U.S. patent application number 14/164748 was filed with the patent office on 2016-11-17 for adjustable compression staple and method for stapling with adjustable compression.
The applicant listed for this patent is Ethicon Endo-Surgery, LLC. Invention is credited to Derek Dee Deville, Korey Kline, Matthew A. Palmer, Kevin W. Smith.
Application Number | 20160331370 14/164748 |
Document ID | / |
Family ID | 39618365 |
Filed Date | 2016-11-17 |
United States Patent
Application |
20160331370 |
Kind Code |
A9 |
Smith; Kevin W. ; et
al. |
November 17, 2016 |
Adjustable Compression Staple and Method for Stapling With
Adjustable Compression
Abstract
A substantially U-shaped staple has a bridge, legs, and an
internally disposed compression device with a bias portion having a
compression surface movably disposed between the legs and a
compression resistor connected to the bridge and to the compression
surface and is formed to resist movement of the compression surface
towards the bridge with a force.
Inventors: |
Smith; Kevin W.; (Coral
Gables, FL) ; Palmer; Matthew A.; (Miami, FL)
; Kline; Korey; (Miami, FL) ; Deville; Derek
Dee; (Coral Gables, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon Endo-Surgery, LLC |
Guaynabo |
|
PR |
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Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20140142625 A1 |
May 22, 2014 |
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|
Family ID: |
39618365 |
Appl. No.: |
14/164748 |
Filed: |
January 27, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13222758 |
Aug 31, 2011 |
8679156 |
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14164748 |
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11971998 |
Jan 10, 2008 |
8679154 |
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13222758 |
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11971998 |
Jan 10, 2008 |
8679154 |
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11971998 |
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60880146 |
Jan 12, 2007 |
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60880146 |
Jan 12, 2007 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/064 20130101;
A61B 17/0644 20130101; F16B 15/0015 20130101 |
International
Class: |
A61B 17/064 20060101
A61B017/064 |
Claims
1. A compression-self-adjusting staple, comprising: a substantially
U-shaped staple having: a bridge; legs; and: an internally disposed
compression device having a bias portion with: a compression
surface movably disposed between the legs; and a compression
resistor: connected to the bridge and to the compression surface;
and being formed to resist movement of the compression surface
towards the bridge with a force.
2. The staple according to claim 1, wherein: the bridge is
substantially rod-shaped with ends; and each of the legs has a base
end integral with a respective one of the ends.
3. The staple according to claim 1, wherein: the bridge and the
legs define a bridge-leg plane; and the legs extend from the bridge
at an angle of between 80 and 100 degrees in the bridge-leg
plane.
4. The staple according to claim 1, wherein: the compression
surface defines two orifices; and each of the legs extends through
one of the two orifices.
5. The staple according to claim 1, wherein: the compression
resistor defines at least one orifice pair; the compression surface
defines two orifices; and each of the legs extends through one of
the two orifices and one of the at least one orifice pair.
6. The staple according to claim 1, wherein: the compression
resistor defines a plurality of orifice pairs; the compression
surface defines two orifices; and each of the legs extends through
one of the two orifices and one of each of the orifice pairs.
7. The staple according to claim 1, wherein: the bridge and the
legs define a compression axis; and the compression surface is
movably disposed between the legs along the compression axis.
8. The staple according to claim 1, wherein the compression device
is connected to the bridge.
9. The staple according to claim 8, wherein the compression
resistor connects the bridge to the compression surface.
10. The staple according to claim 8, wherein the bridge, the legs,
the compression resistor, and the compression surface are
integral.
11. The staple according to claim 1, wherein the compression
resistor is at least partly disposed between the legs.
12. The staple according to claim 1, wherein the compression
resistor is disposed between the bridge and the compression
surface.
13. The staple according to claim 1, wherein the force comprises a
pre-defined opposing force.
14. The staple according to claim 1, wherein the force comprises a
substantially constant force.
15. The staple according to claim 1, wherein the force comprises a
linearly increasing force.
16. The staple according to claim 1, wherein the compression
resistor has an anti-compressive spring constant imparting a
substantially constant anti-compressive force over a pre-defined
compression range.
17. The staple according to claim 1, wherein the staple and the
compression device are of a biocompatible material.
18. The staple according to claim 1, wherein: the compression
surface and the legs define a central compression region in which
is to be disposed a material to be compressed between the
compression surface and stapling points when distal ends of the
legs are deformed; and when the distal ends are deformed in a
staple closing direction into the central compression region, the
bias portion resists movement of the compression surface in the
staple closing direction with a pre-defined, substantially constant
force.
19. The staple according to claim 1, wherein the compression
surface and the bias portion are shaped to impart a pre-defined,
substantially constant bias force upon material disposed between
the compression surface and stapling points when the stapling
points are deformed.
20. The staple according to claim 1, wherein: when stapling points
are deformed toward one another, material disposed between the
compression surface and the stapling points is compressed between
the stapling points and the compression surface; and the
compression resistor maintains a substantially constant compressive
force on the material within a pre-defined range independent of a
degree of compression between the stapling points and the
compression surface.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is: [0002] a divisional of U.S. patent
application Ser. No. 13/222,758 filed on Aug. 31, 2011; and [0003]
a divisional of U.S. patent application Ser. No. 11/971,998 filed
on Jan. 10, 2008 (which application claims the benefit under 35
U.S.C. .sctn.119(e) of U.S. Provisional Application No. 60/880,146
filed Jan. 12, 2007), the complete disclosures of which are hereby
incorporated by reference herein in their entireties.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0004] n/a
FIELD OF THE INVENTION
[0005] The present invention lies in the field of staple fastening,
in particular, staples and instruments capable of applying a single
or a plurality of staples to a material and processes therefor.
More particularly, the present invention relates to a staple
capable of placing a load-bearing force against the material being
stapled and improvements in processes for stapling material. The
device can be used, particularly, in the medical field for stapling
tissue during surgical procedures, whether open, endoscopic, or
laparoscopic.
BACKGROUND OF THE INVENTION
[0006] Conventional staples are, typically, U-shaped and require a
staple cartridge and anvil to fasten the staple onto a material.
The U-shape of the staple can be considered relatively
square-cornered because of the sharp angle at which the legs extend
from the bridge. On activation of a stapling device, the staple
legs are advanced forward so that they penetrate a material on both
sides of a slit or opening. As a staple former is advanced further,
the legs of the staple bend around the anvil causing the tips of
the legs to advance along an arcuate path toward each other so that
the staple ultimately assumes a generally rectangular shape,
thereby compressing the material that has been trapped between the
staple legs, which is tissue in surgical applications. This
compression of the material is the mechanism by which a closure is
effected. Depending on the length of the incision or opening, a
series of staples will be delivered along its length, which can
ensure a blood tight closure in surgical procedures.
[0007] Because the staple has two legs that pierce the material,
they are well suited for fastening two or more layers of material
together when used with the opposing anvil. Whether used in an
office or during a surgical procedure, most staples 1 have similar
shapes--a bridge 2 connecting two relatively parallel legs 4, which
legs are disposed approximately orthogonal to the bridge 2, which,
depending on the material of the staple, results in a
square-cornered U-shape. In surgical stapling devices, it is
beneficial to start the legs 4 in a slight outward orientation to
assist retention of the staples within the cartridge. The staple
illustrated in FIG. 1 is representative of conventional surgical
staples. Such staples are compressed against an anvil to bend the
tips of the legs 4 inward. For purposes sufficient in surgery, the
final stapled configuration has a stapling range from a "least"
acceptable orientation to a "greatest" acceptable orientation. The
"least" acceptable staple range is a position where the tangent
defined by the tip of each leg 4 is at a negative angle to a line
parallel to the bridge 2 and touching the lower portions of both
legs 4. The "greatest" acceptable staple range is a position where
the legs 4 are bent into a shape similar to the letter "B."
[0008] The staple 1 of FIG. 1 is shown in an orientation where the
tips of the legs 4 are bent slightly by an anvil on the way towards
a final stapled form. (This slightly bent orientation is also
present with respect to the staples illustrated hereafter.) The
legs 4 of such slightly bent staples have three different portions:
[0009] a connecting portion 6 (at which the legs 4 are connected to
the bridge 2); [0010] an intermediate portion 8 (at which the
staple is bent; of course it is also possible for the connection
portion 6 to be bent for various fastening purposes); and [0011] a
piercing portion 10 (for projecting through the material to be
fastened; this portion, too, is bent when fastening). Many stapling
devices exist to deploy such staples. Some surgical stapling
instruments are described in U.S. Pat. No. 5,465,895 to Knodel et
al., and U.S. Pat. Nos. 6,644,532 and 6,250,532 to Green et al.
When the staple 1 is bent for fastening, the polygon formed by the
interior sides of the bent staple 1 defines an envelope or a
central region 14. The material to be fastened by the staple 1
resides in and is compressed within the central region 14 when
stapling occurs. When the final staple orientation is B-shaped,
there can be two regions in which the tissue is held and
compressed.
[0012] One common feature associated with conventional staples is
that there is no controllable way of adjusting the compressive
force that is applied by the staple to the material being stapled.
While items such as paper and cardboard can withstand a wide range
of stapler compressive force without breaking or puncturing, living
tissue, such as the tissue to be fastened in a surgical procedure,
has a limited range of compressive force and cannot withstand force
greater than a upper limit within that range without causing tissue
damage. In fact, the range of optimal stapling force for a given
surgical stapling procedure is relatively small and varies
substantially with the type of tissue being stapled.
[0013] While it may be true that the distance between the bending
point of the legs and the bridge (see, e.g., span 12 in FIG. 1) can
be increased to impart less force on material within the staple,
this characteristic does not apply when living tissue having
varying degrees of hardness, composition, and flexibility is the
material being stapled. Even if the staple leg bending distance 12
is increased, if more or less or harder or softer tissue than
expected is actually captured within the staple, the force applied
to the captured tissue will not be controlled and will not be
optimal for that tissue.
[0014] When one, two, or more layers of tissue are being stapled,
it is desirable for the tissue to be at a desired compressive state
so that a desirous medical change can occur, but not to be at an
undesired compressive state sufficient to cause tissue necrosis.
Because there is no way to precisely control the tissue that is
being placed within the staple, it is not possible to ensure that
the tissue is stapled within an optimal tissue compression range,
referred to as an OTC range. Therefore, ruling out of tissue
necrosis is difficult or not possible. Further, tissue presented
within one staple may not be the same tissue that is presented
within an adjacent staple or is within another staple that is fired
during the same stapling procedure. Thus, while one or a few of a
set of staples could actually fasten within the OTC range, it is
quite possible for many other staples in the same stapling
procedure to fasten outside the OTC range.
[0015] What is needed, therefore, is an improved staple and
improved methods of stapling that allow automatic control of the
staple compression force imparted upon the material being stapled
so that compression of the material remains within a desired OTC
range. While prior art surgical stapling instruments have utility,
and may be successfully employed in many medical procedures, it is
desirable to enhance their operation with the ability to deliver a
staple that can automatically tailor the compression force
delivered to the tissue without external mechanics or
operations.
BRIEF SUMMARY OF THE INVENTION
[0016] It is accordingly an object of the invention to provide an
adjustable compression staple and methods for stapling with
adjustable compression that overcome the hereinafore-mentioned
disadvantages of the heretofore-known devices and methods of this
general type and that automatically tailors the compression force
delivered to the tissue.
[0017] When tissue is stapled, liquid is forced out of the tissue.
The OTC range of the tissue is a compression range in which liquid
is removed from the tissue (i.e., desiccates the tissue) without
damaging or necrosing the tissue. As the liquid from the tissue
exits the tissue due to compression exerted upon the tissue by the
staple, however, the compressive force that is being imposed upon
the tissue naturally reduces--because less mass is between the
opposing staple portions. In some instances, this reduction can
allow the imparted tissue compression to exit the OTC range.
Staples according to the present invention each have a
self-adjusting, pre-tensioned compression device that keeps
compression force on the interposed tissue within the OTC
compression range even after being desiccated.
[0018] The prior art staple of FIG. 1 has a stapling range that is
illustrated in FIG. 17. For purposes sufficient in surgery, the
final stapled configuration of the OTC staples of the present
invention has a stapling range that is illustrated, for example, in
FIGS. 18 to 20. A "least" acceptable staple range is a position
where the tangent T defined by the tip of each leg 4 is at a
negative angle .alpha. to a line L parallel to the bridge 2. This
orientation is illustrated with the left half of the staple in FIG.
17 merely for reasons of clarity. See also FIGS. 18 to 20. A
"greatest" acceptable staple range is a position where the legs 4
are bent 180 degrees into a shape similar to the letter "B" (see
the exemplary orientation illustrated in the right-half of FIG. 17)
but, in comparison to the prior art staple range of FIG. 17, as
described below in detail, the tips of the legs 4 of the staples
according to the invention reach only up to a compressing portion
and not further than this compressing portion as shown in FIG. 20,
for example. In such an orientation, the stapled tips of the legs
do not interfere with the OTC device present in the staples
according to the invention.
[0019] The OTC devices for staples according to the invention take
many forms. The OTC device can be integral with the legs of the
staple and project into a central area or can be attached to the
staple to project into the central area. The OTC device can be
sinusoidal in shape with a compressing portion at the end of the
OTC device or can be have multiple cycles of bends between the
bridge of the staple with the compressing portion at the end of the
OTC device. The bending portion can be single or double, the double
bends being in cycle, out of cycle, mirror-symmetrical, to name a
few. The bends can be double-sinusoidal as shown in FIGS. 8, 9, and
11 The OTC device can be contained entirely between the two legs of
the staple or can encircle one or both of the legs and, thereby,
use the legs as a guide, for example, a sliding guide. The leg
encirclement by the OTC device can be single or multiple. Travel of
the OTC device can be limited, for example, by a star washer. The
OTC device can be a compression spring(s) and a plate(s), with the
plate encircling the legs and sliding thereon. The OTC device can
be a compressible material secured on the legs. This material can
be in the shape of a plate or a pillow.
[0020] With the foregoing and other objects in view, there is
provided, in accordance with the invention, a substantially
U-shaped staple having a bridge, legs, and an internally disposed
compression device having a bias portion with a compression surface
movably disposed between the legs and a compression resistor
connected to the bridge and to the compression surface and is
formed to resist movement of the compression surface towards the
bridge with a force.
[0021] In accordance with another feature of the invention, the
bridge is substantially rod-shaped with ends and the base end of
each of the legs is integral with a respective one of the ends.
[0022] In accordance with a further feature of the invention, the
bridge and legs define a bridge-leg plane and the legs extend from
the bridge at an angle of between 80 and 100 degrees in the
bridge-leg plane.
[0023] In accordance with an additional feature of the invention,
the compression surface defines two orifices and each of the legs
extends through one of the two orifices.
[0024] In accordance with yet another feature of the invention, the
compression resistor defines at least one orifice pair, the
compression surface defines two orifices, and each of the legs
extends through one of the two orifices and one of the at least one
orifice pair.
[0025] In accordance with yet a further feature of the invention,
the compression resistor defines a plurality of orifice pairs, the
compression surface defines two orifices, and each of the legs
extends through one of the two orifices and one of each of the
orifice pairs.
[0026] In accordance with yet an added feature of the invention,
the bridge and the legs define a compression axis and the
compression surface is movably disposed between the legs along the
compression axis.
[0027] In accordance with yet an additional feature of the
invention, the compression device is connected to the bridge.
[0028] In accordance with again another feature of the invention,
the compression resistor connects the bridge to the compression
surface.
[0029] In accordance with again a further feature of the invention,
the bridge, the legs, the compression resistor, and the compression
surface are integral.
[0030] In accordance with again an added feature of the invention,
the compression resistor is at least partly disposed between the
legs.
[0031] In accordance with again an additional feature of the
invention, the compression resistor is disposed between the bridge
and the compression surface.
[0032] In accordance with still another feature of the invention,
the force is a pre-defined opposing force.
[0033] In accordance with still a further feature of the invention,
the force is a substantially constant force.
[0034] In accordance with still an added feature of the invention,
the force is a linearly increasing force.
[0035] In accordance with still an additional feature of the
invention, the compression resistor has an anti-compressive spring
constant imparting a substantially constant anti-compressive force
over a pre-defined compression range.
[0036] In accordance with another feature of the invention, the
staple and the compression device are of a biocompatible
material.
[0037] In accordance with a further feature of the invention, the
compression surface and the legs define a central compression
region in which is to be disposed a material to be compressed
between the compression surface and stapling points when distal
ends of the staple legs are deformed. When the distal ends are
deformed in a staple closing direction into the central compression
region, the bias portion resists movement of the compression
surface in the staple closing direction with a pre-defined,
substantially constant force.
[0038] In accordance with an added feature of the invention, the
compression surface and the bias portion are shaped to impart a
pre-defined, substantially constant bias force upon material
disposed between the compression surface and stapling points when
the stapling points are deformed.
[0039] In accordance with a concomitant feature of the invention,
when stapling points are deformed toward one another, material
disposed between the compression surface and the stapling points is
compressed between the stapling points and the compression surface.
The compression resistor maintains a substantially constant
compressive force on the material within a pre-defined range
independent of a degree of compression between stapling points and
the compression surface.
[0040] Although the invention is illustrated and described herein
as embodied in an adjustable compression staple and method for
stapling with adjustable compression, it is, nevertheless, not
intended to be limited to the details shown because various
modifications and structural changes may be made therein without
departing from the spirit of the invention and within the scope and
range of equivalents of the claims. Additionally, well-known
elements of exemplary embodiments of the invention will not be
described in detail or will be omitted so as not to obscure the
relevant details of the invention.
[0041] Other features that are considered as characteristic for the
invention are set forth in the appended claims. As required,
detailed embodiments of the present invention are disclosed herein;
however, it is to be understood that the disclosed embodiments are
merely exemplary of the invention, which can be embodied in various
forms. Therefore, specific structural and functional details
disclosed herein are not to be interpreted as limiting, but merely
as a basis for the claims and as a representative basis for
teaching one of ordinary skill in the art to variously employ the
present invention in virtually any appropriately detailed
structure. Further, the terms and phrases used herein are not
intended to be limiting; but rather, to provide an understandable
description of the invention. While the specification concludes
with claims defining the features of the invention that are
regarded as novel, it is believed that the invention will be better
understood from a consideration of the following description in
conjunction with the drawing figures. The figures of the drawings
are not drawn to scale.
[0042] Before the present invention is disclosed and described, it
is to be understood that the terminology used herein is for the
purpose of describing particular embodiments only and is not
intended to be limiting. The terms "a" or "an", as used herein, are
defined as one or more than one. The term "plurality," as used
herein, is defined as two or more than two. The term "another," as
used herein, is defined as at least a second or more. The terms
"including" and/or "having," as used herein, are defined as
comprising (i.e., open language). The term "coupled," as used
herein, is defined as connected, although not necessarily directly,
and not necessarily mechanically.
[0043] As used herein, the term "about" or "approximately" applies
to all numeric values, whether or not explicitly indicated. These
terms generally refer to a range of numbers that one of skill in
the art would consider equivalent to the recited values (i.e.,
having the same function or result). In many instances these terms
may include numbers that are rounded to the nearest significant
figure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0044] Advantages of the embodiments of the present invention will
be apparent from the following detailed description of the
preferred embodiments thereof, which description should be
considered in conjunction with the accompanying drawings in
which:
[0045] FIG. 1 is a perspective view from above a side of an
exemplary prior art surgical staple;
[0046] FIG. 2 is a perspective view from above a side of a first
exemplary embodiment of an OTC staple according to the
invention;
[0047] FIG. 3 is a perspective view from above a side of a second
exemplary embodiment of an OTC staple according to the
invention;
[0048] FIG. 4 is a perspective view from above a side of a third
exemplary embodiment of an OTC staple according to the
invention;
[0049] FIG. 5 is a perspective view from above a side of a fourth
exemplary embodiment of an OTC staple according to the
invention;
[0050] FIG. 6 is a perspective view from above a side of a fifth
exemplary embodiment of an OTC staple according to the
invention;
[0051] FIG. 7 is a perspective view from above a side of a sixth
exemplary embodiment of an OTC staple according to the
invention;
[0052] FIG. 8 is a perspective view from above a side of a seventh
exemplary embodiment of an OTC staple according to the
invention;
[0053] FIG. 9 is a perspective view from above a side of an eighth
exemplary embodiment of an OTC staple according to the
invention;
[0054] FIG. 10 is a perspective view from above a side of a ninth
exemplary embodiment of an OTC staple according to the
invention;
[0055] FIG. 11 is a perspective view from above a side of a tenth
exemplary embodiment of an OTC staple according to the
invention;
[0056] FIG. 11A is a fragmentary, enlarged perspective view from
below a side of the OTC staple of FIG. 11;
[0057] FIG. 12 is a perspective view from above a side of an
eleventh exemplary embodiment of an OTC staple according to the
invention;
[0058] FIG. 13 is a perspective view from above a side of a twelfth
exemplary embodiment of an OTC staple according to the
invention;
[0059] FIG. 14 is a perspective view from above a side of a
thirteenth exemplary embodiment of an OTC staple according to the
invention;
[0060] FIG. 15 is a perspective view from above a side of a
fourteenth exemplary embodiment of an OTC staple according to the
invention;
[0061] FIG. 16 is a perspective view from above a side of a
fifteenth exemplary embodiment of an OTC staple according to the
invention;
[0062] FIG. 17 is a side elevational view of the prior art surgical
staple of FIG. 1 with the staple tips illustrating an exemplary
range of stapling;
[0063] FIG. 18 is a side elevational view of the staple of FIG. 6
with the staple tips in a first intermediate position of an
exemplary stapling range;
[0064] FIG. 19 is a side elevational view of the staple of FIG. 6
with the staple tips in a second intermediate position of an
exemplary stapling range; and
[0065] FIG. 20 is a side elevational view of the staple of FIG. 6
with the staple tips in a third intermediate position of an
exemplary stapling range.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0066] Herein various embodiment of the present invention are
described. In many of the different embodiments, features are
similar. Therefore, to avoid redundancy, repetitive description of
these similar features may not be made in some circumstances. It
shall be understood, however, that description of a first-appearing
feature applies to the later described similar feature and each
respective description, therefore, is to be incorporated therein
without such repetition.
[0067] Referring now to the figures of the drawings in detail and
first, particularly to FIG. 2 thereof, there is shown a first
exemplary embodiment of an automatic optimal tissue compression
(OTC) staple 20 according to the invention. In this first
embodiment, the bridge 21 has a center bridge portion 22 and an
extension 23 that substantially increases the overall length of the
bridge 21--as compared to the bridge 2 of the staple 1 of FIG. 1.
As the upper bridge portion 22 transitions into the extension 23,
it curves into and within the central region 24 of the staple 20.
This extension 23 can be in any shape or of any material so long as
it delivers a pre-set compressive force to the tissue at a
compressing portion 25, and as long as it allows for absorption
(within the area between the compressing portion 25 and the upper
bridge portion 22) of forces greater than this pre-set force.
Therefore, the shape can be trapezoidal, triangular, sinusoidal, or
any other configuration. An exemplary embodiment of relatively
sinusoidal curves is shown in FIG. 2. These curves traverse two
periods in the illustrated embodiment, however, the number of wave
periods can be varied (smaller or larger). The extension 23 has two
mirror-symmetrical portions each starting from the upper bridge
portion 22 and ending at respective ends of the compressing portion
25. Further, it is noted that neither the extension 23 nor the
compressing portion 25 directly contacts the legs 26 in this
exemplary configuration.
[0068] In the embodiment of FIG. 2, the extension 26 and the
compressing portion 29 are integral with the upper bridge portion
22 and a base end 27 of the legs 26. The legs 26 are shown as
relatively circular in cross-section. The bridge 21 and all of the
compressing components 22, 23, 25 can also be circular in
cross-section. Alternatively, as shown in FIG. 2, any portion of
the extension 23 and/or the compressing portion 25 can have
different cross-sectional shapes, such as ovular, rectangular, or
polygonal. In the embodiment shown, the cross-section of the
extension 23 after the first curve away from the upper bridge
portion 22 is shaped in a "racetrack" form (two relatively straight
sides with two curved ends connecting each end of the sides). The
upper bridge portion 22 can also have a different cross-sectional
shape. The extension 23 and compressing portion 25 are, in this
embodiment, even in cross-sectional area. Different portions of
these parts can, however, have varying cross-sectional areas (i.e.,
varying thicknesses) as desired.
[0069] When the upper bridge 22, the extension 23, and the
compressing portion 25 are shaped to deliver the pre-set
compressive force to the tissue in a substantially longitudinal
direction 28 of an unbent section of the leg portions 26 and to
absorb forces greater than this pre-set force, the overall effect
is to create an OTC device having a given spring coefficient. In
other words, the OTC device maintains the preset compressive force
within the stapled area even after tissue changes states, such as
expanding due to swelling and/or contracting during desiccation.
Variation of the cross-section of any portion of the upper bridge
22, the extension 23, and the compressing portion 25 will allow for
different OTC spring coefficients and, therefore, allows for
adjustment of the compressive and reactive force constants of the
OTC device within the staple 20. Variation of the material making
up all of the staple 20 or any of its portions also permits
adjustment of the OTC force.
[0070] FIG. 3 illustrates a second exemplary embodiment of the OTC
staple 30 according to the invention. In this variation, as
compared to the embodiment of FIG. 2, the OTC portion is not
integral with the bridge 31 and the legs 32. Instead, the OTC
device 33 is separate therefrom and is connected to these staple
portions. Specifically, the OTC device 33 has a compressing portion
34 that directly contacts the tissue being compressed and an
extension 36 for providing the load-bearing force when tissue is
compressed within the central region 37 of the staple 30. The OTC
device 33 also has a connecting portion 35 for attaching the OTC
device 33 to the bridge 31. The extension 36 connects the upper and
lower portions 34, 35 of the OTC device 33. The extension 33 and
the compressing portion 34 are, in this embodiment, different in
cross-sectional area. Here, the cross-sectional area of the
compressing portion 34 is wider than the extension 36. Any portions
of the extension 33 or the compressing portion 34 can be varied to
have same or varying cross-sectional areas (i.e., varying
thicknesses).
[0071] Connection of the OTC device 33 to the staple, for example,
at the bridge 31, can occur by any fastening measure. One exemplary
connection method is spot welding, which is indicated in FIG. 3 by
reference numeral 38. Other exemplary methods of attaching suitable
materials together include soldering and brazing. The type or types
of material of the staple portions 31, 32 and the OTC device 33
will direct a preferable attachment method. In the case of
attaching two materials together that are not suited to be welded,
soldered or brazed, other attachment methods can be used such as
crimping and adhesive bonding. Features can be added to one or both
of the two components to facilitate the crimp or bond. These
features could be configured to have the components snap together.
In the case of dissimilar materials, for example, if the staple
material is stainless steel and the OTC device 33 is of nickel
titanium alloy, then preferred attachment measures include
crimping, adhesive bonding, or snapping.
[0072] In this second embodiment, the OTC device 33 behaves similar
to the OTC portions of the embodiment of FIG. 2 and can be shaped
with the same variations of cross-section and other spatial
characteristics and can be formed with the same variations in
material composition. Variation of any attribute of the OTC device
33 allows for adjustment of the compressive and reactive force
constants thereof on the compressed tissue. The extension 36 can be
any shape or material so long as it delivers a pre-set compressive
force to the tissue at the compressing portion 34 and as long as it
allows for absorption of forces greater than this pre-set force. An
exemplary embodiment selected for this exemplary OTC device 33 is a
relatively sinusoidal set of curves traversing less than two
periods. The extension 36 has two minor-symmetrical portions each
starting from the bridge 31 and ending at respective ends of the
compressing portion 34. In this exemplary embodiment, neither the
extension 36 nor the compressing portion 34 directly contacts the
legs 32. Most of the cross-section of the OTC device 33 has a
racetrack form. Like the embodiment of FIG. 2, the cross-section
can be varied in any desired way to deliver the pre-set compressive
force to the tissue and to absorb forces greater than this pre-set
force.
[0073] FIG. 4 illustrates a third exemplary embodiment of the OTC
staple 40 according to the invention. In this variation, as
compared to the embodiments of FIGS. 2 and 3, the OTC portion 43 is
not symmetrical with respect to the bridge 41 or the legs 42. Also,
like the embodiment of FIG. 3, the OTC portion is not integral with
either the bridge 41 or the legs 42. The OTC device 43 is a
separate part from the bridge 41 and the legs 42 and is fixedly
connected to the bridge 41 at a connection location (for example,
with a spot weld 48; other fixation/connection processes can be
used). In particular, a connecting portion 45 of the OTC device 43
fixedly secures the OTC device 43 to the bridge 41. An extension 46
of the OTC device 43 provides the load-bearing force when tissue is
compressed within the central region 47 of the staple 40 and a
compressing portion 44 directly contacts the tissue being
compressed.
[0074] Notably different from the embodiments of FIGS. 2 and 3 is
the compressing portion 44. Here, the width of the compressing
portion 44 (defined along the line between the two legs 42 of the
staple 40) is greater than the separation distance of the two legs
42. The compressing portion 44 is provided with orifices 49 having
a shape substantially corresponding to the cross-sectional shape of
the upper portion of the staple legs 42 but slightly larger. The
legs 42 pass through and slidably rest within these orifices 49. In
such a configuration, movement of the OTC device 43 out of the
bridge-legs plane is substantially prevented. Because the orifices
49 are shaped to be slightly larger than the cross-section of the
legs 42, the extension 46 acts as a compression spring in the
bridge-legs plane as the compressing portion 44 moves up and down
along the upper portion of the legs 42 (up being defined as the
direction towards the bridge 41 from the piercing tips of the legs
42). Thus, the OTC device 43 of the third embodiment behaves
different from the OTC devices of FIGS. 2 and 3 because of the
form-locking and sliding connection between the connecting portion
44 and the legs 42. A form-locking connection is one that connects
two elements together due to the shape of the elements themselves,
as opposed to a force-locking connection, which locks the elements
together by force external to the elements.
[0075] Like the previous embodiments, the OTC device 43 can be
shaped with variations in cross-section and other spatial
characteristics and can be formed with a variety of material
compositions. The extension 46 and compressing portion 44 are, in
this embodiment, different in cross-sectional area. Here, the
cross-sectional area of the compressing portion 44 is wider than
the extension 46. Any portions of the extension 46 or the
compressing portion 44 can be varied to have same or varying
cross-sectional areas (i.e., varying thicknesses). The extension 46
can be any shape or material so long as it delivers the pre-set
compressive force to the tissue at the compressing portion 44 and
as long as it allows for absorption of forces greater than this
pre-set force. An exemplary embodiment selected for this OTC device
43 is a relatively sinusoidal curve traversing approximately one
sinusoidal period. Virtually all of the cross-section of the OTC
device 43 has a racetrack form, but can be changed as desired to
other shapes (e.g., circular, ovular, polygonal, etc.). As
described above, variation of any attribute of the OTC device 43
allows for adjustment of the compressive and reactive force
constants thereof on the compressed tissue in the central region
47.
[0076] FIG. 5 illustrates a fourth exemplary embodiment of the OTC
staple 50 according to the invention. This variation has some of
the features of the above embodiments. In this variant, like the
embodiment of FIG. 2, the OTC portion is symmetrical with respect
to the bridge 51 and the legs 52 and the OTC device 53 is integral
with the bridge 51. Like the embodiment of FIG. 4, the compressing
portion 54 has a width greater than the separation distance of the
two legs 52 and has ports 55 with a shape substantially
corresponding to the cross-sectional shape of the upper portion of
the legs 52, but slightly larger. The legs 52 pass through these
ports 55. In this configuration, movement of the OTC device 53 out
of the bridge-legs plane is substantially prevented. The extension
56 of the OTC device 53 traverses from the bridge 51 to the
compressing portion 54. Because the ports 55 are shaped to be
slightly larger than the cross-section of the legs 52, the
extension 56 acts as a compression spring in the bridge-legs plane
as the compressing portion 54 moves up and down along the upper
portion of the legs 52. It is the extension 56 that provides the
load-bearing force when tissue is compressed within the central
region 57 of the staple 50. Because of the form-locking and sliding
connection between the compressing portion 54 and the legs 52, the
OTC device 53 of the fourth embodiment behaves similar to the OTC
devices of FIG. 4.
[0077] Here, the OTC device 53 is integral with the legs 52, the
bridge 51, and the compressing portion 54. Because the two sides of
the bridge 51 are not integral, they can separate from one another
when the staple 50 is subjected to a twisting force. If desired, to
substantially prevent such separation, the central portions of the
bridge 51 can be fixedly connected to one another at a connection
location (for example, with a spot weld 58; other connection
processes can be used as well).
[0078] Like the previous embodiments, the OTC device 53 can be
shaped with variations in cross-section and other spatial
characteristics and can be formed with a variety of material
compositions. Any portions of the extension 56 or the compressing
portion 54 can be varied to have the same or varying
cross-sectional areas (i.e., varying thicknesses). The extension 56
and compressing portion 54 are, in this embodiment, different in
cross-sectional areas. Here, the cross-sectional area of the upper
majority of the extension 56 is narrower than the lower portion of
the extension 56 and the cross-section of the lower portion of the
extension 56 gradually increases in width until it is equal to the
cross-section of the compressing portion 54.
[0079] The extension 56 can be any shape or material so long as it
delivers the pre-set compressive force to the tissue at the
compressing portion 54 and as long as it allows for absorption of
forces greater than this pre-set force. An exemplary embodiment
selected for this OTC device 53 is a relatively sinusoidal curve
traversing more than one sinusoidal period. Again, only for
illustrative purposes, the cross-section of the OTC device 53 has a
racetrack shape, but can be changed as desired to other shapes
(e.g., circular, ovular, polygonal, etc.). As described above,
variation of any attribute of the OTC device 53 allows for
adjustment of the compressive and reactive force constants thereof
on the compressed tissue in the central region 57.
[0080] FIG. 6 illustrates a fifth exemplary embodiment of the OTC
staple 60 according to the invention. This variation has some of
the features of the above embodiments. In this variant, like the
embodiment of FIG. 3, the OTC portion is symmetrical with respect
to the bridge 61 and the legs 62 and the OTC device 63 is a
separate part from the bridge 61 and legs 62 of the staple 60. Like
the embodiment of FIGS. 4 and 5, the compressing portion 64 has a
width greater than the separation distance of the two legs 62 and
has ports 65 with a shape substantially corresponding to the
cross-sectional shape of the upper portion of the legs 62, but
slightly larger. The legs 62 pass through these ports 65. In this
configuration, movement of the OTC device 63 out of the bridge-legs
plane is substantially prevented. The extension 66 of the OTC
device 63 traverses from the bridge 61 to the compressing portion
64. Because the ports 65 are shaped to be slightly larger than the
cross-section of the legs 62, the extension 66 acts as a
compression spring in the bridge-legs plane as the compressing
portion 64 moves up and down along the upper portion of the legs
62. It is the extension 66 that provides the load-bearing force
when tissue is compressed within the central region 67 of the
staple 60. Because of the form-locking and sliding connection
between the compressing portion 64 and the legs 62, the OTC device
63 of the fifth embodiment behaves similar to the OTC devices of
FIGS. 4 and 5.
[0081] Connection of the OTC device 63 to the staple 60, for
example, at the bridge 61, can occur by any fastening measure. One
exemplary connection method is spot welding, which is indicated in
FIG. 6 by reference numeral 68. The type or types of material of
the staple portions 61, 62 and the OTC device 63 will direct a
preferable attachment method. In the case of attaching two
materials together that are not suited to be welded, soldered or
brazed, other attachment methods can be used such as crimping and
adhesive bonding. Features can be added to one or both of the two
components to facilitate the crimp or bond. These features could be
configured to have the components snap together. In the case of
dissimilar materials, for example, if the staple material is
stainless steel and the OTC device 63 is of nickel titanium alloy,
then preferred attachment measures include crimping, adhesive
bonding, or snapping.
[0082] Like the previous embodiments, the OTC device 63 can be
shaped with variations in cross-section and other spatial
characteristics and can be formed with a variety of material
compositions. Any portions of the extension 66 or the compressing
portion 64 can be varied to have the same or different
cross-sectional areas (i.e., varying thicknesses). The extension 66
and compressing portion 64 are, in this embodiment, different in
cross-sectional areas. Here, the cross-sectional area of most of
the extension 66 is narrower than the lowermost portion of the
extension 66 and the cross-section of this lowermost portion of the
extension 66 gradually increases in width until it is equal to the
cross-section of the compressing portion 64, which is substantially
wider.
[0083] The extension 66 can be any shape or material so long as it
delivers the pre-set compressive force to the tissue at the
compressing portion 64 and as long as it allows for absorption of
forces greater than this pre-set force. An exemplary embodiment
selected for this OTC device 63 is a relatively sinusoidal curve
traversing more than one sinusoidal period. Again, only for
illustrative purposes, the cross-section of the OTC device 63 has a
racetrack shape, but can be changed as desired to other shapes
(e.g., circular, ovular, polygonal, etc.). As described above,
variation of any attribute of the OTC device 63 allows for
adjustment of the compressive and reactive force constants thereof
on the compressed tissue in the central region 67.
[0084] FIG. 7 illustrates a sixth exemplary embodiment of the OTC
staple 70 according to the invention. This variation has some of
the features of the above embodiments. In this variant, like the
embodiment of FIG. 3, the OTC portion is symmetrical with respect
to the bridge 71 and the legs 72 and the OTC device 73 is a
separate part from the bridge 71 and legs 72 of the staple 70. Like
the embodiment of FIGS. 4 to 6, the compressing portion 74 has a
width greater than the separation distance of the two legs 72 and
has ports 75 with a shape substantially corresponding to the
cross-sectional shape of the upper portion of the legs 72, but
slightly larger. The legs 72 pass through these ports 75. In this
configuration, movement of the OTC device 73 out of the bridge-legs
plane is substantially prevented. The extension 76 of the OTC
device 73 traverses from the bridge 71 to the compressing portion
74. Because the ports 75 are shaped to be slightly larger than the
cross-section of the legs 72, the extension 76 acts as a
compression spring in the bridge-legs plane as the compressing
portion 74 moves up and down along the upper portion of the legs
72. It is the extension 76 that provides the load-bearing force
when tissue is compressed within the central region 77 of the
staple 70. Because of the form-locking and sliding connection
between the compressing portion 74 and the legs 72, the OTC device
73 of the sixth embodiment behaves similar to the OTC devices of
FIGS. 4 to 6.
[0085] Connection of the OTC device 73 to the staple 70, for
example, at the bridge 71, can occur by any fastening measure. One
exemplary connection method is spot welding, which is indicated in
FIG. 7 by reference numeral 78. The type or types of material of
the staple portions 71, 72 and the OTC device 73 will direct a
preferable attachment method. In the case of attaching two
materials together that are not suited to be welded, soldered or
brazed, other attachment methods can be used such as crimping and
adhesive bonding. Features can be added to one or both of the two
components to facilitate the crimp or bond. These features could be
configured to have the components snap together. In the case of
dissimilar materials, for example, if the staple material is
stainless steel and the OTC device 73 is of nickel titanium alloy,
then preferred attachment measures include crimping, adhesive
bonding, or snapping.
[0086] It is noted that the extensions (i.e., springs) in each of
FIGS. 2, 3, 5, and 6 are in the same plane, which can be the
bridge-legs plane (as shown) or out of that plane. In comparison to
these embodiments, the extension 76 has the springs residing in
different planes (i.e., one next to the other.
[0087] Like the previous embodiments, the OTC device 73 can be
shaped with variations in cross-section and other spatial
characteristics and can be formed with a variety of material
compositions. Any portions of the extension 76 or the compressing
portion 74 can be varied to have the same or varying
cross-sectional areas (i.e., varying thicknesses). The extension 76
and the compressing portion 74 are, in this embodiment, different
in cross-sectional areas. Here, the cross-sectional area of most of
the extension 76 is narrower than the lowermost portion of the
extension 76 and the cross-section of this lowermost portion of the
extension 76 gradually increases in width until it is equal to the
cross-section of the compressing portion 74, which is substantially
wider.
[0088] The extension 76 can be any shape or material so long as it
delivers the pre-set compressive force to the tissue at the
compressing portion 74 and as long as it allows for absorption of
forces greater than this pre-set force. An exemplary embodiment
selected for this OTC device 73 is a relatively sinusoidal curve
traversing more than one sinusoidal period. Again, only for
illustrative purposes, the cross-section of the OTC device 73 has a
racetrack shape, but can be changed as desired to other shapes
(e.g., circular, ovular, polygonal, etc.). As described above,
variation of any attribute of the OTC device 73 allows for
adjustment of the compressive and reactive force constants thereof
on the compressed tissue in the central region 77.
[0089] FIG. 8 illustrates a seventh exemplary embodiment of the OTC
staple 80 according to the invention. This variation has some of
the features of the above embodiments. In this variant, like the
embodiment of FIG. 3, the OTC portion is symmetrical with respect
to the bridge 81 and the legs 82, and the OTC device 83 is a
separate part from the bridge 81 and legs 82 of the staple 80. Like
the embodiment of FIGS. 4 to 7, the compressing portion 84 has a
width greater than the separation distance of the two legs 82 and
has ports 85 with a shape substantially corresponding to the
cross-sectional shape of the upper portion of the legs 82, but
slightly larger. The legs 82 pass through these ports 85. In this
configuration, movement of the OTC device 83 out of the bridge-legs
plane is substantially prevented. The extension 86 of the OTC
device 83 traverses from the bridge 81 to the compressing portion
84. Because the ports 85 are shaped to be slightly larger than the
cross-section of the legs 82, the extension 86 acts as a
compression spring in the bridge-legs plane as the compressing
portion 84 moves up and down along the upper portion of the legs
82. It is the extension 86 that provides the load-bearing force
when tissue is compressed within the central region 87 of the
staple 80. Because of the form-locking and sliding connection
between the compressing portion 84 and the legs 82, the OTC device
83 of the seventh embodiment behaves similar to the OTC devices of
FIGS. 4 to 7.
[0090] Like the previous embodiments, the OTC device 83 can be
shaped with variations in cross-section and other spatial
characteristics and can be formed with a variety of material
compositions. Any portions of the extension 86 or the compressing
portion 84 can be varied to have the same or varying
cross-sectional areas (i.e., varying thicknesses). The extension 86
and the compressing portion 84 are, in this embodiment, different
in cross-sectional areas. Here, the cross-sectional area of most of
the extension 86 is smaller and narrower than the lowermost portion
of the extension 86 and the cross-section of this lowermost portion
gradually increases in width until it is equal to the cross-section
of the compressing portion 84, which is substantially wider. Also,
the cross-sectional area of this extension 86 is smaller than
previous embodiments (but it need not be).
[0091] The extension 86 can be any shape or material so long as it
delivers the pre-set compressive force to the tissue at the
compressing portion 84 and as long as it allows for absorption of
forces greater than this pre-set force. An exemplary embodiment
selected for this OTC device 83 is a relatively sinusoidal curve
traversing a more than two periods and also having a second
"interior" curve that traverses sinusoidal periods. In this
embodiment, the OTC device 83 has an uppermost portion that is, in
contrast to the embodiments of FIGS. 3, 6, and 7 a single bar
extending along a majority of the bridge 81.
[0092] Connection of the OTC device 83 to the staple 80, for
example, at the bridge 81, can occur by any fastening measure. One
exemplary connection method is spot welding, which is indicated in
FIG. 8 by reference numeral 88. Because there is contact over most
of the bridge 81, the OTC device 83 can be welded over the entire
length thereof. The type or types of material of the staple
portions 81, 82 and the OTC device 83 will direct a preferable
attachment method. In the case of attaching two materials together
that are not suited to be welded, soldered or brazed, other
attachment methods can be used such as crimping and adhesive
bonding. Features can be added to one or both of the two components
to facilitate the crimp or bond. These features could be configured
to have the components snap together. In the case of dissimilar
materials, for example, if the staple material is stainless steel
and the OTC device 83 is of nickel titanium alloy, then preferred
attachment measures include crimping, adhesive bonding, or
snapping.
[0093] Only for illustrative purposes, the cross-section of the OTC
device 83 has a racetrack shape, but can be changed as desired to
other shapes (e.g., circular, ovular, polygonal, etc.). As
described above, variation of any attribute of the OTC device 83
allows for adjustment of the compressive and reactive force
constants thereof on the compressed tissue in the central region
87.
[0094] FIG. 9 illustrates an eighth exemplary embodiment of the OTC
staple 90 according to the invention. This variation has some of
the features of the above embodiments. In this variant, like the
embodiment of FIG. 3, the OTC portion is symmetrical with respect
to the bridge 91 and the legs 92, and the OTC device 93 is a
separate part from the bridge 91 and legs 92 of the staple 90. Like
the embodiment of FIGS. 4 to 8, the compressing portion 94 has a
width greater than the separation distance of the two legs 92 and
has ports 95 with a shape substantially corresponding to the
cross-sectional shape of the upper portion of the legs 92, but
slightly larger. The legs 92 pass through these ports 95. In this
configuration, movement of the OTC device 93 out of the bridge-legs
plane is substantially prevented. The extension 96 of the OTC
device 93 traverses from the bridge 91 to the compressing portion
94. Because the ports 95 are shaped to be slightly larger than the
cross-section of the legs 92, the extension 96 acts as a
compression spring in the bridge-legs plane as the compressing
portion 94 moves up and down along the upper portion of the legs
92. It is the extension 96 that provides the load-bearing force
when tissue is compressed within the central region 97 of the
staple 90. Because of the form-locking and sliding connection
between the compressing portion 94 and the legs 92, the OTC device
93 of the eighth embodiment behaves similar to the OTC devices of
FIGS. 4 to 8.
[0095] Like the previous embodiments, the OTC device 93 can be
shaped with variations in cross-section and other spatial
characteristics and can be formed with a variety of material
compositions. Any portion(s) of the extension 96 or the compressing
portion 94 can be varied to have the same or varying
cross-sectional areas (i.e., varying thicknesses). The extension 96
and the compressing portion 94 are, in this embodiment, different
in cross-sectional areas. Here, the cross-sectional area of most of
the extension 96 is smaller and narrower than the lowermost portion
of the extension 96 and the cross-section of this lowermost portion
gradually increases in width until it is equal to the cross-section
of the compressing portion 94, which is substantially wider. Also,
the cross-sectional area of this extension 96 is smaller than
previous embodiments (but need not be). With such a relatively
smaller cross-sectional shape, the curves of the extension 96 might
tend to deform or move out of the bridge-legs plane, which tendency
can increase or decrease depending upon the material of the
extension 96. To prevent such deformation and/or movement, a
plurality of guiding tabs 99 are disposed at one or more of the
outside ends of each periodic curve adjacent the legs 92. These
guiding tabs 99 are shaped in a similar manner to the ends of the
compressing portion 94, in that they have ports with a
cross-sectional shape substantially corresponding to the
cross-sectional shape of the upper portion of the legs 92 but
slightly larger. The embodiment illustrated in FIG. 9 provides each
guiding tab 99 with two relatively parallel plates each having one
of the two ports through which the respective leg 92 is disposed
Like the lower portion of the extension 96, the cross-sectional
area of the extension gradually increases in width until it is
equal to the larger cross-section of the plate of the guiding tab
99. Another alternative of the guiding tab 99 is to have only a
single plate with a single port. In such an embodiment (assuming
the material was the same as a dual-plate embodiment), the curves
of the extension 96 would be slightly stiffer because of the
absence of the exterior curve of the guiding tab 99.
[0096] The extension 96 can be any shape or material so long as it
delivers the pre-set compressive force to the tissue at the
compressing portion 94 and as long as it allows for absorption of
forces greater than this pre-set force. An exemplary embodiment
selected for this OTC device 93 is a relatively sinusoidal curve
having a second interior curve that traverses a few sinusoidal
periods and, in this embodiment, has an uppermost portion that is,
like the embodiment of FIG. 8, a single bar extending along a
majority of the bridge 91. Connection of the OTC device 93 to the
staple 90, for example, at the bridge 91, can occur by any
fastening measure. One exemplary connection method is spot welding,
which is indicated in FIG. 9 by reference numeral 98.
Alternatively, the weld can be over the entire span contacting the
bridge 91. The type or types of material of the staple portions 91,
92 and the OTC device 93 will direct a preferable attachment
method. In the case of attaching two materials together that are
not suited to be welded, soldered or brazed, other attachment
methods can be used such as crimping and adhesive bonding. Features
can be added to one or both of the two components to facilitate the
crimp or bond. These features could be configured to have the
components snap together. In the case of dissimilar materials, for
example, if the staple material is stainless steel and the OTC
device 93 is of nickel titanium alloy, then preferred attachment
measures include crimping, adhesive bonding, or snapping.
[0097] Again, only for illustrative purposes, the cross-section of
the OTC device 93 has a racetrack shape, but can be changed as
desired to other shapes (e.g., circular, ovular, polygonal, etc.).
As described above, variation of any attribute of the OTC device 93
allows for adjustment of the compressive and reactive force
constants thereof on the compressed tissue in the central region
97.
[0098] FIG. 10 illustrates a ninth exemplary embodiment of the OTC
staple 100 according to the invention. This variation has some of
the features of the above embodiments. In this variant, like the
embodiment of FIG. 3, the OTC portion is symmetrical with respect
to the bridge 101 and the legs 102, and the OTC device 103 is a
separate part from the bridge 101 and legs 102 of the staple 100.
The compressing portion 104, however, is unlike all of the previous
embodiments. Here, the compressing portion 104 is formed from two
compressing plates, each of these plates being attached to a
respective lower end of two halves of the OTC device 103. The shape
of the compressing portion 104 need not be a plate. It can be
cylindrical, for example. Like previous embodiments, the lowermost
end of the extension 106 gradually increases in cross-section until
it is equal to the compressing portion 104. Each compressing plate,
then, extends towards a respective one of the legs 102 and defines
a respective port 105 for receiving therein the leg 102. The port
105 has a shape substantially corresponding to the cross-sectional
shape of the upper portion of the legs 102, but is slightly larger.
The legs 102 pass through each port 105 to form the OTC device 103.
In this configuration, movement of the OTC device 103 out of the
bridge-legs plane is substantially prevented. The extension 106 of
the OTC device 103 traverses from the bridge 101 to the plates of
the compressing portion 104. Because the ports 105 are shaped to be
slightly larger than the cross-section of the legs 102, the
extension 106 acts as a compression spring in the bridge-legs plane
as the compressing portion 104 moves up and down along the upper
portion of the legs 102. It is the extension 106 that provides the
load-bearing force when tissue is compressed within the central
region 107 of the staple 100.
[0099] In this embodiment, as compared to previous OTC device
embodiments, the two sides of the OTC device 103 move independent
from one another. Thus, if tissue varies in any characteristic
within the central portion 107 (e.g., hardness, thickness,
density), the optimal tissue compression force can be delivered
independently and differently for each of the two differing tissue
segments contacting the respective one of the sides of the OTC
device 103.
[0100] Connection of the OTC device 103 to the staple 100, for
example, at the bridge 101, can occur by any fastening measure. One
exemplary connection method is spot welding, which is indicated in
FIG. 10 by reference numeral 108. As the upper portion contacts
almost all of the bridge 101, the weld 108, instead, can span any
amount of the bridge 101. The type or types of material of the
staple portions 101, 102 and the OTC device 103 will direct a
preferable attachment method. In the case of attaching two
materials together that are not suited to be welded, soldered or
brazed, other attachment methods can be used such as crimping and
adhesive bonding. Features can be added to one or both of the two
components to facilitate the crimp or bond. These features could be
configured to have the components snap together. In the case of
dissimilar materials, for example, if the staple material is
stainless steel and the OTC device 103 is of nickel titanium alloy,
then preferred attachment measures include crimping, adhesive
bonding, or snapping.
[0101] Like the previous embodiments, the OTC device 103 can be
shaped with variations in cross-section and other spatial
characteristics and can be formed with a variety of material
compositions. Any portions of the extension 106 or the compressing
portion 104 can be varied to have the same or varying
cross-sectional areas (i.e., varying thicknesses). The extension
106 and the plates of the compressing portion 104 are, in this
embodiment, different in cross-sectional areas. Here, the
cross-sectional area of most of the extension 106 is smaller and
narrower than the lowermost portion of the extension 86 and the
cross-section of this lowermost portion gradually increases in
width until it is equal to the cross-section of the respective
plate of the compressing portion 104, which is substantially
wider.
[0102] The extension 106 can be any shape or material so long as it
delivers the pre-set compressive force to the tissue at the
compressing portion 104 and as long as it allows for absorption of
forces greater than this pre-set force. An exemplary embodiment
selected for this OTC device 103 is a relatively sinusoidal curve
having almost two sinusoidal periods and, in this embodiment, has
an uppermost portion that is (like the embodiments of FIGS. 8 and
9) a single bar extending along a majority of the bridge 101. For
illustrative purposes, the cross-section of the OTC device 103 has
an ovular shape, but can be changed as desired to other shapes
(e.g., circular, racetrack, polygonal, etc.). As described above,
variation of any attribute of the OTC device 103 allows for
adjustment of the compressive and reactive force constants thereof
on the compressed tissue in the central region 107.
[0103] FIGS. 11 and 11A illustrate a tenth exemplary embodiment of
the OTC staple 110 according to the invention. This variation has
some of the features of the above embodiments. In this variant,
like the embodiment of FIG. 3, the OTC portion is symmetrical with
respect to the bridge 111 and the legs 112, and the OTC device 113
is a separate part from the bridge 111 and legs 112 of the staple
110. The compressing portion 114 is like the embodiment of FIG.
10--it is formed from two compressing plates, each of these plates
being attached to a respective lower end of two halves of the OTC
device 113. The lowermost end of the extension 116 gradually
increases in cross-section until it is equal in area to the
compressing portion 114. Each compressing plate, then, extends
towards a respective one of the legs 112 and defines a respective
port 115 for receiving therein one of the legs 112. In FIG. 11, the
ports 115 cannot be seen because of the presence of one-way washers
119 (described below), but the port 115 is visible in FIG. 11A.
[0104] As set forth above, each port 115 has a shape substantially
corresponding to the cross-sectional shape of the upper portion of
the legs 112 but is slightly larger. The legs 112 pass through each
port 115 to form the OTC device 113. Because the ports 115 are
shaped to be slightly larger than the cross-section of the legs
112, the extension 116 acts as a compression spring in the
bridge-legs plane as the compressing portion 114 moves up and down
along the upper portion of the legs 112. In this configuration,
movement of the OTC device 113 out of the bridge-legs plane is
substantially prevented. It is the extension 116 that provides the
load-bearing force when tissue is compressed within the central
region 117 of the staple 110. In this embodiment (like the
embodiment of FIG. 10), the two sides of the OTC device 113 move
independent from one another. Thus, if tissue varies in any
characteristic within the central portion 117 (e.g., hardness,
thickness, density), the optimal tissue compression force can be
delivered independently and differently for each of the two
differing tissue segments contacting the two plates of the
compressing portion 114.
[0105] Introduced for the first time in this embodiment are one-way
devices 119 (one exemplary embodiment being a star washer that is
illustrated in FIGS. 11 and 11A) disposed on the leg 112 between
the bridge 111 and the compressing portion 114. These devices 119
are shaped to freely move on the leg 112 upwards towards the bridge
111 but not to move in the opposite direction. Thus, as tissue is
being compressed within the central region 117 as the distal ends
of the legs 112 are curved in the stapling action, the tissue
presses against the compressing portion 114 and moves the
compressing portion 114 up towards the bridge 111. Once the
stapling force is removed from the staple 110 (after stapling is
complete), the tissue will most likely not press the washers 119
any further without any additionally supplied outside force. Thus,
the washers 119 limit further movement of the compressing portion
114 from the then-current location of the washers 119 towards the
first bend of the legs 112. These washers also add some friction
when the first stapling movement occurs, which friction may be used
to add to and make up the compression coefficients of the OTC
device 113. If the stapled tissue swells, it is possible for the
washers 119 to be moved if the force is sufficient. After such
swelling ends and desiccation of the tissue occurs, the compressing
portions 114 will be limited in further compression by these
washers 119.
[0106] Like the previous embodiments, the OTC device 113 can be
shaped with variations in cross-section and other spatial
characteristics and can be formed with a variety of material
compositions. Any portions of the extension 116 or the compressing
portion 114 can be varied to have the same or varying
cross-sectional areas (i.e., varying thicknesses). The extension
116 and the plates of the compressing portion 114 are, in this
embodiment, different in cross-sectional areas. Here, the
cross-sectional area of most of the extension 116 is smaller and
narrower than the lowermost portion of the extension 116 and the
cross-section of this lowermost portion gradually increases in
width until it is equal to the cross-section of the respective
plate of the compressing portion 114, which is substantially
wider.
[0107] The extension 116 can be any shape or material so long as it
delivers the pre-set compressive force to the tissue at the
compressing portion 114 and as long as it allows for absorption of
forces greater than this pre-set force. An exemplary embodiment
selected for this OTC device 113 is a relatively sinusoidal curve
traversing more than two sinusoidal periods and having a second
"interior" curve. In this embodiment, the OTC device 113 has an
uppermost portion that is (like the embodiments of FIGS. 8 to 10) a
single bar extending along a majority of the bridge 111. Connection
of the OTC device 113 to the staple 110, for example, at the bridge
111, can occur by any fastening measure. One exemplary connection
method is spot welding, which is indicated in FIG. 11 by reference
numeral 118. This process can be changed if desired. The type or
types of material of the staple portions 111, 112 and the OTC
device 113 will direct a preferable attachment method. In the case
of attaching two materials together that are not suited to be
welded, soldered or brazed, other attachment methods can be used
such as crimping and adhesive bonding. Features can be added to one
or both of the two components to facilitate the crimp or bond.
These features could be configured to have the components snap
together. In the case of dissimilar materials, for example, if the
staple material is stainless steel and the OTC device 113 is of
nickel titanium alloy, then preferred attachment measures include
crimping, adhesive bonding, or snapping.
[0108] For illustrative purposes, the cross-section of the OTC
device 113 has a racetrack shape, but can be changed as desired to
other shapes (e.g., circular, ovular, polygonal, etc.). As
described above, variation of any attribute of the OTC device 113
allows for adjustment of the compressive and reactive force
constants thereof on the compressed tissue in the central region
117.
[0109] FIG. 12 illustrates an eleventh exemplary embodiment of the
OTC staple 120 according to the invention. This variation is
significantly different from the above embodiments. The OTC device
123 is, as above, a separate part from the bridge 121 and legs 122
of the staple 120. Here, however, the compressing portion 124 is a
C-beam having ports 125 that permit passage of a respective one of
the legs 122 therethrough. Each port 125 has a shape substantially
corresponding to the cross-sectional shape of the upper portion of
the legs 122 but is slightly larger. The legs 122 pass through each
port 125 to form the OTC device 123. In this configuration,
movement of the OTC device 123 out of the bridge-legs plane is
substantially prevented.
[0110] The C-beam shape is useful for a variety of reasons. First,
the C-shape provides a central cavity in which a distal end of a
compression device 126 can be held or fastened. Next, the C-shape
also increases resistance to bending forces as compared to a simple
rectangular plate, as is known in construction. Finally, orienting
the open portion of the "C" away from the tissue presents a flat
compressing plate to the tissue to be compressed. With such a
shape, the tissue can be compressed evenly, with no singular
pressure points. Of course, the C-shape is not the only possible
cross-sectional shape. The compressing portion 124 can be a
rectangular plate, an I-beam, an L-beam, or any other desired
shape.
[0111] The compression device 126 can take any form (see, e.g.,
FIG. 13). The exemplary embodiment of FIG. 12 illustrates the
compression device 126 as a conically expanding compression spring.
Connection of the spring 126 and compressing portion 124 to the
staple 120, for example, at the bridge 121, can occur by any
fastening measure. The illustrated exemplary proximal connection
method is a ring of the spring material wrapping around the bridge
121. This proximal end is secured at the center of the bridge 121
and held in place there by placing protuberances 128 on the bridge
121. These protuberances prevent lateral movement of the proximal
ring towards either of the two legs 122. Of course, this ring can
be welded or fastened to the bridge 121 by any fastening process.
The distal end of the spring is a relatively circular coil lying in
the same plane as the interior cavity of the C-beam and having an
outer diameter just slightly less than the interior diameter of the
C-shaped cavity of the compressing portion 124. Thus, the ends of
the C-shape can be used to retain the distal end of the spring 126
within the cavity. Of course, other fastening measures can be used
to secure the spring distal ends to the compressing portion
124.
[0112] It is the spring 126 that provides the load-bearing force
when tissue is compressed within the central region 127 of the
staple 120. Like the previous embodiments, the OTC device 123 can
be shaped with variations in cross-section, winding, and other
spatial characteristics and can be formed with a variety of
material compositions. Any portions of the spring 126 or the
compressing portion 124 can be varied. In particular, the spring
126 can be any shape or material so long as it delivers the pre-set
compressive force to the tissue through the compressing portion 124
and as long as it allows for absorption of forces greater than this
pre-set force. As described above, variation of any attribute of
the OTC device 123 allows for adjustment of the compressive and
reactive force constants thereof on the compressed tissue in the
central region 127.
[0113] FIG. 13 illustrates a twelfth exemplary embodiment of the
OTC staple 130 according to the invention. This variation is
similar to the embodiment of FIG. 12. The OTC device 133 is, as
above, a separate part from the bridge 131 and legs 132 of the
staple 130 and the compressing portion 134 is a C-beam having ports
135 that permit passage of a respective one of the legs 132
therethrough. Each port 135 has a shape substantially corresponding
to the cross-sectional shape of the upper portion of the legs 132
but is slightly larger. The legs 132 pass through each port 135 to
form the OTC device 133. In this configuration, movement of the OTC
device 133 out of the bridge-legs plane is substantially
prevented.
[0114] The C-beam shape has the same benefits as described in the
eleventh embodiment of FIG. 12. Like that embodiment, the C-shape
is not required; the compressing portion 134 can be a rectangular
plate, an I-beam, an L-beam, or any other desired shape.
[0115] The compression device 136 can take any form. In the
exemplary embodiment of FIG. 13, the compression device 136 is a
pair of compression springs 136. Connection of these springs 136
and the compressing portion 134 to the staple 130, for example, at
the bridge 131, can occur by any fastening measure. The illustrated
exemplary proximal connection method is a narrowing of the spring
diameter to be equal or less than the diameter of the legs 132 at
the connection point to the bridge 131. Thus, the springs 136 can
be held by the force imparted on the legs 132 by press-fitting the
narrower spring rings onto a desired location on the legs 132.
Alternatively and/or additionally, the almost ninety degree bend at
the legs-bridge intersection forms a stop preventing further upward
movement of the distal ends of each spring 136. Of course, the
upper ring(s) can be fastened to the staple 130 by any measure,
such as welding, crimping, etc.
[0116] Like the embodiment of FIG. 12, the distal end of the
springs 136 in FIG. 13 is formed by a relatively circular coil
lying in the same plane as the interior cavity of the C-beam and
having an outer diameter just slightly less than the interior
diameter of the C-shaped cavity of the compressing portion 134.
Thus, the ends of the C-shape can be used to retain the distal end
of the spring 136 within the cavity. The coils can be welded to the
C-beam, for example. Of course, other fastening measures and coil
configurations can be used to secure the distal ends of the springs
136 to the compressing portion 134.
[0117] It is the springs 136 that provide the load-bearing force
when tissue is compressed within the central region 137 of the
staple 130. Like the previous embodiments, the OTC device 133 can
be shaped with variations in cross-section and other spatial
characteristics and can be formed with a variety of material
compositions. Any portions of the springs 136 or the compressing
portion 134 can be varied. In particular, the spring 136 can be any
shape or material so long as it delivers the pre-set compressive
force to the tissue through the compressing portion 134 and as long
as it allows for absorption of forces greater than this pre-set
force. As described above, variation of any attribute of the OTC
device 133 allows for adjustment of the compressive and reactive
force constants thereof on the compressed tissue in the central
region 137.
[0118] The spring 136 shown in FIG. 12 floats between the legs 132
and does not touch either leg 132. In contrast, the springs 135 of
FIG. 13 wrap around the legs throughout the entire length. This
orientation presents the possibility of resistance (i.e., friction)
imparted upon the springs 136 by the legs 132 when the springs 136
are compressed. This resistance may be desirable depending upon the
desired OTC device compression coefficient. If resistance is to be
reduced, then sleeves 138 can be inserted onto the legs 132 such
that they "lubricate" or reduce resistance of spring compression.
These sleeves 138 can be made of polytetrafluoroethylene (PTFE),
for example.
[0119] FIG. 14 illustrates a thirteenth exemplary embodiment of the
OTC staple 140 according to the invention. This variation is
similar to the embodiments of FIGS. 12 and 13. The OTC device 143
is, as above, a separate part from the bridge 141 and legs 142 of
the staple 140 and the compressing portion 144 is a C-beam having
non-illustrated ports that permit passage of a respective one of
the legs 142 therethrough (in the view of FIG. 14, the ports are
blocked from view by the C-beam). Each port has a shape
substantially corresponding to the cross-sectional shape of the
upper portion of the legs 142 but is slightly larger. The legs 142
pass through each port to form the OTC device 143. In this
configuration, movement of the OTC device 143 out of the
bridge-legs plane is substantially prevented.
[0120] The C-beam shape has the same benefits as described in the
eleventh embodiment of FIG. 12. Like that embodiment, the C-shape
is not required; the compressing portion 144 can be a rectangular
plate, an I-beam, an L-beam, or any other desired shape.
[0121] The compression device 146 can take any form. The exemplary
embodiment of FIG. 14 is a pair of compression springs 146. Like
the single spring 136 shown in FIG. 12, the compression springs 146
of this embodiment float between the legs 142 and do not touch
either leg 142. Connection of these springs 146 to the staple 140,
for example, at the bridge 141, can occur by any fastening measure.
The illustrated exemplary proximal connection method is a second
C-beam disposed against the bridge 141 and connected thereto by any
fastening measure, such as spot welds 148, for example. With such a
connection configuration, each of the springs 146 can be formed
with a relatively circular coil lying in the same plane as the
interior cavity of each C-beam and having an outer diameter just
slightly less than the interior diameter of the respective C-shaped
cavity of the compressing portion 144. Thus, the ends of the
C-shape can be used to retain the distal end of the spring 146
within the cavity. These end coils can be press-fit or slid into
the C-beam cavity for connection thereto. Alternatively and/or
additionally, these lower and upper loops can be fastened to the
beams by welding, crimping, etc. The respective interior cavities
of the two C-beams can be of different or of equal size.
[0122] It is the springs 146 that provide the load-bearing force
when tissue is compressed within the central region 147 of the
staple 140. Like the previous embodiments, the OTC device 143 can
be shaped with variations in cross-section, winding, and other
spatial characteristics and can be formed with a variety of
material compositions. Any portions of the springs 146 or the
compressing portion 144 can be varied. In particular, the spring
146 can be any shape or winding or of any material so long as it
delivers the pre-set compressive force to the tissue through the
compressing portion 144 and as long as it allows for absorption of
forces greater than this pre-set force. As described above,
variation of any attribute of the OTC device 143 allows for
adjustment of the compressive and reactive force constants thereof
on the compressed tissue in the central region 147.
[0123] FIG. 15 illustrates a fourteenth exemplary embodiment of the
OTC staple 150 according to the invention. The OTC device 153 is,
as above, a separate part from the bridge 151 and legs 152 of the
staple 150. Here, however, this variation differs from the previous
embodiments because the OTC device 153 is a cushion made of a
compressible material. Examples of such material include, but are
not limited to, closed cell polyethylene foam, expanded
polytetrafluoroethylene (PTFE), silicone rubber, silicone rubber
foam, urethane, and electro-spun thermoplastic elastomers. This
cushion 153 defines two channels 154 for receiving therethrough a
respective one of the legs 152. Because the staple legs 152 taper
inwards slightly in a direction from the intermediate portion 155
of the staple 150 to the ends of the bridge 151 (although this
taper is not a requirement), the cross-sectional area of the
channels 154 are larger than the cross-section of a portion of the
legs 152 disposed inside the channels 154. By passing the legs 152
through each channel 154, the OTC device 153 is formed.
[0124] It is this pillow 153 that provides the load-bearing force
when tissue is compressed within the central region 157 of the
staple 150. Like the previous embodiments, the OTC device 153 can
be shaped with variations in cross-section and other spatial
characteristics and can be formed with a variety of material
compositions. The exemplary embodiment illustrated in FIG. 15 is a
pillow having a racetrack cross-sectional shape in the transverse
direction. However, the pillow can be circular, ovular,
rectangular, and polygonal in its outer transverse shape.
[0125] Any portion of the pillow 153 can be varied so long as it
delivers the pre-set compressive force to the tissue at the distal
end of the pillow 153 and as long as it allows for absorption of
forces greater than this pre-set force. As described above,
variation of any attribute of the OTC device 153 allows for
adjustment of the compressive and reactive force constants thereof
on the compressed tissue in the central region 157.
[0126] FIG. 16 illustrates a fifteenth exemplary embodiment of the
OTC staple 160 according to the invention. This variation is
different from the previous embodiments. The OTC device 163 is, as
above, a separate part from the bridge 161 and legs 162 of the
staple 160. The OTC device is a plate 163 made of a
semi-compressible material having properties that will be described
in detail below. Examples of such a material include, but are not
limited to, polyurethane and silicone rubber. The plate 163 defines
two channels 164 for receiving therethrough a respective one of the
legs 162. Because the legs 162 taper inwards slightly in the
bridge-legs plane in a direction from the intermediate portion 165
of the staple 160 to the ends of the bridge 161 (although this
taper is not a requirement), the cross-sectional area of each of
the channels 164 in the bridge-legs plane is larger than the
cross-section of the legs 162 that are to be disposed inside the
channels 164. This larger area is defined by a hole that is longer
in the bridge-legs plane than in the plane orthogonal thereto along
the axis of the leg 162. In the exemplary embodiment shown in FIG.
16, the cross-sectional shape of the channels 164 are ovular or
racetrack shaped. By passing the legs 162 through each channel 164,
the OTC device 163 is formed.
[0127] It is noted that the staple 160 shown in FIG. 16 is
different from the prior art staple of FIG. 1. Specifically, the
connecting portion 166 of the legs 162 tapers in width outwardly in
the direction beginning from the intermediate portion towards the
bridge 161 in a plane that is orthogonal to the bridge-legs plane.
Because the channels 164 have a fixed width in the plane of the
widening (which plane is orthogonal to the bridge-legs plane), and
due to the fact that the fixed width is close in size to the
lower-most portion of the connecting portion 166 (nearest to the
intermediate portion 165), the plate 163 will not be able to move
upwards towards the bridge 161 unless the material of the plate 163
is semi-compressible. Knowledge about the material's ability to
compress and the resistance it provides to upward movement as the
plate 163 progresses upward along the outwards taper of the leg
widening can be used to set or adjust the compressive and reactive
force constants thereof on the compressed tissue in the central
region 167. Any portion of the plate 163 and of the upper leg taper
can be varied so long as the OTC system (plate 163 and taper of the
legs 162) delivers the pre-set compressive force to the tissue at
the distal end of the plate 163 and as long as it allows for
absorption of forces greater than this pre-set force.
[0128] The OTC device of this embodiment can be shaped with
variations in cross-section, taper, and other spatial
characteristics and can be formed with a variety of material
compositions. The exemplary embodiment illustrated in FIG. 16 is a
plate 163 having a racetrack cross-sectional shape in the
transverse direction. However, the pillow can be circular, ovular,
rectangular, and polygonal in its outer transverse shape, for
example.
[0129] The OTC staple according to the invention is applied in the
same manner as a conventional staple, that is: [0130] the staple is
loaded into a staple cartridge; [0131] material to be stapled with
the staple is placed between the staple cartridge and an anvil; and
[0132] the anvil and staple are brought together to press the lower
portion of the legs against the anvil and bend the lower portions
inward to capture the material in the central region and compress
it between the bent portions and the compressing portion of the
staple.
[0133] Because the material to be stapled has a length less than
the distance between the bent lower portions and the bridge, the
captured material partially compresses the OTC device inside the
staple to, thereby, effect the optimal tissue compression feature.
When the staple and material are released from the staple cartridge
and anvil, the OTC device is imparting a pre-set compressive force
against the compressed material. Significantly, the OTC device is
able to move while the material is going through its compression
and expansion cycle(s) until it finally reaches a steady state
size. Even after reaching the steady state, the OTC device imparts
the desired compressive force (within an acceptable minimum range)
so that the material is not permanently damaged due to
overcompression.
[0134] For example, if the material is human tissue, when tissue is
stapled, liquid is forced out of the tissue. During the desiccation
period, the tissue compresses further and further. The OTC device
compensates by enlarging to follow the tissue compression. At some
point in time, the tissue begins to swell (due to the puncturing
and compressing forces imparted thereon). During the swelling
period, the OTC device compensates by reducing to follow the tissue
swelling.
[0135] The foregoing description and accompanying drawings
illustrate the principles, preferred embodiments and modes of
operation of the invention. However, the invention should not be
construed as being limited to the particular embodiments discussed
above. Additional variations of the embodiments discussed above
will be appreciated by those skilled in the art.
[0136] Therefore, the above-described embodiments should be
regarded as illustrative rather than restrictive. Accordingly, it
should be appreciated that variations to those embodiments can be
made by those skilled in the art without departing from the scope
of the invention as defined by the following claims.
* * * * *