U.S. patent application number 11/446646 was filed with the patent office on 2006-12-07 for tissue tension detection system.
Invention is credited to Henry E. Holsten.
Application Number | 20060276726 11/446646 |
Document ID | / |
Family ID | 37495064 |
Filed Date | 2006-12-07 |
United States Patent
Application |
20060276726 |
Kind Code |
A1 |
Holsten; Henry E. |
December 7, 2006 |
Tissue tension detection system
Abstract
An apparatus and a method for determining an amount of tension
applied to first and second organ sections during a surgical
procedure is disclosed. The apparatus includes first and second
contacts on a surgical fastener applier that are operably coupled
to a tension gauge and a tension indicator. The contacts may be
repositionable between a retracted position and an extended
position. The tension indicator may include audible and/or visual
indications and/or alarms for the amount of tension applied to the
first and second organ sections. Alternatively, the apparatus
includes an elongate member attached to the organ sections, wherein
a change in the characteristics of the member indicates an amount
of tension applied to the organ sections.
Inventors: |
Holsten; Henry E.;
(Covington, GA) |
Correspondence
Address: |
UNITED STATES SURGICAL,;A DIVISION OF TYCO HEALTHCARE GROUP LP
195 MCDERMOTT ROAD
NORTH HAVEN
CT
06473
US
|
Family ID: |
37495064 |
Appl. No.: |
11/446646 |
Filed: |
June 5, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60687214 |
Jun 3, 2005 |
|
|
|
Current U.S.
Class: |
600/587 |
Current CPC
Class: |
A61B 17/0682 20130101;
A61B 17/04 20130101; A61B 2090/064 20160201; A61B 2017/1107
20130101; A61B 17/11 20130101 |
Class at
Publication: |
600/587 |
International
Class: |
A61B 5/103 20060101
A61B005/103 |
Claims
1. A method for detecting an amount tension applied to organ
sections, comprising the steps of: providing a member that bridges
a gap at an anastomotic site and is operably associated with a
first organ section and a second organ section; moving the first
organ section towards the second organ section, thereby applying
tension to the organ sections; observing the member while the
tension is applied to the organ sections; and determining the
amount of tension applied to the organ sections by observing
changes in characteristics of the member.
2. The method of claim 1, wherein the characteristics of the member
are selected from the group consisting of: color, length, width,
and depth.
3. The method of claim 1, further comprising the step of: stopping
movement of the organ sections if the tension is greater than a
predetermined value.
4. The method of claim 1, wherein the step of determining the
amount of tension includes the step of moving the first organ
section towards the second organ section.
5. A device for indicating the amount of tension applied to organ
sections comprising: an elongate member having opposing ends,
wherein one end is attached to a first organ section and the
opposing end is attached to a second organ section such that
relative movement of the organ sections towards each other causes a
change in the physical characteristics of the elongate member
corresponding to an mount of tension applied to the first and
second organ sections.
6. The device of claim 5, wherein the device has a width and the
amount of tension is proportional to a change in the width of the
device.
7. The device of claim 5, wherein the device has a length and the
amount of tension is proportional to a change in the length of the
device.
8. The device of claim 5, wherein the device changes from a first
color to a second color, the change in color corresponding to the
tension applied to the device.
9. The device of claim 1, wherein at least one end of the device
separates from at least one organ section when the amount of
tension exceeds a predetermined amount.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to, and the benefit of,
U.S. Provisional Patent Application Ser. No. 60/687,214, filed on
Jun. 3, 2005, the entire disclosure of which is incorporated by
reference herein.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates to a method and/or apparatus
for measuring the tension in body tissue. More particularly, the
present disclosure relates to a method and/or apparatus for
measuring the tension in body tissue at a site of a surgical
anastomosis.
[0004] 2. Background of Related Art
[0005] Anastomosis is the surgical joining of separate hollow organ
sections. Typically, an anastomosis procedure follows a surgical
procedure in which a diseased or defective section of hollow tissue
is removed and the remaining end sections are drawn together and
joined. Depending on the desired anastomosis procedure, the end
sections may be joined by either circular, end-to-end, or
side-to-side organ reconstruction methods.
[0006] In a known circular anastomosis procedure, two ends of organ
sections are drawn together and joined by means of a stapling
device which drives a circular array of staples through the end of
each organ section and simultaneously cores any tissue interior of
the driven circular array of staples to free a tubular passage.
Examples of devices for performing circular anastomosis of hollow
organs are described in U.S. Pat. Nos. 6,053,390; 5,588,579;
5,119,983; 5,005,749; 4,646,745; 4,576,167; and 4,473,077, each of
which is incorporated herein in its entirety by reference.
Typically, these devices include an elongated shaft having a handle
portion at a proximal end thereof to effect actuation of the device
and a staple holding component disposed at a distal end thereof. An
anvil assembly including an anvil shaft with attached anvil head is
mounted to the distal end of the device such that the anvil head is
movable towards the staple holding component. The two ends of the
organ sections are drawn together and clamped between the anvil
head and the staple holding component of the device by securing one
end of the organ section to the anvil assembly, securing the other
end of the organ section about the staple holding component, and
moving the anvil head towards the staple holding component. The
clamped tissue is stapled by driving one or more staples from the
staple holding component so that the ends of the staples pass
through the organ sections and are deformed by the anvil head. An
annular knife is concurrently advanced to core tissue within the
hollow organ to free a tubular passage within the organ. Typically,
this procedure is conducted endoscopically or laparoscopically
using endoscopic instruments.
[0007] Although the circular anastomosis procedure described above
has provided substantial improvements to surgical procedures
requiring anastomosis, additional improvements are desired. For
example, when the two ends of the organ sections to be anastomosed
are drawn together, tension is generated in the organ sections.
Because of the type of surgery, it can be difficult for a surgeon
to determine how much tension is being or has been applied to the
organ sections at the anastomotic site. Excessive tension on the
organ sections at the anastomotic site may result in complications,
e.g., strictures, postoperative leaks, necrosis, etc.
[0008] Accordingly, it would be desirable to provide a surgical
apparatus and/or method for measuring the tissue tension at an
anastomotic site and providing a surgeon with immediate data
indicating the magnitude of the tension. It would also be desirable
to provide an apparatus which is suitable for use with a circular
anastomosis device and could measure the initial and residual
tension at an anastomotic site during a surgical procedure.
SUMMARY
[0009] In one embodiment, an apparatus positioned on a circular
anastomosis fastener applier is provided in accordance with the
principles of the present disclosure. The apparatus includes a
first contact located on an anvil assembly and a second contact
positioned on a staple cartridge. The first and second contacts may
be movable between an extended position for contacting the organ
sections and a retracted position. The anvil assembly is
repositionable towards and away from the staple cartridge. The
first and second contacts are operably connected to a tension
gauge, which provides a signal to a tension indicator. The tension
indictor provides visual and/or audible indication of the amount of
tension applied to first and section organ sections that are to be
anastomosed. As the first organ section is moved towards the second
organ section, the first contact is moved towards the second
contact, thereby providing an input for the tension gauge and
ultimately an indication on the tension indicator as to the amount
of tension applied to the organ sections. The tension indicator may
be located on a housing of the fastener applier or may be remotely
located therefrom. In addition, the tension indicator may include
audible and/or visual alarms that alert the operator that a
predetermined tension has been achieved.
[0010] In another embodiment, the first and second contacts are
fixed in position on the anvil assembly and the staple
cartridge.
[0011] In a further embodiment, a device is provided for attachment
to first and second organ sections in accordance with the
principles of the present disclosure. The attached device may be
viewed with an endoscope. The device is a generally elongate
member, wherein one end of the member is attached to a first organ
section and an opposing end is attached to a second organ section.
As the organ sections are drawn together, tension applied to the
organ sections is also applied to the member. When a predetermined
amount of tension is applied, the member may change color or one of
its physical dimensions (i.e. length, width, or thickness).
Alternatively, one or both ends of the member may separate from its
attachment point to an organ section. Further still, the member may
be positioned such that there is a predetermined amount of slack in
the member prior to the anastomotic procedure. As the organ
sections are drawn towards one another, the slack in the member is
taken up. When the predetermined amount of tension is achieved, the
member will be taut, thereby providing visual indication to the
operator.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] Embodiments of the presently disclosed apparatus are
described herein with reference to the drawings, wherein:
[0013] FIG. 1 is a front perspective view of an embodiment of the
presently disclosed apparatus;
[0014] FIG. 2 is a front perspective view of an alternate
embodiment of the presently disclosed apparatus;
[0015] FIG. 3 is a side view of another embodiment of the presently
disclosed apparatus located at an anastomotic site between two
organ sections;
[0016] FIG. 4 is a side view of a further embodiment of the
presently disclosed apparatus located at an anastomotic site
between two organ sections with no tension applied to the organ
sections; and
[0017] FIG. 4A is a side view of the apparatus of FIG. 4 with
tension applied to the organ sections.
DETAILED DESCRIPTION OF EMBODIMENTS
[0018] Embodiments of the presently disclosed method and apparatus
for measuring tissue tension at an anastomotic site will now be
described in detail with reference to the drawings wherein like
numerals designate identical or corresponding elements in each of
the several views. As is common in the surgical apparatus art, the
term proximal will refer to a location on the device closer to the
operator of the device, e.g., surgeon, while the term distal will
refer to a location on the device further away from the operator of
the device.
[0019] FIG. 1 illustrates one embodiment of the presently disclosed
apparatus for measuring tissue tension at an anastomotic site shown
generally as 10. Apparatus 10 is supported on a circular
anastomosis fastener applier shown generally as 20. Apparatus 10
includes a pair of contacts or leads 12 and 14 which are positioned
at a distal end of circular anastomosis fastener applier 10.
Contact 12 includes a first end positioned to extend through an
opening 16 formed in an anvil assembly 22 of fastener applier 20. A
second end of contact 12 communicates with a tension gauge (not
shown), e.g., strain gauge, supported within housing 24 of fastener
applier 10. Contact 14 includes a first end positioned to extend
through an opening 19 defined in a staple holding component or
staple cartridge 26 of fastener applier 20. A second end of contact
14 communicates with the tension gauge in housing 24 (not shown).
Contacts 12 and 14 are positioned to contact each organ section
adjacent the anastomotic site to supply a signal indicative of the
magnitude of tissue tension to the tension gauge. The tension gauge
translates the signal sent by contacts 12 and 14 into data
identifying the magnitude of tension in the organ sections.
Contacts 12 and 14 can be connected to the tension gauge by wires
or the like. In one embodiment, a tension indicator 30 is supported
on housing 24. Tension indicator 30 communicates with the tension
gauge to display in real time the tension in the organ sections. It
is envisioned that fastener applier 20 may include a part which is
connectable to a strain gauge and indicator which are located
externally of housing 24.
[0020] During an anastomotic procedure, anvil assembly 22 is
repositioned towards staple cartridge 26 and moves a first organ
section towards a second organ section, thereby applying an amount
of tension to the organ sections. Anvil assembly 22 is
repositionable, in relation to staple cartridge 26, throughout a
plurality of positions including a first position that is spaced
apart from staple cartridge 26 and a second position that is in
close cooperative alignment with the staple cartridge 26.
[0021] In one embodiment, contacts 12 and 14 are retractable into
and out of openings 16 and 19, wherein contacts 12, 14 are
repositionable between an extended position and a retracted
position. In one embodiment, contacts 12 and 14 are extended from
openings 16 and 19 in response to approximation of the anvil
assembly 22 and staple holding component 24. Alternatively, a
manual switch may be provided to extend the contacts.
[0022] FIG. 2 illustrates an alternate embodiment of the presently
disclosed apparatus for measuring tissue tension at an anastomotic
site shown generally as 100. Apparatus 100 is similar to apparatus
10 in that apparatus 100 includes a first contact 112 mounted on an
anvil assembly 122 of fastener applier 120 and a second contact 114
mounted on a staple holding component or staple cartridge 124 of
fastener applier 120. However, contacts 112 and 114 are flat
contacts which are mounted on an outer rim of both anvil assembly
122 and staple holding component 124 at a position to contact organ
sections at a location adjacent the anastomotic site. Each contact
112 and 114 communicates with a tension gauge (not shown) supported
within fastener applier 120 which communicates with a tension
indicator 130 as discussed above with respect to apparatus 10. As
discussed above, it is envisioned that the tension gauge and
indicator may be located externally of the fastener applier.
[0023] In a further embodiment, tension indicators 30, 130 may
include an audible and/or visual alarm indicator (i.e. red light,
buzzer, horn, bell, etc.) that informs the operator that a
predetermined amount of tension is being applied to the organ
sections. The setting for the alarm indicator is operator
adjustable and the procedure to be performed is one of several
criteria that is considered when establishing the predetermined
amount of tension for the alarm setting.
[0024] FIG. 3 illustrates another embodiment of the presently
disclosed apparatus for measuring tissue tension shown generally as
200 which is separate from a fastener applier. Apparatus 200 can be
applied across an anastomotic site 230 to produce a reference
indication of the magnitude of the tension where the organ sections
are joined. Apparatus 200 includes an elongated member 210 formed
of a material which bridges anastomotic site 230 and is, in one
embodiment, initially slack. When excess tension exists in the
anastomosed tissue, the material goes taut or releases from the
tissue. In another embodiment, member 210 is secured to organ
sections 232 and 234 using an adhesive or the like. Member 210 can
be monitored endoscopically using an endoscope or other viewing
equipment. Although apparatus 200 is illustrated as a strip of
material, it is also contemplated that apparatus 200 may be a
suture or any other material for maintaining the two sections of
the anastomotic site in close approximation. It is further
contemplated that apparatus 200 may be formed of a biocompatible
and/or bioabsorbable material.
[0025] In another embodiment shown in FIG. 4, device 300 is formed
of a body of material 310 which can be visualized via x-ray, MRI,
CT scan, ultrasound or any other known device. Body of material 310
is positioned to bridge an anastomotic site 330. In one embodiment,
when excess tension is present in the tissue or organ sections 332
and 334, body 310 undergoes a physical change to indicate excess
tension at anastomotic site 330, e.g., body 310 may be stretched
(see FIG. 4A), such that the change in the width and/or length of
body 310 is indicative of the change in tension applied to organ
sections 332 and 334. Further still, changes to the thickness of
body 310 indicate the change in tension applied to organ sections
332 and 334. It is envisioned that other changes may occur upon
application of tension to body 310, e.g., a color change may occur
from a bioabsorbable marker, or a release from the organ sections
may indicate a change in tension, etc.
[0026] The embodiments illustrated in FIGS. 3-4A are configured for
measuring the tension applied to organ sections 232 and 234 or 332,
334 prior to approximation of the organ sections with a surgical
stapling apparatus as well as during approximation and subsequent
to the approximation. Further still, the disclosed embodiments are
capable of measuring and indicating the amount of tension applied
to the organ sections before, during, and after the firing of
surgical staples from the surgical stapling apparatus. It is
contemplated that devices 200, 300 may be formed from an elastic
material as well as non-elastic materials.
[0027] In one embodiment, device 200 (FIG. 3) is attached to organ
sections 232, 234 prior to approximation of organ sections 232,
234. This occurs after a section of the subject organ is removed
between organ sections 232, 234. Device 200 is attached using known
endoscopic techniques through an access port (e.g. cannula) (not
shown). Once attached, device 200 may be monitored through the
access port using an endoscope (not shown). As organ sections 232,
234 are approximated using a circular anastomosis fastener (i.e.
apparatus 10 as shown in FIG. 1) tension is applied to organ
sections 232, 234. If the applied tension exceeds a predetermined
amount, device 200 may detach at one or both attachment points or
have a certain amount of slack between the attachment points.
Specifically, once device 200 is attached to the spaced apart organ
sections 232, 234, movement of the organ sections towards one
another (i.e. approximation) reduces the tension applied to device
200 and causes it to sag or go slack, whereupon, device 200 may
detach from one or both of its attachment points.
[0028] In an alternate embodiment, device 200 is attached as
described hereinabove to organ sections 232, 234 after
approximation, but prior to joining organ sections 232, 234. In
this configuration, the practitioner observes device 200 as before.
If the tension applied to organ sections 232, 234 exceeds a
predetermined amount during the joining of the sections, device 200
may detach from one or both of the organ sections or go slack, as
discussed hereinabove.
[0029] In a further embodiment, device 200 is attached as discussed
hereinabove to organ sections 232, 234 after organ sections 232,
234 are anastomosed. In this configuration, device 200 is observed
as before, wherein tension in the anastomosed organ sections 232,
234 will create tension in the attached device 200. If the tension
exceeds a predetermined amount, device 200 may stretch and/or
deform, thereby indicating an excess tension condition.
Alternatively, device 200 may include a sac of ink or dye that is
released upon exceeding a predetermined amount of tension.
[0030] In another embodiment, a marker which reacts to strain or
tension is applied to one or both of the organ sections to be
joined. The marker can be an ink, polymer, or the like. When excess
tension or any strain exists in the tissue sections, the marker
reacts to the strain to provide an indication or reference of
magnitude. The marker's reaction to the amount of tension applied
to the organ sections may include changes in the marker's physical
dimensions, a change in the marker's color, a reduction in an
amount of slack in the marker, or separation of one end of the
marker from an organ section. In addition, markers or devices 200,
300 may include a container (e.g. a pouch or a sac) that is
embedded in marker 200, 300 such that an indicator (e.g. an ink or
a dye) stored in the container is released when the tension applied
to the organ sections exceeds a predetermined value.
[0031] In yet another embodiment, an electromechanical device may
be operatively connected across the anastomotic site. The
electromechanical device is configured to provide an output which
provides an indication or measurement of tension at the site.
[0032] It will be understood that various modifications may be made
to the embodiments disclosed herein. Thus, the above description
should not be construed as limiting, but merely as illustrative of
the disclosed apparatus and method. Those skilled in the art will
envision other modifications within the scope and spirit of the
claims appended hereto.
* * * * *