U.S. patent application number 12/187486 was filed with the patent office on 2009-02-12 for method and apparatus for delivery of a ligating suture.
Invention is credited to Brian J. Cavanaugh, James J.A. Cavanaugh.
Application Number | 20090043317 12/187486 |
Document ID | / |
Family ID | 40342037 |
Filed Date | 2009-02-12 |
United States Patent
Application |
20090043317 |
Kind Code |
A1 |
Cavanaugh; Brian J. ; et
al. |
February 12, 2009 |
METHOD AND APPARATUS FOR DELIVERY OF A LIGATING SUTURE
Abstract
An apparatus for ligating a medical protrusion comprises a
ligating suture having a proximal end and a distal end configured
to circumscribe the medical protrusion, and a one-way lock
positioned there between. The apparatus further comprises an
endoscope, a cutter blade configured to cut the suture, and a
device for ligating a medical protrusion. The device comprises a
tubular body having a proximal end and a distal end, a handle
positioned at the proximal end, an endoscope controller operably
connectable to the endoscope, a cutting controller operably
connectable to the cutter blade, a suture controller configured to
be operatively coupled with the suture, a curved bridge positioned
at the distal end, the bridge having a proximal end and a distal
end, and an armature, having a proximal end and a distal end,
configured to releaseably retain at least a portion of the
suture.
Inventors: |
Cavanaugh; Brian J.;
(Hingham, MA) ; Cavanaugh; James J.A.;
(Osterville, MA) |
Correspondence
Address: |
RAYMOND R. MOSER JR., ESQ.;MOSER IP LAW GROUP
1030 BROAD STREET, 2ND FLOOR
SHREWSBURY
NJ
07702
US
|
Family ID: |
40342037 |
Appl. No.: |
12/187486 |
Filed: |
August 7, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60963958 |
Aug 8, 2007 |
|
|
|
Current U.S.
Class: |
606/144 ;
600/104 |
Current CPC
Class: |
A61B 2017/2923 20130101;
A61B 2017/0496 20130101; A61B 2017/0451 20130101; A61B 2017/2939
20130101; A61B 17/12009 20130101; A61B 90/361 20160201; A61B
17/0467 20130101; A61B 17/0487 20130101 |
Class at
Publication: |
606/144 ;
600/104 |
International
Class: |
A61B 17/138 20060101
A61B017/138 |
Claims
1. A device for ligating a medical protrusion, the device
comprising: a) a tubular body having a proximal end and a distal
end; b) a handle positioned at the proximal end; c) an endoscope
controller operably connectable to an endoscope having at least one
lighting means and at least one image capturing means positioned at
the distal end; d) a cutting controller operably connectable to a
cutter blade; e) a suture controller configured to be operatively
coupled with a ligating suture; f) a curved bridge positioned at
the distal end, said bridge having a proximal end and a distal end;
and g) an armature connected to the distal end of the bridge and
configured to releaseably retain at least a portion of the ligating
suture, said armature having a distal and proximal end, wherein the
armature is configured to place at least a portion of the ligating
suture about the medical protrusion and wherein the manipulation of
the suture controller is configured to cause the ligating suture to
ligate the medical protrusion and wherein manipulation of the
cutting controller is configured to result in the separation of at
least a portion of the ligating suture from the ligated medical
protrusion.
2. The device of claim 1, wherein the cutter blade is
removable.
3. The device of claim 1, wherein the endoscope can move with
respect to the device allowing the user to visually capture the
medical protrusion to be ligated.
4. The device of claim 1, wherein the armature is balloon shaped
wherein the distal end is round and the proximal end is "V"
shape.
5. The device of claim 1, wherein the endoscope is removable.
6. The device of claim 1, wherein the armature, when viewed from
the side, is curved.
7. The device of claim 1, wherein the armature is offset with
respect to the tubular body axis.
8. The device of claim 1, wherein the armature is configured to
receive the removable ligating suture manually.
9. The device of claim 1, wherein the armature has "C" shaped cross
section.
10. The device of claim 9, wherein the edges of the "C" shape
armature cross section are configured to provide a narrower opening
than the suture diameter.
11. The device of claim 1, wherein the armature is configured such
that the cutter blade cuts the suture in such a way as to leave
little excess suture material with the ligated medical
protrusion.
12. The device of claim 1, wherein the armature distal end is
movable with respect to the curved bridge.
13. The device of claim 1 further comprising an armature movement
controller operably connected to the armature, wherein the armature
movement controller is configured to control movement of the
armature about an axis passing through the armature proximal end
and parallel to the plane of the armature.
14. The device of claim 1 further comprising a ligating loop having
a distal one way locking loop and a proximal support member.
15. The device of claim 14, wherein the ligating suture is
configured such that pulling the support member in the proximal
direction, causes the constriction of the distal one-way locking
loop when circumscribed about a medical protrusion.
16. The device of claim 14, wherein the one-way lock is a preformed
ball having a projection at an angle with respect to its base, and
wherein the projection is configured to allow slidable movement of
the suture in one direction only.
17. The device of claim 14, wherein the ligating suture is
biodegradable.
18. The device of claim 14, where the ligating suture is
elastized.
19. An apparatus for ligating a medical protrusion, the apparatus
comprising: a) a ligating suture, said suture having a proximal end
and a distal end configured to circumscribe the medical protrusion,
and a one-way lock positioned there between; b) an endoscope having
at least one lighting means and at least one image capturing means;
c) a safety cutter blade configured to cut the suture at the
proximal end of the one-way lock; and d) a device for ligating a
medical protrusion, the device comprising i) a tubular body having
a proximal end and a distal end, ii) a handle positioned at the
proximal end, iii) an endoscope controller operably connectable to
the endoscope, iv) a cutting controller operably connectable to the
cutter blade, v) a suture controller configured to be operatively
coupled with the suture, vi) a curved bridge positioned at the
distal end, said bridge having a proximal end and a distal end, and
vii) an armature configured to releaseably retain at least a
portion of the suture, said armature having a proximal end and a
distal end, wherein the armature is configured to place at least a
portion of the suture about the medical protrusion and wherein the
manipulation of the suture controller is configured to cause the
suture to ligate the medical protrusion and wherein manipulation of
the cutting controller is configured to result in the separation of
at least a portion of the ligating suture from the ligated medical
protrusion.
20. The apparatus of claim 18, wherein the cutter blade is
removable.
21. The apparatus of claim 18, wherein the endoscope is movable
with respect to the apparatus allowing the user to visually capture
the medical protrusion to be ligated.
22. The apparatus of claim 18, wherein the endoscope is
removable.
23. The apparatus of claim 18, wherein the armature is balloon
shaped with a rounded distal end and a "V" shaped proximal end.
24. The apparatus of claim 18, wherein the armature, when viewed
from the side, is curved.
25. The apparatus of claim 18, wherein the armature is offset with
respect to the tubular body axis.
26. The apparatus of claim 18, wherein the armature is configured
to receive the removable suture manually.
27. The apparatus of claim 18, wherein the armature has "C" shaped
cross section.
28. The apparatus of claim 18, wherein the edges of the "C" shape
armature cross section are configured to provide a narrower opening
than the suture diameter.
29. The apparatus of claim 18, wherein the armature is configured
such that the cutter blade cuts the suture in such a way as to
leave little excess suture material with the ligated medical
protrusion.
30. The apparatus of claim 18, wherein the armature distal end is
movable with respect to the curved bridge.
31. The apparatus of claim 18 further comprising an armature
movement controller operably connected to the armature, wherein the
armature movement controller is configured to control movement of
the armature about an axis passing through the armature proximal
end and parallel to the plane of the armature.
32. The apparatus of claim 18 further comprising a ligating loop
having a distal one-way locking loop and a proximal support
member.
33. The apparatus of claim 18, wherein the ligating suture is
configured such that pulling the support member in the proximal
direction, causes the constriction of the distal one-way locking
loop when circumscribed about a medical protrusion.
34. The apparatus of claim 18 wherein the suture is
biodegradable.
35. A method for ligating a medical protrusion, the method
comprising: a) delivering the suture to a site of the medical
protrusion, wherein said suture comprises a proximal end and a
distal end having a shape of a balloon, and a one-way lock
positioned there between; b) mounting the suture distal end around
the protrusion using a device having a balloon shaped, concave
upwards armature by circumscribing the armature around the
protrusion; c) constricting the suture distal end to provide a
ligation around the medical protrusion; and d) cutting the suture
distal end and the lock from the rest of the suture.
36. A method for loading a suture to a device for ligating a
medical protrusion, the method comprising: a) providing the suture
comprising a proximal end and a distal end having a shape of a
balloon, a one-way lock and a cord positioned there between; b)
providing the device comprising an armature configured to
releaseably retain at least a portion of the suture, said armature
having a proximal end and a distal end; c) pressing the lock at the
armature proximal end; d) pressing an edge of the suture distal end
into a side of the armature, sliding in the suture distal end into
the rest of the armature around its circumference; and e) coupling
the suture proximal end with the hook.
37. A method for ligating a medical protrusion with a suture, the
method comprising: a) mounting the suture to the device; b)
negotiating the device to reach the site of the medical protrusion
inside a patient's body; c) delivering the suture to a site of the
medical protrusion, wherein the suture comprises a suture proximal
end and a suture distal end having a shape of a balloon, and a
one-way lock positioned there between; d) mounting the suture
distal end around the protrusion using a device having a balloon
shaped, concave upwards armature by circumscribing the armature
around the protrusion; e) constricting the suture distal end to
provide a ligation around the medical protrusion; and f) cutting
the suture distal end and the lock from the rest of the suture.
38. The method of claim 34, wherein negotiating the device to reach
the site of the medical protrusion inside a patient's body
comprises ascertaining the movement of the device using an
endoscope.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims benefit of U.S. provisional patent
application Ser. No. 60/963,958, filed Aug. 8, 2007, which is
herein incorporated by reference.
FIELD OF THE INVENTION
[0002] The invention relates to a device or apparatus, systems and
methods for medical tissue protrusion removals, and more
specifically, to methods for ligating medical tissue
protrusions.
BACKGROUND
[0003] Nasal polyps are an outgrowth of sinus linings that protrude
into the nasal cavities, and are the result of nasal allergy
infection and other causes of nasal obstruction, which interrupts
the normal function of the sinuses. The nasal blockage caused by
polyps further impairs the passage of air through the nasal
passages leading to infection, snoring, loss of taste, and
disorders of sleep. Furthermore, the nose and sinuses are vital
anatomical parts to breathing: they allow incoming air to be
warmed, cleaned, and moisturized for transport into the lungs.
Therefore, removal of nasal polyps by surgical intervention
eliminates obstruction and restores nasal and sinus function. This
is critical to respiratory health.
[0004] Because removal of polyps, most of which originate in the
deep recesses of the nose, demands utilization of a surgical
operating team and appropriate anesthesia in a surgical suite, the
procedure is costly, inconvenient and associated with the usual
post-operative problems such as bleeding, infection, pain, slow
recovery and anesthetic side effects.
[0005] The present surgical procedure for nasal polyp removal in a
blind area is to identify the size and origin of the polyp using an
endoscope (light source and lens viewing) and, after stabilizing
the tissue to be removed, use a cutting device, ligature and/or
cautery to free the protruding lesion from its base, stop bleeding,
and extract the polyp from the cavity with a surgical snare. The
tissue removal requires several surgical procedures: endoscopy,
tissue removal and hemostasis with different instruments prior to
extraction of the tissue. Each of these procedures involves time
and tissue manipulation utilizing instruments that are
single-purpose tools. They cannot be used jointly and, because of
the size of the operative field, they need to be used one after
another for the planned surgery. In fact, during the tissue removal
process, each instrument must be available simultaneously for
quick, effective, trouble-free extraction. The presence of post
operative bleeding which demands nasal packing is the most
troublesome complication for patient and surgeon.
[0006] Systems currently in practice almost exclusively remove the
nasal polyp by cutting and cauterizing the base which demands use
of a surgical suite and anesthesia. No workable substitute system
including the use of a non-surgical technique such as ligature
application for compression of the polyp base exists.
[0007] Since the origin of most nasal polyps is within the sinus
cavity, not the nose, the base of the polyp tissue is difficult to
identify and encircle. Tying a surgical knot in the small recesses
of the nose where most polyps originate is cumbersome and
ineffective leading to complications. Instruments that rely on a
circular surgical loop for delivery of a ligature at the mouth or
ostium of the sinus cannot reach the base of the polyp tissue for
removal. For these reasons previously designed instruments for
nasal polyp removal by ligature compression of the base of the
polyp have not been successful and are not in general use.
[0008] Accordingly, there is a need for methods and instruments
that address the above mentioned problems and can provide a simple,
convenient and rapid approach to this medical procedure. This
approach would allow, in most situations, the physician, not
necessarily a surgeon, the use of a private medical office rather
than a hospital operating suite. It would eliminate the use of an
anesthetic and thus eliminate many of the complications of the
current procedure providing safety and patient comfort at a
fraction of the cost.
SUMMARY
[0009] The present invention provides an apparatus for ligating a
tissue protrusion, thereby restricting blood flow to the protrusion
and thus allowing the tissue to drop off and be eliminated
naturally. The device comprises a tubular body having a proximal
end and a distal end, a handle positioned at the proximal end, and
an endoscope controller operably connected to a cutter blade. The
device also has a suture controller that is configured to be
operatively coupled with a ligating suture, a curved bridge
positioned at the distal end of the instrument with the bridge
having a proximal end and a distal end, and an armature, having a
proximal end and a distal end, that is configured to releasably
retain at least a portion of the ligating suture. The armature is
configured to place at least a portion of the ligating suture
around the medical protrusion. The suture controller is configured
to allow the ligating suture to ligate the medical protrusion while
the cutting controller is configured to separate at least a portion
of the suture from the ligated medical protrusion.
[0010] This invention also provides a new method for ligating a
medical protrusion with a suture. The suture is mounted on the
apparatus and the device is inserted into the body to reach the
site of the medical protrusion. The distal end of the device
containing the suture material has a balloon-shaped curved armature
of which the larger distal end allows ease of capture of the
bulbous shaped polyp and the narrow "V" shaped proximal end of
which is configured to guide the constricting suture loop tight to
the narrow base of the polyp. In another embodiment, the present
invention provides for a ligating device that places an elastized
band about the medical protrusion.
[0011] Other aspects and advantages of the present invention will
become apparent from the following detailed description of the
proposed surgical instrument.
DETAILED DESCRIPTION OF DRAWINGS
[0012] FIG. 1 illustrates an apparatus incorporating a flexible
endoscope for ligating a medical protrusion according to an
embodiment of the present invention.
[0013] FIG. 2 illustrates a ligating suture according to another
aspect of the present invention.
[0014] FIG. 3 illustrates a cutter blade according to yet another
aspect of the present invention.
[0015] FIG. 4 is a top view of the distal end of the device 100 of
FIG. 1.
[0016] FIG. 5 is a bottom view of the distal end of the device 100
of FIG. 1.
[0017] FIG. 6 is a side view of the distal end of the device 100 of
FIG. 1.
[0018] FIG. 7 is a cross section view of the armature according to
various aspects of the present invention.
[0019] FIG. 8 illustrates an apparatus incorporating an operable
and removable armature, and camera for ligating a medical
protrusion according to another embodiment of the present
invention.
[0020] FIG. 9 illustrates further detail of the operable and
removable armature shown in the distal end of the apparatus shown
in FIG. 8.
[0021] FIG. 10 illustrates further detail of a possible one-way
lock which could be incorporated into the ligating loop of the
present invention.
[0022] FIG. 11 illustrates an apparatus with a straight handle, and
removable and operable armature, for ligation a medical protrusion
according to another embodiment of the present invention.
[0023] FIGS. 12-14 illustrates each step of a possible procedure
for ligating a polyp in the nasal cavity of a patient using the
apparatus of the present invention.
[0024] FIGS. 15-17 illustrates the step of a possible procedure for
loading the ligating loop into the apparatus of the present
invention.
[0025] FIG. 18 illustrates another embodiment of the ligating loop
of the present invention.
DETAILED DESCRIPTION
[0026] As used herein, the term "a" refers to "one or more" unless
otherwise mentioned. As used herein, the term "include" refers to
"includes without limitation". As used herein, the term
"circumscribe" refers to creating a loop around an object or
encircling an object. As used herein, the terms "cut" or "cutting"
refers to cutting, shearing or disuniting an object.
[0027] While various conventional techniques may benefit from the
apparatuses and methods discussed herein, another aspect of the
present invention is a technique for treating the condition of
medical protrusions itself. According to this technique, a ligation
is made around the protrusion, and no incision is made. The
ligation is intended to be tight such that the blood flow to the
protrusion is substantially restricted. Due to the lack of blood
supply, the protrusion tissue dies, and eventually the protrusion
falls off the patient's body by itself, without requiring any
cutting or cauterizing as required by conventional techniques.
[0028] FIG. 1 illustrates an apparatus 140 for ligating a medical
protrusion in accordance with certain aspects of the present
invention. The apparatus 140 comprises a device 100 for ligating a
medical protrusion, an endoscope 112, a ligating suture 200 (FIG.
2), and a cutter blade 300 (FIG. 3). The endoscope 112 has one or
more lighting means, such as means that either generate or
transport light, for example, fiber optic cables, miniature LEDs,
among various others, and one or more image capturing means, such
as, digital cameras and analog cameras (still or motion medium),
among others. Power and image data transfer for electronics are
either contained in the removable section of the handle 100 or are
transferred via a power/data cord 126 or via any type of wireless
protocol. It is understood that this apparatus could incorporate a
replaceable and operable armature as illustrated in 808 (FIG. 8),
and a possible handle as illustrated in 1102 (FIG. 11).
[0029] FIG. 2 illustrates the suture 200 which is a ligating
suture, according to certain aspects of the present invention
According to various embodiments, the suture 200 comprises a
biodegradable material in a thread-like structure. The suture 200
includes a suture proximal end 204 and a suture distal end 202
connected by an interstitial cord 212. A one-way lock 208 is
positioned between the suture distal end 202 and the suture
proximal end 204. In certain embodiments the suture distal end 202
has a shape of a loop (shown). Only the suture distal end 202,
which is used for ligating the protrusion may be made of a
biodegradable material, and the rest of the suture 200 may be made
of another material. In the embodiment illustrated by FIG. 2, the
suture distal end 202 is a balloon shaped loop. The suture 200 is
configured such that pulling the suture proximal end 204 away from
the suture distal end 202 constricts the suture distal end 202
loop. According to one embodiment, this constriction is enabled by
the one-way lock 208 (a possible one-way lock configuration is
illustrated in FIG. 10) which is a preformed ball having a
projection 210 embedded at an angle with respect to the suture
thread passing through the preformed ball 208. The projection 210
is configured to allow slidable movement of the suture thread in
one direction through the one-way lock 208. As illustrated in FIG.
2, this configuration is achieved by having the projection 210
project such that if the cord 212 were to be pulled away from the
suture distal loop 202, the projection 210 does not offer any
resistance. However, in case of reverse movement, the projection
210 offers resistance to the portion of the engaging suture
material. For example, as shown in FIG. 2, the projection 210
prevents movement in the reverse direction by obstructing the
sliding motion of the suture material.
[0030] According to certain aspects, the projection 210 is made of
a biodegradable material, identical to that of the suture 200.
However, the material, in one embodiment, in the projection 210 is
compressed higher than in the rest of the suture 200, and
accordingly the projection 210 has the suture material with a
higher density, thereby causing the projection to bite into and
restrain the softer suture thread. Those skilled in the art will
appreciate that multiple such equivalent configurations can provide
a one-way lock in a manner similar to that described of FIG. 2, and
all such obvious mechanisms are included within the scope of the
present claims.
[0031] Further, conventional tied knots need an amount of end
length so that they are not untied at an inopportune time, thereby
leaving a stub of suture material out of the ligation, which is a
cause for potential irritation to the patient and highly
undesirable. The one-lock 208 as disclosed herein is not a tied
knot. Nor does it require an end length stubbing out. The present
suture 200 thus provides for a ligation of a medical protrusion
without leaving undesirable knots.
[0032] The suture proximal end 204 is usable for constricting the
suture distal end 202 loop. The pulling action of the suture
proximal end 204 enables in constricting the loop 202. As will be
apparent to those in the art, the pulling functionality of the
suture proximal loop 204 may be implemented in multiple ways.
According to one embodiment, the suture proximal end 204 is a
preformed ball 903 (FIG. 9) configured to be operably coupled to a
cupping means 904 (FIG. 9). The cupping means grips by "cupping"
around the suture proximal end 204 preformed ball, and the cupping
means are pulled to actuate the pulling of the suture proximal end
204. According to another embodiment, as also illustrated in FIG.
2, the suture proximal end 204 is a loop, configured to be operably
coupled to a hooking means (not shown in FIG. 2, but shown in 404
(FIG. 4 and FIG. 6). The hooking means when pulled, pull the suture
proximal end 204 thereby constricting the suture distal end 202
loop.
[0033] FIG. 3 illustrates the cutter blade 300 according to various
aspects of the present invention. According to an aspect, the
cutter blade 300 includes a safety blade edge 302 and a cutter
blade coupling device 304 to couple to the cutter controller 124.
In the embodiment of FIG. 3, the safety blade edge 302 has a "V"
shape, which advantageously shears off the cord 212 from the suture
distal end 202 more easily than a flat blade, and eliminates the
need for an anvil (a base required as support for the flat blade to
operate) that may get worn and become less effective with use.
Further, the safety blade edge 302 advantageously slices the cord
212 off the suture distal end 202 very near to the one-lock 208,
leaving substantially negligible or no thread material extending
out from the one-lock 208. This results in a neat cut eliminating
potential patient irritation. Further, the cutter blade 300 is a
replaceable blade, configured to mate with the apparatus 140
releasably, and may be easily replaced after use. This aspect is
particularly advantageous in light of communicable infections, such
as for example, HIV, Hepatitis, and other serious transferable
diseases among various others. The speed at which things can be
handled in dangerous situation is important, and the cutter blade
300 as illustrated above is quickly and easily replaceable with
minimal safety concerns because the safety blade edge 302 is
concealed to the inside, as illustrated. This advantageously allows
for the users to handle the cutter blade without the danger of
getting infected unduly, because the sharp edge of the blade is not
exposed.
[0034] The device 100 for ligating a medical protrusion includes a
tubular body 116 having a proximal end 120 and a distal end 108. A
handle 102 is positioned at the proximal end 120. It is understood
that this apparatus could incorporate a possible straight handle as
illustrated in 1102 (FIG. 11) which is in line with the tubular
body 116. A finger brace 104 is used to help guide the suture loop
over the polyp without accidentally advancing the suture
controller. The device further includes an endoscope controller 122
operably connectable to the endoscope 112, a cutting controller 124
operably connected to the cutter blade 300, and a suture controller
106 operatively coupled with the suture 200. A curved bridge 108 is
positioned at the distal end 128. The bridge has a bridge proximal
end 128 and a bridge distal end 130. The device 100 further
includes an armature 110. The armature 110 is positioned in
proximity of the bridge 108 and towards the bridge distal end 130.
The armature 110 has an armature proximal end 132 and an armature
distal end 134. The armature 110 is configured to releaseably
retain at least a portion of the suture 200. The armature 110 is
configured to place at least a portion of the suture 200 about the
medical protrusion. The suture controller 106 is configured to
ligate the suture 200 about the medical protrusion, and the cutting
controller 124 is configured to operate the cutter blade 300 so as
to detach the portion of the suture 200 ligating the medical
protrusion from the apparatus 140.
[0035] FIG. 4 is a partial top view of the armature 110 loaded with
the suture 200. The dotted lines indicate the structure beneath the
top covering wall of endoscope 112. The hook 404 is coupled with
the suture proximal end 204 (loop) by tilting the suture controller
106 clockwise and moving it forward to the suture load position
127. As will be apparent to those in the art, the coupling
functionality of the suture controller 106 as illustrated in FIG. 4
and FIG. 6 may be implemented in multiple ways. The suture
controller 106 is configured to pull the suture proximal end 204
(loop) on actuation of the suture controller 106 towards the
proximal end of the device 100 whereby the ratchet 105 controls the
tension of the suture 200 allowing the user to "feel" the amount of
the pressure necessary to keep the cord 212 tight and to facilitate
the cutting with the safety blade edge 302. The one-lock 208 is
positioned substantially towards the armature proximal end 132.
FIG. 5 illustrates a bottom view of the armature 110 along the
section 5-5 of FIG. 1. The armature proximal end 132 has a cup 502
(see also 502 of FIG. 6) that holds the one-lock 208 in position
and a slot 504 that passes only the suture cord 212. According to
certain embodiments, when viewed from the top or bottom, the
armature 110 has a balloon shape with the armature distal end 134
having a substantially rounded shape and the armature proximal end
132 having a substantial "V" shape, also referred to as the
armature opening 402. In certain embodiments, when viewed from the
side (FIG. 6), the armature 110 is curved, such as, for example,
convave upwards, convex downwards, among others. In certain
embodiments, the curve of the armature 110 is offset towards the
armature distal end 134. According to the embodiment illustrated by
FIG. 6, the curve is concave upwards and offset 608 towards the
armature distal end 134 or the tip 134 of the armature. Further,
the armature 110 is positioned at an offset 608 with respect to the
tubular body 116 axis A-A'. For example, in the illustrated
embodiment, the armature 110 is positioned below the tubular body
116 axis A-A' when viewed from the side. In certain other
embodiments, the armature 110 may be positioned above the tubular
body 116 axis A-A' when viewed from the side. The armature 110 may
be coupled to the device 100 at or around the proximal end 128,
such as, for example, to the curved bridge 108 at the bridge distal
end 130, in the embodiment illustrated by FIG. 6 and FIG. 9.
According to certain aspects, the armature 110 is configured to be
releasably coupled to the device 100. That is, armatures of varied
shapes or sizes may be mounted on the device 100 in a simple attach
and release configuration, as already known in the art, and as also
shown in one embodiment in FIG. 8 and FIG. 9.
[0036] According to certain embodiments, as also illustrated by
FIGS. 4-7, the armature opening 402 is advantageously configured to
be parallel to normal tissue around the medical protrusion.
Further, the armature distal end 134 is curved upwards (FIG. 6).
Also, as illustrated in FIG. 7, the armature 110 has a "C" shaped
cross section 700. Edges 702 of the "C" shape provide a narrower
opening than the suture 200 thread diameter, while hollow 704 of
the "C" section is larger than the suture 200 thread diameter.
[0037] According to one embodiment, the armature is configured to
receive the removable suture 200 manually. For example, the suture
200 is finger loadable by hooking the one-lock 208 of the suture
200 into cup 502, hooking cord 212 under hook 506, moving hook 404
forward to its load position, hooking loop 204 over hook 404 and
finally pressing distal loop 202 into the opening 704 at the inside
of the armature with the finger or a thin shaft. Even for armatures
having relatively smaller size, this design provides a convenient
way to load the suture 200 manually and conveniently, as most human
fingers will be able to load the suture conveniently for armatures
configured for even small medical protrusions, such as, for
example, nasal polyps among others. Further, the suture 200 is
easily loadable in its entirety, in a few seconds, and does not
require the person loading the suture to be extensively trained.
Furthermore, only the suture 200 is required, and no suture
cartridges or additional material is needed. In this fashion, the
suture 200 can be advantageously loaded quickly in to the same
device 100 for subsequent protrusion removal while the patient is
still under the influence of relevant medicines, such as, for
example, local anesthesia.
[0038] FIG. 8 illustrates another apparatus 800 for ligating a
medical protrusion in accordance with certain aspects of the
present invention. In this embodiment apparatus 800, with further
detail in FIG. 9, illustrates the armature 808 as movable about
hinge 806, to allow rotational movement of armature 808 about a
rotational axis perpendicular to tubular body 116, along axis A-A',
distal end 134 of which follows ark 905 when armature controller
804 is manipulated. The feature in this aspect of this pivot
readily allows for the capture of a polyp by allowing for a change
in the angle of the opening of the armature in relation to the
angle of the polyp. This aspect also has a replaceable head that
disassembles at joint 814 to allow alternate heads of different
sizes and shapes to be used as needed based on the size and
location of polyp and the limitations of the nose and sinus cavity.
The controller wire 812 disengages the replaceable heads at the
wire pivot lug 810. Further illustrated in this embodiment is a
handle 802 which contains apparatus for self contained rechargeable
power, and Bluetooth capability or other if desired to project an
image to a user adjustable flat screen suspended from a user
adjustable boom. It is understood that this embodiment of the
apparatus of the present invention could incorporate a flexible
endoscope.
[0039] FIG. 10 illustrates a possible one-way lock configuration
that may be used in the present invention. In an embodiment not
shown, the free end of the loop could snap into the body of the
one-way lock 208 when necessary to capture a protrusion or entity
where there is no access to an open end, such as to act like an
instant tourniquet . Further, in an embodiment not shown, this
one-way lock configuration with the ability to snap into the body
of the one-way lock 208 the proximal end is either grip-able or
could be couple to a device.
[0040] FIG. 11 illustrates another apparatus 1100 for ligating a
medical protrusion in accordance with certain aspects of the
present invention. In this embodiment the apparatus 1100
illustrates the handle 1102 in line with the tubular body 116, to
allow for greater ease in capturing a polyp located on the head
side of the nasal or sinus cavities without the handle interfering
with the patient's face. In this aspect, the tilting of the
armature is achieved with use of the armature controller wheel
1122. To operate the finger depression is dialed on the armature
controller wheel 1122 up towards the distal end of the apparatus or
back towards the proximal end. The cutter controller 1124 operates
by pressing the finger button on it towards the distal end of the
tool. This cutter controller 1224 is spring loaded to return to
position and retract the blade. It is understood that this
embodiment of the apparatus of the present invention could
incorporate the armature 110 as well.
[0041] According to another embodiment of the present invention, a
method for ligating a medical protrusion using a suture, such as
the ligating suture 200 is provided. Ligating the medical
protrusion using the ligating suture 200 comprises mounting of the
suture 200 to the device 100, negotiating the device 100 to the
site of the medical protrusion inside a patient's body, delivering
the suture's ligating portion, such as the suture distal end 202
loop over the protrusion to capture at least a portion of the
protrusion, constricting the loop 202 about the base of the
protrusion, and cutting the loop around the medical protrusion from
the rest of the suture 200. FIGS. 12 to 14 illustrate the basic
steps involved in ligating a medical protrusion after the mounting
of the suture 200 to the device 100 has been performed.
[0042] The suture 200 is mounted on a device for ligating a medical
protrusion, such as the device 100 in the fashion as described
above. Loading the suture is further illustrated in FIGS. 15 to 17.
The suture 200 loaded device 100 is then negotiated into a
patient's body to the relevant area where the protrusion to be
ligated exists. This is effected by inserting the armature 110 or
armature 808 of the device 100 into the relevant patient's body
part. An endoscope, such as the endoscope 112, provides a view of
the path to the remote body part where the protrusion exists,
enabling the user of the device 100 to direct the armature 110 or
armature 808 to the proximity of the protrusion.
[0043] Once the device 100 is in proximity of the desired
destination, the device 100 is manipulated by the user over the
bulbous of the protrusion deliver the ligating suture 200 to the
base of the protrusion. The suture 200 needs to be delivered by the
device 100 on the protrusion such that the suture 200 may form a
clean, precise and deep ligation around the protrusion. Many
features of the device 100, as disclosed herein by various
embodiments, are instrumental in providing these features. For
example, the suture 200 advantageously comprises of a ligating
portion, such as the loop 202 (or "the suture loop"), which has a
balloon shape. The armature 110 that holds the loop 202 stiff for
ease of delivery to the protrusion site is similarly balloon
shaped--the opening of the armature 110 near the armature proximal
end 132 is "V" shaped while the armature distal end 134 is
approximately semi-circular. Further, the armature 110 is curved
when viewed from the side, for example, it is curved concave
upwards, and the tip of the armature distal end 134 may be further
bent upwards. This bent shape allows the armature distal end 134 to
negotiate over difficult to reach protrusions easily. At the same
time the "V" shaped armature proximal end 132 opening combined with
the concave upward shape allows the opening 132 to get very close
to the base of the protrusion, allowing the suture to capture a
fuller portion of the protrusion and form a tighter ligation of the
protrusion. The armature 110 having a bent tip at the armature
distal end 134 advantageously circumscribes the protrusion by
peeling out first of the armature distal end 134 and continuing to
peel out of the armature 110 successively close to the "V" shaped
armature proximal end 132 guiding the loop 202 as close to the base
of the polyp as allowed. It is appreciated that this bent tip shape
of the armature 110 enables it to circumscribe protrusions having a
greater height, or in otherwise difficult to access positions. In
certain embodiments where the armature 110 has a balloon shape with
the armature distal end 134 having a substantially rounded shape
and the armature proximal end 132 having a substantial "V" shape,
the armature distal end 134 will allow for capture of a bulbous
outer end of the protrusion while the "V" shaped armature proximal
end 132 will allow for positioning in close at the thinner base of
the protrusion. These features allow for a larger portion of the
polyp to be extracted as these features allow for circumscribing
protrusions conveniently in comparison with circular type armatured
suture loops. In this way, a user may conveniently mount the suture
loop 202 on the protrusion, such that the opening of the armature
110 is substantially parallel to the normal tissue lining and
generally perpendicular to the protrusion growth. The concave
upward shape of the armature 110 allows for the armature to get
particularly close to the base of the protrusion circumscribing and
therefore capturing a fuller portion of the protrusion.
[0044] Constricting the suture loop 202 around the protrusion
includes actuating the suture controller 106 to pull the suture
proximal end 204. The movement of the proximal end 204 away from
the suture loop 202 (suture distal end 202) causes the cord 212 to
pull away through the one-way lock 208, reducing the circumference
of the suture loop 202 and thereby constricting the suture loop 202
around the protrusion. The user of the device 100 can determine
using the endoscope 112, or otherwise, the amount of constriction
of the suture loop 202 required to ligate the protrusion.
[0045] Cutting the suture loop 202 includes actuating the cutting
controller 124 that causes the cutter blade 300 (FIG. 1) to be
incident on the suture 200 on the cord 212 very close to the
one-lock 208. The incidence of the safety blade edge 302 on the
suture 200 causes the cord 212 to cut the suture loop 202. It is
intended that the cutter blade 300 is incident on the suture 200 as
close to the one-lock 208 as possible, thereby making a clean cut
and leaving no or minimal stub. The clean cut made possible by the
blade according to various aspects of the present invention
eliminates or minimizes potential irritation by such a stub to the
patient.
[0046] It is believed that the suture with the one-way one-lock
discussed above could be replaced with an elastized band. The
elastized band would be loaded into the armature in a fashion that
would cause the band to be stretched outward in all directions over
a convex channel located to the outside of the armature 110.
Actuating the elasticized band controller would roll an edge off
the armature causing it to snap in place to the bottom side of the
armature 110 causing it to contract about the base of the medical
protrusion. Suitable elastized bands include those made of rubber
and other biological compatible materials.
[0047] In an alternate configuration the one way device can capture
lengths of tissue where the ends of the tissue are not available
say in clamping off a vein prior to cutting it or temporarily
shutting off a sperm duct for a reversible vasectomy. The device
end 1808 shown on FIG. 18 can be looped over a continuous length of
tissue and then snapped into a depression 1806 prior to actuating
903. The channel 1802 to 1804 is only wide enough to accept the
cord of the suture loop. Removal of the ligation device is as easy
as cutting the cord near 1804 with a scalpel. In a further
configuration of the above snap-able device the size can be altered
to a much larger scale and with an added handle at 903 the device
can have EMS and military uses as an instant tourniquet to stop
bleeding in emergencies.
[0048] The present invention, in its various aspects, provides
multiple advantages over conventional apparatuses or methods. For
example, the suture as disclosed in accordance with various
embodiments advantageously eliminates the tied knot and the
associated requirement to have a stub of an extended thread, which
is potential source of irritation. The suture further has a balloon
shaped armature for holding the suture loop rigid while passing
over the ligating protrusion. This balloon shaped suture in
conjunction with the device for delivering the suture
advantageously helps in capturing a fuller portion of the
protrusion, and in capturing protrusions larger in size or in
relatively inaccessible configuration. The device as provided in
accordance with various aspects, provides for a simpler movement of
endoscope, especially for applications, such as, for example, nasal
protruding removal. Further, the present invention provides for a
cutter blade with enhanced safety features that address the
concerns of dangerous infectious conditions such as, for example,
HIV, Hepatitis and the like, in the environments that need quick
replacements of the cutter blade. Further, the technique of
substantially constricting the blood supply to kill the protrusion
tissue, eventually causing protrusion removal without requiring any
incisions or cauterizing advantageously eliminates the problems
associated with managing the wounds, and also provides patient
comfort in the long run. Finally, the method to removal nasal polyp
with the present invention described herein is minimally invasive,
requires no surgery, allows for ambulatory care, and anesthesia is
not required though topical anesthesia may used.
[0049] While particular embodiments and/or individual features of
the present invention and its applications have been illustrated
and described, it would be obvious to those skilled in the art that
various other changes, modifications and adaptation to other
procedures can be made without departing from the spirit and scope
of the invention. Further, it should be apparent that all
combinations of such embodiments and features are possible and can
result in preferred executions of the invention. Therefore, the
appended claims are intended to cover all such changes and
modifications that are within the scope of the invention.
* * * * *