinary skill in the
art that the present discussion is a description of exemplary
embodiments only and is not intended as limiting the broader
aspects of the present invention, which broader aspects are
embodied in the exemplary constructions.
[0018] In describing the various figures herein, the same reference
numbers are used throughout to describe the same material,
apparatus, or process pathway. To avoid redundancy, detailed
descriptions of much of the apparatus once described in relation to
a figure is not repeated in the descriptions of subsequent figures,
although such apparatus or process is labeled with the same
reference numbers.
[0019] As seen in reference to FIGS. 1-3, a sleeve 10 is provided
having a general conical shape and which defines a first opening 12
at a larger end of the sleeve and a smaller opening 14 along the
tapered terminal tip of sleeve 10. As best seen in reference to
FIG. 1, sleeve 10 may be provided by a material which is
sufficiently flexible and which enables the sleeve 10 to assume a
flattened configuration for storage and shipping.
[0020] As seen in reference to FIGS. 2 and 3, when an implant 20,
such as a silicone implant, is placed through opening 12 into the
interior of sleeve 10, sleeve 10 can be manipulated to conform to
the shape of the implant 20 as well as to apply pressure to direct
the implant 20 along the length of the sleeve and toward opening
14.
[0021] Preferably, sleeve 10 is of a flexible material. In one
embodiment of the invention, sleeve 10 can be provided by a fabric
material such as a plastic-containing fabric which is pliable yet
resistant to stretching. It is also envisioned that use of a
transparent plastic or other suitable polymer material which has
sufficient properties including flexibility and non-elasticity may
be used. It is believed that there are advantages to using a
transparent or semi-transparent material to assist the surgeon in
proper orientation of the implant 20 within the interior of sleeve
10. Suitable transparent materials may include Mylar.RTM., plastics
made from Tygon.RTM. brand of plastics, vinyls, polyvinyl chloride,
and other similar materials. One suitable material which is
flexible and transparent includes compositions of ethylene and
alpha-olefin copolymers such as the compositions used in IV saline
bags. Suitable multilayer films and sealed structures are taught in
U.S. Pat. No. 6,743,523 and U.S. Pat. No. 7,267,885 both assigned
to Baxter International Inc., and which are incorporated herein by
reference. As disclosed therein, suitable films heat sealed to form
suitable containers, are transparent with minimal hazing, and can
be sterilized using gas sterilization or heat with intact seals and
remain sufficiently flexible and pliable for the necessary
manipulation described herein.
[0022] Other attributes of sleeve 10 include the ability to provide
sleeve 10 as a sterile component. Accordingly, the material must be
capable of withstanding at least one of several conventional
sterilization techniques such as a steam autoclave, chemical gas
sterilization, or irradiation. Additionally, the interior surface
of sleeve 10 may preferably have a low coefficient of friction to
facilitate passage of the implant 20 through the sleeve 10. It has
been found that using a surgically appropriate lubricant will
facilitate passage of the implant 20 through the interior of sleeve
10. Such lubricants may be applied directly to the implant 20 or
the sleeve can be coated with lubricant or supplied pre-coated with
a lubricant that is already present within sleeve 10.
[0023] Since the size of silicone implants 20 may vary in a range
from about 150 cc to about 800 cc, the dimensions of opening 14 may
be varied to accommodate various size implants 20. Preferably,
sleeve 10 is provided with an opening 14 sized to fit the smallest
implant. The tip opening 14 may be enlarged by cutting portions of
the sleeve to provide a larger opening. If desired, indicia may be
present on the exterior of sleeve 10 to allow the cutting of the
sleeve to the proper dimensions for the size of the implant 20.
[0024] Alternatively, the tip opening 14 can have a diameter sized
to allow the largest standard implant of 800 cc to exit the sleeve.
According to this invention, it has been found that an opening 14
having a diameter of about 6 cm will allow delivery of the implant
into the surgical pocket. As described below, use of an optional
tip would allow for a sleeve to be provided having a single opening
size to accommodate the largest implant. Selection of an
appropriate tip can then be made based upon the size of the
implant.
[0025] While it is believed preferable that sleeve 10 be provided
from a single structural substrate, it is also recognized that an
equivalent device can be provided of a flexible sleeve 10 having a
separate inner liner (not illustrated) which may be present within
the interior of sleeve 10. The liner could either be integral with
sleeve 10 or may be a separate layer of material manually inserted
within the interior of sleeve 10 at the time of use.
[0026] The larger opening 12 of sleeve 10 allows the implant to be
placed within the sleeve with little force or manual manipulation.
When the implant is within the interior of sleeve 10, the larger
opening may be twisted closed as seen in FIGS. 2 and 3. Thereafter,
the surgeon is able to apply manual pressure via the sleeve to the
implant 20. The surgeon is thus able to apply pressure to the
implant, forcing the implant toward the smaller opening 14. As seen
in reference to FIGS. 2 and 3, the implant can be forced through
the small opening 14.
[0027] As the surgeon is manipulating the implant through sleeve
10, the opening 14 is placed within the surgical pocket designed
for receiving the implant. Accordingly, tip 14 is inserted through
an incision associated with the surgical pocket. As the implant is
forced through opening 14, the surgical pocket can be manipulated
slightly to create a vacuum that assists in the placement of the
implant into the pocket. Additionally, another useful feature of
the apparatus and process is that as approximately half of the
implant 20 has been exerted through opening 14, the remainder of
the implant will flow through the sleeve without additional
manipulation. Accordingly, once the opening 14 is positioned within
the surgical pocket, implant 20 can be manipulated so that the
prosthesis 20 is forced into the surgical pocket. The surgeon is
able to control the positioning and orientation of the implant 20
by proper rotation and positioning of the sleeve 10 containing the
implant 20.
[0028] It has been found that use of a sleeve 10 can greatly reduce
the amount of time required for insertion of an implant 20. It has
been found that the step of inserting a simple implant can occur
within a timeframe of about 3 to 20 seconds minutes as compared to
a time interval of 5 to 15 minutes for a traditional hand
manipulation of an implant. Additionally, because the implant can
be inserted through a small opening, the size of the surgical
incision can be made smaller than would otherwise be required for a
silicone implant.
[0029] The use of the sleeve 10 and implant 20 can be used with
incisions. For instance, periareolar, trans axillary, intramammary
incisions can be used with the above process and apparatus for
insertion of an implant.
[0030] In accordance with this invention, it has been found
beneficial to initially lubricate the exterior of implant 20 with
an appropriate surgical lubricant such as K-Y.RTM. brand sterile
lubricant. Following lubrication, the lubricated implant 20 is
placed within the sleeve 10 and the implant 20 is forced through
opening 14 as a pre-lubrication step. Following this
pre-lubrication step, the implant can again be placed within the
sleeve and subsequently inserted into the patient's surgical
pocket.
[0031] It is also envisioned that, depending upon the coefficient
of friction of the interior of sleeve 10 and/or any associated
liner, it may be possible to provide other types of lubricants,
including dry or powdered lubricant products to the interior of
sleeve 10. Such lubricants are activated by being moistened and
would provide an alternative to manually coating the prosthesis
with a lubricant.
[0032] If desired, sleeve 10 can further define a structural tip
(not illustrated) in association with opening 14. The tip could be
provided of a more elastic material that facilitates insertion of
the tip into the surgical pocket. For instance, a separate tip
could provide for an extension beyond the existing opening 14 and
which would have a narrower initial diameter providing a longer tip
which may be more easily inserted within the interior of a surgical
pocket. The ability of an optional tip to expand allows the implant
20 to pass through sleeve 10 and opening 14 while positioning the
exiting implant 20 further within the surgical pocket. The use of
the tip is believed beneficial in that it prevents the passage of
the implant from extruding the sleeve from the incision. In other
words, the tip provides a deeper positioning for the sleeve 10 more
accurately directs the placement of the implant within the surgical
pocket. The use of an expandable tip may facilitate the insertion
time and lessen the learning curve for surgeons who are using the
sleeve 10.
[0033] An important attribute of sleeve 10, including any optional
tip structure 14, is that the interior surface of sleeve 10,
including opening 14 and any associated tip member, must provide
for a smooth and substantially uninterrupted passageway. It is
important that any seams that may be formed or abutments between
one type of material to another or from opening 14 to an associated
tip must be of a sufficient smoothness such that the surface of the
implant 20 is not degraded. Accordingly, it is envisioned that
sonically welded seams or the use of a unitary extrusion process is
desired for forming appropriate sleeves 10. In addition, to the
extent opening 14 may be "cut to size", it is important that the
material, once cut, not present any cutting artifacts or roughened
edges that could damage the implant 20. Similarly, the identical
concerns must be met by any optional tip used with sleeve 10 such
that the material of the tip as well as its method of attaching the
tip to the sleeve 10 and sleeve opening 14 must not present any
potential implant contact surfaces that could result in damage to
the implant.
[0034] Although preferred embodiments of the invention have been
described using specific terms, devices, and methods, such
description is for illustrative purposes only. The words used are
words of description rather than of limitation. It is to be
understood that changes and variations may be made by those of
ordinary skill in the art without departing from the spirit or the
scope of the present invention which is set forth in the following
claims. In addition, it should be understood that aspects of the
various embodiments may be interchanged, both in whole, or in part.
Therefore, the spirit and scope of the appended claims should not
be limited to the description of the preferred versions contained
therein.
* * * * *