U.S. patent application number 13/677750 was filed with the patent office on 2013-03-21 for silicone breast implant delivery.
This patent application is currently assigned to KELLER MEDICAL, INC.. The applicant listed for this patent is Keller Medical, Inc.. Invention is credited to Howard E. Preissman.
Application Number | 20130073040 13/677750 |
Document ID | / |
Family ID | 43030988 |
Filed Date | 2013-03-21 |
United States Patent
Application |
20130073040 |
Kind Code |
A1 |
Preissman; Howard E. |
March 21, 2013 |
Silicone Breast Implant Delivery
Abstract
A tapered sleeve is provided that includes a hydrophilic coating
on an inner surface. In use, the device is typically removed from
sterile packaging and soaked to activate the lubricous properties
of the coating. 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 device.
Inventors: |
Preissman; Howard E.;
(Stuart, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Keller Medical, Inc.; |
Stuart |
FL |
US |
|
|
Assignee: |
KELLER MEDICAL, INC.
Stuart
FL
|
Family ID: |
43030988 |
Appl. No.: |
13/677750 |
Filed: |
November 15, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13109806 |
May 17, 2011 |
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13677750 |
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12387215 |
Apr 29, 2009 |
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13109806 |
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Current U.S.
Class: |
623/8 |
Current CPC
Class: |
A61F 2210/0076 20130101;
A61F 2/12 20130101; C09J 5/00 20130101; A61F 2230/0067 20130101;
A61F 2230/0071 20130101 |
Class at
Publication: |
623/8 |
International
Class: |
A61F 2/12 20060101
A61F002/12 |
Claims
1. A method of inserting a pre-filled prosthesis into a surgical
pocket with a tapered sleeve having a length and defining proximal
and distal openings, the method comprising: fitting the sleeve into
a basin in a compacted state, the basin at least partially filled
with fluid; soaking the sleeve in the fluid to activate a lubricous
coating adhered to an inner surface of the sleeve; removing the
sleeve from the basin; inserting the prosthesis into the sleeve
through the proximal opening; introducing the sleeve into the
surgical pocket; and manipulating the sleeve to conform to a shape
of the prosthesis and apply pressure to direct the prosthesis along
the length of the sleeve toward the distal opening, out of the
distal opening and into the surgical pocket.
2. A method of inserting a breast augmentation prosthesis into a
surgical pocket within a breast with a tapered sleeve having a
length and defining proximal and distal openings, the method
comprising: hydrating the sleeve to lubricate an inner surface of
the sleeve by activating a hydrophilic coating adhered to the
sleeve; inserting the breast augmentation prosthesis into the
sleeve through the proximal opening; introducing the sleeve into
the surgical pocket within the breast; and manipulating the sleeve
to conform to a shape of the prosthesis and apply pressure to
direct the prosthesis along the length of the sleeve toward the
distal opening, out of the distal opening and into the surgical
pocket within the breast.
3. A method of preparing a delivery system for use in implanting a
pre-filled prosthesis into a surgical pocket, the method
comprising: soaking the sleeve in fluid to activate a lubricous
coating adhered to an inner surface of the sleeve; inserting the
prosthesis into the sleeve through the proximal opening;
manipulating the sleeve to conform to a shape of the prosthesis and
apply pressure to direct the prosthesis along the length of the
sleeve toward the distal opening, out of the distal opening; and
reinserting the prosthesis into the sleeve to be ready for
prosthesis implantation.
4. A method of preparing a delivery system for use in implanting a
pre-filled prosthesis into a surgical pocket, the method
comprising: fitting the sleeve into a basin in a compacted state,
the basin at least partially filled with fluid; soaking the sleeve
in the fluid to activate a lubricous coating adhered to an inner
surface of the sleeve; removing the sleeve from the basin; and
inserting the prosthesis into the sleeve through the proximal
opening.
Description
CROSS-RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/109,806, filed May 17, 2011, which is a
divisional of U.S. patent application Ser. No. 12/387,215, filed
Apr. 29, 2009, each of which is fully incorporated herein by
reference.
BACKGROUND
[0002] Silicone breast implants were re-approved in the United
States in November 2006 after having been withdrawn from the
market. Implant recipients cite safety, scarring, and "natural"
look and feel to be the top three indicators in selecting between
saline- and silicone-filled implants for breast augmentation. Given
that the more natural look and feel offered by silicon is a
pre-requisite for many patients, silicone implants have already
achieved nearly 50% market share following their return to the
market.
[0003] But because silicone implants are pre-filled (to alleviate
leakage concerns) they have generally required larger access
incisions than saline implants. Due to the possibility of visible
scars associated with the larger incisions, some patients have
remained apprehensive about selecting silicone implants.
[0004] An additional consideration that has thus-far weighed
against silicone implant selection involves the amount of time
required for insertion. Hand manipulation can be time consuming
even a highly skilled surgical practitioner. The time spent has a
direct bearing on the expense of the procedure.
[0005] The extent (and nature) of such manipulation also impacts
the safety of the procedure. Stated plainly, the poking and pushing
required to manually insert a prefilled silicone implant can be
quite rough. Indeed, clinical studies have shown that the majority
of silicone implant leaks/ruptures are attributable to sharp
instrument damage and/or local stress forces exerted on the implant
at the time of insertion.
[0006] Advances have been made in the construction methods and
materials used in silicone breast implants over the last decade
(e.g., the introduction of cohesive gels, textured shells, and
anatomical shapes). However, little improvement has been made in
the method of inserting the implants. That is, until use of the
device described in U.S. patent application Ser. No. 12/228,072 to
Keller.
[0007] The Keller filing describes a device and methods addressing
each of the above-referenced issues. It discloses a
specially-adapted pastry bag type device for implant introduction.
The device enables silicon implant insertion though smaller
incisions at dramatically reduced introduction time as compared to
the common practice for silicon implant introduction. Likewise, the
potential for implant damage has been significantly reduced. By
addressing the cited delivery challenges through use of the Keller
device, the popularity of silicon-based implants is poised to
overtake that of saline-filed counterparts. This scenario is made
more likely given ultimate market introduction of the Keller device
with improvements as described herein.
SUMMARY
[0008] Like the original Keller device, the present invention
comprises a truncated conical sleeve. The frustum-shaped device is
adapted to receive a silicon breast implant and by squeezing the
sleeve, expel the implant from its smaller end into a tissue
pocket. The implant delivery sleeve is constructed of a flexible
fabric and similar in size to store-bought pastry bags.
[0009] More specifically, since the size of silicone implants may
vary in a range from about 150 cc to about 800 cc, the dimensions
of the sleeve may vary. A proximal opening sized to fit any implant
in this size range and a distal opening sized to fit the smallest
implant may be desirable. The distal/tip opening then may be
enlarged by trimming the sleeve to provide a larger opening.
Indicia may be present on the exterior of sleeve as a guide for
cutting to the proper dimensions.
[0010] In use, the small end of the delivery sleeve is placed
through a skin incision into a tissue pocket and pressure is
applied to force the implant from the sleeve into the pocket in
use. Such action avoids rough or gross manipulation as required by
manual implantation. As such, use of the sleeve makes for a more
"gentle" procedure reducing the potential for implant damage and/or
adjacent tissue trauma.
[0011] In addition, the small size of the delivery sleeve opening
allows the physician flexibility in his/her surgical approach by
allowing the access through the inframammary, periareolar, or
axillary sites. In all cases, the incision is smaller and less
noticeable than otherwise required for inserting silicone implants,
thereby diminishing any scarring.
[0012] While similarly advantageous in regard to the above, the
present invention incorporates additional features and advantages
in use as compared to the Keller system.
[0013] For instance, the sleeve is advantageously constructed of
rip-stop nylon fabric. In such construction, the fabric is
advantageously between about 3/4 to about 11/2 oz weight material
per sailmaker's yard. It may be as heavy 21/4 oz or heavier still
by the same standard. To offer maximum translucency when wet-out (a
feature useful for determining/confirming implant orientation
within the sleeve), the fabric is preferably not pigmented. Other
material options are possible as well, but the rip-stop nylon
offers particular advantages in terms of durability and ease of
handling, especially in connection with its use as further
described below.
[0014] Other constructional features define another optional aspect
of the present invention. Specifically, the device is
advantageously cut from rip-stop nylon cloth that is adhered along
an overlapping seam with double-sided tape. 3M, Inc. offers 5 mill
transfer tape that is suitable for this purpose; suitable fabric
may be obtained from Challenge Sailcloth, Inc. So-constructed, no
binding of the fabric edges is required to prevent unraveling or
other problems. Cost is utterly minimized, without any compromise
in performance. Still, other constructional approaches may be
employed without departing from other aspects of the present
invention.
[0015] Regardless, the interior of the sleeve is packaged and
supplied with a user-activated coating thereon. An example of such
coating is hydrophilic coating. It is user-activated by soaking the
sleeve in fluid (e.g., deionized water or sterile saline solution)
as further described below. It is stably adhered to or bonded to
the sleeve. A number of coatings and/or suppliers thereof may
supply and/or apply the coating. A preferred vendor is AST
Products, Inc. applying LUBRILAST hydrophilic coating and/or other
coating(s) as described in U.S. Pat. Nos. 6,238,799 and 6,866,936
incorporated herein by reference in their entireties. Other
suitable coatings can be applied as well to devices such as the
device set forth in Keller U.S. patent application Ser. No.
12/228,072 filed on Dec. 7, 2007, and which is incorporated herein
by reference.
[0016] So-coated, the interior of the sleeve becomes extremely
slippery/lubricous when soaked. The lubricous coating adhered to
the sleeve, then, controllably allows the silicone implant to be
manipulated down and out of the tapered device into place by a
squeezing/pushing motion. Preferably, such motion is applied to the
sleeve proximal to the bulk of the implant. Delivering an implant
by such action avoids damage to the implant and/or further fuss or
fiddle in delivering a pre-filled implant, such as a silicone
breast implant.
[0017] The construction of the sleeve facilitates preparing it for
use in the manner described by allowing compaction of the sleeve
into a basin (i.e., a disposable bowl or other undersized
container--such as the implant packaging itself--as typically
available in an operating room). Specifically, the foldable (vs.
merely flexible) nature of the fabric and non-interfering seam
provide advantages. These features allow the device to be easily
folded, crumpled or otherwise compacted to fit into such a
container and at least substantially submerged in fluid without
continued manual effort and/or compression under another object to
push or hold it down. Moreover, such action (the compaction) is
accomplished without damage to the sleeve. Ideally, no significant
trace of the sleeve manipulation is evident when the device is put
to use. That does not mean that no visual evidence of the
manipulation remains. Rather, no structural damage has
occurred.
[0018] The coating may be applied to the subject device(s) in a
number of ways. In one approach, if the end of the sleeve is open,
it can be closed-off by an object (such as a ball) and the interior
filled with coating fluid that is subsequently poured-out. In
another approach, the exterior of the sleeve can be masked with a
removable layer (e.g., adhered paper or tape) to avoid coating the
outer surface when spraying or dip-coating. In another approach,
the interior of the sleeve is blocked from receiving coating (e.g.,
by taping-off the ends of the sleeve with double-stick tape or
otherwise) and only the exterior of the device is coated. After
removing the tape (e.g.; by cutting-off the sealed/blocked ends),
the sleeve is rolled-over/everted so that now only the interior
surface is coated. In any case, it is desirable to avoid
hydrophilic coating on the exterior of the finished device in order
to permit better physician grip on the sleeve after its
soaking.
[0019] The present invention includes such features as described
above. Still further, it includes methods associated with and/or
activities implicit to the use of the devices described.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The figures provided herein are not necessarily drawn to
scale, with some components and features being exaggerated for
clarity. Each of the figures diagrammatically illustrates aspects
of the invention. Of these:
[0021] FIG. 1 shows the subject sleeve and a pre-filled implant for
delivery therethrough;
[0022] FIGS. 2A and 2B illustrate manipulation of the sleeve;
[0023] FIG. 3A-3F illustrate preparatory acts in using the subject
device;
[0024] FIGS. 4A-4D illustrate use of the present invention in a
breast augmentation procedure;
[0025] FIGS. 5A-5D illustrate use of the present invention in an
alternative surgical approach for breast augmentation.
[0026] Variation of the invention from the embodiments pictured is,
of course, contemplated. Moreover, details commonly understood by
those with skill in the art may be omitted.
DETAILED DESCRIPTION
[0027] FIG. 1 illustrates a pre-filled silicone implant 2 and
sleeve 10 according to the present invention provided to facilitate
implant delivery. Sleeve 10 has general conical shape that defines
a first opening 12 at a larger end and a smaller opening 14 at a
terminal end.
[0028] The tip of the device may include indica 16 coordinated to
various implant sizes to facilitate trimming the opening to the
correct size. The indica provide a guide for a practitioner to cut
along a selected line in order to size the exit diameter of the
device for a given implant in a size range, for example, of between
about 150 cc to about 800 cc. By so-trimming the sleeve, exit
diameters from between about 3 cm to about 6 cm are provided. For a
more typical range of implant sizes, the openings may be sized
approximately as follows (width dimension measured with the sleeve
laid flat): 4.5 cm for 300 cc implants, 5.0 cm for 300 cc to 450 cc
implants, and 5.5 cm for 450 cc to 550 cc implants.
[0029] Sleeve 10 is advantageously constructed with a seam 18
formed using double-sided tape to close overlapping edges 20, 22 of
a cut sheet. Of course, other joining methods (e.g., ultrasonic
welding), and/or constructional approaches may be employed.
[0030] Apart from such optional aspects, sleeve 10, necessarily
includes a user-activated lubricious coating 24 adhered to the
interior of the sleeve. So-coated, no introduction of further
lubricant into the sleeve or over the surface of the implant is
required for implant delivery. Instead coating 24 is stably adhered
to the sleeve, and simply activated (e.g., by hydration) for use.
Such a coating substantially mitigates or altogether eliminates
risk associated with the introduction of additional foreign body
material (in the form of applied lubricant) into the patient along
with the implant.
[0031] Given that lubricant need not be applied to the surface of
the implant and that the implant is neither directly manipulated
during delivery nor introduced in such a way that it touches the
recipient's skin, the implantation procedure may proceed as a "no
touch" approach. Such an approach is advisable in avoiding capsular
contracture.
[0032] Capsular contracture is an abnormal response of the immune
system to foreign materials. The exact cause of contracture is not
known. However, noted factors include bacterial contamination,
silicone breast implant rupture or leakage, and hematoma. Methods
which have reduced capsular contracture include limiting handling
of the implants and skin contact prior to insertion as well as
irrigation with triple-antibiotic solutions. Use of the present
invention easily enables practicing these methods and further
addresses the noted factors as a gentle, no-touch means of implant
delivery.
[0033] As shown in FIGS. 2A and 2B, when an implant 2, such as a
silicone implant, is set into sleeve 10, the sleeve can be
manipulated to apply pressure to direct the implant along the
length of the sleeve and toward distal opening 14. The flexible
sleeve is conformed to the implant where there is slack in the
material, and the implant to the sleeve where sleeve material is
taut. The larger proximal opening 12 of the sleeve allows for
implant introduction into the sleeve with little or substantially
no digital force or manual manipulation.
[0034] With the implant set within the sleeve, the sleeve body 26
may be twisted closed. By any combination of such twisting and
progressive compression action (such progression illustrated in
transition from FIG. 2A to FIG. 2B) the surgeon is able to apply
pressure via the sleeve to the implant and force it out of the
delivery device and into a surgical pocket as illustrated in
subsequent figures. Generally, a proximal hand 30 grip is used
primarily to drive the implant forward, with the distal hand 32
grip more for offering stability and guidance to the end of the
sleeve.
[0035] In addition, when introducing the implant into a surgical
pocket, the pocket can be manipulated by a retractor to force the
pocket open. Such action opens the void/space into which the
implant is to be set, and may further help draw the implant inward
by creating a partial vacuum. Moreover (although by no means
necessary), the retractor may next be brought to bear on the sleeve
to further assist the user's manipulation of the sleeve to extrude
the implant into the surgical pocket.
[0036] FIGS. 3A-3F offer more detail regarding use of the subject
delivery sleeve. Specifically, this series of figures illustrates
the manner in which the sleeve and an implant are prepared. FIG. 3A
shows each an implant 2 in its packaging 4, the sleeve 10 (removed
from sterile packaging), scissors 40, and a basin 50 as typically
found in a surgical suite. The basin is shown partially filled with
saline 52 (optionally including antibiotic solution and/or
Betadine.RTM.). To activate the lubricious coating inside the
sleeve, the sleeve is folded or simply pushed into basin 50 in a
compacted state as shown in FIG. 3B to soak. The sleeve preferably
remains in fluid until time for use.
[0037] At least some of the fluid in the basin can be poured-off
into the implant packaging container 4 as shown in FIG. 3C in order
to bathe the implant in solution (especially useful if loaded with
antibiotics) prior to implantation.
[0038] If trimming the sleeve end is desired in order to better fit
a specific implant size, it may occur next as illustrated in FIG.
3D. However, sleeve 10 may be trimmed as soon as it is unpackaged.
Alternatively, the delivery sleeve may be specifically sized and/or
packaged in coordination with a given size of implant to avoid any
such need.
[0039] FIG. 3E illustrates the sleeve 10 with an implant therein.
Because of the translucent nature of the sleeve material, implant
orientation can be visually confirmed as indicated in relation to
the landmark offered by the tape seam 18. Prior to delivering the
implant in a medical procedure, a test run may be performed as
illustrated in FIG. 3F by running the implant through the sleeve.
After which, the implant is re-loaded in the sleeve for
implantation deployment. Performing such a test run offers a
valuable fit check, especially when the sleeve end had been trimmed
to accommodate larger-sized implants to ensure that the implant
will push-out cleanly.
[0040] FIGS. 4A-4D illustrate use of the subject device in
delivering an implant employing a transaxillary approach. An
incision 60 is created in an axillary site leading to a
subcutaneous pocket (not shown) under left breast 62. The pocket
may be formed by employing various dissection techniques known to
skilled practitioners. The access incision is shown held open by a
small retractor 40. The pocket itself may be created in either the
subglandular or subpectoral space. The submuscular plane tends to
be less vascular, and is associated with fewer sensory alterations
of the nipple areolar complex. So, a subpectoral pocket may be
preferred.
[0041] In any case, FIG. 4B illustrates a larger Deaver retractor
passing through incision 60 into the breast pocket. In addition,
the distal tip of sleeve 10 is received within the incision. As
shown in FIG. 4C, while the implant is squeezed forward along the
sleeve, the retractor may be used to urge the surgical pocket open
and/or bear down on the sleeve as described above.
[0042] FIG. 4D illustrates left breast 62 enlarged as desired. Once
right breast 64 is similarly treated and symmetry confirmed (with
any subsequent adjustments made), the breast pocket incisions are
closed.
[0043] Note, prior to undertaking implant delivery, an inflatable
sizer will typically be placed in the pocket under each breast.
These sizer(s) may be placed to aid in prosthesis size selection,
and can also be over-filled to provide intraoperative tissue
expansion. FIG. 5A illustrates a first sizer emplaced using a
periareolar approach (sizer fill tube 70 shown). With a second
sizer in place, FIG. 5B shows the Deaver retractor inserted into
the right breast 64 pocket and sleeve 10 being introduced into the
incision. In doing so, the tip or distal end of the sleeve may be
crimped or crumpled-down as shown to aid in passing through the
incision.
[0044] Indeed, the same technique may be employed irrespective of
access approach chosen. However, the technique may be more helpful
or necessary for introduction into smaller incisions.
[0045] FIG. 5C illustrates implant extrusion into the breast pocket
much as shown in FIG. 4C. A complete augmentation procedure (save
final incision closure) in which both breasts 62 and 64 are filled
is presented in FIG. 5D.
[0046] Regardless of the surgical approach taken, it has been found
that the step of inserting a prefilled silicone implant can occur
within a timeframe of about 5 to about 20 seconds employing the
subject invention as compared to a time interval of up to 5 to 15
minutes for a traditional hand manipulation of the same 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. Essentially,
saline implant-size incisions can effectively be used to deliver
pre-filled silicone implants.
[0047] Illustrative examples of such use under confidential
clinical site conditions include:
TABLE-US-00001 Exterior Silicon Breast Sleeve Incision Implant
Incision Opening Size (cm) Volume (cc) Site Implant Style Size
(cm)* Left Right Left Right Axillary Moderate Plus 4.5 3.2 3.5 275
200 Periaerolar Moderate Plus 6.0 5.0 5.0 550 550 Periaerolar
Moderate Plus 5.5 5.5 5.5 400 400 Periaerolar Moderate Plus 6.0 4.0
4.0 400 400 Periaerolar High Profile Smooth Round 5.5 3.0 3.5 500
500 *Opening Size measured when sleeve is laid flat on table.
[0048] Viewed otherwise, a larger silicone implant can be delivered
for a given incision-size as will be appreciated by those with
skill in the art. Such a consideration may be important especially
when considering a periareolar approach as illustrated in FIGS.
5A-5D.
[0049] The periareolar approach may sometimes be preferred because
the color of the areola can offer "camouflage" to help the incision
scar blend in. The periareolar approach is often less surgically
challenging than a transaxial approach. But since the size of the
incision is coordinated with that of the areola in a periareolar
approach, the size of pre-filled implant that could previously be
inserted therethrough is sometimes limited. Use of the subject
device relaxes this limitation, thereby offer each of the patient
and surgeon more (often better) options.
[0050] The invention includes the methods set forth above in terms
of method of manufacture, preparation and/or use. The methods may
be performed using the subject devices and sometimes by other
means.
[0051] The methods may include the act of providing a suitable
device. Such provision may be performed by the end user. In other
words, the act of "providing" merely requires that the end user
access, approach, position, set-up, grasp or otherwise obtain the
requisite device for the subject method. Methods recited herein may
be carried out in any order of the recited events which is
logically possible, as well as in the recited order of events.
[0052] Exemplary aspects of the invention, together with details
regarding material selection and manufacture have been set forth
above. As for other details of the present invention, these may be
appreciated in connection with the above-referenced patents and
publications as well as generally known or appreciated by those
with skill in the art. The same may hold true with respect to
method-based aspects of the invention in terms of additional acts
as commonly or logically employed.
[0053] In addition, though the invention has been described in
reference to several examples, optionally incorporating various
features, the invention is not to be limited to that which is
described or indicated as contemplated with respect to each
variation of the invention. Various changes may be made to the
invention described and equivalents (whether recited herein or not
included for the sake of some brevity) may be substituted without
departing from the true spirit and scope of the invention. In
addition, where a range of values is provided, it is understood
that every intervening value, between the upper and lower limit of
that range and any other stated or intervening value in that stated
range is encompassed within the invention.
[0054] Also, it is contemplated that any optional feature of the
inventive variations described may be set forth and claimed
independently, or in combination with any one or more of the
features described herein. Stated otherwise, it is to be understood
that each of the improvements described herein independently offer
a valuable contribution to the state of the art. So too do the
various other possible combinations of the improvements/features
described herein and/or incorporated by reference, any of which may
be claimed.
[0055] Reference to a singular item, includes the possibility that
there are plural of the same items present. More specifically, as
used herein and in the appended claims, the singular forms "a,"
"an," "said," and "the" include plural referents unless
specifically stated otherwise. In other words, use of the articles
allow for "at least one" of the subject item in the description
above as well as the claims below. It is further noted that the
claims may be drafted to exclude any optional element. As such,
this statement is intended to serve as antecedent basis for use of
such exclusive terminology as "solely," "only" and the like in
connection with the recitation of claim elements or use of any
"negative" limitation.
[0056] Without the use of such exclusive terminology, the term
"comprising" in the claims shall allow for the inclusion of any
additional element--irrespective of whether a given number of
elements are enumerated in the claim, or the addition of a feature
could be regarded as transforming the nature of an element set
forth in the claims. Except as specifically defined herein, all
technical and scientific terms used are to be given as broad a
commonly understood meaning as possible while maintaining claim
validity.
* * * * *