Note: Descriptions are shown in the official language in which they were submitted.
~ WO 9Y13747 2 ~ 7 6 5 8 a PCI'NS93111094
~.
APPARATUS FOR SlMULTArlEOUSLY HOLDING AND SEALING TISSUE
pr. OF ThE IN~ilENTTON
This invention relates to a method and
apparatus f or sealirlg incisions on skin or other
organ surfaces by drawing and holding the edges of
the inriRio~ in tight proximity to form a seam while
5 directing thermal enl-rgy onto the seam to denature
the protein substance therein.
Optical energy tranS~formed to thermal energy has
been used to convert biological tissue into a
denatured prot~-;n~lr~ R substance for facilitating
10 healing and wound cll~sure. This healing technique
is referred to generally as laser tisS~ue welding.
Examples of such laser tissue welding methods are
eRrrih~d in U.S. Pat~nt No.~s 4,672,969, 4,854,320,
5,002,051, and 5,14~,984. These methods deliver
15 optical energy to tightly approximated tis~ue in the
vicinity of a wound. This application of thermal
energy results in the denaturation of tissue protein
inrlllt~in~ collagen, with disruption of the cell
walls which allows the intra- and intercellular
20 fluids to mix. Additional heat further denatures
this protein soup which binds together creating
something akin to a "biological glue".
In many prior methods of optical energy wound
closure, thermal energy is delivered through an
25 optical f iber to the tissue bein~ reconstructed .
Typically, one end o~ the fiber is connected to a
laser that supplies optical energy to the wound
site . Another end of the f iber is typically 3paced
a predett~rmined distance from the tissue, the
30 distance t~t~rt~ntling on the tissue type. A foot pedal
or hand held device activates and deactivates the
laser. The parameters such as intensity and
WO 95/13747 - - ~ 1 7 6 5 8 0 PCT/US93/1109
duration of the optical energy are controlled 80
that substantially all of the tissue being heated is
raised to a predet~rmine-l noll de~ructive
temperature. The minimum predetf~rmin~d temperature
5 is one at which tissue is converted to a denatured
proteinaceous substance. The maximum predetc rm;n~l
temperature is one at which water in the tissue
boils .
Critical to tissue welding methods is the
lO necessity to place edges of tissue being repaired in
tight approximation. Placing the tissue edges in
cloae or tight proximity allows the denatured tissue
constituents to form an intercel 1111Ar matrix
resulting in tissue fusion. Certain skin tissue
15 types require precision when applying the optical
energy to seal the edges. A drawback to a current
skin tissue welding procedures is that to ensure
precision, the optical energy must be applied slowly
and carefully thereby increasing the application
2 0 time .
Another drawback to a laser tissue welding
procedure is that when closing an i n~ n, the
laser tissue welding surgery can be unnecessarily
tedious as the surgeon welds at successive points
25 along the incision. This welding process is
,- ~1 it ated because the distal end of the optical
fiber that directs the energy for the welding must
be placed a predet~rmi n~cl distance to the tissue
being reconstructed or the area being reconstructed.
30 If the distal end of the ~iber is not at the
predet~rm;n~cl distance from the area being sealed or
reconstructed, the tissue temperature would be
heated outside the aforementioned predet~rm; n
temperature range for proper tissue fusion.
-
~ WO 95/13747 ~ ! 2 1 7 6 5 8 0 311 1094
8U2QLaRY OF TI~E lhv~A~l~
An object of lthis invention is to provide an
vved method and apparatus for reconstructing
tissue .
Another object-of this invention is to provide
an apparatus through which laser welding energy
passes and is directed at the tissue that is to be
sealed or fused.
It i8 al30 an object of this invention to place
a device adjacent 7to the tissue to cause the
formation of a proteinaceous framework for denatured
protein in the vicinity of biological tissue to seal
tissue with greater~ ~ff~ nry and less time.
It is another object of this invention to
reconstruct tissue that have; n~ i nn~:l or lesions by
placing an apparatus above the surface of the tissue
and by delivering energy to areas along the incision
~eam .
It is further an object of this invention to
reconstruct tissue ~rith any energy source, such as
an ultrasonic or thermal source, while maintaining
at all times proper distance between a media
delivering the energy to the tissue itself so that
the final temperaturl~ of the tissue may be precisely
maintained .
It is an additional object of this invention to
seal an i nt~i ~ j nn in tissue by moving edges of the
; n~ nll in tight approximation to f orm a seam and
maintaining the edgeg in Al i ~ L while heating the
tissue along the seam.
These and other objects are providing with an
apparatus for sea~ing tissue having a first
elongated member pivotally -n~a~; n~ a second
elongated member to form a clamp that opens and
closes. The member!; have an edge with a surface
W0 95/13747 Z 1 7 6 5 8 ~ PCT/US93/11094
adapted to grasp tissue and pull the edges of the
tissue into close approximation to form a seam when
the clamp closes. An energy source provides energy
which is capable of heating the tissue to f orm an
5 adhesive prot~i n~ oll~ substance. The source is
optically coupled to a layer of material that is
supported by at least one o~ the members and that is
tr~nsmissive to the energy that heats tissue. A
delivering device directs energy from the source
10 through the layer of material or through portholes
that nllow the energy source to be recessed from the
tissue at the tissue seam when the edges are pulled
into close or tight approximation. The layer of
material has a ~hi~kn~cs that maintains a
15 predet~mi n~l distance between the directing device
and the tissue seam when energy from the source is
directed at the tissue.
~ W0 95/13747 .~ 2 ~ 7 ~ 5 8 0 PCT~US93~11094
BRIEF L ~S~;KIr 1~ OF THE
Figs. 1 and 2 j are pel~e~:~ive views of the
apparatus for simultaneously sealing and holding
tissue, where Fig. 1 iB a view of the apparatus
holding tissue, and where Fig. 2 is a view of the
5 apparatus prior to grasping the tissue;
Fig. 3 is a front sectioned view along line 3-3
of Fig. 1, and
Fig. 4 iB a top view of the apparatus shown in
Fig. 1. ~
.
.
W095/13747 , : ' ~ 2 ~ 76580 PCT/US93/11094~
DL.D~nIr l~ OF THE l.~rrrCr~L EMi30DIMENTS
Ref erring to Figs . 1-2, there i5 shown an
apparatus 10 for tissue welding having an energy
source 12 optically connected to a proximal end of
a delivery device 14. A distal end of delivery
device 14 is connected to clamp 16. Clamp 16
engages with tissue 18 to pull edges 20 and 22 of
lesion or; nr; F~ n 24 together in tight contact to
form a seam 26. Once engaged, optical energy from
source 12 is fed through device 14 and clamp 16 to
seam 26. The optical energy is applied with
sufficient amplitude and duration to heat tissue 18
to an adhesive protr-; n~reO~l~ substance to seal the
seam 2 6 .
Referring to Figs. 1-4, clamp 16 includes a
first elongated member 28 pivotally connected with
rod 30 to second elongated member 32. A spring (not
shown~ may be attached to rod 30 and members 28 and
32 to close clamp. First and second elongated
members 28 and 32 have edges 34 and 36 respectively
which engage the surface of tissue 18. Edges 34 and
36 extend parallel to each other and seam 26.
Connected t~ one end of members 28 and 32 are
handles 40 and 42 which permit a user to rotate
members 28 and 32 on rod 30.
Connected to and extending parallel to rod 30
between members 28 and 32 is transmissive material
44. Material 44 is transparent to energy being
emitted through delivery device 14 to seal seam 26.
Material 44 has two functions. First when edges 20
and 22 are pulled in tight contact, the tissue 18
contacts material 44 and its edges are held in
alignment. Thus material 44 prevents tissue edges
20 and 22 from ke ~nq overly everted or inverted.
Second, Material 44 maintains the proper spacing
~ W095113747 - ~ 2 ~ 7 6 5 8 0 PcTlus93lllo94
i
between the distal e~ld of device 14 and the surface
of tissue 18. By maintaining the proper spacing,
the tissue 18 is precisely heated to a pr~ t~rr;ne
temperature range bounded by a minimum t~ _ ~Lu- e:
5 at which tissue denatures, and a maximum temperature
at which water in tissue boils.
The preferred thiCl~n~cc of the tr~n~;Csive
material when the tissue 18 is skin is summarized in
the following Table I. These parameters are by no
10 means all exclusive; it is envisioned that other
parameters can be uslr~d with modifications and it is
intended that this table be exemplary of a preferred
L only.
TABLE I
IJ~SER P~UAIIE7ERS FOR Sl~IR TISSUE
T i ssue Hater i a l Spot 5 i 2e Ranae of E~posure Ap, rox .
Thickness Thickness Diameter power Duration Tissue Flnal
~m10 (rm) ~with 400 ~ ~watts) On/Off Energy Trans-
fiber) ferred J/~H2
3 3 .925-1.14 rm 1.65-1.85 1.0 sec/ 13.31
1.0 sec
Rather thaD directing energy through material
44, delivery device 14 may optionally direct energy
through a porthole 52 (FIG. 3) in material 44 that
allows the distal en~ of device 14 to be recessed
from tis~cue 18. In another I ' _';r nt, delivery
device 14 can be 3~ositioned in material 44 to
directly contact tissue 18.
t Energy source 12 is preferably a Laser energy
source emitting coherent light energy from about 1.2
- 10 to 1. 4 micrometers. ~Energy source 12 is preferably
SUBSIITIII~ SHEEr (I~ULE 2B~
WO9S/13747 ` ~ 2 1 7 6 5 8 0 PCr/US9311109~ ~
enabled and disabled by a foot activator 50 or a
switch (not shown) positioned on handle 40 or 42.
The distal end of delivery device 14 is
positioned between material 44 and rod 30. The
5 delivery device 14 which source 12 is connected, i8
preferably a fiber optic cable which is capable of
side firing at its distal end (See Fig. 4~.
Although a side f iring optic cable is shown as
delivery device 14, cables which have end firing may
10 be used as well.
During operation of apparatus 10, clamp 16 is
positioned over; nni ~:inn 24 so that delivery device
14 distal end aligns with the incision 24. Once in
position, handles 40 and 42 are rotated by the user
so that edge6 of members 28 and 32 engage the
surface of tissue 18. Handles 40 and 42 continue to
be rotated to draw tissue edges 20 and 22 in tight
proximity and in contact with material 44.
Once tissue edges 20 and 22 are in tight
20 proximity and in contact with material 44, foot
activator 50 is depressed to enable source 12.
Thermal energy f rom source 12 is delivered through
device 14, material 44 to seam 26 of tissue 18.
Device 14 preferably delivers energy through
25 material 44 and along the entire length of seam 26.
Alternately device 14 delivers thermal energy
to a portion of seam 25 and then clamp 16 is opened,
moved to a new location over seam 26. Once
positioned over the new location, the clamp 16 would
30 be closed to tightly approximate the edges 20 and 22
of the tissue 18 at the new location, and then
thermal energy would be delivered to the new seam 26
location to seal the i nr~ inn 24 .
The thermal energy f rom source is delivered
35 with sufficient amplitude and duration to heat
WO 95/13747 ; 2 1 7 6 5 8 0 PCr~US93~11094
tissue 18 to a predet~nminr~d null ~e.,l ructive
temperature range. This range i5 bounded by a
minimum rate at which tissue forms a denatured
proteinaceous substa~nce and a maxi~num rate at which
5 water in tissue boils. The preferred maximum
temperature at which the tissue 18 is heated is
slightly less than the temperature tissue shrinkage
occurs .
Once the tiss~le 18 has been heated to the
10 predetr~rminr~rl non-destructive temperature range, the
foot activator 50 ~would be depressed to disable
energy source 12. ~andles 40 and 42 would then
pivot members 28 and 32 to open clamp 16 and release
tissue 18.
This concludes l;he description of the preferred
'i l 8. A reading by those akilled in the art
will bring to mind va~rious changes without departing
~rom the spirit and scope of the invention. It i5
intended, however, --that the invention only be
Z~ li ited by the ~ollowing ~rr~D~"d cl~
