U.S. patent application number 09/861915 was filed with the patent office on 2002-03-28 for curved implantable sheath and method of making same.
Invention is credited to Gabbay, Shlomo.
Application Number | 20020036220 09/861915 |
Document ID | / |
Family ID | 46277652 |
Filed Date | 2002-03-28 |
United States Patent
Application |
20020036220 |
Kind Code |
A1 |
Gabbay, Shlomo |
March 28, 2002 |
Curved implantable sheath and method of making same
Abstract
The present invention provides a method for making a curved
implantable sheath. A sheet of flexible material is urged into
engagement with a member having a curved surface having a desired
configuration. The sheet and member are placed in a fixation
solution so that the sheet assumes the configuration of the surface
engaged thereby.
Inventors: |
Gabbay, Shlomo; (Short
Hills, NJ) |
Correspondence
Address: |
Gary J. Pitzer
Amin & Turocy, LLP
National City Center
1900 E. 9th Street, 24th Floor
Cleveland
OH
44114
US
|
Family ID: |
46277652 |
Appl. No.: |
09/861915 |
Filed: |
May 21, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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09861915 |
May 21, 2001 |
|
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09669821 |
Sep 26, 2000 |
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Current U.S.
Class: |
224/191 |
Current CPC
Class: |
A61F 2/06 20130101; A61F
2/04 20130101; A61F 2/062 20130101; A61L 27/36 20130101; A61L
27/3604 20130101; A61B 2017/00243 20130101 |
Class at
Publication: |
224/191 |
International
Class: |
A45F 005/00; B65D
001/00 |
Claims
What is claimed is:
1. A method for making a sheath having a curved contour,
comprising: providing a sheet of a biological tissue material, the
sheet having ends spaced apart from each other by elongated side
edges; mounting the sheet to an elongated member having a curved
exterior portion such that at least a substantial portion of the
sheet engages the exterior portion; placing the sheet and elongated
member in a fixation solution so that at least part of the sheet is
fixed to a configuration defined by the exterior portion of the
elongated member engaged thereby; and separating the sheet from the
elongated member to provide an elongated sheath of substantially
biocompatible material having a curved contour corresponding to the
curved exterior portion of the elongated member.
2. The method of claim 1, prior to placing the sheet and elongated
member in a fixation solution, the method further comprising:
forming a generally tubular apparatus with the sheet of the
biological tissue material; and urging the elongated member into
the tubular apparatus.
3. The method of claim 2, the elongated member having a generally
cylindrical sidewall portion that extends arcuately between
opposite ends thereof.
4. The method of claim 2, the sidewall portion of the elongated
member having a radius of curvature extending between the opposite
ends thereof that is greater than about forty-five degrees.
5. The method of claim 3, the elongated member having an outer
diameter that approximates the diameter of the tubular
apparatus.
6. The method of claim 2, the forming further comprising securing
the side edges of the sheet of biological material relative to each
other, such that when the elongated member is urged into the
tubular apparatus, the relative spacing between the side edges of
the sheet of biological material remains substantially
unchanged.
7. The method of claim 6, further comprising removing a strip of
tissue adjacent and coextensive at least one of the side edges to
form an elongated sheath having a curved contour that extends
arcuately between opposite ends thereof and having generally
C-shaped cross section.
8. An elongated sheath produced according to claim 7, the elongated
sheath having a curved contour extending arcuately between opposite
ends thereof and having generally C-shaped cross section.
9. The method of claim 5, the securing of the side edges further
comprising suturing the side edges relative to each other to define
a suture line that extends between the ends of the tubular
apparatus.
10. The method of claim 8, further comprising removing the suture
line to define an elongated sheath having a curved contour that
extends arcuately between opposite ends thereof and having
generally C-shaped cross section.
11. The method of claim 1, wherein the biological tissue material
comprises animal pericardium.
12. An elongated sheath produced according to claim 1.
13. A method of making an implantable sheath having a curved
contour, comprising: providing a sheet of tissue, the sheet having
ends spaced apart from each other by elongated side edges; placing
the sheet into engagement with a surface of an elongated member,
the surface being curved about a long axis that extends between
ends of the elongated member; urging the side edges of the sheet
toward each other so as to cover at least part of the curved
surface of the elongated member; fixing the sheet in a fixation
solution so that at least part of the sheet assumes a contour
defined by the at least part of the curved surface of the elongated
member engaged by the sheet; and separating the sheet relative to
the elongated member to provide an elongated sheath of
substantially biocompatible material having a curved contour
corresponding to the at least part of the curved surface of the
elongated member.
14. The method of claim 13, the urging further comprising applying
retaining elements to hold the sheet relative to the elongated
member such that at least a substantial portion of the sheet
engages the at least part of the curved surface of the elongated
member.
15. The method of claim 14, the retaining elements including
sutures that connect the opposed side edges of the sheet.
16. The method of claim 15, the sutures being applied to connect
the side edges prior to placing the sheet into engagement with the
elongated member.
17. The method of claim 14 further comprising removing the
retaining elements after fixation to provide a curved sheath having
a generally C-shaped cross section.
18. The method of claim 14, the elongated member extending
arcuately between spaced apart ends of the elongated member
according to a radius of curvature, such that after fixation the
curved sheath extends arcuately between the ends of the sheet
according to radius of curvature.
19. The method of claim 14, further comprising removing the
retaining elements together with a strip of tissue from the sheet
located adjacent and coextensive to at least one of the side edges
of the sheet to form an elongated sheath having a curved contour
that extends arcuately between opposite ends thereof and having
generally C-shaped cross section.
20. A curved implantable sheath comprising: an elongated sheet of
biological tissue material having first and second ends spaced
apart from each other by opposed side edges; the elongated sheet
extending arcuately between the first and second ends according to
a radius of curvature; and the side edges of the elongated sheet
being urged toward each other about a central axis that extends
arcuately between the first and ends according to the radius of
curvature to define a generally C-shaped cross section of the
curved sheath, the curved sheath having undergone a fixation
process to maintain such configuration.
Description
RELATED APPLICATION
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 09/669,821, which was filed on Sep. 26, 2000,
and entitled SYSTEM AND METHOD FOR MAKING A CALOTTE-SHAPED
IMPLANTABLE SHEATH.
TECHNICAL FIELD
[0002] The present invention relates to implantable tissue and,
more particularly to a curved implantable sheath and to a method
for making a curved sheath.
BACKGROUND
[0003] Various configurations of implantable structures are
employed to help repair diseased and malformed organs and other
tissue. By way of example, congenital cardiac malformations as well
as other diseased conditions, require treatment, which can include
drug therapy and/or surgery. Often times, it is necessary to
replace or reconstruct an artery or other major vessel, such as the
aorta or pulmonary artery.
[0004] In one particular condition, known as hypoplastic left heart
syndrome, severe aortic valve hypoplasia and/or aortic valve
atresia develop. As a result of such conditions, the aorta may
significantly underdevelop, providing a rudimentary ascending aorta
having a diameter of about one to about four millimeters. Also as a
consequence of limited outflow from the heart, the left ventricle
develops abnormally and may be virtually absent.
[0005] Because certain curved shapes are difficult to reproduce, a
generally flat sheath of biocompatible tissue typically is used for
many types of procedures. In other cases a homograft, such as from
a cadaver is used.
SUMMARY
[0006] The following presents a simplified summary of the invention
in order to provide a basic understanding of some aspects of the
invention. This summary is not an extensive overview of the
invention. It is intended to neither identify key or critical
elements of the invention nor delineate the scope of the invention.
Its sole purpose is to present some concepts of the invention in a
simplified form as a prelude to the more detailed description that
is presented later.
[0007] One aspect of the present invention provides a method for
making a curved implantable sheath. A sheet of flexible material is
urged into engagement with a member having a curved surface of a
desired configuration. The sheet and member are placed in a
fixation solution so that the sheet assumes the configuration of
the surface engaged thereby.
[0008] Another aspect of the present invention provides a method
for making a sheath having a curved contour. The method includes
mounting a sheet of a biological tissue material to an elongated
member having a curved exterior portion. The sheet and elongated
member are placed in a fixation solution so that at least part of
the sheet is fixed to a configuration corresponding to the exterior
portion of the elongated member. The sheet is separated from the
elongated member to provide an elongated sheath of substantially
biocompatible material having a desired curved contour.
[0009] According to another aspect of the present invention, the
sheet can be formed to have a generally C-shaped cross section.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] To the accomplishment of the foregoing and related ends,
certain illustrative aspects of the invention are described herein
in connection with the following description and the annexed
drawings. These aspects are indicative, however, of but a few of
the various ways in which the principles of the invention may be
employed and the present invention is intended to include all such
aspects and their equivalents. Other advantages and novel features
of the invention will become apparent from the following detailed
description of the invention when considered in conjunction with
the drawings, in which:
[0011] FIG. 1 is an example of a base member having a surface over
which tissue may be fixed in accordance with the present
invention;
[0012] FIG. 2 is a cross-sectional view of the base member of FIG.
1 taken along line 2-2;
[0013] FIG. 3 is an example of tissue held against the surface of a
base member in accordance with the present invention;
[0014] FIG. 4 is an example of tissue being fixed to a desired
shape in accordance with the present invention;
[0015] FIG. 5 is an example of a calotte-shaped sheath produced
from tissue treated in accordance with the present invention;
[0016] FIG. 6 is another example of tissue being fixed to a desired
shape in accordance with the present invention;
[0017] FIG. 7 is yet another example of tissue being fixed to a
desired shape in accordance with the present invention;
[0018] FIG. 8 is a generally flat sheet of flexible material;
[0019] FIG. 9 is an example of a generally tubular structure that
can be formed from the sheet of FIG. 8;
[0020] FIG. 10 is the tubular structure of FIG. 9 mounted over a
curved member in accordance with the present invention;
[0021] FIG. 11 is an example of a curved tubular sheath that can be
produced in accordance with an aspect of the present invention;
[0022] FIG. 12 is an example of a curved sheath of tissue in
accordance with an aspect of the present invention;
[0023] FIG. 13 is an example of heart having a congenital
defect;
[0024] FIG. 14 is the heart of FIG. 13 after part of associated
vessels have been removed; and
[0025] FIG. 15 is an example of a heart in which a curved sheath of
tissue has been applied in accordance with the present
invention.
DESCRIPTION OF THE INVENTION
[0026] Various illustrative aspects of the present invention will
now be described in connection with the following figures.
[0027] The present invention provides a system and method that may
be used to fix tissue to a desired shape so as to better conform to
contoured organs and tissue against which the tissue is to engage
when implanted. While the following examples will be described with
respect to forming a calotte-shaped sheath of tissue, those skilled
in the art will understand and appreciate that other shapes, such
as cylindrical sheaths and curved arches, also may be formed in
accordance with the present invention.
[0028] Turning now to FIGS. 1 and 2, a generally semi-spherical
base 10 is illustrated. The base 10, which may be a bowl formed of
a rigid material (e.g., a metal or plastic material), has an inner
surface 12 and an outer surface 14. In this example, the inner
surface 12 is curved in a convex manner and the outer surface 14 is
curved in a generally concave manner.
[0029] In accordance with an aspect of the present invention, the
inner and/or outer surfaces 12 and 14, respectively, may be
dimensioned and configured to correspond to the shape of a selected
part of a human brain. It is to be appreciated that other shapes
and sizes may be utilized to process tissue to have a desired
contour, such as for implantation in other types of surgical
procedures. In addition, the inner surface 12 may be dimensioned to
have radius of curvature that is less than the outer surface 14.
The inner and outer surfaces 12 and 14 also may have different
shapes or contours. As a result, differently dimensioned and/or
shaped sheaths may be formed with the same base 10.
[0030] In this example, the base 10 also has a plurality of
apertures 16 located near an open end 18 of the base. The apertures
16 provide a convenient way to secure a sheet of tissue 20 to the
outer surface 14 of the base 10, such as shown in FIG. 3. The sheet
of tissue 20 may be substantially any type of biological tissue. By
way of example, the tissue may be animal pericardium (e.g., equine,
bovine, porcine, etc.), collagen, animal dura mater, or other type
of suitable sheet of tissue. To provide better results, the sheet
of tissue should be a generally fresh, soft sheet of tissue. The
sheet of tissue 20 may be in nearly any shape, such as rectangular,
circular, elliptical, etc.
[0031] By way of illustration, one or more sutures 22 are sewn
through a perimeter edge 24 of the tissue 20 so as to hold at least
a substantial portion of the tissue in engagement with the outer
surface 14 of the base 10. For the example when the tissue is
animal pericardium, the smooth or visceral side of the pericardium
should engage the outer surface 14 with the more rough side
exposed. Typically at least a central part 26 of the tissue 20 is
maintained in completely against the surface 14, and it is this
part of the tissue that is used to form a calotte-shaped sheath in
accordance with an aspect of the present invention.
[0032] While the example of FIG. 3 illustrates sutures being
utilized to temporarily attach the tissue relative to the base 10,
it is to be appreciated that other means also may be utilized to
hold the tissue relative to the base in accordance with an aspect
of the present invention. For example, suitable hooks or clamps
could be employed to secure the tissue relative to the base 10 or
other appropriate structure.
[0033] FIG. 4. illustrates an example of a system 30 that may be
employed to fix the tissue 20 to a desired shape in accordance with
an aspect of the present invention. In this example, the system 30
includes a chamber 32 that contains a volume of a suitable fixation
solution 34. The combination of the tissue 20 attached to the base
10 is immersed into the fixation solution 34 for sufficient period
of time so as to fix the tissue that is exposed to the solution to
substantially the same shape as the outer surface 14 of the base.
By way of example, the fixation solution 34 is a solution that
includes glutaraldehyde, which is well known in the art. A time
period of about twenty-four hours in a glutaraldehyde solution
should be sufficient to fix the tissue 20.
[0034] The tissue 20 may then be removed from the solution 34 and
detached from the base 10. The tissue 20 is then trimmed to a
desired size to form a calotte-shaped sheath 40, such as shown in
FIG. 5. When the sheath 40 is to be used in neurosurgery as
substitute dura mater, for example, the sheath may have diameter
from about 10 cm to about 14 cm, although other sized sheaths also
could be formed in accordance with an aspect of the present
invention. The trimmed peripheral portion may be discarded or used
to form other implantable tissue products.
[0035] After initial fixation and trimming, the calotte-shaped
sheath 40 may be placed back in a suitable solution, such as may
contain glutaraldehyde, for additional curing. In particular, the
natural tissue sheath 40 further may be cross-linked with
glutaraldehyde and undergo a detoxification process with heparin
bonding, such as according to the NO-REACT.RTM. treatment process
from Shelhigh, Inc. of Millburn, N.J. The NO-REACT.RTM. tissue
treatment process helps improve the biocompatibility of the sheath
40.
[0036] FIG. 6 illustrates another system 50, in accordance with an
aspect of the present invention, which may be employed to form an
implantable calotte-shaped sheath 40. The system 50 includes a base
52 having a curved, generally semi-spherical (e.g. convex) outer
surface 54. For example, the base 52 may be hollow bowl, although
any structure having a desired outer surface 54 could be used. A
sheet of biological tissue 20 is placed onto the outer surface 54
of the base 52, as shown in FIG. 6.
[0037] In contrast to the sutures and apertures utilized in the
system of FIGS. 3 and 4, a generally tubular apparatus 58, such as
a hollow cylinder, is used to hold the tissue 20 in a desired
position relative to the base 52. In particular, the tubular
apparatus 58 has a tissue-engaging end 60 that engages the tissue
20 and sandwiches the tissue between the outer surface 54 and the
end 60. The engagement between the tissue-engaging end 60 and the
tissue 20 may form a substantially liquid tight seal. In order to
improve the seal, a rubber or other soft material may be provided
at the end 60. As a result, an interior surface 62 of the tubular
apparatus 58 and a portion 64 of the tissue 20 extending within the
end 60 define a volume for holding a fixation solution 34. That is,
the fixation solution 34 may be provided into the tubular apparatus
58 to fix the portion 64 of the tissue 20 within the annular end 60
to substantially the same shape as the outer surface contacted
thereby. If some of the solution 34 leaks through the juncture
between the tubular apparatus 58 and the tissue 20, the fluid
simply would need to be replenished. Advantageously, the weight of
the fixation solution 34 further helps to hold the central portion
64 of the tissue 20 against the outer surface 54 to promote a
desired shape during fixation.
[0038] After fixing the tissue 20 for a suitable time period (e.g.,
about twenty-four hours), the tissue may then be removed from the
system 50 and trimmed to form a calotte-shaped sheath 40, such as
shown in FIG. 5.
[0039] While the apparatus 58 is shown and described as being
generally cylindrical it is to be appreciated that other shapes
also could be used in accordance with the present invention.
Typically, however, the tissue-engaging end 60 of the apparatus
should conform to the contour of the outer surface 54 and have a
sufficient diameter so as to fix a desired portion 64 of the tissue
20.
[0040] FIG. 7 illustrates yet another example of a system 80 that
may be utilized, in accordance with an aspect of the present
invention, to form a calotte-shaped sheath 40 of tissue. The system
80 includes a base portion 82 having a convex inner surface 84. The
base portion 82, for example, may be a bowl similar to the other
system arrangements shown and described herein. An appropriate
support apparatus 86 may be employed to hold the base portion 82 in
a desired position, such that an open end 88 faces upwards. In this
example, sheet of tissue 20 is placed against the inner surface 84
of the base. For the example where the tissue 20 is animal
pericardium, the smooth side engages the inner surface 84. The
tissue 20 may be smoothed out by hand (or by a suitable instrument)
so that at least a substantial portion (e.g., a central portion) of
the tissue 20 is substantially flush against the inner surface 84
the base 82.
[0041] After the tissue is at a desired position, a volume of a
suitable fixation solution 34, such as may include glutaraldehyde,
is added to a volume defined by the sheath 20 within the base 82.
The weight of the fixation solution 34 helps maintain engagement
between at least a substantial portion of the tissue 20 and the
inner surface 84, thereby promoting fixation of the tissue to the
desired shape. In order to facilitate engagement between the tissue
20 and the inner surface 84, a cup-shaped member, such as felt or
other diffusable material, may be placed over the tissue within the
base to help hold the tissue against the inner surface 84 of the
base 82. After the tissue 20 has been fixed for a suitable time
phase, the tissue may be removed and trimmed to a desired shape,
such as to form the calotte-shaped sheath shown in FIG. 5.
[0042] FIGS. 8-12 and the accompanying description illustrate an
example of a method that can be implemented to provide a curved
sheath of tissue in accordance with an aspect of the present
invention. For purposes of simplicity of illustration, identical
reference numbers refer to corresponding parts throughout FIGS.
8-12.
[0043] FIG. 8 illustrates a generally flat sheet 100 of flexible
material that can be utilized to form a curved sheath of tissue in
accordance with an aspect of the present invention. The sheet 100
includes ends 102 and 104 that are spaced apart from each other by
a pair of elongated side edges 106 and 108. For example, the sheet
100 can be a flexible sheet of animal tissue, such as pericardium
or another suitable thin sheet of tissue (e.g., dura matter, molded
collagen, etc.). When pericardium is used, the sheet 100 includes a
visceral side 110 that is generally smoother than the other side
112.
[0044] In accordance with an aspect of the present invention, the
side edges 106 and 108 are urged toward each other so that the
intermediate portion of the sheet 100 extending between such edges
has a curved shape. As shown in FIG. 9, for example, the side edges
106 and 108 are connected together, such as by sutures 114, to form
a tube 116 of the biological tissue material having a generally
cylindrical sidewall 118. Other types of retaining mechanisms also
could be utilized to secure the edges 106 and 108 relative to each
other, such as clips, fasteners, etc.
[0045] Thus, from FIG. 9, it will be appreciated that the sheet 100
can be employed to form a generally cylindrical sidewall having
desired diameters at each of its ends 102 and 104, which diameters
can be the same or different. That is, the resulting structure 116
can be frusto-conical. Because, at this stage, the tissue of the
sheet 100 is flexible (e.g., formed of relatively fresh natural
tissue), it is flacid and thus tends to collapse to a relatively
flat tube 116, such as shown in FIG. 9.
[0046] In accordance with an aspect of the present invention, part
of the sheet 100 is urged against a curved surface. The combination
of sheet 100 and curved surface are immersed in a fixation solution
so that at least that part of the sheet 100 takes on the contour of
the curved surface.
[0047] With reference to the example of FIG. 10, the biological
tube 116 is depicted as being mounted over a curved mandrel 120. As
shown in FIG. 10, for example, the tube is mounted over a curved
mandrel having a generally circular cross section. Alternatively,
the mandrel 120 can have a varying cross-sectional diameter and/or
have a plurality of ribs or circumferentially extending
corrugations. The particular dimensions and configuration of the
mandrel 120 can vary according to the desired shape and size of the
tissue being formed in accordance with an aspect of the present
invention.
[0048] In one aspect the elongated mandrel 120 extends arcuately
between its ends 122 and 124. For example, the arcuate extent of
the mandrel 120 has a radius of curvature that is greater than
about forty-five degrees and, in another aspect, could have a
radius of curvature greater than about ninety degrees, as shown in
FIG. 10. The curved mandrel 120 also has an outer cross-sectional
diameter that approximates or is slightly greater than the inner
diameter of the biological tube 116. As a result, the tube 116 is
held on the mandrel 120 by friction.
[0049] While FIGS. 9 and 10 have been shown and described as
creating the tube 116 and then sliding the tube over the mandrel
120, it is to be understood that the sheet 100 could be wrapped
around and secured relative to the mandrel. For example, the ends
106 and 108 of the sheet 100 can be urged around and secured
relative to the mandrel, such as by sutures 114 or by clamps,
retaining bands, and the like.
[0050] In accordance with an aspect of the present invention, the
assembly that includes the biological tube 116 and the curved
mandrel 120 are immersed in a fixation solution, such as including
an aldehyde solution (e.g., glutaraldehyde). Accordingly, at least
the part of the sheet 100 exposed to the fixation solution assumes
the contour of the mandrel 120 that such tissue engages. After
appropriate fixation, the tube 116 can be removed from the mandrel
120 to provide a curved tubular sheath 126 such as shown in FIG.
11. Additional fixation may be implemented relative to the curved
tubular sheath 126. As a result, the tubular sheath 126 is
permanently fixed to provide an arcuately extending cylindrical
sidewall 118 corresponding to the configuration of the mandrel
120.
[0051] In accordance with an aspect of the present invention, the
tubular sheath 122 can be trimmed to a desired shape and size. In
one particular aspect, as shown in FIG. 12, the suture line 114 and
some adjacent tissue extending coextensively with the sheath 122
between the ends 102 and 104 can be excised from the tubular
sidewall 118. As a result, an elongated curved sheath 124 of tissue
is formed, which sheath has a generally C-shaped cross section
extending between its ends 102 and 104. The sheath 124 has
elongated side edges 130 and 132 that extend arcuately between the
spaced apart ends 102 and 104 of the sheath. As a result, the
sheath 124 has the appearance of a curved trough or gutter. Because
of the fixation process, the sheath 128 maintains its C-shaped
cross section (e.g., based on the circumference of the mandrel) as
well as its arcuate length (e.g., corresponding to the radius of
curvature of the mandrel).
[0052] The fixed tissue sheath 128 as well as the tubular sheath
126 can be detoxified to improve the biocompatibility thereof. By
way of illustration, the sheath can be cross-linked with
glutaraldehyde and undergo a detoxification process with heparin
bonding, such as according to the NO-REACT.RTM. treatment process.
The NO-REACT.RTM. tissue treatment process helps improve the
biocompatibility of the sheath and render the sheath substantially
cytocompatible.
[0053] The curved C-shaped cross section of the sheath 124
facilitates reconstruction and repair of vessels, such as part of a
vessel enlargement. For example, the side edges 126 and 128 can be
anastomosed to exposed side edges of a patient's vessel, such as an
artery or vein. It is to be appreciated that the curved length of
tubular material, such as shown in FIG. 11, also provides a useful
conduit, such as may be employed to repair or replace a curved
vessel or be attached to a heart valve prosthesis.
[0054] By way of illustration, FIGS. 13-15 show part of a procedure
(e.g., the Norwood procedure) that utilizes a curved sheath of
tissue to repair a defective aorta in accordance with an aspect of
the present invention.
[0055] FIG. 13 illustrates a heart 200 having a congenital cardiac
malformation, such as may occur in an infant suffering from
hypoplastic left heart syndrome. As is apparent from the figure,
the heart 200 includes a diminutive ascending aorta 202, such as
due to severe aortic valve hypoplasia or aortic valve atresia.
Thus, one aspect of the procedure is to enlarge the diameter of the
aortic arch. Also, as shown in FIG. 13, the main pulmonary trunk
204 extends from the outflow of the left ventricle 206, with left
and right pulmonary arteries 208 and 210 branching from the main
trunk. The descending aorta 212 also is coupled to the pulmonary
artery via a ductus vessel 214.
[0056] As shown in FIG. 14, the main trunk of the pulmonary artery
204 has been transected adjacent to the take off at the right
pulmonary artery 210. The main pulmonary artery stump is closed,
such as by suturing a patch 216 (e.g., a NO-REACT.RTM. pericardial
patch or a homograft) thereto. The aorta 212 also has been
separated from the pulmonary artery by removing the dutus 214.
[0057] The aorta 202, 212 also is illustrated in an open condition,
such as after having been opened by an axial incision 218. The
incision 218 extends from the descending aorta 212 to the ascending
aorta 202 near a level proximal the exposed rim of the main
pulmonary artery trunk 204.
[0058] A curved sheath 220 of biocompatible biological tissue
material is anastomosed to the open aorta to enlarge the aorta in
accordance with an aspect of the present invention. For example,
the sheath 220 has a generally C-shaped cross section and extends
arcuately along its length (see, e.g., FIG. 12). The sheath 220
includes side edges 222 that extend arcuately between ends 224 and
226. The end 224 of is sewn to the descending aorta 212. The side
edges 222 of the curved sheath 220 are then sutured to the exposed
edges of the aortic arch defined by the incision 218.
[0059] An aperture can be formed through the patch near the end 224
thereof for an aorto-pulmonary shunt, which may be operatively
coupled between the aperture and the pulmonary artery. The shunt,
for example, could be a short cylinder of a biological tissue
material, such as a length of a fixed tubular length of
biocompatible material (see, e.g., FIG. 11). Alternatively, the
shunt could be formed of a PTFE material or other suitable
biocompatible material.
[0060] The end 226 of the sheath 220 and part of the ascending
aorta, which define an augmented aorta, are then anastomosed to the
main pulmonary artery 204. This provides an outflow path from the
right ventricle 206 to the augmented aorta. Advantageously, the
native portion of the augmented aorta can continue to grow with the
patient.
[0061] It is to be appreciated that a curved sheath 124, 220 of
biological tissue material can be useful in the repair or
reconstruction of other types of defects and diseases. In
particular, the curved sheath can be utilized in non-cardiac
procedures (e.g., neurosurgery, bladder repair, etc.). In addition,
while a single arcuate curve is illustrated as extending between
the ends of the sheath, it is to be appreciated that any number of
curves can be implemented in a sheath in accordance with an aspect
of the present invention. The particular dimensions and
configuration of a sheath being produced will vary according to its
intended application.
[0062] What has been described above includes examples of the
present invention. It is, of course, not possible to describe every
conceivable combination of components or methodologies for purposes
of describing the present invention, but one of ordinary skill in
the art will recognize that many further combinations and
permutations of the present invention are possible. Accordingly,
the present invention is intended to embrace all such alterations,
modifications and variations that fall within the spirit and scope
of the appended claims. Furthermore, to the extent that the term
"includes" and variants thereof or the term "having" and variants
thereof are used in either the detailed description or the claims,
each such term is intended to be inclusive in a manner similar to
the term "comprising."
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