U.S. patent application number 10/636791 was filed with the patent office on 2005-03-03 for medical closure device.
This patent application is currently assigned to SCIMED LIFE SYSTEMS, INC.. Invention is credited to Chopra, Gopal.
Application Number | 20050049634 10/636791 |
Document ID | / |
Family ID | 34135587 |
Filed Date | 2005-03-03 |
United States Patent
Application |
20050049634 |
Kind Code |
A1 |
Chopra, Gopal |
March 3, 2005 |
Medical closure device
Abstract
Several alternative designs, structures, assemblies, treatment
methods and/or methods of manufacturing medical closure devices
adapted and/or configured for closing an opening, for example, an
incision or a puncture in the tissue of a patient, for example, the
dural membrane of a patient. Some embodiments include a medical
closure device including an elongated tubular member extending
along a longitudinal axis. The tubular member including a distal
section and a proximal section, and the distal section is
expandable from a first configuration to a second expanded
configuration through the application of a compressive force upon
the distal section along the longitudinal axis.
Inventors: |
Chopra, Gopal; (San
Francisco, CA) |
Correspondence
Address: |
CROMPTON, SEAGER & TUFTE, LLC
1221 NICOLLET AVENUE
SUITE 800
MINNEAPOLIS
MN
55403-2420
US
|
Assignee: |
SCIMED LIFE SYSTEMS, INC.
|
Family ID: |
34135587 |
Appl. No.: |
10/636791 |
Filed: |
August 7, 2003 |
Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61M 39/0606 20130101;
A61B 2090/3954 20160201; A61B 17/3421 20130101; A61B 2017/00867
20130101; A61B 2017/0419 20130101; A61B 17/0057 20130101; A61B
2017/3492 20130101; A61B 2017/0065 20130101; A61B 2017/3486
20130101; A61B 2017/00986 20130101; A61B 2017/3484 20130101; A61B
2017/00659 20130101; A61B 2017/00911 20130101 |
Class at
Publication: |
606/213 |
International
Class: |
A61B 017/08 |
Claims
What is claimed is:
1. A medical device for closing an opening in a tissue in a body of
a patient, the device comprising: an elongated tubular member
extending along a longitudinal axis, the tubular member including a
distal section and a proximal section, wherein the distal section
is expandable from a first configuration to a second expanded
configuration through the application of a predetermined
compressive force upon the distal section along the longitudinal
axis.
2. The medical device of claim 1, wherein the distal section
includes a plurality of portions, and at least one of the portions
has a reduced column strength relative to other portions of the
distal section.
3. The medical device of claim 2, wherein the portion of reduced
column strength is configured to create an outwardly extending bend
or fold in the distal portion relative to the longitudinal axis
when the predetermined compressive force is applied to the distal
section.
4. The medical device of claim 3, wherein the distal section
defines an outer surface, and the outwardly extending bend or fold
in the distal portion expands the outer perimeter of at least a
portion of the outer surface of the distal section.
5. The medical device of claim 1, wherein the distal section
defines an outer surface, and when the distal section is in the
first configuration, the outer surface of the distal section has a
first sized outer perimeter, and when the distal section is in the
second configuration, the outer surface of the distal section has a
second sized outer perimeter greater than the first sized outer
perimeter.
6. The medical device of claim 1, wherein the distal section
defines an outer surface, and when the distal section is in the
first configuration, the outer surface of the distal section is
sized to have an outer perimeter that is adapted for insertion
through the opening in the tissue in the body of the patient, and
when the distal section is in the second configuration, at least a
portion of the outer surface of the distal section is expanded in
size to have an outer perimeter that is greater than when in the
first configuration.
7. The medical device of claim 6, wherein when the distal section
is in the second configuration, at least a portion of the outer
surface of the distal section is expanded in size to have an outer
perimeter that is greater than an outer perimeter of the opening in
the tissue in the body of the patient.
8. The medical device of claim 1, wherein the proximal section
defines an outer surface having an outer perimeter that is greater
than an outer perimeter of the opening in the tissue in the body of
the patient.
9. The medical device of claim 1, wherein the elongated tubular
member further includes an intermediate section connecting the
distal section and the proximal section.
10. The medical device of claim 9, wherein the intermediate section
is configured to extend within the opening in the body of the
patient between the distal section and the proximal section.
11. The medical device of claim 10, wherein the tissue in the body
of the patient includes an inner surface and an outer surface, and
the device is configured such that when the device is inserted into
the opening to close the opening, the proximal section is
configured to contact the outer surface of the tissue, and the
distal section, when in the second expanded configuration, is
configured to contact the inner surface of the tissue.
12. The medical device or claim 1, wherein the opening in the
tissue in the body of the patient comprises an opening in the dural
membrane of the patient.
13. A medical device for closing an opening in a dural membrane of
a patient, the device comprising: a tubular proximal section
defining an outer surface having an outer perimeter; a tubular
intermediate section connected to the proximal section, the
intermediate section defining an outer surface having an outer
perimeter that is less than the outer perimeter of the proximal
section; and a tubular distal section connected to the intermediate
section, the distal section being configured to be radially
expandable from a first configuration to a second expanded
configuration through the application of a predetermined
compressive force upon the distal section.
14. The medical device of claim 13, wherein the proximal section is
configured to contact the outer surface of the dural membrane, the
intermediate section is configured to extend within the opening in
the dural membrane between the proximal section and the distal
section, and the distal section, when in the first configuration,
is adapted for insertion through the opening in the dural membrane,
and when in the second configuration, is configured to contact the
inner surface of the dural membrane.
15. The medical device of claim 13, wherein the outer perimeter of
the proximal section is configured to be greater than an outer
perimeter of the opening in the dural membrane.
16. The medical device of claim 13, wherein a tubular distal
section is configured to be inserted through the opening in the
dural membrane when in the first configuration, and is adapted to
expand and close the opening when in the second, expanded
configuration.
17. The medical device of claim 13, wherein the intermediate
section is configured to extend within the opening in the dural
membrane.
18. The medical device of claim 13, wherein the distal section
includes a plurality of portions, and at least one of the portions
has a reduced column strength relative to other portions of the
distal section.
19. The medical device of claim 18, wherein the portion of reduced
column strength is configured to create an outwardly extending bend
or fold in the distal portion relative to the longitudinal axis
when the predetermined compressive force is applied to the distal
section.
20. The medical device of claim 19, wherein the distal section
defines an outer surface, and the outwardly extending bend or fold
in the distal portion expands the outer perimeter of at least a
portion of the outer surface of the distal section.
21. A method of closing an opening in a tissue in a patient, the
method comprising: providing an elongated tubular member extending
along a longitudinal axis, the tubular member including a distal
section and a proximal section, wherein the distal section is
expandable from a first configuration to a second expanded
configuration through the application of a predetermined
compressive force upon the distal section along the longitudinal
axis; inserting the distal section through the opening in the
tissue in the patient while the distal section is in the first
configuration; applying a predetermined compressive force to the
distal section along the longitudinal axis to expand the distal
section from the first configuration to the second expanded
configuration.
22. The method of claim 21, wherein the distal section includes a
plurality of portions, and at least one of the portions has a
reduced column strength relative to other portions of the distal
section.
23. The method of claim 22, wherein the portion of reduced column
strength is configured to create an outwardly extending bend or
fold in the distal portion relative to the longitudinal axis when
the predetermined compressive force is applied to the distal
section.
24. The method of claim 23, wherein the distal section defines an
outer surface, and the outwardly extending bend or fold in the
distal portion expands the outer perimeter of at least a portion of
the outer surface of the distal section.
25. The method of claim 21, wherein the distal section defines an
outer surface, and when the distal section is in the first
configuration, the outer surface of the distal section has a first
sized outer perimeter, and when the distal section is in the second
configuration, the outer surface of the distal section has a second
sized outer perimeter greater than the first sized outer
perimeter.
26. The method of claim 21, wherein the distal section defines an
outer surface, and when the distal section is in the first
configuration, the outer surface of the distal section is sized to
have an outer perimeter that is adapted for insertion through the
opening in the tissue in the body of the patient, and when the
distal section is in the second configuration, at least a portion
of the outer surface of the distal section is expanded in size to
have an outer perimeter that is greater than when in the first
configuration.
27. The method of claim 26, wherein when the distal section is in
the second configuration, at least a portion of the outer surface
of the distal section is expanded in size to have an outer
perimeter that is greater than an outer perimeter of the opening in
the tissue in the body of the patient.
28. The method of claim 21, wherein the proximal section defines an
outer surface having an outer perimeter that is greater than an
outer perimeter of the opening in the tissue in the body of the
patient.
29. The method of claim 21, wherein the elongated tubular member
further includes an intermediate section connecting the distal
section and the proximal section.
30. The method of claim 29, wherein when the distal section is
inserted through the opening, the intermediate section extends
within the opening in the body of the patient between the distal
section and the proximal section.
31. The method of claim 30, wherein the tissue in the body of the
patient includes an inner surface and an outer surface, and when
the distal section is inserted through the opening the proximal
section contacts the outer surface of the tissue, and when the
distal section is expanded from the first configuration to the
second expanded configuration, a portion of the distal section
contact the inner surface of the tissue.
32. The method of claim 21, wherein the opening in the tissue in
the body of the patient comprises an opening in the dural membrane
of the patient.
33. A method for closing an opening in a dural membrane of a
patient, the method comprising: providing a closure device
comprising a tubular proximal section defining an outer surface
having an outer perimeter, a tubular intermediate section connected
to the proximal section, the intermediate section defining an outer
surface having an outer perimeter that is less than the outer
perimeter of the proximal section, and a tubular distal section
connected to the intermediate section, the distal section being
configured to be radially expandable from a first configuration to
a second expanded configuration through the application of a
predetermined compressive force upon the distal section; inserting
the device into the opening while the distal section is in the
first configuration such that the distal section extends through
the opening, the intermediate section extends within the opening,
and the proximal section remains outside of the opening; and
applying a predetermined compressive force to the distal section
along the longitudinal axis to expand the distal section from the
first configuration to the second expanded configuration.
34. The method of claim 33, wherein the proximal section is
configured to contact the outer surface of the dural membrane, the
intermediate section is configured to extend within the opening in
the dural membrane between the proximal section and the distal
section, and the distal section, when in the first configuration,
is adapted for insertion through the opening in the dural membrane,
and when in the second configuration, is configured to contact the
inner surface of the dural membrane.
35. The method of claim 33, wherein the outer perimeter of the
proximal section is configured to be greater than an outer
perimeter of the opening in the dural membrane.
36. The method of claim 33, wherein a tubular distal section is
configured to be inserted through the opening in the dural membrane
when in the first configuration, and is adapted to expand and close
the opening when in the second, expanded configuration.
37. The method of claim 33, wherein the distal section includes a
plurality of portions, and at least one of the portions has a
reduced column strength relative to other portions of the distal
section.
38. The method of claim 37, wherein the portion of reduced column
strength is configured to create an outwardly extending bend or
fold in the distal portion relative to the longitudinal axis when
the predetermined compressive force is applied to the distal
section.
39. The method of claim 38, wherein the distal section defines an
outer surface, and the outwardly extending bend or fold in the
distal portion expands the outer perimeter of at least a portion of
the outer surface of the distal section.
40. A medical device for closing an opening in a dural membrane of
a patient, the device comprising: a tubular member having a
proximal section adapted to contact the outer surface of the dural
membrane, an intermediate section adapted to extend within the
opening, and a distal section adapted to extend through the
opening; and means for radially expanding the distal section from a
first configuration to a second expanded configuration.
Description
TECHNICAL FIELD
[0001] The invention generally pertains to medical closure devices,
such as medical devices for closing an opening in tissue bounding a
cavity in the anatomy of a patient.
BACKGROUND
[0002] It is sometimes necessary in diagnosis and/or treatment of
disease to gain access to, or navigate within certain anatomies of
a patient. During such procedures, it is sometimes necessary to
penetrate certain tissue that bounds a cavity in the anatomy of a
patient. For example, certain treatment or operations require that
an opening be created in tissue such as a membrane or vessel wall
within the anatomy of the patient. For example, in some procedures,
an opening, such as an incision or puncture, in created in the
dural membrane of a patient to gain access to anatomies therein.
The dural membrane covers the inside of the cranium and the spinal
canal, and forms an enclosed system that contains other membranes,
the brain, spinal cord, and Cerebrospinal fluid (C.S.F.).
[0003] After such procedures, it is often desirable to close the
opening in the tissue. There are some known methods and devices for
closing openings in tissue--each having advantages and
disadvantages. There is an ongoing need to provide alternative
designs, structures, assemblies, and/or treatment methods for
closing an opening in the tissue of a patient, for example, the
dural membrane of a patient.
SUMMARY OF SOME EMBODIMENTS
[0004] The invention provides several alternative designs,
structures, assemblies, treatment methods and/or methods of
manufacturing medical closure devices adapted and/or configured for
closing an opening, for example, an incision or a puncture in the
tissue of a patient, for example, the dural membrane of a
patient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] The invention may be more completely understood in
consideration of the following detailed description of various
embodiments of the invention in connection with the accompanying
drawings, in which:
[0006] FIG. 1 is a schematic cross sectional side view of a closure
device in a first, unexpanded configuration;
[0007] FIG. 2 is a schematic cross sectional side view of the
closure device of FIG. 1, inserted into an opening in the dural
membrane of an adult human being using an elongated insertion
device;
[0008] FIG. 3 is a schematic cross sectional side view of the
closure device of FIG. 2, wherein the distal portion of the closure
device is being engaged by the insertion device such that it is
partially expanded;
[0009] FIG. 4 is a schematic cross sectional side view of a the
closure device of FIG. 3, wherein the distal portion of the closure
device has been fully expanded to close the opening in the dural
membrane;
[0010] FIG. 5 is a schematic cross sectional side view of an
alternative embodiment of a closure device in a first, unexpanded
configuration; and
[0011] FIG. 6 is a schematic cross sectional side view of the
closure device of FIG. 5, wherein the distal portion of the closure
device has been fully expanded to close the opening in the dural
membrane.
[0012] While the invention is amenable to various modifications and
alternative forms, specifics thereof have been shown by way of
example in the drawings and will be described in detail. It should
be understood, however, that the intention is not to limit the
invention to the particular embodiments described. On the contrary,
the intention is to cover all modifications, equivalents, and
alternatives falling within the spirit and scope of the
invention.
DETAILED DESCRIPTION OF SOME ILLUSTRATIVE EMBODIMENTS
[0013] For the following defined terms, these definitions shall be
applied, unless a different definition is given in the claims or
elsewhere in this specification.
[0014] All numeric values are herein assumed to be modified by the
term "about,"whether or not explicitly indicated. The term "about"
generally refers to a range of numbers that one of skill in the art
would consider equivalent to the recited value (i.e., having the
same function or result). In many instances, the terms "about" may
include numbers that are rounded to the nearest significant
figure.
[0015] Weight percent, percent by weight, wt %, wt-%, % by weight,
and the like are synonyms that refer to the concentration of a
substance as the weight of that substance divided by the weight of
the composition and multiplied by 100.
[0016] The recitation of numerical ranges by endpoints includes all
numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3,
3.80, 4, and 5).
[0017] As used in this specification and the appended claims, the
singular forms "a", "an", and "the" include plural referents unless
the content clearly dictates otherwise. As used in this
specification and the appended claims, the term "or" is generally
employed in its sense including "and/or" unless the content clearly
dictates otherwise.
[0018] The following detailed description should be read with
reference to the drawings in which similar elements in different
drawings are numbered the same. The drawings, which are not
necessarily to scale, depict illustrative embodiments and are not
intended to limit the scope of the invention. For example, although
shown and discussed with specific reference to some embodiments
which are adapted for use in closing an opening, such as an
incision or puncture, in the dural membrane in the body of a
patient, it should be understood that the invention may be adapted
or configured for use in other portions of the anatomy. For
example, certain aspects of the invention may be applicable for use
in closing an opening in any tissue that bounds a cavity in the
anatomy of a patient. For example, certain aspects of the invention
may be applicable for use in closing tissue such as other
anatomical tissues or membranes or walls within the anatomy, for
example, within the vasculature, abdominal (i.e. to close an
incision made during a laparascopy or laparotomy) or other portions
of the anatomy.
[0019] An additional note with respect to the following description
is that, while the closure device is described in terms of
different sections, the device, or multiple sections thereof, may
be made as a single element, for example, through extrusion,
molding, casting, and the like. Variations in sizes and
flexibility, as well as the inclusion of rigid or semi-rigid
materials, should not be interpreted as requiring a certain method
or type of construction. While the present description is written
largely in terms of use in a human patient, the present invention
may also be used with other organisms, for example in veterinary
procedures by applying adaptations suited to a particular
organism's anatomy.
[0020] Refer now to FIG. 1, which is a diagrammatic cross sectional
side view of one example embodiment of a closure device 10 adapted
and/or configured for closing an opening in tissue bounding a
cavity in the anatomy of a patient. In this embodiment, the device
10 includes a body member, such as an elongated tubular member 12
having a distal end 14 and a proximal end 16. The tubular member 12
includes a distal section 18 an intermediate section 19, and a
proximal section 20, and defines an inner lumen 22 extending there
through. The tubular member 12, and the inner lumen 22 defined
thereby, extend generally along a longitudinal axis, X. In this
document, the term "longitudinal" should be understood to mean in a
direction corresponding to an elongated direction of the closure
device 10. The tubular member 12 defines an outer surface 24 having
an outer perimeter, and an inner surface 26 having an inner
perimeter. The outer surface 24 includes a distal portion 24a
corresponding to the distal section 18, an intermediate portion 24b
corresponding to the intermediate section 19, and a proximal
portion 24c corresponding to the proximal section 20. The distal
end 14 of closure device 10 may be angled or tapered, or may be
generally flat, as shown or otherwise adapted to facilitate
insertion.
[0021] Although shown as including a generally circular cross
section, tubular body member 12, proximal member 28, and the lumen
22, or portions of any of these, may include any of a broad variety
of cross sectional shapes, often dependent upon the shape and size
of the opening in the tissue to be closed or sealed, and/or upon
the shape and size of other devices that may be used with the
closure device 10. The structure, or portions thereof, may include
any of a broad variety of cross-sectional shapes, for example,
circle, oval, square, rectangle, or other polygon or like shapes,
or combinations thereof. Additionally, although the sections 18,
19, and 20 and the lumen 22 are shown as including generally
constant outer and inner diameters along the length thereof, in
other embodiments, these diameters may change or taper along the
length of each segment 18, 19, and 20 or along the length of the
lumen 22.
[0022] In this embodiment, the device 10 also includes a first
non-return valve 36 disposed in the lumen 22 at proximal end 16,
and a second non-return valve 38 disposed in the lumen 22 at the
distal end 14. The non-return valves 36 and 38 are adapted so that
a needle, trochar, guidewire, catheter, or other such device or
structure may be introduced through the valves 36 and 36 without
allowing substantial fluid within the lumen of closure device to
escape, and, conversely, without allowing foreign particles to
enter the lumen 22 of closure device 10. For example, the
non-return valve may be a hemostatic valve, membrane, or the like.
In some embodiments, the non-return valves may be adapted and/or
configured to include ports that can be accessed multiple
times.
[0023] The proximal section 20 includes a proximal portion 28
disposed adjacent the proximal end 16 of the tubular member 12. The
proximal portion 28 defines the outer surface portion 24c that has
an outer perimeter. The intermediate section 19 of the tubular
member defines outer surface portion 24b that has an outer
perimeter, and the outer surface portion 24c has a greater outer
perimeter than the outer surface portion 24b. In other words, the
proximal portion 28 is bigger around than the intermediate section
32. Additionally, in the embodiment shown, the proximal portion 28
defines a distal side surface 25a and a proximal side surface 25b.
The distal side surface 25a forms a stepped up or shoulder area 27
where the intermediate section 19 and proximal portion 28 meet. The
proximal portion 28 can be a separate member that is attached or
connected to the outer surface 24 of the of the tubular member 12
at the proximal section 20, or can be a widening or expansion in
unitary construction with the tubular member 12 to created the
increased outer perimeter. As will be discussed in more detail
below, in at least some embodiments, the widened proximal portion
28 is adapted and/or configured such that the outer surface 24c has
an outer perimeter that is larger than an outer perimeter of the
opening in the tissue of the patient that is to be closed. As such,
in at least some embodiments, the widened proximal portion 28 can
be adapted and/or configured to acts as a stop and/or as a sealing
portion that contacts the outer surface of the tissue in which the
opening is being closed or sealed.
[0024] The intermediate section 19 of the tubular member 12 extends
distally of the proximal portion 28, and as indicated above,
includes an outer surface portion 24b that has an outer perimeter
that is smaller than the outer perimeter of the proximal portion
28. The intermediate section 19 can be a separate member that is
attached or connected to the proximal section 20, or can be of
unitary construction with the proximal section 20. As will be
discussed in more detail below, in at least some embodiments, the
intermediate section 19 can have an outer surface 32 that has an
outer perimeter that is sized and/or configured for insertion into
the opening in the tissue to be closed or sealed. It can also have
a length that is sized and/or configured to extend within the
opening to be closed or sealed, and in some embodiments, at least
the entire length of the opening to be closed or sealed. Therefore,
in at least some embodiments, the intermediate section 19 is
adapted and/or configured to extend within the opening in the
tissue to be closed or sealed between the widened proximal portion
28 and the distal section 18.
[0025] The distal section 18 of the tubular member 12 extends
distally of the intermediate section 19, and also includes an outer
surface portion 24c that has an outer perimeter. The distal section
18 can be a separate member that is attached or connected to the
intermediate section 19, or can be of unitary construction with the
intermediate section 19. The distal section 20 includes at least a
portion thereof that is adapted and/or configured to be radially
expandable from a first configuration, wherein the outer surface
portion 24c of the distal section 18 is sized for insertion into
and through the opening in the tissue to be closed, to a second,
radially expanded configuration, wherein at least a portion of the
outer surface portion 24c of the distal section 18 has a larger
outer perimeter than when in the first configuration. As such, the
distal section 18 of the tubular member 12, when in the first,
unexpanded configuration, is adapted and/or configured to be
inserted through the opening in the tissue to be closed or sealed,
and into the interior of the opening in the tissue. Thereafter, the
distal section 18 can be expanded into the second, expanded
configuration, wherein it can be adapted and/or configured to act
as a stop and/or as a sealing portion that contacts the inner
surface of the tissue in which the opening is being closed or
sealed. In the embodiment of FIG. 1, the distal section 18 is shown
in a first, or unexpanded configuration.
[0026] In some embodiments, the distal section 18 is configured
such that the radial expansion of at least a portion of the distal
section can be achieved through the application of sufficient
compressive longitudinal force to the distal section 18. For
example, in some embodiments, the distal section 18 includes at
least one area 30 along the length thereof that has a reduced
column strength relative to other portions of the distal section
18. Some embodiments may include multiple areas of reduced column
strength. Such areas 30 of reduced column strength are adapted to
bend or fold in an outward direction relative to the longitudinal
axis, such that the outer surface 24a expands radially outward when
a sufficient compressive longitudinal force is applied to the
distal section 18. In other words, the area 30 has a weaker column
strength than adjacent areas, and as such, it is adapted to give,
and/or bend in an outward direction when the distal section 18 is
placed under sufficient compressive force. This giving and/or
bending in an outward direction resulting in radial outward
expansion of at least a portion of the distal section 18 allows the
distal section 18 to transition from the unexpanded to the expanded
configuration.
[0027] The area 30 of reduced column strength can be achieved or
created in any of a number of ways. For example, in the embodiment
shown, the inner surface 26 of the distal section 18 includes a
cylindrical portion having a reduced wall thickness to create the
area 30 of reduced column strength. In other embodiments, an area
of reduced column strength can be achieved through other means or
mechanisms, for example, other structure, such as one or more
groove, channel, furrow, notch, cut, fold, crease, wrinkle, ridge,
kink, or other such structure defined in the wall of the distal
section 18 that may result in reduced column strength, or a
propensity to fold outwardly under compressive force. Additionally,
an area 30 having reduced column strength or having a propensity to
fold outwardly under compressive force may be created by using
materials in such areas having different properties relative to the
remainder of the distal section 18. For example, such an area may
be created by using a material having a different modulus of
elasticity from the remaining portions of the distal section 18.
For example, such an area may include or be made of material having
a reduced elastic modulus (i.e., increased flexibility) relative to
other portions of the distal section 18, and would therefore have
reduced column strength, and/or have a propensity to fold outwardly
under compressive force.
[0028] Some embodiments may also include a binding mechanism to
help maintain the distal section 18 in the expanded configuration.
For example, in the embodiment shown, a binding material 32, such
as an adhesive or other bonding agent or mechanism may be disposed
on the inner surface 26 of the distal section 18. The binding
material 32 may be disposed on either side, or on both sided of the
area 30 such that when the area 30 of reduced column strength bends
or folds in an outward direction, adjacent portions of the inner
surface 26 about the fold can be bound together to help maintain
the expanded configuration.
[0029] Reference will now be made to FIGS. 2-4 for description of
one example or use and/or operation of the example embodiment shown
in FIG. 1. FIG. 2 is a diagrammatic side view of the closure device
10 of FIG. 1, in the unexpanded first configuration, inserted into
an opening 50 in tissue 52 of a patient. For example, the opening
50 may be in the dural membrane 52 of a patient. The dural membrane
52 forms an enclosed system that contains other membranes, the
brain, spinal cord, and Cerebrospinal fluid (C.S.F.). The dural
membrane 52 is located beneath other tissue 54, and encloses and
defines a cavity 56, for example, the subarachnoid space of a
patient. As shown, the dural membrane 52 includes an outer surface
53 and an inner surface 55. Some examples of procedures and devices
that involve creating an opening in the dural membrane are
disclosed copending U.S. patent application Ser. No.: 10/328,560
filed on Dec. 23, 2002, entitled METHODS AND APPARATUSES FOR
NAVIGATING THE SUBARACHNOID SPACE; Ser. No. 09/905,670 filed on
Jul. 13, 2001, entitled METHODS AND APPARATUSES FOR NAVIGATING THE
SUBARACHNOID SPACE; Ser. No. 10/328,349 filed on Dec. 23, 2002,
entitled INTRODUCER SHEATH; and Ser. No. 10/328,373, filed on Dec.
23, 2002, entitled GUIDE CATHETER FOR INTRODUCTION INTO THE
SUBARACHNOID SPACE AND METHODS OF USE THEREOF, all of which are
incorporated herein by reference.
[0030] The closure device 10 is shown inserted through the tissue
54 above the dural membrane 52, and into the opening 50. The distal
section 18 and the intermediate section 19 are sized to extend
through or within the opening 50, while the widened proximal
portion 28 is adapted and/or configured such that the outer surface
24c has an outer perimeter that is larger than an outer perimeter
of the opening 50. The distal section 18 is shown in the unexpanded
first configuration extending into the subarachnoid space 56. The
intermediate section 19 is shown as extending within the opening
50. The proximal section 20, including proximal portion 28, is
shown on the outside, or proximal side, of the opening 50. The
distal side surface 25a of the widened proximal portion 28 makes
contact with the outer surface 53 of the dural membrane 52 about
the opening 50.
[0031] The closure device 10 can be inserted into the opening 50
using any suitable device or mechanism. For example, an insertion
device, such as a needle 60, trochar, or the like, can be disposed
into the lumen 22 of the device 10. The needle 60, or other device,
can then be used to insert the closure device 10 into the opening
50, and the device 10 can be advanced into the opening 50 until the
widened proximal portion 28 makes contact with the outer surface 53
of the dural membrane 52. In some embodiments, the needle 60 may be
inserted through both of the non-return valves 36 and 38, which can
be adapted to provide a frictional fit with the needle 60 such that
insertion can be made with relatively little or no movement of the
device 10 relative to the needle 60. In some embodiments, the
needle 60 or other insertion device can be adapted or configured to
include properties or structures that facilitate insertion and/or
cooperation with the device 10. For example, some embodiments may
include a tapered or sharpened distal tip 62 to facilitate
insertion, or protrusions 61 on the outer surface thereof that are
adapted to create or provide additional frictional fit or
engagement with the valves 36 and 38.
[0032] Although depicted as being inserted with a needle 60, the
device can be inserted into the opening 50 using any suitable
insertion instrument, technique or apparatus. For example, in other
examples, a guidewire, catheter, or the like, may be disposed such
that it extends through the opening 50 in the dural membrane 52 and
into subarachnoid space 56, and may be used to guide or facilitate
the introduction of closure device 10.
[0033] Refer now to FIG. 3, wherein the distal section 18 is shown
in a partially expanded configuration, in transition between the
unexpanded configuration, and a fully expanded configuration. Once
the device 10 is inserted into the opening 50, as shown in FIG. 2,
the needle 60 can begin to be withdrawn, as shown in FIG. 3, for
example, along longitudinal axis X. In some embodiments, it may be
necessary during withdrawal of the needle 60 to apply pressure to
the widened proximal portion 28 such that it maintains a desired
position, for example, in contact with the outer surface 53 of the
dural membrane 52 about the opening 50.
[0034] During withdrawal of the needle 60, the needle 60 can engage
structure in the distal section 18 of the tubular member 12. For
example, in the embodiment shown, the needle 60, through friction,
engages the distal non-return valve 38. The protrusions 61 on the
needle 60 can aid in the frictional engagement of the distal
non-return valve 38, or may in some embodiments provide for an
interference fit with the distal non-return valve 38. As the needle
60 is withdrawn, a compressive longitudinal force is applied to the
walls of the tubular member 12 due to the frictional or
interference engagement of the needle 60 with the distal non-return
valve 38. The compressive longitudinal force is sufficient to cause
the areas 30 of reduced column strength on the distal section 18 to
bend or fold in an outward direction relative to the longitudinal
axis X. As the bend or fold is created, the outer surface 24a
expands radially outward. In the embodiment shown in FIG. 3, the
longitudinal force and the bending and/or folding of the distal
section 18 about the area 30 creates a proximal region or fold 65
in the distal section 18 that is pulled toward the inner surface 55
of the dural membrane 52. Additionally, a distal region or fold 63
in the distal section 18 is created, and the distal region 63 is
pulled toward the proximal region 65.
[0035] Refer now to FIG. 4, wherein the distal section 18 is shown
in a fully expanded configuration. In this fully expanded
configuration, at least a portion of the proximal region or fold 65
in the distal section 18 is pulled against the inner surface 55 of
the dural membrane 52. Additionally, the distal region or fold 63
is pulled toward the proximal region 65, and the adhesive material
32 can act to bind the two regions 63 and 65 together to help
maintain the expanded configuration. The outer surface 24a of the
distal region has expanded radially outward such that it has an
outer perimeter that is greater than the outer perimeter of the
opening 50 in the dural membrane 52. As such, the opening 50 has
been closed by the closure device 10. The closure device is
maintained in position by the radially expanded distal section
engaging the inner surface 55 of the dural membrane, and the
widened proximal portion 28 engaging the outer surface 53 of the
dural membrane 52 about the opening 50. The intermediate section 19
extends through the opening, and interconnects the distal section
18 and the proximal portion 28. When in place, and the distal
section is in the expanded configuration, the closure device 10
acts to at least substantially close or seal the opening 50.
[0036] In some other embodiments, it is also contemplated that a
binding mechanism, such as an adhesive type material, may b e used
on the outer surface 24a of the distal section 18. For example, an
adhesive material could be included on the outer surface of the
proximal region 65 of the distal section 18. At least a portion of
the outer surface of this region 65 may come into contact with the
inner surface 55 of the dural membrane, and an adhesive material
applied thereto could provide for a bond between the proximal
region 65 and the inner surface 55 of the dural membrane. Such a
bond may help maintain the closure device 10 in the expanded
configuration, and may additionally help to seal the opening.
Additionally, in some embodiments, a binding mechanism, such as an
adhesive type material, may be used on an outer surface of the
proximal portion 28. For example, an adhesive material may be
applied to the distal side surface 25a and could provide for a bond
between the proximal portion 28 and the outer surface 53 of the
dural membrane. Such a bond may help maintain the closure device 10
in position relative to the opening, and may additionally help to
seal the opening 50. It is contemplated that in at least some such
embodiments, the adhesive material used would be compatible with
the tissue or anatomy in which it is being used.
[0037] Additionally, in some embodiments, when the closure device
10 is in place within the anatomy, it can be used as a port for
introduction of other devices and/or structures. For example, with
the closure device 10 in place, in some embodiments, additional
structures may be introduced into the cavity defined by the tissue,
(such as the subarachnoid space in the case of the dural membrane),
through the lumen 22 within the closure device 10. For example, a
guidewire, catheter, introducer sheath, needle, trochar,
endoscopes, flush tubes, and other devices, or the like, may be
advanced through the lumen 22 via the valves 36 and 38 and into the
cavity 56. Such additional devices may then be navigated or
advanced within the cavity 56, or may take samples of fluid, such
as CSF, or may introduce material, such as drugs, marker fluid, or
the like, into the cavity 56. The closure device 10, including for
example the non-return valves 36 and 38 may be adapted and/or
configured to be accessed multiple times by one or more devices,
and in some examples, can remain in place for a period of time to
act as an access port to the anatomy. Additionally, while the
embodiments shown include a single lumen 22, other embodiments may
include multiple lumens. Such an embodiment can be, for example,
adapted for use with or introduction of multiple devices, such as
guidewires, catheters and the like, through the separate
lumens.
[0038] Additionally, the closure device 10 may act as a platform
for additional structures or devices. For example, the distal
section 18 may include a transducer, for example, a microsensor
embedded into a wall of the closure device 10 for sensing the
temperature, pressure, body chemistry or the like inside the cavity
56, such as the subarachnoid space, or other anatomy in which the
device 10 is used. Such a transducer may be coupled to an electric
(i.e. a wire) or optic connection running along, through, or
embedded into the tubular member 12 from a distal location to a
proximal location. In other embodiments, such a transducer may be a
wireless sensor, for example, a wireless resonant pressure or
temperature sensor. The transducer may be included for determining
a physiologic property during an operation, or to assist in
diagnosis. Any of a wide variety of small sensing devices may be
used as a transducer including, for example, resonant sensors,
micromachined sensors, or even more conventional sensors which,
though relatively bulky, may be incorporated into or attached to
the closure device 10.
[0039] The size and dimensions of the closure device 10, and/or
components or segments thereof, is greatly dependent upon the size
and dimensions of the particular anatomy in which it is intended
for use, and the size of the opening in the anatomy that is being
closed. Thus, the lengths and diameters of different segments of
the closure device 10 may thus be adapted for particular usages,
and can vary greatly. For example, the outer diameter and length of
the intermediate section 19 and the distal section 18 in the
unexpanded configuration may be adapted for entry into a particular
opening size in a particular anatomy, as the allowed outer
diameters and length available and necessary for entry may vary
from one particular opening size and anatomy to the next, as well
as from one patient to the next. Likewise, the length and outer
diameter of the proximal section, including the proximal portion
28, and the distal section 18 in an expanded configuration may also
vary greatly, depending upon the size of the opening to be closed,
and the available space in the anatomy. In some example
embodiments, the device can have dimensions that are particularly
adapted and/or configured for closing an opening in the dural
membrane. Additionally, the dimensions of the lumen 22 and of the
non-return valves 36 and 38 may vary greatly, depending upon the
dimensions of the other components or sections, and upon the
dimensions of other devices, if any, that are intended for use with
the device.
[0040] With respect to the proximal section 20, it is possible to
have an even larger lumen 22 within that section to make the lumen
more easily accessed and/or passed. For example, because the
proximal section 20 is not inserted into the opening 50 the outer
diameter of the proximal section 20 is not as subject to the
anatomical limits of a patient into whom the device is inserted,
and hence there are fewer limits on the inner lumen 22 diameter in
the proximal section 20, either.
[0041] A wide variety of materials may be used to make the closure
device 10, or sections or portions thereof. For example, the
closure device 10, including the tubular body member 12, the
proximal member 28, or portions thereof, can be manufactured from
any suitable material to impart the desired characteristics. Some
examples of suitable materials can include, for example, polymers,
metal-polymer composites, metals, metal alloys, or the like, or
combinations or mixtures thereof. Examples of some suitable
materials include, but are not limited to, polymers such as
polyoxymethylene, polybutylene terephthalate, polyether block
ester, polyether block amide, fluorinated ethylene propylene,
polyethylene, polypropylene, polyvinylchloride, polyurethane,
polytetrafluoroethylene (PTFE), polyether-ether ketone, polyimide,
polyamide, polyphenylene sulfide, polyphenylene oxide, polysufone,
nylon, perfluoro(propyl vinyl ether), polyether-ester,
polymer/metal composites, etc., or mixtures, blends or combinations
thereof. One example of a suitable polyether block ester is
available under the trade name ARNITEL, and one suitable example of
a polyether block amide is available under the trade name
PEBAX.RTM., from ATOMCHEM POLYMERS, Birdsboro, Pa. In some
embodiments, the polymer material of certain sections of the
closure device 10 can be blended with a liquid crystal polymer
(LCP). For example, the mixture can contain up to about 5% LCP.
This has been found to enhance torqueability in some
embodiments.
[0042] Some examples of suitable metals and metal alloys include
nickel-titanium alloy, such as linear elastic or superelastic
nitinol, nickel-chromium alloy, nickel-chromium-iron alloy, cobalt
alloy, stainless steel, such as 304v stainless steel; or the like;
or other suitable material.
[0043] The closure device 10, for example the tubular body member
12 and the proximal member 28, can be made of unitary construction,
or can be made up of a plurality of tubular segments coupled
together, each segment being made of materials having the same or
different properties. For example, in some embodiments, different
portions or sections of the device 10 can include or be made of
materials, or have structure that renders them more flexible or
softer than other portions of the device 10. For example, in some
embodiments, the distal section 18 may be more flexible or softer
than at least a part of the intermediate or proximal sections 19
and 20. Likewise, in some embodiments, the distal section 18 can be
less flexible or harder than at least a part of the of the
intermediate or proximal sections 19 and 20. These are only a
couple of examples, but it should be understood that variances in
the characteristics of the different sections can be achieved as
desired.
[0044] It can be appreciated that the closure device 10 can be made
of a single layer of material, or a plurality of layers. For
example, the tubular body member 12 and the proximal member 28, can
include one or more layers disposed or stacked on top of one
another. The different layers may be made of the same material or
different materials. In one example, one of the layers may be made
of a generally less flexible polymer than the other(s). In another
example, one or more of the layers may be made of or doped with an
indicator material to enhance imaging. Additionally, in some
embodiments, one of the layers may act as a support layer, and can
include, for example, support structure, such as a braid, coil, or
other such structures. The closure device 10, including the tubular
body member 12 and the proximal member 28 can be constructed using
any appropriate technique, for example, by extrusion, a heat
bonding process, casting, molding, and the like.
[0045] In some embodiments, the device 10 may be provided with an
initial rigid shape, but may be re-shaped by a physician before
insertion to better match the anatomy of the patient. For example,
the distal section 18, intermediate section 19, and/or proximal
section 20, or portions thereof, may be made of a material such as
PTFE that is rigid, but may be heated and re-shaped, so that once
re-cooled, the distal section, intermediate section 18, and/or
proximal section 20 will retain the new shape.
[0046] In some embodiments, the closure device, or portions thereof
can be made of or include a lubricious material, for example
tetrafluoroethylene, or a copolymer of tetrafluoroethylene with
perfluoroalkyl vinyl ether (more specifically, perfluoropropyl
vinyl ether or perfluoromethyl vinyl ether), or the like. Also, in
some embodiments, the closure device, or sections or portions
thereof can include a coating, for example a lubricious, a
hydrophilic, a protective, or other type of coating may be applied
over portions or all of the device 10, or within the lumen 22 of
the device. Hydrophobic coatings such as fluoropolymers provide a
dry lubricity which can improve insertion, and when disposed in the
lumen 22, and improve insertions of other devices therethrough.
Lubricious coatings can also aid in this manner. Suitable
lubricious polymers are well known in the art and may include
silicone and the like, hydrophilic polymers such as polyarylene
oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl
cellulosics, algins, saccharides, caprolactones, and the like, and
mixtures and combinations thereof. Hydrophilic polymers may be
blended among themselves or with formulated amounts of water
insoluble compounds (including some polymers) to yield coatings
with suitable lubricity, bonding, and solubility. Some other
examples of such coatings and materials and methods used to create
such coatings can be found in U.S. Pat. Nos. 6,139,510 and
5,772,609, which are incorporated herein by reference.
[0047] The distal section 18 (as well as the rest of closure device
10, as desired) may also include one or more markers or a coating
to enhance its imaging visibility, for example MRI visibility, and,
for some embodiments, may include radiopaque materials or other
high visibility materials adapted for use with other imaging
technologies, such as fluoroscopy. For some embodiments suggested
herein, the closure device may be made of material and structure
compatible with certain imaging techniques, for example an MRI
scanning compatible material or structure. For example, ferrous
materials, such as some stainless steel alloys often used to
provide braided reinforcement to catheters, are typically
magnetically responsive, and are generally not used in conjunction
with MRI equipment, or are provided with structure that would
render them compatible with MRI equipment. However, other
embodiments, may not include materials that are currently MRI
compatible.
[0048] Refer now to FIG. 5 which is a side view of another
illustrative embodiment showing a closure device 110, this time
including some alterations to the tubular member 112. In this
embodiment, the device 110 also includes a body member, such as an
elongated tubular member 112 having a distal end 114 and a proximal
end 116. The tubular member 112 includes a distal section 118 an
intermediate section 119, and a proximal section 120, and defines
an inner lumen 122 extending there through. The tubular member 112,
and the inner lumen 122 defined thereby, extend generally along a
longitudinal axis, X. Likewise, the tubular member 112 defines an
outer surface 124 having an outer perimeter, and an inner surface
126 having an inner perimeter. The outer surface 124 includes a
distal portion 124a corresponding to the distal section 118, an
intermediate portion 124b corresponding to the intermediate section
119, and a proximal portion 124c corresponding to the proximal
section 120. Similar to the embodiment discussed above, the device
110 also includes a first non-return valve 136 disposed in the
lumen 122 at proximal end 116, and a second non-return valve 138
disposed in the lumen 122 at the distal end 114.
[0049] The proximal section 120 and intermediate section 119 are
configured substantially similar to the proximal section 20 and
intermediate section 19 embodiment shown in FIG. 1-4. For example,
the proximal section 120 includes a proximal portion 128 defining
the outer surface portion 24c that has an outer perimeter that is
greater than the outer perimeter of outer surface portion 24b.
Additionally, the proximal portion 128 defines a distal side
surface 125a and a proximal side surface 125b, and a stepped up or
shoulder area 127.
[0050] However, the distal segment 118 in this embodiment includes
a plurality of areas 130 along the length thereof that have a
reduced column strength relative to other portions of the distal
section 118. Such areas 130 of reduced column strength are adapted
to bend or fold in an outward direction relative to the
longitudinal axis, such that the outer surface 124a expands
radially outward when a sufficient compressive longitudinal force
is applied to the distal section 118. This giving and/or bending in
an outward direction resulting in radial outward expansion of at
least a portion of the distal section 118 allows the distal section
118 to transition from an unexpanded to an expanded configuration.
In this embodiment, the areas 130 of reduced column strength are
created by reducing the wall thickness on a portion of the inner
surface 126 of the distal section 118.
[0051] In FIG. 5, the closure device 110 has been inserted into an
opening 50 in tissue 52 of a patient, for example, an opening 50 in
the dural membrane 52 of a patient. A needle 60 was used for
insertion, and the needle 60 is being withdrawn, such that the
distal section 118 is in a partially expanded configuration. During
withdrawal, the needle 60, engages the distal non-return valve 138,
and a compressive longitudinal force is applied to the walls of the
tubular member 112. The compressive longitudinal force is
sufficient to cause the areas 130 of reduced column strength to
bend or fold in an outward direction relative to the longitudinal
axis X. As the bends or folds are created, the outer surface 24a
expands radially outward. In the embodiment shown in FIG. 5, the
longitudinal force and the bending and/or folding of the distal
section 118 about the areas 30 creates a plurality of folds 165,
each fold 165 being proximal to an adjacent area 130. The folds 165
are pulled in a proximal direction. The proximal--most fold 165 is
pulled toward the inner surface 55 of the dural membrane 52.
Additionally, the longitudinal force creates a plurality of folds
163, each fold 163 being distal to an adjacent area 130. Each of
the folds 163 is pulled toward the associated proximal fold 165
about the areas 130.
[0052] Refer now to FIG. 6, wherein the distal section 118 is shown
in a fully expanded configuration. In this fully expanded
configuration, at least a portion of the most proximal fold 165 is
pulled against the inner surface 55 of the dural membrane 52.
Additionally, each of the folds 163 is pulled toward the associated
folds 165 about each of the areas 130. An adhesive material 132 can
act to bind each of the two folds 163 and 165 together to help
maintain the expanded configuration. The outer surface 124a of the
distal region 118 has expanded radially outward such that it has an
outer perimeter that is greater than the outer perimeter of the
opening 50 in the dural membrane 52. As such, the opening 50 has
been closed by the closure device 110. The closure device is
maintained in position by the radially expanded distal section 118
engaging the inner surface 55 of the dural membrane, and the
widened proximal portion 128 engaging the outer surface 53 of the
dural membrane 52 about the opening 50. The intermediate section
119 extends through the opening 50, and interconnects the distal
section 118 and the proximal portion 128. When in place, and the
distal section 118 is in the expanded configuration, the closure
device 110 acts to at least substantially close or seal the opening
50.
[0053] The present invention should not be considered limited to
the particular examples described above, but rather should be
understood to cover all aspects of the invention as fairly set out
in the attached claims. For example, as discussed above, it should
be understood that other embodiments of such devices can be adapted
and/or configured for use in portions of the anatomy other than the
dural membrane to close or seal an opening in other tissue. Various
modifications, equivalent processes, as well as numerous structures
to which the present invention may be applicable will be readily
apparent to those of skill in the art to which the present
invention is directed upon review of the instant specification. It
should be understood that this disclosure is, in many respects,
only illustrative. Changes may be made in details, particularly in
matters of shape, size, and arrangement of steps without exceeding
the scope of the invention. The scope of the invention is, of
course, defined in the language in which the appended claims are
expressed.
* * * * *