U.S. patent application number 12/819415 was filed with the patent office on 2010-10-07 for surgical device and method.
Invention is credited to Hazem Ezzat, M. Mounir Gazayerli, Gary L. Jones.
Application Number | 20100252611 12/819415 |
Document ID | / |
Family ID | 38623239 |
Filed Date | 2010-10-07 |
United States Patent
Application |
20100252611 |
Kind Code |
A1 |
Ezzat; Hazem ; et
al. |
October 7, 2010 |
Surgical Device and Method
Abstract
A surgical device for cutting a portion of a body comprising a
knife capable of moving from a first position to a second position
which is spaced apart from the first position; a smart memory
material (SMM) capable of going from one physical state to another
physical state; and an activating apparatus which is in
communication with the smart memory material and which can cause
the change in the physical state of the smart memory material,
which change in state causes the movement of the knife thereby
facilitating cutting of the desired body portion.
Inventors: |
Ezzat; Hazem; (Troy, MI)
; Gazayerli; M. Mounir; (Troy, MI) ; Jones; Gary
L.; (Farmington Hills, MI) |
Correspondence
Address: |
REISING ETHINGTON P.C.
P O BOX 4390
TROY
MI
48099-4390
US
|
Family ID: |
38623239 |
Appl. No.: |
12/819415 |
Filed: |
June 21, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11977005 |
Oct 23, 2007 |
7766928 |
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12819415 |
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10366170 |
Feb 13, 2003 |
7287682 |
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11977005 |
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10348087 |
Jan 20, 2003 |
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10366170 |
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Current U.S.
Class: |
227/180.1 ;
606/174 |
Current CPC
Class: |
A61B 2017/07278
20130101; A61B 17/072 20130101; A61B 2017/00867 20130101; A61B
2017/07214 20130101; A61B 17/07207 20130101; A61B 2017/320052
20130101 |
Class at
Publication: |
227/180.1 ;
606/174 |
International
Class: |
A61B 17/072 20060101
A61B017/072; A61B 17/3201 20060101 A61B017/3201 |
Claims
1. A surgical device for cutting a portion of a body comprising: an
upper jaw including an anvil; a lower jaw including a knife in
communication with a smart memory material to move the knife from a
lower position upward to an upper position spaced apart from the
lower position toward the anvil, wherein the smart memory material
is capable of moving from a first physical state in which the knife
is in an undeployed state and a second physical state in which the
knife is deployed upward toward the anvil to facilitate cutting of
the body portion; and an activating apparatus in communication with
the smart memory material for causing the smart memory material to
change from the first physical state to the second physical
state.
2. The surgical device of claim 1, wherein the lower jaw also
includes a supply of staples in communication with a second smart
memory material for deploying the supply of staples towards the
anvil and piercing the body portion located therebetween, wherein
the second smart memory material is capable of moving from a first
physical state in which the supply of staples is in an undeployed
state and a second physical state in which the supply of staples is
deployed towards the anvil.
3. The surgical device of claim 2, wherein the supply of staples
includes two rows of staples with the knife disposed between the
rows.
4. The surgical device of claim 1 wherein the SMM is at least one
of a metallic alloy or a polymeric material.
5. The surgical device of claim 1 wherein the activating apparatus
causes the SMM to expand in volume thereby moving the knife.
6. The surgical device of claim 1 wherein the SMM is a metallic
alloy comprised of a composition, which can go from a martensite
phase to an austenite phase.
7. The surgical device of claim 1 wherein the SMM is at least one
of a metallic alloy comprised of nickel and titanium, a metallic
alloy composed of copper, zinc and aluminum, or a metallic alloy
composed of iron, nickel and aluminum.
8. A method of cutting a body portion comprising: providing the
device of claim 1; and cutting the desired body portion.
9. A surgical device for cutting a portion of a body comprising: a
first jaw including an anvil; a second jaw disposed beneath the
first jaw in a closed position to define a longitudinally extending
space therebetween, and including a knife in communication with a
smart memory material to move the knife from a first position
toward the anvil and transversely across the longitudinally
extending space to a second position spaced apart from the first
position, wherein the smart memory material is capable of moving
from a first physical state in which the knife is in an undeployed
state and a second physical state in which the knife is deployed
toward the anvil to facilitate cutting of the body portion; and an
activating apparatus in communication with the smart memory
material for causing the smart memory material to change from the
first physical state to the second physical state.
10. The surgical device of claim 9, wherein the second jaw also
includes a supply of staples in communication with a second smart
memory material for deploying the supply of staples towards the
anvil and piercing the body portion located therebetween, wherein
the second smart memory material is capable of moving from a first
physical state in which the supply of staples is in an undeployed
state and a second physical state in which the supply of staples is
deployed towards the anvil.
11. The surgical device of claim 10, wherein the supply of staples
includes two rows of staples with the knife disposed between the
rows.
12. The surgical device of claim 9 wherein the SMM is at least one
of a metallic alloy or a polymeric material.
13. The surgical device of claim 9 wherein the SMM is at least one
of a metallic alloy comprised of nickel and titanium, a metallic
alloy comprised of copper, zinc and aluminum, or a metallic allow
comprised of iron, nickel and aluminum.
14. A method of cutting a body portion comprising: providing the
device of claim 9; and cutting the desired body portion.
15. A surgical device for cutting a portion of a body comprising: a
first jaw including an anvil extending in a longitudinal direction
in a closed position of the device; a second jaw including a knife
extending in the longitudinal direction in the closed position and
being in communication with a smart memory material to move the
knife toward the anvil in a direction transverse to the
longitudinal direction, wherein the smart memory material is
capable of moving from a first physical state in which the knife is
in an undeployed state and a second physical state in which the
knife is deployed upward toward the anvil to facilitate cutting of
the body portion; and an activating apparatus in communication with
the smart memory material for causing the smart memory material to
change from the first physical state to the second physical
state.
16. The surgical device of claim 15, wherein the second jaw also
includes a supply of staples in communication with a second smart
memory material for deploying the supply of staples towards the
anvil and piercing the body portion located therebetween, wherein
the second smart memory material is capable of moving from a first
physical state in which the supply of staples is in an undeployed
state and a second physical state in which the supply of staples is
deployed towards the anvil.
17. The surgical device of claim 15, wherein the supply of staples
includes two rows of staples with the knife disposed between the
rows.
18. The surgical device of claim 15 wherein the SMM is at least one
of a metallic alloy or a polymeric material.
19. The surgical device of claim 15 wherein the SMM is at least one
of a metallic alloy comprised of nickel and titanium, a metallic
alloy comprised of copper, zinc and aluminum, or a metallic allow
comprised of iron, nickel and aluminum.
20. A method of cutting a body portion comprising: providing the
device of claim 15; and cutting the desired body portion.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 11/977,005, filed Oct. 23, 2007, which is a divisional
application of U.S. patent application Ser. No. 10/366,170, filed
Feb. 13, 2003 and issued as U.S. Pat. No. 7,287,682 on Oct. 10,
2007, which is a continuation-in-part application to U.S. patent
application Ser. No. 10/348,087 filed Jan. 20, 2003, all hereby
incorporated by reference.
FIELD OF THE INVENTION
[0002] The invention pertains to a surgical device for attaching
staples to a portion of a body. The invention also pertains to a
surgical device for cutting a portion of a body.
[0003] The invention also pertains to smart memory materials that
can change from one physical phase to another physical phase upon
application of a stimulus and the use of those materials in a
surgical device.
BACKGROUND OF THE INVENTION
[0004] Medical stapling devices for endoscopic or laparoscopic
surgery employ very complex mechanisms. Frequently, the devices
rely on a set of cam bars and the like to eject the surgical
staples from the staple cartridge. (See U.S. Pat. No. 3,499,591.)
Complex linkages contained within the body of the device are used
to articulate the staple cartridge and an anvil into position
during the surgical procedure. (See U.S. Pat. No. 6,250,532.) The
range of motion, flexibility and size of such stapling devices are
restricted by these mechanisms. Examples of complicated apparatus
for applying surgical staples to attach an object to body tissue is
described in U.S. Pat. Pub. 2002/0117534, published Aug. 29, 2002.
The apparatus requires complex mechanical actuating mechanisms for
rotating and articulating the surgical device and then to cause the
staple to be ejected from a store of staples. A flexible connection
(fire wire) with a high level of fatigue life is needed between the
push rod and the pusher plate at the pivot point of the articulated
joint. In a similar fashion, see U.S. Pat. No. 6,250,532. The
devices described in the patents contain complex linkages to eject
the staples from the staple cartridge/magazine limiting the
range-of-motion for the articulated end of the device. In some of
the devices, cam bars are used to deploy the staples. The ability
of the cam bars to deflect or flex is limited to approximately
+/-45.degree. of movement. Additional, when operating at the
extremes of this travel, early fatigue failure of the cam bars is
possible.
[0005] The power required to actuate the device of the invention
disclosed herein is supplied to the staple cartridge through very
small and flexible wires. Because of the small size and
flexibility, the required space and packaging requirements are
significantly less in comparison to the cam bars described in the
patents of the prior art.
[0006] Polymeric materials having smart memory characteristics are
described in "Shape Memory Polymers": A. Yondlen, S. Kelch Angen,
Chem Int. Ed. 2002, 41(12), pp. 2034-2057. The use of smart memory
materials is discussed in U.S. Pat. No. 5,509,923. See also U.S.
Pat. No. 6,388,043, herein incorporated by reference.
[0007] An apparatus for endoscopically applying body staples to
body tissue is described in U.S. Pat. No. 5,484,095.
[0008] Other patents which are generally related to surgical
devices or smart memory materials are recited below.
TABLE-US-00001 ISSUED/ PATENT NO./ PUBLISHED PUBLICATION NO.
APPL'N. DATE U.S. Pat. No. 5,236,437* Aug. 17, 1993 U.S. Pat. No.
5,242,458 Sep. 7, 1993 U.S. Pat. No. 5,411,519 May 2, 1995 U.S.
Pat. No. 5,431,323* Jul. 11, 1995 U.S. Pat. No. 5,467,911 Nov. 21,
1995 U.S. Pat. No. 5,484,095 Jan. 16, 1996 U.S. Pat. No. 5,509,923
Apr. 23, 1996 U.S. Pat. No. 5,636,780 Jun. 10, 1997 U.S. Pat. No.
5,645,209 Jul. 8, 1997 U.S. Pat. No. 5,681,330 Oct. 28, 1997 U.S.
Pat. No. 5,711,472 Jan. 27, 1998 U.S. Pat. No. 5,797,959 Aug. 25,
1998 U.S. Pat. No. 5,810,881 Sep. 22, 1998 U.S. Pat. No. 6,019,758
Feb. 1, 2000 U.S. Pat. No. 6,159,146 Dec. 12, 2000 U.S. Pat. No.
6,250,532 B1 Jun. 26, 2001 U.S. Pub. 2001/0007057 A1 Pub. Jul. 5,
2001 U.S. Pub. 2001/0030219 A1 Pub. Oct. 18, 2001 U.S. Pub.
2002/0072759 1 Pub. Jun. 13, 2002 U.S. Pub. 2002/0096550 1 Pub.
Jul. 25, 2002 U.S. Pub. 2002/0117534 A1 Pub. Aug. 29, 2002 U.S.
Pat. No. 6,488,196 B1 Dec. 3, 2002
[0009] It is an object of the present invention to employ a
surgical device for cutting a portion of a body where the surgical
device has a knife that is capable of moving from a first to a
second position which positions are spaced apart and to utilize a
smart memory material which functions as described above; namely,
utilizing an activating apparatus which is a communication with the
smart memory material and by virtue of the change in the physical
state can cause the movement of the knife thereby facilitating the
cutting of the desired body portion.
[0010] It is also an object of the present invention to describe a
method of performing a surgical operation employing the
above-described surgical device for cutting a portion of the
body.
SUMMARY OF THE INVENTION
[0011] Described is a surgical device for cutting a portion of a
body comprising a knife capable of moving from a first position to
a second position which is spaced apart from the first position; a
smart memory material (SMM) capable of going from one physical
state to another physical state; and an activating apparatus which
is in communication with the smart memory material and which can
cause the change in the physical state of the smart memory
material, which change in state causes the movement of the knife
thereby facilitating cutting of the desired body portion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a top view of the surgical device of the present
invention.
[0013] FIG. 2 is a side-sectional view of the surgical device of
the present invention showing movement of the anvil in an open
phantom view.
[0014] FIG. 3 is a side-sectional view of the surgical device of
the present invention showing the smart memory material aligned
with a store of staples.
[0015] FIG. 4 is a schematic view of the surgical device of the
present invention in a ready state.
[0016] FIG. 5 is a schematic view of the surgical device of the
present invention in an engaged state depicting the attachment of
the staples and movement of the surgical knife.
[0017] FIG. 6 is a side-sectional view of one embodiment of the
surgical device of the present invention in the ready state.
[0018] FIG. 6A is a side-sectional view of one embodiment in the
engaged state; namely, the staples are secured towards the
anvil.
[0019] FIG. 7 is a side-sectional view of the surgical device of
the present invention depicting the surgical knife in a recessed
area.
[0020] FIG. 8 is a side-sectional view of the surgical device of
the present invention showing the surgical knife in an engaged
position, out of the recessed area.
[0021] FIG. 9 is a side-sectional view of a second embodiment of
the surgical device of the present invention in a ready state.
[0022] FIG. 10 is a side-sectional view of the second embodiment of
the surgical device of the present invention in an engaged view
with the staples secured.
[0023] FIG. 11 is a sectional view through lines 11-11 of FIG.
3.
[0024] FIG. 12 is a sectional view along the lines 12-12 of FIG.
3.
[0025] An alternative embodiment of the invention is shown in FIGS.
13-15 and 17-19. FIG. 13 is a side-sectional view of an alternative
embodiment of the present invention.
[0026] FIG. 14 is a side-sectional view of an alternative
embodiment of the present invention wherein the surgical knife is
in a first position prior to a surgical cutting operation.
[0027] FIG. 15 is a side-sectional view of an alternative
embodiment of the present invention wherein the surgical knife is
in a second position from the first position of FIG. 14 wherein the
surgical knife has moved from the first position to the second
position.
[0028] FIG. 16 is another embodiment of the invention.
[0029] FIG. 17 is a sectional view taken along the lines 17-17 of
FIG. 13.
[0030] FIG. 18 is a sectional view taken along the lines 18-18 of
FIG. 13.
[0031] FIG. 19 is a perspective view of a wedge with surgical knife
utilized in the present invention.
[0032] FIG. 20 is an alternative embodiment of the wedge with
surgical knife utilized in the present invention.
DETAILED DESCRIPTION OF THE INVENTION
Definitions:
[0033] Smart memory material (SMM) means a material or composition
that can move from a first to a second physical state and then back
to its desired original physical state by activation or stimuli.
The change in state may result in an increase in volume of the
SMM.
[0034] An "activating apparatus" means an apparatus that can
stimulate the SMM thereby changing the state. The stimuli can be
the application of heat and/or electrical current to SMM or some
other mechanism that can effectuate the change in physical state.
One example of physical state change is going from a martensite
phase to an austenite phase.
[0035] The application of smart memory material can simplify a
surgical stapling device into four basic components: a staple
cartridge, an anvil for staple closure, an energy/power source
(remote or local) and a switch/trigger (remote or local). The
staple cartridge contains the surgical staple, a surgical blade and
a SMM actuator/driver. The actuator/driver is used to drive the
surgical staple from the cartridge, through the tissue and into
contact with the anvil to initiate closure of the staples. The
actuator/driver is also used to drive the surgical blade to create
an incision in the tissue. The energy/power source is to supply the
thermal energy or magnetic field to elicit a response of the smart
materials actuator/driver and is triggered by the switch.
[0036] The flexibility of this concept provides several advantages
over current devices as follows: [0037] Staple actuator/driver can
be located in the staple cartridge with staple [0038] Surgical
blade and actuator/driver may be incorporated in staple cartridge
[0039] Staple cartridge and anvil may be affixed to any
device/handle for positioning during procedure [0040] Staple
cartridge and anvil mechanism may be adapted to endoscopic or
laparoscopic surgical procedures [0041] Staple cartridge is not
limited in length by a mechanical actuation device [0042] The
staple cartridge may be of various cross sections to fit the
surgical application [0043] The surgical device may work with any
form or size staple [0044] Staple cartridge may contain one, two, .
. . to n staples in one, two, . . . n rows [0045] Staple cartridge
may be configured to staple in linear, circular, concave, convex,
parabolic or zigzag patterns, and the like [0046] The device
facilitates driving individual staples from the staple cartridge
sequentially, alternately and any combination thereof, and the like
[0047] The device facilitates driving multiple staples or sets of
staples in one operation [0048] The device facilitates driving sets
of staples from a staple cartridge in a variety of configurations:
single, multiple or alternating rows [0049] The device may be
utilized to tack surgical incisions
[0050] The surgical device herein is designed in such a way that it
may be attached to any type of handle or device to
articulate/manipulate its position and/or orientation. If the
handle or device has the ability to articulate +/-180.degree. (yaw)
and rotate 360.degree., the desired development can be articulate
through these extremes. This is possible because of the simplicity
of the interface between the staple cartridge and the
handle/device. The interface need only contain a method to hold the
staple cartridge and an electrical connector. The electrical
connector can be nothing more than electrical contains that are
engaged by the staple cartridge when it is attached to the
handle/device. The electrical connector is used to supply a voltage
via small wires from the switch which is connected to the energy
source. The electrical connector, integral to the staple cartridge,
connects to the SMM contained in the cartridge to eject the staple
when the voltage is supplied via the switch.
[0051] In the various embodiments, similar components use the same
reference numerals.
[0052] For a first embodiment FIGS. 1 and 2 show the top sectional
and side cross section of one embodiment for a surgical (stapling)
device 20. The surgical (stapling) device 20 has an energy source
21, contained in the body 27 of the device, a switch 22 that
triggers the energy source, an anvil 23, a handle 26 to actuate the
anvil 23 and a staple-actuator cartridge 24. There is also upper
cover 33 and lower cover 35.
[0053] The handle 26 is pivoted about pin 25. The anvil 23 pivots
about pin 28 and is connected to the handle 26 by pin 29, which
rides in a slot 30 in the body 27. As handle 26 is rotated from the
opened (FIG. 2) to the closed position (FIGS. 1 and 3), the anvil
23 is then rotated from an open position to a closed position to
clamp tissue (not shown) between the surface of the anvil 23 and
the upper surface 31 of the staple-actuator cartridge 24.
[0054] The energy source 21, in a generic sense, is any source of
power that initiates or elicits a response in a smart memory
material. Examples are not limited to but include a voltage being
applied directly to SMM to create a current that generates heat, a
voltage being applied to a coil to generate heat or a magnetic
field to stimulate the smart memory material. The energy source may
also encompass any electrical, fluid, magnetic or chemical reaction
that can be used to elicit a response from a smart memory material.
The energy source may be a heating or cooling source.
[0055] In the staple-actuator cartridge 24, there is a plurality of
staples 40 contained in a plurality of slots 41, as shown in FIGS.
6 and 6A. The plurality of staples 40 may be configured in single
row or parallel rows (not shown). In the staple-actuator cartridge
24, a plurality of staples 40 are located in a plurality of slots
41 against the forward walls 42 and aft walls 43 of slots 41. The
forward walls 42 and aft walls 43 act, as guides for staples 40 and
pushers 49. The staples 40 are located in the downward position 44
against upper surface 45 of pushers 49. The plurality of pushers
49, is generally equivalent to the number of slots 41 and plurality
of staples 40 having grooves in which a driver 50 is contained. The
driver 50 is formed from smart memory material, for the embodiment
shown in FIGS. 6, 6A and runs from the forward end 51 of the
staple-actuator cartridge 24 to the aft end 52 of the
staple-actuator cartridge 24. The SMM driver 50 is attached to the
energy source 21 at connector 46.
[0056] FIGS. 4 and 5 show a block diagram for the control logic for
the embodiment in FIGS. 6 and 6A.
[0057] When switch 22 is moved from the neutral position to the
forward position, the energy source 21 will apply a voltage to the
driver 50. The voltage in this instance can only be applied after
the safety interlock(s) 51 are closed. As the voltage passes into
driver 50, the resistance of the smart memory material will begin
to generate heat. As the heat (energy) increases, the smart memory
material will begin to go into a phase change such as from
martensite to austenite. As this phase change occurs, driver 50
will begin to contract, causing the plurality of pushers 49 to move
upward. As the plurality of pushers 49 move upward the plurality of
staples 40 will begin to be ejected from the staple-actuator
cartridge 24 and make contact with anvil 23. As driver 50 continues
to contact, a force sufficient to completely drive the plurality
staples 40 from the staple-actuator cartridge 24 and against anvil
23 to cause the plurality staples 40 to deform into their closed
position 41 as shown in FIGS. 5 and 6A, securing the tissue (not
shown). By closed position is meant that the legs of the staple are
crimped, preferably together in slots 61 securely fastening the
tissue to itself or to a mesh or substrate (not shown).
[0058] Contained in the staple-actuator cartridge 24, are driver
60, pusher 61 and surgical blade 62 as shown in FIGS. 5, 7 and 8.
When switch 22 is moved from the forward position through the
neutral position into the rearward position, the energy source 21
will apply a voltage to driver 60. The voltage in this instance
preferably is applied after the safety interlock indicating
completed staple ejection is closed. As the voltage passes into
driver 60, the resistance of the smart memory material will begin
to generate heat. As the heat (energy) increases, the smart memory
material will begin to go into a phase change from martensite to
austenite. As this phase change occurs, driver 60 will begin to
contract, causing pusher 61 to move upward. As driver 60 continues
to contract, sufficient force is generated to drive pusher 61
upward, in turn driving surgical blade 62 into its upwardmost
position as shown in FIG. 8. As the surgical blade 62 is driven
upward, it can make an incision into the tissue between the rows of
staples.
[0059] An alternative embodiment is shown in FIGS. 9 and 10. In the
staple-actuator cartridge 24, there is a plurality of staples 40
contained in a plurality of slots 41. From this point forward in
this embodiment, the device will be described in the singular since
for clarification.
[0060] In the staple-actuator cartridge 24, the staple 40 is
located in slot 41 against the forward wall 70 and aft wall 71.
Staple 40 is located in the downward position 72. The SMM driver 75
is folded in such a way as to form an "S" shaped forward leg 76 and
aft leg 77. The driver 75 is trapped between staple 40, the
reaction surface 80, forward wall 70 and aft wall 71. When the
energy source 21 applies a voltage (energy) to the driver 75,
forward leg 76 and aft leg 77 will expand. As forward leg 76 and
aft leg 77 expand, the upper segment (in the shape of a bar) 78 of
the driver 75 reacts against the bottom leg 81 of staple 40 and
reaction surface 80. As the forward leg 76 and aft leg 77 expand,
the forward end 82 and aft end 83 of upper bar 78 are guided by the
forward wall 70 and aft wall 71 of staple-actuator cartridge 24. As
the forward leg 76 and aft leg 77 expand, the staple 40 is moved
linearly until it contacts the surface of the anvil 23 to initiate
closure of the staple 40. The forward leg 76 and aft leg 77 expand
until staple 40 is ejected from staple-actuator cartridge 24 and
forward staple leg 85 and aft staple leg 86 are fully closed or
crimped as shown in FIG. 10, securing the tissue and/or mesh or
substrate (not shown).
[0061] The surgical stapling device can be configured to eject the
staples from the staple-actuator cartridge individually or in any
combination. A solid-state logic controller in the stapling device
handle can facilitate this feature which one of ordinary skill in
the art can assemble.
[0062] It is to be appreciated that the staple-actuator cartridge
is not limited to linear forms. Because of the flexibility of the
smart material (i.e., shape memory alloys and shape memory
polymers), the staple-actuator cartridge can take on any form:
circular, concave, convex, parabolic, zigzag or the like. The cross
sectional shape of the staple-actuator cartridge can also be
tailored to meet the surgical need.
[0063] Another embodiment of the present invention is that depicted
in FIGS. 13-15.
[0064] The surgical device 100 has handle 106 and anvil 102. The
device contains the energy source 108 which is connected to the SMM
material 110 retained within assembly 112 having a top portion 114
and a bottom portion 116. The anvil 102 has an extension portion
118 that is engagement with the SMM material 110. As the SMM
material moves, the anvil 102 moves upward when viewing FIG. 13
causing arm 120 to rotate upward.
[0065] In the embodiment depicted in FIG. 13, a surgical blade 122
is attached to or a portion of a wedge 124 (best shown in FIG. 19)
which has attached thereto the SMM material 110. The wedge has
angled surface 126 to indicate the initiation of action. The wedge
has a bottom surface 128 and a back side surface 130 which forms
approximately a 90.degree. angle at their juncture 132. The wedge
124 has a top portion 134, a front portion 136 and side 138. Side
138 as can be seen from FIG. 19 is substantially smaller than back
side portion 130 reflecting the angled surface 126 from the back
portion 134 to the front surface 136. The wedge 124 has a groove
138 which rides a "T" shaped track. The wedge slides on the track
during the cutting operation of the blade. In a resting or first
position, the blade 122 is positioned at the front portion 140 of
the surgical device which may take any configuration but is shown
as a semicircular configuration for ease of insertion into the body
portion for ease of handling during a clinical operation. The
surgical device 100 has a bottom portion 142. The SMM material 110
can be secured to the wedge 124 by any convenient mechanism such as
by adhesion and the like, with or without the use of heat or other
securing method.
[0066] The surgical device 100 has a wedge receiving section 150 in
which top portion 152 receives the blade 122 and bottom portion 154
which receives wedge segment 124. The blade receiving slot 153 is
shown in FIG. 17.
[0067] As the wedge 124 moves from the position on the right as
shown in FIG. 13 to the end section 150, the front portion of the
wedge surfaces 136 & 126 initiation movement against pushers
160 and therefore against the staples 162 and against the bottom
surface 164 of the anvil thereby engaging body tissue. After the
staples engage the tissue, the blade 122 will cut the tissue.
[0068] FIGS. 14 and 15 are further details of the surgical device
of FIG. 13. FIG. 14 indicates that the surgical knife 122 is on the
right portion of the apparatus of the surgical device where the SMM
material 110A is circled about pulley 170 which rotates about pivot
point 104. The surgical knife moves from the right to the left as
shown in FIG. 15 where the surgical knife 122 fits into the
receiving segment 152. As the surgical knife moves from the right
to the left portion of the surgical device, the SMM material 110A
goes from a linear position as shown in FIG. 14 to a curled
position 174 in FIG. 15. In other words, by the application of heat
the SMM material goes from a linear mode as depicted in FIG. 14
into a more curled position where the curl is in segment 176 of the
FIG. 15. The operation of FIGS. 13-15 indicates that one SMM
material 110 operates the anvil to an open or closed position.
Another or different SMM material 110A activates the movement of
the surgical knife from the right portion of FIG. 14 to the left
portion of FIG. 15. While it is expected that these would be two
separate operable SMM materials, it is obvious to one of skill in
the art that the materials can be lengthened and there could be
separate segments that would have the ability to operate both
actions namely the movement of the anvil and the movement of the
blade. For convenience, the electrical connections of FIGS. 13-15
are not supplied in detail but would be clear to one of skill in
the art.
[0069] FIG. 16 is a schematic view of another alternative of the
present invention. The surgical device 100 of FIG. 16 is an
alternative embodiment of the operation of the wedge 124 and
surgical knife 122. In FIG. 16, the heating mechanism 108 is
attached to the SMM 110A. The embodiment shown in FIG. 16, however,
does not have the pulley arrangement as shown in FIG. 15. In the
embodiment of FIG. 16, the surgical knife moves from the right
portion of the surgical device 100 to the left portion of the
surgical device stopping at receiving position 150. The action of
the SMM is primarily retained in the horizontal plane of the
surgical device 100 without the SMM going around a pulley. In the
embodiment of FIG. 16, the SMM is primarily in a linearly fashion
and during the movement from one phase to another. The SMM can
collect in a retaining box 180 in FIG. 16.
[0070] FIG. 20 is an alternative embodiment of the wedge with
surgical knife utilized in the present invention.
[0071] The wedge 200 is comprised of sloping surfaces 202A and
202B. FIG. 20 is comprised of FIG. 20A which is a perspective view
of the wedge utilized in the present invention. FIG. 20B is a view
of FIG. 20A from the back. FIG. 20C is a view of FIG. 20A from the
front and FIG. 20D is an interior view of FIG. 20A showing the
attachment of the SMM to the interior portion of the wedge.
[0072] The wedge has exterior side surface 204 of bottom surface
206 and interior surface 208 exterior surfaces are 204A and 204B.
The surgical knife has a cutting edge 210 and a back portion 212.
Extension 214 of the blade likewise has angles for movement of the
wedge when it comes in contact with the pushers for movement of the
staples. The angle for surface 214 is comparable to that for
surfaces 202A and B. The SMM 220 is attached to the interior
surface 208A and B of the extension 214 of the surgical knife. The
wedge 200 has a front lip 230.
[0073] It is to be appreciated that the surgical device utilizing
its smart memory material need not utilize the knife portion. In
that case, the stapling device can operate as described herein.
Alternatively, the surgical device need not utilize the staple
portion. In which case the knife portion may be utilized as
described herein. Preferably, however, the knife and stapling
mechanism are utilized together as shown.
[0074] The driver for ejecting the staples from the staple-actuator
cartridge is not limited to smart memory alloy materials. A smart
memory polymer can also provide the actuating force and
displacement. Some smart memory materials include Nitinol (an
acronym for Nickel Titanium Naval Ordnance Laboratory) which is a
family of intermetallic materials, which contain a nearly equal
mixture of nickel (about 55 wt. %) and titanium. Some of those
alloy compositions are superelastic materials such as alloy N, S
and C and others are actuator materials, such as alloy B, M, H and
Flexinol (trademark of Nitinol Devices and Components for nickel
titanium intermetallic alloys).
[0075] Nitinol exhibits unique behavior. The two terms used to
describe this behavior are "Shape Memory" and
"Superelasticity".
[0076] SHAPE MEMORY: Shape memory effect describes the process of
restoring the original shape of a plastically deformed sample by
heating it. This is a result of a crystalline phase change known as
"thermoelastic martensitic transformation". Below the
transformation temperature, Nitinol is martensitic. The soft
martensitic microstructure is characterized by "self-accommodating
twins", a zigzag like arrangement. Martensite is easily deformed by
de-twinning. Heating the material converts the material to its high
strength, austenitic condition. The transformation from austenite
to martensite (cooling) and the reverse cycle from martensite to
austenite (heating) do not occur at the same temperature. There is
a hysteresis curve for every Nitinol alloy that defines the
complete transformation cycle. The shape memory effect is
repeatable and can typically result in up to 8% strain
recovery.
[0077] SUPERELASTICITY: Martensite in Nitinol can be stress induced
if stress is applied in the temperature range above Af (austenite
finish temperature). Less energy is needed to stress-induce and
deform martensite than to deform the austenite by conventional
mechanisms. Up to 8% strain can be typically accommodated by this
process. Since austenite is the stable phase at this temperature
under no-load conditions, the material springs back to its original
shape when the stress is removed. This extraordinary elasticity is
also called "pseudoelasticity" or transformational
"superelasticity". The typical stress-strain curve of a properly
processed Nitinol alloy shows the loading and unloading plateaus,
recoverable strain available, and the dependence of the loading
plateau on the ambient temperature as is well known in the art. The
loading plateau increases with the ambient temperature. As the
material warms above the austenite finish temperature, the
distinctive superelastic "flag" curve is evident. Upon cooling, the
material displays less elasticity and more deformation until it is
cooled to where it is fully martensite; hence, exhibiting the shape
memory property and recovering its deformation upon heating.
Nitinol alloys are superelastic in a temperature range of
approximately 50 degrees above the austenite finish temperature.
Alloy composition, material processing, and ambient temperature
greatly effect the superelastic properties of the material. For
medical devices binary Nitinol alloys, when processed correctly,
are at their optimum superelastic behavior at body temperature.
[0078] Nitinol Devices & Components manufactures binary Nitinol
materials with Afs ranging from -15 degrees centigrade to +100
degrees centigrade for both superelastic and shape memory
applications.
[0079] Smart memory materials can also be metallic alloys of
copper, zinc and aluminum or iron, nickel and aluminum, and the
like.
[0080] Many modifications and variations of the present invention
are possible in light of the above teachings. Therefore, it is to
be understood that within the scope of the appended claims, the
inventions may be practiced otherwise than as specifically
described. For example, numerous mechanisms may be available for
articulating and modifying the size and configuration of the
surgical device. Moreover, the reference numerals are merely for
convenience and are not intended to be in any way limiting.
Similarly, the components of the invention can be arranged relative
to one another in a variety of configurations other than those
shown.
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