U.S. patent application number 14/472576 was filed with the patent office on 2015-03-05 for insertable prosthesis and prosthesis board for anastomosis.
The applicant listed for this patent is Luiz Gonzaga Granja Filho. Invention is credited to Luiz Gonzaga Granja Filho.
Application Number | 20150066065 14/472576 |
Document ID | / |
Family ID | 38801843 |
Filed Date | 2015-03-05 |
United States Patent
Application |
20150066065 |
Kind Code |
A1 |
Granja Filho; Luiz Gonzaga |
March 5, 2015 |
INSERTABLE PROSTHESIS AND PROSTHESIS BOARD FOR ANASTOMOSIS
Abstract
Prosthetic devices are provided used for anastomosis of
extremity with lateral, extremity with extremity and lateral with
lateral without clamping and sutureless or with quick clamping
sutureless, in which the graft is inserted in at least one of the
intraluminal parts of the tubular member of the insertable
prosthesis, the flanges including lateral inserts allowing the
configuration of different prosthesis sets. Also described is a
board of prostheses including one flange with multiple holes
through which intraluminal parts or occluders will be inserted,
according to the need of the anastomosis to be carried out. Also
provided are prostheses in which the grafts cover only externally
their extraluminal parts.
Inventors: |
Granja Filho; Luiz Gonzaga;
(Recife/PE, BR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Granja Filho; Luiz Gonzaga |
Recife/PE |
|
BR |
|
|
Family ID: |
38801843 |
Appl. No.: |
14/472576 |
Filed: |
August 29, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12303536 |
Mar 30, 2009 |
8828030 |
|
|
PCT/BR2007/000145 |
Jun 6, 2007 |
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14472576 |
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Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61B 2017/1139 20130101;
A61B 17/11 20130101; A61B 2017/1135 20130101; A61B 2017/1132
20130101; A61F 2/01 20130101; A61F 2/064 20130101; A61B 2017/1107
20130101 |
Class at
Publication: |
606/153 |
International
Class: |
A61B 17/11 20060101
A61B017/11 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 6, 2006 |
BR |
PI 0602385-1 |
Claims
1. A prosthesis comprising a fixed flange and a tubular member
having a conical internal form, and at least one pleated external
head having a rigid extremity, wherein the at least one head has a
low-profile configuration and is alignable, mobile and provides a
variable internal diameter.
2. The prosthesis according to claim 1, wherein the prosthesis is a
rigid, single-piece prosthesis composed of a calibered intraluminal
part whose lumen has a conical shape and is continuous with an
outer part, comprising heads, separated from the intraluminal part
by a low profile rigid flange, which contains at least two
diametrically opposed orifices, wherein the caliber at an origin
point of the intraluminal part is equal to the sum of internal
calibers of the heads.
3. The prosthesis according to claim 1 wherein the flange further
comprises lateral reinforcement through holes arranged about a
periphery thereof.
4. The prosthesis according to claim 3, wherein the through holes
are D-shaped and are arranged in pairs, one hole immediately
adjacent the other thereby forming a double hole.
5. The prosthesis according to claim 1, further comprising an
anastomotic trunk, which may be made with autologous, homologous,
heterologous or synthetic biological grafts.
6. A prosthesis comprising a flange and a tubular member, the
flange comprising a threaded lumen and the tubular member
comprising a mating thread on an exterior portion thereof, the
threaded tubular member having an internal end and an external end
opposite thereto, wherein the external end has a diameter equal to
or less than the internal end.
7. The prosthesis according to claim 6, wherein the diameter of the
threaded tubular member's external end is less than the internal
end.
8. The prosthesis according to claim 6, wherein the tubular member
has a form selected from the group consisting of: circular,
beveled, notched, conic, funneled, and pleated.
9. The prosthesis according to claim 6, further comprising an
anastomotic trunk, made with autologous, homologous, heterologous
or synthetic biological grafts.
10. The prosthesis of claim 9, wherein the internal and external
ends have the same diameter and wherein the tubular member is
configured to receive the anastomotic trunk therethrough.
11. The prosthesis of claim 10, wherein the anastomotic trunk is
everted, thereby covering the tubular member and is
circumferentially fixed to it.
12. An insertable anastomosis prosthesis, comprising: a fixed
flange and a tubular member wherein the tubular member has a single
lumen throughout an extension thereof, the lumen having a shape
derived from an intersection of multiple tubular members, which are
beveled.
13. The prosthesis, according to claim 12, wherein the flange
comprises a plurality of holes, arranged about a periphery thereof,
the holes being D-shaped and arranged in pairs, one hole
immediately adjacent the other forming a double hole.
14. The prosthesis of claim 13, wherein the double holes comprise a
thread previously tied to them.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. patent
application Ser. No. 12/303,536, filed Jun. 6, 2007, which is a
.sctn.371 National Phase filing of International Patent Application
No. PCT/BR07/00145, the entire contents of all of which are
incorporated by reference herein as if fully set forth.
FIELD OF THE INVENTION
[0002] The present invention refers in general to anastomotic
devices and, more specifically, to a prosthetic device of multiple
lateral inserts allowing anastomosis without clamping and
sutureless or, in cases of organs with normal walls, with quick
clamping sutureless, where a vascular graft or any other is
inserted into the lumen of each prosthesis and turned by casing in
order to cover part of it, which will remain inside the graft
(vein, artery or tissue), being fixed onto the tubular member of
the prosthesis by a circular stitch or other methods. The flange of
the prosthesis has several spaced out openings on its periphery,
allowing the prosthesis to be sutured in the tissue, vein, artery
or any other organ outside the anastomosis. Moreover, the flange of
the prosthesis also has at least one lateral insert that allows the
prostheses to be tightly united one to the other. The present
invention also refers to a board of prostheses, with at least two
intraluminal parts of different types, calibers and shapes that may
be activated or deactivated according to the needs of the
anastomosis.
BACKGROUND
[0003] A prior art presents several trials provide solutions for
anastomotic devices projected to correct vascular abnormalities,
which present the following typical features:
[0004] U.S. Pat. No. 3,254,650, of Jun. 7, 1966, describes a method
and devices to execute anastomosis procedures by applying with
adhesive two separated connectors in a body member and removing
this body member portion contained among the connectors, joining
the said connection devices for joining the remaining portions of
the body member.
[0005] U.S. Pat. No. 3,265,069, of Aug. 9, 1966, describes devices
or instruments for use by surgeons in reunion of body ducts, which
in the course of operations were separated. The instruments
comprise a pair of elongated similar elements and articulately
connected, in an intermediary manner, and with an support for
finger retention in a distal end, comprising a generally
cylindrical shape with a cylindrical channel that passes through it
in the other distal end, in order to receive tubular body ducts
kept by the instrument while the body ducts are reconnected.
[0006] U.S. Pat. No. 3,774,615, of Nov. 27, 1973, describes a
device to connect the end of interrupted tubular organs without
sewing, comprising a connecting ring on which the end of the
interrupted organ are pulled, the ring is preferably locked up by a
fixation resource. The ring and fixation resource are made of inert
material, and preferably a hydrophilic gel that can be dilated
until its equilibrium or can be a hydrogel incompletely dilated,
which is submitted to additional dilatation where it is applied.
The connecting ring can be supplied with a groove and can be placed
in a ring shaped fixation resource and kept there joining it to the
fixation resource in the groove or simply kept by a screw. Two
connection rings can also be used and kept joined by a coupling
member.
[0007] U.S. Pat. No. 4,366,819, of Jan. 4, 1983, describes an
anastomotic joint for surgery with a graft of coronary artery
deviance comprising a mounting of four elements including a
cylindrical tube with at least one locking indentation of ring
flange in one influx end and a plurality of grooves of locking ring
in a flow end; a ring flange with a central opening and a plurality
of long and short spigots, the long spigots are engaged in the
locking indentation, with a graft engaged among them; a fixation
ring with a central opening and a plurality of spigots positioned
around the opening; and a locking ring with a opening with a
plurality of locking ring edges for engaging with the locking ring
grooves. In surgical implants, an aortic wall with a hole engages
between the ring flange and the fixation ring and is kept in this
position by spigots of the fixation ring, and the four elements
engage together forming an integral anastomotic joint. A first
alternate modality includes an anastomotic joint of three elements
with a combination of fixation ring and locking ring. A second
alternate modality includes an anastomotic joint of four elements
with a slightly jolted end in a influx end, exposing the graft
material in the anastomotic "ostium".
[0008] Other prior arts are equally mentioned, based on some
information of "The Cardiothoracic Surgery Network". The "Simmetry
Aortic Connector System", developed by St. Jude Medical, is a
connector made with nitinol, selected by vein diameter with an
adventitia removed to allow adjust of the connector and to prevent
its displacement by the blood current. Then, the device may make an
angle of 90.degree. with the aorta. Among the disadvantages, there
is the fact that it can be used only in extreme cases due to the
difficult usage of this technique; it did not obtain a satisfactory
result in many surgeries and it is being drowned out of market by
the manufacturer; it is not applicable in calcified aorta; presents
suture; presents contact with blood flow (foreign body); it does
not widen the anastomosis area (restrictive anastomosis); performs
only one anastomosis at a time; it is a product restrict to
end-to-side anastomosis; a great mobilization of the venous graft
occurs, damaging it, and can eventually form thrombus; there is a
risk of perforation of the posterior wall of aorta; and the
adventitia is removed (most resistant vascular layer).
[0009] Another known device is the PAS-Port.TM. System, a device
used in 3 steps, and the vein wall is mounted over the device and
is manually reversed on it, by tool and adapted to aorta with an
angle of 90.degree.. The method alerts that the surgeon shall
select with due care the point of aorta and the vein size. The
device is made of stainless steel and is available in only one size
that allows the use of veins with external diameter of 4 to 6 mm,
aorta with an internal diameter of 18 mm. It is available in only
one size, limiting its applicability. As disadvantages of this
prior art, the device has contact with blood flow (foreign body);
it does not widen the anastomosis area (restrictive anastomosis);
it uses veins with external diameter of 4 to 6 mm and aorta with an
internal diameter of 18 mm; it does not perform multiple nor
visceral anastomosis; it performs just only end-to-side
anastomosis; a great mobilization of the used biological graft
occurs, damaging its inner layer, which generates the formation of
thrombus; there is a big risk of kinking at the origin (angle of
90.degree.) and risk of posterior wall perforation in the aorta at
the moment the device is introduced under its light; the suture is
substituted with disadvantages by stainless steel (9 pins, distant
among them, maximizing the risk of bleeding).
[0010] Also as prior art, there is the CorLink Device, currently
commercialized by Ethicon/Johnson & Johnson, that allows the
creation of anastomosis between the ascending aorta and a saphenous
vein segment. Aortic Anastomotic Device (AAD) is a self-expanded
device with extra luminal nitinol constituted by a de um central
cylinder with five interconnected elliptical arches and 2 groups of
5 pins in the end portion of the cylinder. The pins, after the
eversion of venous walls in the device, fix the aggregate
penetrating into the venous graft wall. A blade makes an opening in
the wall of aorta and permits the coupling of AAD, which also fix
the wall of aorta by pins. With this device: it poses a serious
risk of bleeding, especially in friable aortas, thin, calcified or
fibrous, restricting its applicability, also with risks, even in
aortas with normal walls; in small gauge anastomosis, there is a
risk of thrombosis, hyperplasia, intimal proliferation and fibrosis
(reaction to foreign body type in origin of anastomosis) with
consequent stenosis resulting in occlusion of anastomosis; sutures
are used in some cases; there is cases of infarction caused by
equipment; there is a recurring need of re-operations in patients;
the device presents contact with blood flow (foreign body); it is
not flexible; it does not multiple anastomosis; an inadequate
mobilization of venous graft occurs, and can cause damage to its
intimal layer, it could form thrombus; it is used only in extreme
cases because it is a technique of complex usage; the suture is
substituted by stainless steel in contact with blood flow.
[0011] Another known device is the St Jude Distal Connector that
consists of a stainless steel clip mounted on a catheter,
comprising a balloon for subsequent expansion and connector
mounting. The catheter is introduced backward from the end, by
doing a small hole in the anastomosis site, the clip fixes the vein
in the hole, the catheter goes to coronary and releases the
connector. The catheter is removed and a suture is done in
side-to-side anastomosis. With St Jude Distal Connector, occurrence
of leakage problems were detected in 20% of the used connectors;
the use of a metallic clip requires due care for handling to avoid
distortion in the anastomosis; late angiographies reveal smaller
circular diameter of anastomosis made with o St. Jude Distal
Connector, when compared to controls made with conventional suture;
there is remarkably risk of bleeding and the graft is very
mobilized, and lacerations can occur in its inner layer, allowing
the formation of thrombus.
[0012] The HeartFlo.TM. is a multi-suture instrument for
anastomosis with wires automatically applied in end-to-side and
side-to-side anastomosis. The surgeon manually ties the suture
wires (10 wires) and concludes the anastomosis similarly to the
traditional process. Besides of being a product of complex
handling, it makes suture in anastomosis (keeping the undesirable
foreign body in the internal origin of the anastomosis) and is
restricted to end-to-side and side-to-side anastomosis. There is
also an excessive mobilization of graft, and can cause lesions in
its intimal layer, which would be the inductor that forms the
thrombus.
[0013] Another technique and known device is the Solem Graft
connector, produced by the Swedish company Jomed. It is constituted
by a stent made of nickel and titanium coated with
polytetrafluorethylene used to connect the internal thoracic artery
the left anterior descending coronary artery. The results has not
been satisfactory, because it poses risk of bleeding; there is also
an excessive mobilization of graft, probably damaging intimal
layers, allowing the formation of thrombus; it is not flexible, by
this fact, causes trauma to grafts; it does not make multiple
anastomosis, at a single time; presents contact with blood flow
(foreign body); and is frequent the need of-operations.
[0014] The Magnetic Vascular Positioner System is produced by
Ventrica and comprises 4 magnetic rings and the anastomosis is
processed by magnetic attraction of 4 ports. However, initial
experimental results demonstrate leakage, also a undesired contact
of materials with blood flow. On the other hand, it is necessary to
be careful to avoid the capitation of excess of tissue among the
magnets. With this system, there is also a need of suture in some
cases; there is occurrence of infarction caused by equipment; and
is frequent the need of-operations in patients; and also requires
clamping.
[0015] Also, as a device known by the medical area, the Combined
Anastomotic Device and Tissue Adhesive, developed by Grundeman
& Borst group, combines micro mechanical technique with use of
adhesive (glue). The use of this method can result in leakages and
need traditional sutures; it is frequent the need of reoperation
due to leakage/bleeding; and performs only one anastomosis at a
time.
[0016] Finally, it is also experimentally practiced anastomosis
assisted by laser, where the results are not different from
conventional isolated sutures, because there is a need of suture in
some cases; there is a risk of bleeding e leakage; and does not
perform multiple anastomosis.
[0017] Even so divulged nowadays, anastomosis with clamper, by
insecurity, and almost totality of surgeons perform conventional
sutures throughout the route of anastomosis, with an intention of
avoiding leakages and bleedings, it means the use of dampers just
makes the procedure more expensive, once the conventional suture is
also applied.
[0018] In short, the conventional anastomosis, with clamping and
with suture, standardized in 1906 by Alexis Carrel, remains the
first choice for any type of anastomosis and organs to be
anastomosed.
[0019] With an expectation of changing the current situation,
Brazilian patent number PI9706197-2, describes and claims a
prosthesis for vascular anastomosis, or in any other organ or
tissue, without the use of clamping and sutureless, solving, in an
elegant and efficient manner, the limitations inherent to
prosthesis of the above mentioned prior art, when used in vascular
anastomosis performed, mainly in thin aortas, calcified and
friable; or in any other application where a clamping of a vein or
artery can pose excessive trauma for conditions of a given patient.
The prosthesis that is subject of that request allows the
embodiment of fast and safe anastomosis, without obstruction of
vein or artery lumen of which anastomosis is made, also allows
anastomosis in tissues, veins or arteries in bad conditions and
never would accept a clamping used in conventional anastomosis.
This is achieved by a generally cylindrical shaped prosthesis with
a flange orthogonally extending from its external side wall, in a
point in the prosthesis length between its ends; the referred
flange has openings distributed around its surface. The description
of the usage method and specific construction of the prosthesis is
presented in the drawings of the descriptive report of that
request, as well as the document C19706197-2, Certificate of
Addition of the first.
[0020] Although these anastomotic devices can be presented as
suited to the purposes for which they were projected, they are not
so suited for the purposes of the present invention, as described
herein below.
SUMMARY
[0021] The present invention refers to the variations of the
currently known anastomotic devices so as to make possible multiple
latero-lateral, termino-terminal and termino-lateral anastomoses
without clamping and sutureless or with a quick clamping and
sutureless if the organ presents normal walls, where a vascular
graft or any other is inserted into the lumen of each prosthesis
and turned by casing in order to cover part of it, which will
remain inside the graft (vein, artery or tissue), being fixed onto
the tubular member of the prosthesis by a circular stitch. The
flange of the prosthesis has a number of spaced-out openings in its
periphery, allowing the prosthesis to be sutured only for its
fixing onto the tissue, vein, artery or any other organ outside the
anastomosis. Besides, the flange of the prosthesis also has at
least one lateral insert that allows the prostheses to be tightly
united one to the other. The prosthesis may also have varied
dimensions and shapes to simultaneously accommodate grafts of
varied sizes and types.
[0022] One objective of the present invention is to produce an
anastomotic device of multiple lateral inserts having a tubular
member and a flange allowing the configuration of the most varied
types of anastomotic sets of different types and calibers (for
instance, prosthesis with anastomotic trunk--formed by the union of
several grafts by one of its extremities--in the wanted extension
and diameter, sufficient to cover the intraluminal part of the
prosthesis. The anastomotic trunk may be made with autologous,
homologous, heterologous or synthetic biological grafts.
[0023] Another objective of the present invention is to produce a
board of prostheses including a flange with multiple intraluminal
parts or with multiple holes through which intraluminal or
occluding parts will be inserted, according to the need of the
anastomosis to be carried out.
[0024] Additional objectives of the present invention and other
modalities will come up as the description continues. These
modalities will be described in sufficient detail to allow experts
in the matter to implement the invention. Moreover, it must be
understood that other modalities may be used and that structural
changes may be carried out without distancing themselves from the
scope of the invention. In the accompanying drawings, reference
characters of similar reference designate the same or similar parts
through all the several views.
[0025] The following detailed description, thus, is not to be taken
in a limiting sense and the scope of the present invention is
better defined by the annexed claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] For the invention to more fully understood, it will be now
described through examples regarding the annexed drawings, of
which:
[0027] FIG. 1 illustrates one first realization of the prosthesis
for anastomosis equipped with flanges with lateral inserts so as to
form the most different types of prosthetic sets.
[0028] FIG. 2 illustrates a second realization of the prosthesis
for anastomosis equipped with flanges with lateral inserts so as to
form the most different types of prosthetic sets, in which the
intraluminal parts may be either fixed or removable and
threaded.
[0029] FIG. 3 illustrates one third realization of the prosthesis
for anastomosis equipped with flanges with inserts in the
diametrical direction, so as to form circular prosthetic sets, in
which the intraluminal parts may be either fixed or removable and
threaded.
[0030] FIG. 4 illustrates one fourth realization of the prosthesis
for anastomosis equipped with flanges with inserts in the
diametrical direction, having small holes for better fixing of the
parts so as to form circular prosthetic sets, in which intraluminal
parts may be either fixed or removable and threaded.
[0031] FIG. 5 illustrates the fifth realization of the prosthesis
for anastomosis equipped with flanges with inserts in the axial
direction so as to form circular prosthetic sets, in which
intraluminal parts may be either fixed or removable and
threaded.
[0032] FIG. 6 illustrates the sixth realization of the prosthesis
for anastomosis equipped with flanges with inserts in the
longitudinal direction so as to form insertable prosthetic sets on
a right line, in which the intraluminal parts may be either fixed
or removable and threaded.
[0033] FIG. 7 illustrates the seventh realization of the prosthesis
for anastomosis equipped with flanges with inserts in the
longitudinal direction so as to form insertable prosthetic sets on
a right line, in which the intraluminal parts may be either fixed
or removable and threaded.
[0034] FIG. 8 illustrates the eighth realization of the prosthesis
for an anastomosis equipped with flanges with inserts in every
direction so as to form sets of insertable prostheses in any
position and number, where intraluminal parts may be either fixed
or removable and threaded, being beveled in one, two, three or four
bevels.
[0035] FIG. 9 illustrates the ninth realization of the prosthesis
for anastomosis equipped with flanges with inserts in every
direction so as to form sets of insertable prostheses in any
position and number in which the intraluminal parts may be either
fixed or removable and threaded, while also having occluders to
plug the holes that are not used.
[0036] FIG. 10 illustrates a board of prostheses with threaded
holes and the intraluminal parts may be either fixed or removable
and threaded, also having occluders to plug the holes that were not
used.
[0037] FIG. 11A illustrates the prosthesis board with the double
intraluminal part and the round flange with double outlet.
[0038] FIG. 11B illustrates the upper view of the prosthesis board
of FIG. 11A with double intraluminal part, showing the holes
through which the stitches will pass to facilitate fixing the
grafts to the intraluminal parts.
[0039] FIG. 12A illustrates the prosthesis board with double
intraluminal part and non-round flange, with the possibility of
being either elliptical or rectangular.
[0040] FIG. 12B illustrates the upper view of the prosthesis board
of FIG. 12A, with double intraluminal part, showing the holes
through which the stitches will pass to facilitate the fixing of
the grafts to the intraluminal parts.
[0041] FIG. 13A illustrates the prosthesis board with triple
intraluminal part and round flange with triple outlet.
[0042] FIG. 13B illustrates the upper view of the prosthesis board
of FIG. 13A, with triple intraluminal part, showing the holes
through which stitches will pass to facilitate fixing of the grafts
to the intraluminal parts.
[0043] FIG. 14A illustrates the prosthesis board with threaded,
double, removable intraluminal part and round flange with double
exit.
[0044] FIG. 14B illustrates the upper view of the prosthesis board
of FIG. 14A, with threaded, double intraluminal part, showing the
holes through which will pass the stitches to facilitate fixing of
the grafts to the intraluminal parts.
[0045] FIG. 15A illustrates the prosthesis board with threaded,
double, removable intraluminal part and non-round flange, with the
possibility of being either elliptical or rectangular.
[0046] FIG. 15B illustrates the upper view of the prosthesis board
of FIG. 15A, with threaded, double intraluminal part showing the
holes through which will pass the stitches to facilitate fixing of
the grafts to the intraluminal parts.
[0047] FIG. 16A illustrates the prosthesis board with triple,
threaded and removable intraluminal part and round flange with
triple outlet.
[0048] FIG. 16B illustrates the upper view of the prosthesis board
of FIG. 16A, with intraluminal, triple, threaded part showing the
holes through which will pass the stitches to facilitate fixing of
the grafts to the intraluminal parts.
[0049] FIG. 17A illustrates the prosthesis board with double,
fixed, beveled intraluminar part and round flange with double
outlet.
[0050] FIG. 17B illustrates the prosthesis board with threaded,
double, removable and beveled intraluminal part and round flange
with double outlet.
[0051] FIG. 17C illustrates the upper view of the prosthesis board
of FIG. 17A, with double, fixed or removable, beveled intraluminal
part, showing the holes through which the stitches will pass to
facilitate fixing of the grafts to the intraluminal parts.
[0052] FIG. 18A illustrates the prosthesis board with double,
fixed, beveled intraluminal part, with the possibility of being
either elliptical or rectangular.
[0053] FIG. 18B illustrates the prosthesis board with double,
threaded, removable, beveled intraluminal part, and non-round
flange, with the possibility of being either elliptical or
rectangular.
[0054] FIG. 18C illustrates the upper view of the prosthesis board
of FIG. 18A, with double, fixed or removable, beveled intraluminal
part, showing the holes through which will pass the stitches to
facilitate fixing of the grafts to the intraluminal parts.
[0055] FIG. 19A illustrates the prosthesis board with triple,
fixed, beveled intraluminal part and round flange with triple
outlet.
[0056] FIG. 19B illustrates the prosthesis board with triple,
threaded, removable and beveled intraluminal part and round flange
with triple outlet.
[0057] FIG. 19C illustrates the upper view of the prosthesis board
of FIG. 19A, with triple, fixed or removable, beveled intraluminal
part, showing the holes through which will pass the stitches to
facilitate fixing of the grafts to the intraluminal parts.
[0058] FIG. 20A illustrates the prosthesis board with triple
intraluminal part (with the possibility of being double or having
any other number), either fixed or removable, beveled, with round
flange with double outlet and a tubular body before the
intraluminal part, so as to cause grafts to contact each other
before leaving the prosthesis.
[0059] FIG. 20B illustrates the upper view of the prosthesis board
of FIG. 20A.
[0060] FIG. 21A illustrates the prosthesis board with triple
intercommunicable intraluminal part in the shape of a clover,
beveled and round flange with double holes on the surface of the
flange to fix the graft and the organ.
[0061] FIG. 21B illustrates the upper view of the prosthesis board
of FIG. 21A.
[0062] FIG. 22A illustrates a prosthesis board with two heads
(medusa head) by intraluminal part, where grafts are individually
connected.
[0063] FIG. 22B illustrates a prosthesis board with three heads
(medusa head) by intraluminal part, where grafts are individually
connected.
[0064] FIG. 23A illustrates a single head for a simple prosthesis
and a prosthesis board, the single head being of a variable caliber
for one same caliber of calibrous and short and removable
intraluminal part threaded to the flange without intraluminal
part.
[0065] FIG. 23B illustrates a single head for a simple prosthesis
and for a prosthesis board, the single head being of a variable
caliber for the same caliber of calibrous and short, removable and
threaded intraluminal part to the flange with intraluminal
part.
[0066] FIG. 24 illustrates a double head for a simple prosthesis
and for a prosthesis board, the double head having a pleated,
flexible, movable extremity.
[0067] FIG. 25 illustrates a triple head for a simple prosthesis
and a prosthesis board, the triple head having a pleated extremity
of discreetly smaller calibers than those of the grafts that will
cover them, and the prosthesis lumen having the shape of a cone
trunk in its interior.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0068] In regards with the drawings, in which similar reference
characters indicate similar elements for all views, the figures
illustrate one of the realization forms of the present invention in
the form of prosthesis for anastomosis with flanges having multiple
inserts to form a set of prostheses and of a prosthesis board to
make flexible the use of the wanted intraluminal parts.
[0069] FIG. 1 presents a prosthesis made up of two parts united by
lateral, tightly closed insert 1 and stitches in its flanges. Each
part has half a flange and a tubular member orthogonal to it. The
flange formed by the junction of the two parts has internal 3 and
external 4 holes, tabs or double holes or fold (the latter ones are
not shown) and also small, juxtaposed holes 2 situated on the
periphery of each half of the flange, through which threads (made
of steel, silk, polypropylene, etc.) will pass to reinforce the
union of the parts. The tubular member has at least one groove on
its external surface, where the grafts will be anchored after
eversion (already shown). The double holes, tabs or fold of the
flange have the purpose of anchoring the tabs of the threads on
their way through the internal holes on the upper surface of the
flange.
[0070] FIG. 2 represents another type of lateral, tightly closed
insert 1 between the flanges, giving stability and dispensing with
the use of stitches passed through the juxtaposed holes of the
periphery of each part of the flange. Again, the double holes or
external tabs or fold (small extension of the tubular member over
the flange) are not shown on the flange. It shows that there is no
need of small juxtaposed holes of the flange.
[0071] FIG. 3 and FIG. 4 present only different forms of their
flanges or their halves (respectively circular and semicircular),
whereas in FIG. 3 the same insert is kept as in FIG. 1 with the
small juxtaposed holes 2 and, in FIG. 4, only the same type of
insert of FIG. 2.
[0072] FIG. 5 shows a prosthesis with circular flange split into 3
parts, each having a segment of the flange with multiple holes and
a tubular member. These segments of the flange are tightly
inserted, forming a single flange, being fixed through stitches
(stainless steel, polypropylene, silk, etc.) passed through small
juxtaposed holes located next to their insert edges. In this flange
have been shown internal holes, the external holes (for double
suture of the prosthesis to the organ wall), the interposed holes
between the internal holes (to anchor the thread tabs into the
flange surface, avoiding that they block the lumen of the
prosthesis tubular members) and the small juxtaposed holes 2, whose
stitches make sure that the three parts of the prosthesis will be
united. In this prosthesis, two parts might be inserted with the
insert represented in FIG. 4 and only the last one to be
simultaneously inserted into the other two, such as the insert of
FIG. 3 or 5, needing the small juxtaposed holes.
[0073] The prostheses of FIGS. 1-5 have their tubular members
covered by graft that passed through their lumen, was everted and
fixed to it with an external circumferential stitch or by any other
method. The technique on the use of these techniques consists in
passing at least two opposed stitches in U with parallel legs, from
up down through the internal holes, anchored in the middle by
double holes, tabs or fold; to transfix or not the wall of the
organ in the place of the anastomosis (whose incision size, if
rectilinear, will be equal to half the total perimeter of tubular
members of the prosthesis) and return or not to the external hole
of the flange, from down up, if it is wanted to make a suture of
the flange at the friable walls, reducing its mobilization. Thus,
the threads will be tied, compressing the organ wall over the
tubular members or over the upper surface of the single flange.
Also, these threads fix the parts of the prosthesis among
themselves and provide greater stability.
[0074] FIGS. 6 and 7 show a prosthesis with three parts aligned and
inserted in the same ways as described. Its use technique is also
similar to that described above. This configuration is especially
indicated for small-diameter organs and can be made in multiple
anastomoses in series and aligned at one time, without clamping and
sutureless. These prostheses have transversal external grooves on
their tubular members to avoid that the everted grafts
circumferentially fixed to them flow off. All their edges are
blunt, not cutting ones.
[0075] FIG. 8 represents a series of independent prostheses with
tightly shut lateral inserts on their flanges, and may be inserted
by all their edges to similar ones or which are multiple in the
extension of their flanges. Any configuration is possible: aligned,
triangular, trapezoidal, square, rectangular, etc., and the shape
of their flanges may vary, such as: semicircular, fitting into
another bigger, circular one by touching it; circular with touching
circulars, etc. Any shape of slotting and final shape of its
flanges is possible, such as the composition of a puzzle fitting
together. It must be said that any one of them is independent and
may e used in isolation. Here its tubular members are orthogonal
and set to the flange. Neither the flange holes nor the double
holes, small juxtaposed holes or the transversal grooves of the
tubular members have been shown. The technique for is use, once the
prostheses-grafts sets have been assembled, is similar to the
described above. It is important to stress that the final
composition to be given may be chosen at the time of the
anastomotic procedure, depending on the shape, diameter and
conditions of the organ that will receive it.
[0076] FIG. 9 represents a set of independent prostheses with
tightly shut lateral inserts on is flanges, but differs from that
of FIG. 8 in that its tubular members are separated from the flange
and threaded externally to the lumen of the flange that has an
internal thread 5. It also shows an occluder device 6 without
lumen, with external threading, that may plug any hole of the
flange one does not wish to use anymore. The prosthesis-graft set
may be assembled after the total threading of the tubular member
into the flange and, thus, the graft will be everted and
circumferentially fixed to its external surface. Or the graft may
initially pass by the flange lumen and be fixed to it with stitches
from the graft to its holes. Next, the graft is retrogradely passed
by the lumen of the tubular member, which will then be smoothly
threaded to the flange while the graft is everted on it. This would
allow, even after the anastomosis is made, a tubular member to be
removed and replaced by an occluder. The use technique is the same
as the one described above.
[0077] FIG. 10 represents the so-called prosthesis board for
anastomosis including a big flange, either square or of another
shape, with multiple holes 7 in is periphery and multiple threaded
center lumens 8, which might be dispersed by means of any drawing
or randomly, through which also externally threaded tubular members
will pass. It is possible to use the wanted number of lumens,
occluding the others with occluders (tubular members without lumen
and externally threaded). In this board, the lumens 8 may have
variable calibers and may separately receive grafts of any caliber.
The technique for its use is the already described one, both in the
form to fix the grafts to the flange or to the tubular members.
[0078] FIGS. 11A to 13B represent prostheses with two and three
tubular members 9 fixed to the flange, which, besides the holes
mentioned above, have small holes 10 on the touching spot between
the tubular members through which fine threads will pass from up
down and unite the edges of the grafts drawing them to the lower
surface of the flange, making easier their eversions and, next,
binding them around the tubular member in order to
circumferentially fix them onto their external grooves. The
technique for their uses is the same.
[0079] FIGS. 14A to 16B represent prostheses that differ from the
prostheses of FIGS. 11A to 13B as their tubular members are
separated from the flanges and they are threaded up to the wanted
depth. Here the grafts may initially be united by their extremities
to the center of the lower face of the flange by stitches passed
through the small holes 10 existing there. Tubular members 9 are
then threaded up to the wanted height while being coated by the
everted grafts. At the end of the threading, the thread lines bind
the grafts on the tubular members and fix them
circumferentially.
[0080] FIGS. 17A to 17C represent prostheses that differ from the
prostheses from FIGS. 14A and 14B as their tubular members have a
bevel 11 inwards, although they could be doubly, triply and
quadruply beveled. These bevels are important as they increase the
origin area of the anastomosis while facilitating their future
characterizations should it be necessary, for instance, in
hemodynamic restudies, especially if they are made with
radiographically opaque material. They may be tubular members fixed
to the flange as in FIG. 17A of threaded as in FIG. 17B.
[0081] The prostheses from FIGS. 18A to 18C differ from the
prostheses of FIGS. 17A and 17C only in that they have oval or
rectangular flanges with round corners.
[0082] The prosthesis of FIG. 19A differs from the prostheses of
FIG. 13A in that they have their tubular members beveled to
increase the origin area of the anastomosis and facilitate its
catheterizations at least by the fact that the lower edge of the
bevel is in the intima of the organ wall to which it was fixed.
[0083] The prosthesis of FIG. 19A differs from the prosthesis of
FIG. 16A in that its tubular members are beveled for the reasons
already mentioned.
[0084] FIG. 19C is an upper view of FIGS. 19A and 19B.
[0085] Up to here, the prostheses shown have their grafts
individualized on their course through the interior of the tubular
members. Now, the prostheses of FIGS. 20A and 20B have a segment 12
common to the tubular members, having the same small holes on the
spot and height where the tubular members lose their individuality.
This triple tubular member in a single piece may have its
intraluminal parts either beveled or not. This triple tubular
member in a single piece may be either fixed or have threads in its
common part and be threaded to the flange at one time. This common
segment of the tubular members, whose diameter is equal to the sum
of the diameters of the tubular members in isolation, cause the
grafts to relate among themselves before emerging from the
prosthesis. The fact that they individualize themselves inside the
lumen of the prosthesis increases the versatility of the direction
of these grafts upon leaving the prosthesis, allowing them to be
directed to any position with zero risk of shoving. The grafts may
be united in a touching point to the three, to be retrogradely
introduced in the lumen of the tubular members with the threads
passing by the small central holes, to be fixed to the lower
surface of the prosthesis, to be everted and again
circumferentially fixed by those same threads. This allows for a
considerable time saving, making unnecessary the confection by
suture or another method of the anastomotic trunks, while also
avoiding the inadvertent exposition of the threads in the lumen of
the grafts, besides reducing the risk of bleeding, as there are no
suture lines between them. The prosthesis of FIGS. 20A and 20B
makes very simple and quick the confection of a termino-lateral,
ample, multiple anastomoses at one time with a single prosthesis,
without clamping and sutureless. Its use technique is similar to
the previous ones as well the holes of its flange.
[0086] The prosthesis represented by FIGS. 21A and 21B has some
very singular characteristics. It has a flange with only four
double equidistant holes 13. It has a triple tubular member,
beveled inwards, but a single lumen. To coat the tubular member, it
is necessary the confection of an anastomotic trunk that will also
be everted and externally fixed to the tubular member through
stitches passed by its holes situated in the thickness of the
tubular member or by the small tabs external to it, adjacent to the
flange or even small holes or tabs situated on the flange. If they
are tabs, they are fixed to its lower surface. In order to be well
adjusted to the tubular member, the tabs or holes must also be
present in the groove formed by the junction of the two tubular
members. This clover-like drawing keeps the original form and
diameter of the grafts as if they were individualized, which is
important from the physiological point of view, differently from
forming a single mouth, which might take up a triangular form, not
a circular one. A great advent is represented by just these four
double holes 13. The threads would be previously tied to the double
holes 13 in their lower surface, their legs would be fixed and
there would not be more thread tabs situated on the upper surface
of the flange, making unnecessary double holes, tabs or folds to
anchor them, besides bringing to an end the concern over
interposition of the prosthesis lumen by thread tabs. This previous
fixing of the threads to the flange would render the procedure
quicker and safer, making the risk that the threads break up at the
moment they are tied almost null, as their tabs would not undergo
friction against the edges of the hole. Here, differently from what
has been described, a thread tab must never be tied with another of
the same thread, but with one of the adjacent thread. Thus, threads
with different colors will make applying the technique even easier.
Contiguous tabs of different colors must always be tied among
themselves. Thus, in this case, each thread will have its two tabs
passed together, almost at the same point. Next, an incision is
made in the middle of the parallel and opposed legs of the threads
and this without risk that they are cut out even if the organ wall
is longitudinally and/or transversally cut, crisscrossing the
center of the anastomosis. Finally, the anastomotic set is
introduced and the legs of the different threads are tied up two by
two, compressing the organ wall over the triple tubular member,
making sure that a perfect hemostasia is produced, if it is a
vessel. Also here, the anastomosis may be without clamping and
sutureless, termino-lateral or termino-terminal.
[0087] The prostheses of FIGS. 22A and 22B are of a thick caliber
in their origin and low profile or thickness (a few millimeters).
They may have their heads 14 either aligned or in the form shown.
The heads are movable with a rigid extremity. Thus, their
intraluminal part may have an oval or elliptical form, always
having transversal grooves, as shown. This way, they may be used
without coating of their intraluminal part, with their heads being
externally covered by the grafts (fixed to their rigid part), which
may be of any type, preferably autologous. Due to the fact that
they have a low profile, thick caliber and probable high laminar
flow, thanks to the perfect cylindrical form provided by the
prosthesis, the risk of their being obstructed by thrombogenicity
related to the contact with the foreign body (prosthesis material)
with the blood, in the case of vascular anastomoses, is
considerably reduced.
[0088] Obviously, it may be used as already described, with its
intraluminal part covered by everted anastomotic autologous trunk
fixed to it circumferentially. In this case, the grafts would pass
retrogrately by the lumen of the tubular member and heads 14. Also
its use technique is similar to that of the prostheses that do not
have threads for their fixing previously tied to their flange.
[0089] FIG. 23A represents a prosthesis with flange and tubular
member separated and united by threading between them. The flange
has lumen with internal screw thread and, externally, the tubular
member. Tubular members, when completely threaded, are at one
internal extremity and at an external one. The internal,
intraluminal extremity will always have the largest possible
diameter so as to allow the lumen to pass from the flange. The
external extremity may have its diameter equal to or smaller than
the internal one, never larger than it. When the external diameter
is smaller, the interior of the tubular member has the shape of a
cone trunk so that the flow can be laminar in vascular anastomoses.
Several tubular members may pass by the same flange with an
external extremity of very small diameter or even a maximum
diameter equal to that of its internal extremity. The reason for
this is to always allow the confection of proximal anastomoses with
ample origin even if the grafts are fine. Conventional anastomoses
with fine grafts, besides being technically difficult, are shortly
lived, often closing immediately after their conclusion. Here, it
becomes very simple to anastomize without clamping and sutureless,
termino-lateral, even a graft with a diameter shorter than 1 mm. If
the used tubular member has internal and external extremities with
the same diameter, that is, the maximum one, it is preferred that
the graft or anastomotic trunk passes by the lumen of the
prosthesis, in case it is everted, that it covers the intraluminal
part and that it be circumferentially fixed to it. This way, if the
grafts are autologous, there will be no foreign body in the origin
of the anastomosis, which is the ideal condition, besides the fact
that the anastomosis is multiple, at one time, ample, without
clamping and sutureless. When grafts coat the heads externally,
once the anastomotic set is introduced in the lumen of the organ,
the tubular member may be partially unthreaded in order to
guarantee its complete absence of protuberance in the lumen of the
organ. This flange may have, preferably, only double holes, or have
internal, external, double holes, tabs or folds. Thus its use
technique will depend on how its flange is shown. These techniques
have already been described. Obviously, any type of graft may be
used with this prosthesis or any of those mentioned above.
[0090] FIG. 23B represents a prosthesis with flange and an
asymmetric tubular member fixed orthogonally to it, with a
calibrous internal part and an external one of a smaller caliber.
It differs from the prosthesis of FIG. 23A in that it does not have
its versatility to allow the use of several tubular members with
calibers equal to or different than its internal and external
parts. Also here, the interior of the tubular member has the form
of a cone trunk, which, in the case of vessels, guarantees the use
of a laminar, not whirling flow, which would occur if there were an
abrupt reduction at right angles of the caliber of the internal,
larger part, to the caliber of the smaller, external part. This
prosthesis must have a low profile (few millimeters in total
thickness, including the external part, the flange and the internal
part) and be as calibrous as possible in its origin. Thus, even
small-caliber grafts may cover the external part being fixed to
them and be safely used while making termino-lateral anastomoses
without clamping and sutureless. This calibrous origin, besides
guaranteeing longer life to the graft, also facilitates
catheterization of the prosthesis lumen in contrasted studies like
cardiac catheterization. Made in radiographically opaque material,
not even in microanastomoses, it will be difficult to locate the
origin of the anastomosis and selectively catheterize it, which
would significantly reduce costs, due to the smaller amount of
radiographic opaque contrast and, especially, due to the risk of
toxic complications (kidneys, etc.) presented by those contrasts.
The technique of its use will also depend on the presentation of
its flange, again, if only with double holes or with multi
internal-external holes, double holes, tabs or folds. Thus, in this
prosthesis, the fluid will get in touch with the material with
which it was made, which should be as biocompatible and inert as
possible.
[0091] The prostheses shown by FIGS. 24 and 25 are in a single
piece, with single flange and single intraluminal tubular member
and extraluminal double or triple heads 14. The tubular member also
has a conic internal form directed to each head. The heads may be
either pleated, flexible or with rigid extremity. They may be
either fixed to the flange by any method, such as suture, glue, by
coating the upper circular extremities to the flange and being
fixed to them circumferentially, etc. Again, those are prostheses
that guarantee a large caliber of the origin of the independent
anastomosis of the graft caliber. Also here the fluid will contact
the material of the prosthesis. Thus the need that they are of a
thick caliber and low profile, minimizing the risks related to this
contact: foreign-body type reaction, thrombogenicity, etc. In order
to lessen even more such undesirable reactions, those prostheses
could be made previously by the industry, with their internal and
external surfaces coated, for instance, with homologous, treated
and free-dried biological tissue. Perhaps, if such prostheses were
immersed in those preparations of endothelial free-dried cells and
had microporous internal and external surfaces, by adding any kind
of little antigenic biological glue, their surfaces could remain
totally and uniformly coated by such cells, thus lessening said
reactions. Also their intraluminal parts might be beveled in one,
two, three or four bevels, increasing the anastomosic area even
more, rendering the contrasted restudy easier and, fundamentally,
reducing the amount of the material that made the prosthesis. The
technique for its application is like those already described,
according to the flange configuration.
* * * * *