U.S. patent application number 15/914282 was filed with the patent office on 2018-07-12 for adaptive devices and methods for endoscopic wound closures.
This patent application is currently assigned to Biolife, L.L.C.. The applicant listed for this patent is Biolife, L.L.C.. Invention is credited to Charles E. Entenmann, John Tifton Fordham, Louis M. Guzzi, Talmadge Kelly Keene.
Application Number | 20180193011 15/914282 |
Document ID | / |
Family ID | 52689334 |
Filed Date | 2018-07-12 |
United States Patent
Application |
20180193011 |
Kind Code |
A1 |
Keene; Talmadge Kelly ; et
al. |
July 12, 2018 |
Adaptive Devices and Methods for Endoscopic Wound Closures
Abstract
This invention is directed to devices and methods for improving
wound closures produced during endoscopic surgery. These methods
are directed to delivering and applying a quantity of hemostatic
agents in either powder, solid, liquid, or gel form onto an open
wound produced e.g., by polyp removal, followed by the application
of pressure. The method is implemented preferably using existing
endoscopic equipment; however, modifications to existing endoscopic
insertion tubes, application and tamping devices and endoscopic
clips deployed from the distal end of the insertion tube during
endoscopic surgery are also within the scope of this invention.
Inventors: |
Keene; Talmadge Kelly;
(Ruskin, FL) ; Fordham; John Tifton; (Indialantic,
FL) ; Guzzi; Louis M.; (Longwood, FL) ;
Entenmann; Charles E.; (Key Largo, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Biolife, L.L.C. |
Sarasota |
FL |
US |
|
|
Assignee: |
Biolife, L.L.C.
|
Family ID: |
52689334 |
Appl. No.: |
15/914282 |
Filed: |
March 7, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15022281 |
Mar 16, 2016 |
|
|
|
PCT/US14/56011 |
Sep 17, 2014 |
|
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15914282 |
|
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|
61878677 |
Sep 17, 2013 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/00491 20130101;
A61B 2017/00296 20130101; A61B 90/361 20160201; A61B 2017/003
20130101; A61B 2017/0065 20130101; A61B 2017/00876 20130101; A61B
2017/00676 20130101; A61B 2017/0417 20130101; A61B 10/04 20130101;
A61B 2017/00522 20130101; A61B 2017/00659 20130101; A61B 17/0057
20130101; A61B 2017/00668 20130101; A61B 2017/00544 20130101; A61B
2017/00685 20130101; A61B 2090/306 20160201; A61B 2017/00579
20130101; A61B 2017/00623 20130101; A61B 2017/22067 20130101 |
International
Class: |
A61B 17/00 20060101
A61B017/00; A61B 10/04 20060101 A61B010/04 |
Claims
1. A device for arresting blood flow from a wound within the
alimentary canal of a living organism accessible only from a
natural body orifice by endoscopic surgery, comprising: an
endoscopic instrument inserting into the living organism through
the natural body orifice; a retaining device traversing said
endoscopic instrument for positioning in close proximity to, or in
contact with the wound; a hemostatic substance traversing and
exiting said endoscopic instrument into close proximity to the
wound; said retaining device retaining said hemostatic substance
adjacent to the wound for a time period sufficient to achieve
hemostasis; and said hemostatic substance being a resin/ferrate or
hydrogen resin in powder or tablet form.
2. A device for arresting blood flow from a wound within the
alimentary canal of a living organism as set forth in claim 1, said
retaining device comprising: an expandable bowl traversing said
endoscopic instrument and expanding upon exiting said endoscopic
instrument for positioning in close proximity to, or in contact
with the wound; said expandable bowl retaining said hemostatic
substance adjacent to the wound for a time period sufficient to
achieve hemostasis and to form a scab over the wound.
3. A device for arresting blood flow as set forth in claim 2,
further including: a plurality of barbed ends coupled to said
expandable bowl for penetrating the alimentary canal adjacent to
the wound for holding said expandable bowl in place.
4. A device for arresting blood flow as set forth in claim 1,
wherein: said expandable bowl includes an expandable magnetic bowl;
and said hemostatic substance includes magnetite for holding said
hemostatic substance against the wound.
5. A device for arresting blood flow from a wound within the
alimentary canal of a living organism as set forth in claim 1, said
retaining device comprising: a first barbed magnet traversing said
endoscopic instrument and piercing the alimentary canal in close
proximity to, or in contact with the wound; a second barbed magnet
traversing said endoscopic instrument and piercing the alimentary
canal in close proximity to, or in contact with the wound; a pull
suture interengaging between said first barbed magnet and said
second barbed magnet to pull said first barbed magnet and said
second barbed magnet together to close the wound; said first barbed
magnet and said second barbed magnet retaining said hemostatic
substance adjacent to the wound for a time period sufficient to
achieve hemostasis.
6. A device for arresting blood flow from a wound within the
alimentary canal of a living organism as set forth in claim 1, said
retaining device comprising: a push/pull wire coupling with a
spring wire traversing said endoscopic instrument and rotating said
spring wire upon exiting said endoscopic instrument for positioning
in close proximity to, or in contact with the wound; a first and
second barbed ends coupled to said spring wire for penetrating the
alimentary canal adjacent to the wound for holding said spring wire
in place; and said spring wire defining an arcuate form upon said
spring wire abutting said endoscopic instrument and causing said
first and said second barbed ends to pull together and close the
wound.
7. A device for arresting blood flow from a wound within the
alimentary canal of a living organism as set forth in claim 1, said
retaining device comprising: an expandable clip traversing said
endoscopic instrument and expanding upon exiting said endoscopic
instrument for engaging in close proximity to, or in contact with
the wound; said expandable clip collapsing for defining a wire jaw
to pull together and close the wound; a magnetic barrel coupled to
said expandable clip; a hemostatic substance and magnetite
magnetically coupled to said magnetic barrel and retaining said
hemostatic substance adjacent to the wound for a time period
sufficient to achieve hemostasis.
8. A device for arresting blood flow from a wound within the
alimentary canal of a living organism accessible only from a
natural body orifice by endoscopic surgery, consisting of: an
endoscopic instrument insertable into the living organism through
the natural body orifice; an expandable bowl traversing said
endoscopic instrument and expanding upon exiting said endoscopic
instrument for positioning in close proximity to, or in contact
with the wound; a hemostatic substance traversing and exiting said
endoscopic instrument into close proximity to the wound; said
expandable bowl retaining said hemostatic substance adjacent to the
wound for a time period sufficient to achieve hemostasis and to
form a scab over the wound; and said hemostatic substance being a
resin/ferrate or hydrogen resin in powder or tablet form.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of application Ser. No.
15/022,281, filed Mar. 16, 2016, which is a 371 of PCT/US14/56011,
filed Sep. 17, 2014, which claims benefit of Application No.
61/878,677, filed Sep. 17, 2013.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not applicable
INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT
DISC
[0003] Not applicable
BACKGROUND OF THE INVENTION
Field of the Invention
[0004] This invention is directed to a method for improving wound
closures during endoscopic surgery after polyp removal and biopsy
samples are taken. More specifically, this disclosure is directed
to applying a quantity of resin ferrate or other hemostatic
substances in either powder, solid, liquid or gel form onto an open
wound, followed by the application of pressure. The methods are
implemented preferably using existing endoscopic equipment;
however, modifications to existing endoscopic insertion tubes and
adaptive devices are also within the scope of this invention. The
wound may be located in the alimentary tract or other serosal
mucosa.
Description of Related Art
[0005] Endoscopy is the medical science of looking inside or
typically within the body for medical reasons using an endoscope.
An endoscope is an instrument used to examine the interior of a
hollow organ or cavity of the body. Unlike most other medical
imaging devices, endoscopes are inserted directly into the
organ.
[0006] An endoscope typically includes a rigid or flexible tube, a
light delivery system to illuminate the organ. The light source is
typically being positioned outside the body, the light being
directed typically by an optical fiber system to illuminate the
interior organ. The endoscope also includes a lens system for
transmitting the image from the objective lens to the viewer, and
an eyepiece. Additional channels are provided to allow entry of
medical instruments and manipulators.
[0007] A healthcare provider may use an endoscope for any of a
plurality of purposes, including investigation of symptoms such as
symptoms in the digestive system including nausea, vomiting,
abnormal pain, difficulty swallowing, and gastrointestinal
bleeding. The endoscope may also be used to confirm a diagnosis,
most commonly by performing a biopsy, to check for conditions such
as anemia, bleeding, inflammation, and cancers of the digestive
system. Treatment may also be administered by an endoscope such as
cauterization of a bleeding vessel, the widening of a narrow
esophagus, cutting off of a polyp or removing a foreign object
within the organ.
[0008] One particularly useful application of the endoscope is the
removal of polyps and other growths within the interior walls of
the organ under examination. However, the techniques for removing
the polyp include typically either a cutting device or a heated
loop device, both of which leave a wound at the base of the polyp
which typically bleeds profusely. To arrest the blood flow from the
incision, surgical clamps are the most preferable means of
arresting that blood flow. A plurality of these small surgical
clamps is attached around and across the wound so as to effect a
wound closure. However, these clamps are difficult to apply, are
small and unable to approximate wide wounds, and do not often
effect a complete wound closure leaving some bleeding. Moreover,
the clamps must be left in place for a time sufficient to arrest
bleeding, after which they are eventually eliminated by normal
bowel movement in the colon or intestine.
[0009] Another means for arresting blood flow from a wound of this
nature is to simply spray a powder starch-like material onto the
wound until it is sufficiently covered to absorb the blood flow and
cause the cessation of blood flow from that wound. However, due to
a lack of containment of this powder, a large quantity of this
material is required to effect bleeding cessation, leaving a
substantially greater amount of material than typically needed if
applied directly to the wound from an exposed wound.
[0010] The present invention provides a method of wound closure
after a polyp or removal during endoscopic surgery and the like.
This method is directed to applying a quantity of a hemostatic
substance in either powder, solid, liquid, or gel form onto the
open wound followed by the application of pressure. Various
adaptive devices are provided to accomplish both the deployment of
the hemostatic substance onto the wound and the application of
pressure thereagainst to effect complete hemostasis.
[0011] The foregoing examples of the related art and limitations
related therewith are intended to be illustrative and not
exclusive. Other limitations of the related art will become
apparent to those skilled in the art upon a reading of the
specification and a study of the drawings.
BRIEF SUMMARY OF THE INVENTION
[0012] This invention is directed to a method for improving wound
closures after polyp removal during endoscopic surgery. This method
is directed to applying a quantity of a hemostatic substance e.g.,
resin ferrate in either powder, solid, liquid, or gel form onto an
open wound produced by polyp removal followed by the application of
pressure. The method is implemented preferably using existing
endoscopic equipment, however, modifications to existing endoscopic
insertion tubes is also within the scope of this invention.
Powder Form of Hemostatic Substance
[0013] Using the powder or granular form of the resin ferrate or
other granular or particulate hemostatic substance, this material
may be delivered through the central channel of an endoscope by air
pressure, by plunger, by a screw feed, by gravity, or by a liquid
carrier. To direct and apply pressure against the resin ferrate
powder, several devices may be employed. For example, a flexible
bowl or funnel formed of thin resilient material deployed against
and covering the wound. Powder directed into the bowl or funnel is
then pressed against the wound. When the powder is combined with
magnetite, thin magnetic wires deployed from the distal end of the
endoscope will capture the magnetic powder, after which the
magnetic wires are directed against the wound for a time sufficient
for the powder to become affixed onto the open wound. Other powder
deployment and pressure application devices are also disclosed.
Tablet/Solid Form of Hemostatic Substance
[0014] Several embodiments of this disclosure utilize a solid or
compressed powder device for deployment onto the wound. One
embodiment is in the form of a donut-shaped disc which is held
within the end of the insertion tube and provides viewing access by
the camera within the insertion tube. The camera thus provides
accurate placement of the disc over the wound site.
[0015] In another embodiment, a solid disc is temporarily bonded or
adhered on the side of the bleeding tip providing guided
positioning and pressure of the disc against the wound site for a
time sufficient to adhere the disc to the wound site.
[0016] Mini-sized solid tablets which slidably translate within a
delivery tube are delivered sequentially onto the wound site. The
column of tablets may be pushed by a plunger or connected by an
elongated suture and pulled from the end of the bending tip. The
hemostatic substance forming the disc may include magnetite which
may be manipulated and applied by a magnet.
Motive Force
[0017] A number of means for moving the hemostatic powder or solid
tablets along the hollow interior of a delivery tube within the
insertion tube may be employed, namely, a plunger, gas or air
pressure, a venture, and various forms of augers or feed
screws.
[0018] The following embodiments and aspects thereof are described
and illustrated in conjunction with systems, tools and methods
which are meant to be exemplary and illustrative and not limiting
in scope. In various embodiments one or more of the above-described
problems have been reduced or eliminated while other embodiments
are directed to other improvements. In addition to the exemplary
aspects and embodiments described above, further aspects and
embodiments will become apparent by reference to the drawings and
by study of the following descriptions.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
[0019] FIG. 1 is a pictorial view of a typical endoscope
assembly.
[0020] FIG. 2 is a section view in the direction of arrows 2-2 in
FIG. 1.
[0021] FIG. 3 is a schematic section view of the deployment of one
embodiment of the invention by applying a quantity of a hemostatic
powder over a wound site within an intestine.
[0022] FIG. 4 is a schematic section view of another embodiment of
the invention showing deployment of a quantity of a hemostatic
substance powder over a wound site within an intestine.
[0023] FIG. 5 is a schematic section view of another embodiment of
the invention deploying a quantity of a hemostatic powder over a
wound site of an intestine.
[0024] FIGS. 6A, 6B and 6C are schematic section views of another
embodiment of the invention showing placement of a quantity of a
hemostatic powder over a wound site within an intestine.
[0025] FIG. 7 is a schematic section view of another embodiment of
the invention being deployed to place a quantity of a hemostatic
powder over a wound site within an intestine.
[0026] FIGS. 8A and 8B are schematic section views showing the
deployment of another embodiment of the invention utilizing a
balloon tamponade to place and press hemostatic powder against a
wound site.
[0027] FIG. 9 is a schematic section view of another embodiment of
the invention incorporating a balloon tamponade with an internal
magnet to deploy and compress hemostatic powder containing
magnetite against a wound site.
[0028] FIG. 10 is a schematic section view of another embodiment of
the invention in the form of a large inflatable balloon which has
been deployed and then inflated to fill the intestine to apply
pressure against a hemostatic powder over the wound site.
[0029] FIG. 11 is a schematic section view showing the deployment
of yet another embodiment of the invention in the form of an
expandable stent to apply pressure against a hemostatic powder
after being applied over the wound site.
[0030] FIGS. 12A and 12B are schematic section views showing the
sequential application of a hemostatic powder onto a wound site
through a second scope line and then deploying a balloon tamponade
through a main line to apply pressure thereagainst.
[0031] FIGS. 12C and 12D are schematic section views showing the
sequential deployment of a hemostatic powder through an application
catheter and confined by a clear cap which is also used to apply
pressure against the hemostatic powder.
[0032] FIG. 13 is a schematic section view showing the hemostatic
powder with magnetite being applied over a wound site as
facilitated by an external magnet.
[0033] FIG. 14 is a schematic section view showing the application
of a ferrate spray solution in the form of Fe+.sup.3 against a
wound site.
[0034] FIGS. 15A, 15B and 15C are schematic section views showing
sequential deployment of an endoscopic clip formed of magnetic
material which attracts and holds a quantity of hemostatic powder
plus magnetite powder magnetically adhered thereto ready for being
applied against a wound site as or after the clip is engaged the
tissue around the wound site.
[0035] FIGS. 16A and 16B show the sequential application of a
hemostatic tablet having a viewing hole formed centrally
therethrough for a camera to facilitate accurate positioning of the
hemostatic tablet directly over a wound site.
[0036] FIGS. 17A and 17B show the sequential application of a
hemostatic tablet adhered against the exterior surface of the
bending tip to be forcibly applied against the wound site.
[0037] FIG. 18 is a schematic section view showing a hemostatic
tablet adhered to the end of a delivery tube being held against a
wound site for a time sufficient for adherence of the hemostatic
tablet against the wound site.
[0038] FIG. 19 shows another embodiment of the invention which
includes a rapid dissolve substance mixed with a hemostatic powder
or tablet that leaves some hemostatic powder behind as it is being
held against a wound site.
[0039] FIG. 20 is a pictorial view of another embodiment of the
invention utilizing a delivery tube to pump a hemostatic powder
beneath a wound covering placed over a wound site.
[0040] FIG. 21 is a schematic section view showing another
embodiment of the invention including the delivery of a quantity of
a hemostatic powder plus magnetite mixed with tiny magnets against
a wound site.
[0041] FIGS. 22A and 22B are schematic section views that show the
sequential delivery of a plurality of mini hemostatic tablets
through a delivery tube, one at a time, as forced to move by a
plunger through a delivery tube, the mini hemostatic tablets
extending over the wound and being retained in place when the resin
plus ferrate reacts with blood in the wound site.
[0042] FIGS. 23A and 23B are similar views to FIGS. 22A and 22B
except that the mini hemostatic tablets are connected together by a
suture which is pulled in the direction of the arrow to deliver
each of the mini hemostatic tablets over the wound site one at a
time.
[0043] FIGS. 24A and 24B show the deployment of small magnets
having barbs disposed on one end which pierce and are retained
within the wound site, the magnets being applied by a plunger
through a hollow delivery tube, after which a quantity of a
hemostatic powder plus is applied over the anchored magnets to hold
the powder in place within the wound site.
[0044] FIGS. 25A and 25B are sequential schematic views showing
deployment of barbed anchors opposingly attached across a wound
site and a pull suture interengaged between the anchors to pull the
anchors together to close the wound.
[0045] FIG. 26 is a perspective view of another embodiment of the
invention including a coiled hemostatic powder-coated sheet which
uncoils when deployed from a hollow delivery tube after which it is
positioned against the wound site.
[0046] FIGS. 27A and 27B are schematic section views showing the
deployment of a hemostatic powder through a hollow expandable
distributing head having apertures formed along its outwardly
facing surface, the hemostatic powder being distributed over the
wound site, after which the distributing head is then utilized in
FIG. 26B to tamp the hemostatic powder into place over the wound
site.
[0047] FIGS. 28A, 28B and 28C are sequential schematic section
views of the deployment of an end-barbed spring clip which engages
into the edges of the wound site to be drawn together to close the
wound as a pull wire is drawn into the delivery tube as the clip
spring is arcuately formed.
[0048] FIGS. 29 to 34 show a number of embodiments of means for
delivering the hemostatic powder or solid pellets through the
insertion tube and bending tip. In FIG. 29, a plunger is utilized
while in FIG. 30, gas under pressure forces the hemostatic powder
for discharge through the bending tip. In FIG. 31, a venturi is
utilized to draw the hemostatic powder into the venturi for
discharge under gas pressure from the end of the bending tip. FIG.
32 shows a drill auger utilized to force the hemostatic powder or
solid pellets through the insertion tube. FIG. 33, shows the
utilization of an outer auger to force the hemostatic powder or
solid pellets through the insertion tube. FIG. 34 discloses a wire
auger for the same purpose.
[0049] Exemplary embodiments are illustrated in reference figures
of the drawings. It is intended that the embodiments and figures
disclosed herein are to be considered to be illustrative rather
than limiting.
DETAILED DESCRIPTION OF THE INVENTION
Nomenclature
[0050] 10. endoscopic assembly [0051] 12. light guide connector
[0052] 14. universal cord [0053] 16. endoscope head [0054] 18.
eyepiece [0055] 20. controls [0056] 22. biopsy port [0057] 24.
insertion tube [0058] 26. bending tip [0059] 28. biopsy suction
channel [0060] 30. fiber optic light guides [0061] 32. fiber optic
image bundle [0062] 34. water tube [0063] 36. air tube [0064] 38.
tip bending control wires [0065] 40. hemostatic powder [0066] 42.
flexible bowl [0067] 44. funnel shaped bowl [0068] 46. magnetic arm
bowl [0069] 48. elastic ring [0070] 50. hemostatic powder with
magnetite [0071] 52. barbed bowl [0072] 54. inflatable balloon
[0073] 56. balloon tamponade [0074] 58. magnet [0075] 60. balloon
[0076] 62. stent [0077] 64. application catheter [0078] 66. clear
cap [0079] 68. application catheter [0080] 68a. venturi [0081] 70.
magnet [0082] 72. FE.sup.+3 spray [0083] 74. spray nozzle [0084]
76. endoclip [0085] 78. resilient wire jaws [0086] 80. insertion
tool [0087] 82. magnetized barrel [0088] 84. styptic powder [0089]
86. hemostatic tablet [0090] 88. hemostatic tablet [0091] 90.
camera [0092] 92. hemostatic tablet [0093] 100. wound covering
[0094] 102. hemostatic powder with magnets and magnetite [0095]
104. plunger [0096] 106. hemostatic tablets [0097] 108. suture
[0098] 110. barbed magnets [0099] 112. barb [0100] 114. barbed
anchor [0101] 116. barb [0102] 118. barbed anchor [0103] 120. barb
[0104] 122. wire [0105] 124. hemostatic powder coated sheet [0106]
130. hemostatic powder distribution head assembly [0107] 132.
distribution head [0108] 134. apertures [0109] 140. spring wire
clip [0110] 142. spring wire [0111] 144. barbs [0112] 146. pivot
anchor [0113] 148. push/pull wire [0114] 150. funnel [0115] 152.
drive auger [0116] 154. outer auger [0117] 156. central feed
passage [0118] 158. wire auger
[0119] As referenced herein, the term "hemostatic powder" is
preferably WOUNDSEAL powder, a resin/ferrate or hydrogen resin as
taught in U.S. Pat. No. 6,187,347. The term "hemostatic tablet or
solid" is preferably STATSEAL, refers to a compressed form of
WOUNDSEAL powder. The term "intestine" is used to designate the
alimentary tract or other serosal mucosa.
[0120] Referring now to FIGS. 1 and 2, an endoscope assembly is
shown generally at numeral 10 and includes an endoscope head 16
having an eye piece 18 and controls 20 thereon. The endoscope
assembly 10 also includes a side insertion biopsy port 22 which
leads to an elongated insertion tube 24. Connected to the side of
the eyepiece 16 is an elongated flexible inward cord 14 having a
light guide connector 12 disposed at the distal end of universal
cord 14.
[0121] In well known fashion, the insertion tube 24 houses a biopsy
suction channel 28, fiber optic light guides 30, a fiber optic
image bundle 32, a water tube 34, an air tube 36, and a plurality
of evenly spaced tip bending control wires 38. These control wires
38 are controlledly actuated to bend the bending tip 26 in any
desired direction as seen in FIG. 1. The endoscopic assembly 10 is
the working tube that is inserted through an endoscope. The
insertion tube 24 may pass directly through the endoscope head 16
or may be covered with a sheath to protect the hemostatic
substance. Both sheath and tube pass through the endoscope head
16.
[0122] FIGS. 3 to 11 depict expandable devices which are deployed
in collapsed form through the insertion tube 24 and then
automatically expand when exiting the bending tip 26. FIG. 3 shows
a flexibly expandable bowl 42 applied over the wound after bending
tip 26 as shown. Hemostatic powder 40 is forced through the
insertion tube 24 into the bowl 42. The bowl 42 is then compressed
in the direction of arrow A to apply pressure to the wound to press
the powder 40 into contact with the wound to stop bleeding. The
bowl 42 may have a rigid bottom with flexible sides that move in
accordion fashion. The sides of the bowl 42 may flex outwards
allowing pressure to be applied. The entire bowl 42 may be
flexible.
[0123] In FIG. 4, a flexibly expandable funnel shaped bowl 44 is
applied over the wound and hemostatic powder 40 is forced through
the insertion tube 24 into the bowl 44 which is then compressed to
apply pressure to press the powder 40 into contact with the wound
to stop bleeding. The bowl 44 may have a rigid bottom with flexible
sides that accordion. The sides of the bowl 44 may flex outwards
allowing pressure to be applied.
[0124] FIG. 5 shows an expandable magnetic arm bowl 46 in
combination with hemostatic powder with magnetite 50 which is held
within the magnetic bowl 46 to facilitate application against the
wound. The magnetic bowl 46 may be deployed with the hemostatic
powder 50 attached prior to application or forced through the
insertion tube 24 after deployment.
[0125] In FIGS. 6A, 6B and 6C, a barbed expandable netted bowl 52
includes barbed end points which are designed to penetrate the
tissue and hold the bowl 52 in place when forced in the direction
of D. The bowl 52 is then filled with hemostatic powder 40, after
which the following actions may take place in any order. The bowl
52 closes, detaches from the bending tip 26, and then collapses.
The collapsing of the bowl 52, forces the hemostatic powder 40 onto
the wound, while slightly approximating the wound.
[0126] In one embodiment, the sides of the bowl 52 may be elastic,
and there may be an elastic ring 48 at the end of the insertion
tube as seen in FIG. 6A. The bowl 52 is attached to the intestine
around the wound which is then filled with powder. There are wires
attached to the barbs to keep the bowl 52 open during filling and
open for attachment. After attachment of the barbs and removal of
the insertion tube 24 in FIG. 6B, the wires pull from the barbs,
and the elastic net plunger collapses about itself in all
directions, closing and applying pressure on the hemostatic powder
40 against the wound approximating the wound. The bowl 52 remains
at the wound site.
[0127] In another embodiment, the arms of the bowl 52 are made of
wire. The bowl 52 is attached and filled with powder as previously
described, after which the insertion tube 24 is rotated whereupon
the wires wrap around themselves, closing the bowl 52, applying
pressure on the hemostatic powder 40 against the wound,
approximating the wound. The rotation then shears the wires,
leaving the bowl 52 connected to the wound site.
[0128] In another embodiment, the arms of bowl 52 are made of wire.
The bowl 52 is deployed and attached around the wound after which
the bowl 52 is filled with powder 40 and then retracted into the
bending tip 26. Applying pressure to the powder against the wound
approximates the wound. The locking ring 48 closes the small end of
the bowl 52, and the wires are cut/broken closing the bowl 52 and
leaving it in place.
[0129] In another embodiment after attachment and fill of the bowl
52 the bowl 52 may be crushed, holding its crushed shape. The
crushing applies pressure to the hemostatic powder 40 on the wound.
This design would not approximate the wound.
[0130] In further embodiments, an outer bowl 52 may be used to hold
an inner collapsible netting in place until it can be deployed and
filled with hemostatic powder 40. The bowl 52 may also be
magnetized to allow it to hold a magnetic hemostat 50. The bowl 52
could be filled with hemostatic powder 50 prior to adhering to the
intestine walls. The bowl 52 may also be adhered to means other
than barbed points. The barbed points may be made from biosorbable
materials, metal, or plastic,
[0131] In FIG. 7, an inflatably expandable balloon 54 is employed
to both contain the hemostatic powder 40 and to apply pressure via
mechanical force (pushing the tube) on further inflation of the
balloon. An application catheter 68 is extendable from the bending
tip to deliver the hemostatic powder 40 to the wound site. The
balloon 54 may be designed to create a funnel at low pressure and
create a flatter surface with increased pressure against the wound
site.
[0132] FIGS. 8A and 8B disclose an expandable balloon tamponade 56
to place and press the hemostatic powder 40 against a wound site.
The balloon tamponade 56 contains the hemostatic powder around the
wound site, after which the side is used as a tamponade to apply
pressure to the wound in the direction of arrow G in FIG. 8B.
[0133] FIG. 9 incorporates the expandable balloon tamponade 56 with
an internal magnet 58 to deploy and compress magnetic hemostatic
powder 50 containing magnetite against a wound site. The powder 50
may be on the balloon prior to application or applied after the
balloon 56 is inflated via a second tube or through an alternative
tube. The magnet 58 holds the powder 50 in place so that it can be
applied to the wound.
[0134] In FIG. 10, a large inflatable balloon 60 is deployed
through and from the insertion tube 24 and then inflated to fill
the intestine to apply pressure against hemostatic powder 40 over
the wound site. A magnet may be used in conjunction with the
balloon, powder or a solid tablet.
[0135] FIG. 11 shows an expandable stent 62 which applies pressure
against hemostatic powder 40 after being applied and expanded over
the wound site. The stent 62 may be biosorbable or removable, and
may also be magnetic or a portion thereof to hold and concentrate
the powder 40.
[0136] FIGS. 12A and 12B show the sequential application of
hemostatic powder 40 onto a wound site through a second application
catheter 64, after which the balloon tamponade 56 is deployed
through the application catheter 68 after which the bending tip 26
is straightened at 26a and urged in the direction of arrow J to
apply pressure against the powder. In FIGS. 12C and 12D, the
sequential deployment of hemostatic powder 40 through an
application catheter 64 and confinement of the hemostatic powder 40
within a clear cap 66 attached over the end of the bending tip 26
is there shown. The cap 66 is also used to apply pressure against
the powder 40 as seen in FIG. 12D by urging the cap 66 in the
direction of arrow K after straightening the bending tip 26. The
cap 66 may also contain a clear disk through which powder is
filled. This disc may act as a plunger as the cap is used to apply
pressure.
[0137] FIG. 13 shows the hemostatic powder with magnetite 50 being
applied over a wound site as facilitated by an external magnet 70.
In FIG. 14, application of a ferrate spray solution 72 in the form
of Fe+.sup.3 from a spray nozzle 74 against a wound site is there
shown. If sufficient quantity of trivalent salts are applied to
blood, it will clot very rapidly. The Fe+.sup.3 spray 72 may be any
trivalent soluble salt solution, a gel solution containing a
soluble trivalent salt, or a bio-derived substance that induces
clotting or absorbs blood components. Examples would be a collagen
solution/gel, a thrombin containing solution/gel, or a fibrin
containing solution/gel. The gel component may be polyvinyl
alcohol, gelatin, or the like. The spray 72 may be used in
conjunction with any other components in this application, for
example, with the clear cap or a balloon funnel. The purpose is to
contain, direct and concentrate the spray 72. The spray 72 may be
used in conjunction with a gauze or other device for retention and
pressure application.
[0138] FIGS. 15A and 15B show sequential deployment of an
endoscopic clip 76 ("endoclip") formed having a magnetic barrel 82
which attracts and holds a quantity of hemostatic powder with
magnetite powder 50 magnetically adhered thereto ready for being
applied against a wound site as or after the resilient wire jaws 78
of the endoscopic clip 76 have engaged the tissue around the wound
site by urging of an insertion tool 80 in the direction of arrow L.
After urging of the wire jaws 78 into the tissue surrounding the
wound, the insertion tool is urged in the direction of L' to
further set the wire jaws and close the wound. The magnetic
hemostatic powder 50 will simultaneously be deposited over the
closed wound to effect hemostasis. The magnetic hemostatic powder
50 may be applied to the magnetic barrel 82 prior to use or after
deployment of the endoscopic clip 76.
[0139] FIG. 15C shows the endoscopic clip containing a styptic
powder 84, or a bio-derived substance that induces hemostasis or
clot formation. The styptic powder 84 is designed to release after
endoscopic clip 76 deployment to assist with hemostasis. The
styptic may be a solid or gel.
[0140] In FIGS. 16A and 16B, the sequential application of a
hemostatic tablet 86 having a viewing hole formed centrally
therethrough for a camera 90 facilitates accurate positioning of
the hemostatic tablet 86 directly over a wound site. A clear disc
(not shown) may be used between the scope and the tablet to protect
the scope. The camera 90 extends coaxially with the bending tip 26
and with the tablet 86 which is frictionally held in the position
shown until deployed in the direction of arrow M. The tablet 86 may
be designed to stay whole or break apart upon deployment and may
need a protective coating to prevent it from wetting during
deployment.
[0141] FIGS. 17A and 17B show the sequential deployment of a
hemostatic tablet 88 adhered against the exterior surface of the
bending tip 26 to be forcibly applied against the wound site in the
direction of arrow N. The tablet 88 may need a protective coating
to prevent it from wetting during deployment.
[0142] FIG. 18 is a view showing a hemostatic tablet 92 adhered to
the end of the delivery tube 68 and being urged in the direction of
O against a wound site for a time sufficient for adherence of the
tablet 92 to effect hemostasis against the wound site.
[0143] In FIG. 19, another embodiment includes a rapid-dissolve
substance mixed with hemostatic powder to form a tablet 94 that
leaves the hemostatic powder behind as it is being held against a
wound site. This rapid-dissolve substance may either be a rapidly
dissolving component in the tablet or a dissolving coating.
[0144] FIG. 20 shows a delivery tube 68 pumping hemostatic powder
beneath a wound covering 100 placed over a wound site. The covering
100 may also contain an agent to induce or assist with hemostasis
or clot formation. Examples would be a trivalent salt solution or
solid, thrombin, fibrin, activated cellulose or a combination. The
covering 100 is attached to the wound through the interaction of
the moisture in the tract, e.g. a PVA coating with an absorptive
backing that works similar to a stamp used for postage.
[0145] In FIG. 21, delivery of a quantity of hemostatic powder with
magnetite 102 is mixed with tiny magnets against a wound site. The
combination of components would form a malleable solid.
[0146] FIGS. 22A and 22B show the sequential delivery of a
plurality of mini hemostatic tablets 106 through a delivery tube
68, one at a time in the direction of arrow P, as forced to move by
a plunger 104 through the delivery tube 68. The mini hemostatic
tablets 106 are deployed to extend over the wound and retained in
place by reaction with blood in the wound site. Upon wetting and/or
when force is applied to the tablets 106, they may, at least in
part, disintegrate into powder.
[0147] FIGS. 23A and 23B are similar views to FIGS. 22A and 22B
except that the mini hemostatic tablets 106 are connected together
by a flexible suture 108 which is pulled in the direction of arrow
R to deliver each of the mini hemostatic tablets 106 over the wound
site, one at a time. The tablets 106 may break away from the suture
108 as indicated into separate tablets, or the tablets may be
connected together by a second suture (not shown).
[0148] FIGS. 24A and 24B show the sequential deployment of small
magnets 110 having end barbs 112 which pierce and are retained
within the wound site. The magnets 110 are applied by a plunger 104
through a hollow delivery tube 68, after which a quantity of
hemostatic powder with magnetite 50 is applied over the anchored
magnets 110 to hold the powder 50 in place within the wound site.
As many magnets 110 as are needed may be deployed to completely
cover the wound site.
[0149] FIGS. 25A and 25B show deployment of barbed anchors 114 and
118 opposingly attached across a wound site and a pull suture 122
interengaged between the anchors 114 and 118 to pull the anchors
114 and 118 together in the direction of arrow S to close the
wound. The anchors 114 and 118 may be deployed in pairs and pulled
to approximate the wound or several anchors may be deployed. The
multi anchor system may have one anchor 114 fixed to the end of the
pull suture 122 and every anchor 118 subsequent to the first being
a one-way pull type allowing the wound to be slowly approximated in
the direction of arrows T-T. The anchors 114 and 118 may be
magnetic to allow a magnetic hemostatic powder to be applied and
held in place after the anchors are deployed or the anchors may be
coated with a styptic or other hemostatic agent.
[0150] In FIG. 26, a coiled hemostatic powder-coated sheet 124
uncoils when deployed from the hollow delivery tube 68, after which
it is positionable against the wound site. The sheet 124 may be
coiled with the hemostatic agent 40 on either side thereof. A
sheath may be necessary to protect the hemostatic powder 46.
[0151] FIGS. 27A and 27B show the deployment of hemostatic powder
40 through a hollow expandable distributing head assembly 130
having apertures 134 formed along its outwardly facing surface, the
powder 40 being distributed through apertures 134 in the direction
of arrow U over the wound site, after which the distributing head
132 is then utilized in FIG. 26B to tamp the powder 40 in the
direction of arrow V into place over the wound site.
[0152] FIGS. 28A, 28B and 28C are sequential views of the
deployment of spring wire clip 140 having barbs 144 at each end of
a spring wire 142 which engage into tissue at the edges of the
wound site when push/pull wire 148 is extended in the direction of
arrow W. As the spring wire clip 140 is deployed from the
application catheter 68 by pushing the push/pull wire 148 in the
direction of arrow W, the spring wire pivots about pivot anchor 146
as seen in FIG. 28B. After the barbs 144 are set, they are drawn
together in the direction of arrow X to close the wound as the
push/pull wire 148 is drawn in the direction of arrow W' into the
delivery tube as the spring wire 142 is arcuately formed to close
the wound. The clip 140 may also be constructed of a material that
retains shape, like titanium, and when pulled, it springs back from
a straight wire into a loop. This clip would be much smaller than
other endoclips currently marketed.
[0153] FIGS. 29 to 34 show a number of embodiments for delivering
the hemostatic powder 40 or hemostatic pellets through the
application catheter 68. In FIG. 29, the plunger 104 is utilized to
push the hemostatic powder 40 while in FIG. 30, gas under pressure
forces the hemostatic powder 40 to discharge from the application
catheter 68. In FIG. 31, a venturi 68a is utilized to draw the
hemostatic powder 40 or 50 into the venturi 68a for discharge under
gas pressure from the end of the application catheter 68. FIG. 32
shows a drill auger 152 utilized to force the hemostatic powder 40
or hemostatic pellets out through the application catheter 68. FIG.
33, shows the utilization of an outer auger 154 to force the
hemostatic powder 40 or hemostatic pellets through a central feed
passage 156 and outwardly from the application catheter 68. FIG. 34
discloses a wire auger 158 for the same purpose.
[0154] While a number of exemplary aspects and embodiments have
been discussed above, those of skill in the art will recognize
certain modifications, permutations and additions and
subcombinations thereof. It is therefore intended that the
following appended claims and claims hereinafter introduced are
interpreted to include all such modifications, permutations,
additions and subcombinations that are within their true spirit and
scope.
* * * * *