U.S. patent application number 13/763420 was filed with the patent office on 2013-06-13 for balloon insertion apparatus and method of sealing a tissue puncture.
This patent application is currently assigned to ST. JUDE MEDICAL PUERTO RICO LLC. The applicant listed for this patent is ST. Jude Medical Puerto Rico LLC. Invention is credited to Kedar R. Belhe, Michelle Boucha-Rayle, Catherine A. Pipenhagen.
Application Number | 20130150884 13/763420 |
Document ID | / |
Family ID | 38225475 |
Filed Date | 2013-06-13 |
United States Patent
Application |
20130150884 |
Kind Code |
A1 |
Belhe; Kedar R. ; et
al. |
June 13, 2013 |
BALLOON INSERTION APPARATUS AND METHOD OF SEALING A TISSUE
PUNCTURE
Abstract
The present invention provides apparatus and methods of closing
internal tissue punctures. The apparatus and method provide for an
introducer sheath having at least one side port enabling aspiration
of an internal tissue puncture site and injection of a sealant.
Inventors: |
Belhe; Kedar R.;
(Minnetonka, MN) ; Boucha-Rayle; Michelle;
(Minnetonka, MN) ; Pipenhagen; Catherine A.;
(Chanhassen, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ST. Jude Medical Puerto Rico LLC; |
Caguas |
PR |
US |
|
|
Assignee: |
ST. JUDE MEDICAL PUERTO RICO
LLC
Caguas
PR
|
Family ID: |
38225475 |
Appl. No.: |
13/763420 |
Filed: |
February 8, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11325206 |
Jan 4, 2006 |
8382794 |
|
|
13763420 |
|
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|
Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B 17/0057 20130101;
A61B 2017/22067 20130101; A61M 25/10 20130101; A61B 2017/00637
20130101; A61M 25/0662 20130101; A61B 17/00491 20130101; A61B
2017/00654 20130101 |
Class at
Publication: |
606/213 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Claims
1. An internal tissue puncture sealing apparatus, comprising: a
first thin, elongated conduit having a first central lumen and
first and second ends, the first end being insertable through the
internal tissue puncture and having an inflation segment in fluid
communication with the central lumen; an expandable member disposed
at the first end, the expandable member being selectively
inflatable with a fluid via the central lumen; a second thin,
elongated conduit having a second central lumen receptive of the
first thin, elongated conduit and having a distal and a proximal
end, the proximal end having at least one valved side-port in fluid
communication with an annulus between the first thin, elongated
conduit and the second thin, elongated conduit.
2. An internal tissue puncture sealing apparatus according to claim
1, further comprising a volume of sealant in fluid communication
with the valved side-port for selective injection of the sealant to
a situs of the internal tissue puncture via the annulus.
3. An internal tissue puncture sealing apparatus according to claim
1 wherein the valved side-port comprises a vacuum evacuation
port.
4. An internal tissue puncture sealing apparatus according to claim
1 wherein the valved side-port comprises a vacuum evacuation port
and a sealant introduction port.
5. An internal tissue puncture sealing apparatus according to claim
1 wherein the valved side-port comprises branches to a vacuum
evacuation port and a sealant introduction port; and wherein the
vacuum evacuation port is in fluid communication with a vacuum
syringe, and the sealant introduction port is in fluid
communication with a sealant-containing syringe.
6. An internal tissue puncture sealing apparatus according to claim
1 wherein the valved side-port is selectively positionable between
a closed position, a position open to an evacuator, and a position
open to a sealant.
7. An internal tissue puncture sealing apparatus according to claim
1, further comprising a spacer disposed on the first thin,
elongated conduit limiting an insertion distance of the first thin,
elongated conduit through the second thin, elongated conduit.
8. An internal tissue puncture sealing apparatus according to claim
1, further comprising a spacer disposed on the first thin,
elongated conduit limiting an insertion distance of the first thin,
elongated conduit through the second thin, elongated conduit such
that the first end thereof extends beyond the distal end of the
second thin, elongated conduit by a predetermined distance.
9. An internal tissue puncture sealing apparatus according to claim
1 wherein the expandable member is coaxial and flush with the first
thin, elongated conduit when uninflated.
10. An internal tissue puncture sealing apparatus according to
claim 1 wherein the first thin, elongated conduit and expandable
member comprise a balloon catheter.
11. An internal tissue puncture sealing apparatus according to
claim 1 wherein the second thin, elongated conduit comprises a
vascular insertion sheath.
12. A vascular puncture sealing system, comprising: a balloon
catheter; an introducer assembly receptive of the balloon catheter;
at least one side port in the introducer assembly for evacuating
the introducer assembly.
13. A vascular puncture sealing system according to claim 12,
further comprising a volume of sealant in fluid communication with
the side port of the introducer assembly.
14. A vascular puncture sealing system according to claim 12
wherein the side port comprises a three-way valve.
15. A vascular puncture sealing system according to claim 12
wherein the side port comprises a three-way valve operable between
a closed position, an first open position fluidly connecting the
introducer assembly with a vacuum device, and a second open
position fluidly connecting the introducer assembly with a sealant
supply.
16. A vascular puncture sealing system according to claim 12
wherein the side port comprises a three-way valve operable between
a closed position, an first open position fluidly connecting the
introducer assembly with a vacuum device, and a second open
position fluidly connecting the introducer assembly with a sealant
supply; wherein the vacuum device comprises a first syringe, and
the sealant supply comprises a second syringe containing a volume
of sealant.
17. A vascular puncture sealing system according to claim 12
wherein the side port comprises a translucent valve for providing
visual indication of blood flow.
18. A vascular puncture sealing system according to claim 12
wherein one of the balloon catheter and introducer assembly
comprises a stopper sleeve limiting insertion of the balloon
catheter into the introducer assembly.
19. A vascular puncture sealing system according to claim 12
wherein the side port comprises a valve operable between a closed
position an open position fluidly connecting the introducer
assembly with a sealant supply; wherein the sealant supply
comprises a syringe containing a volume of sealant; wherein the
sealant comprises a gel or foam comprising one of: collagen,
polyvinyl alcohol, polyethylene glycol, cyanoacrylates, chitosan,
or poly-n-acetyl glucosamine.
20. An internal tissue puncture sealing apparatus, comprising: a
balloon catheter; an introducer assembly having an introducer lumen
receptive of the balloon catheter and at least one side port in
flow communication with the introducer lumen, the at least one side
port providing a common access point for applying a vacuum force to
evacuate the introducer lumen and delivering sealant to the
introducer lumen after evacuating the introducer lumen.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional of application Ser. No.
11/325,206, filed Jan. 4, 2006, and entitled BALLOON INSERTION
APPARATUS AND METHOD OF SEALING A TISSUE PUNCTURE, pending, the
disclosure of which is hereby incorporated herein, in its entirety,
by this reference.
FIELD OF THE INVENTION
[0002] The present invention relates to medical devices, and, more
particularly, to tissue puncture sealing devices.
BACKGROUND OF THE INVENTION
[0003] Various medical procedures, particularly cardiology
procedures, involve accessing a corporeal vessel or other lumen
through a percutaneous sheath. The sheath necessarily requires the
formation of a hole or opening in the vessel wall so that a medical
procedure can be performed via the sheath. After the particular
medical procedure has been performed, the sheath must eventually be
removed from the vessel and the access hole in the vessel wall must
be closed.
[0004] Historically, the access hole is closed by the application
of prolonged manual pressure over the puncture site by a physician
or other trained medical professional. The time involved with this
method is extensive and costly. In addition, because patients are
often treated with a variety of anticoagulant and thrombolytic
agents, the manual pressure required to close the access opening in
the vessel wall may be even longer. The discomfort and delay in
mobilization for patients resulting from this prolonged manual
pressure is significant.
[0005] Therefore, a number of vascular closure devices have been
developed to close an access opening in the vessel wall more
efficiently. For example, closing an access opening in the vessel
wall may involve packing a resorbable sealing plug at the hole or
sandwiching the hole between the sealing plug and an anchor.
Examples of such vascular closure devices and methods are described
in U.S. Pat. Nos. 6,090,130 and 6,045,569 and related patents that
are hereby incorporated by reference.
[0006] Alternatively, closing an access opening in the vessel wall
may include the use of a balloon catheter. For example, an access
opening in the vessel wall may be closed by inserting a balloon
catheter through the opening in the vessel wall, inflating the
balloon, pulling the balloon against the inner wall of the vessel,
introducing a procoagulant to the incision site external to the
puncture in the vessel wall, and withdrawing the balloon catheter.
This method relies on a biochemical reaction between the
procoagulant and the blood. The reliance on a biochemical reaction,
however, can be problematic. For example, the mixing of the
procoagulant with the blood is arbitrary. Therefore, in many cases
an exaggerated dose of the procoagulant is applied in an attempt to
ensure hemostatis. An exaggerated dose, however, can accidentally
enter the blood stream and introduce complications. Moreover,
reliance on a chemical reaction based on arbitrary mixing between
the procoagulant and the blood often results in an inconsistent
seal composition, which in turn results in inconsistent hemostatic
sealing performance.
SUMMARY OF THE INVENTION
[0007] In one of many possible embodiments, the present invention
provides an internal tissue puncture sealing apparatus. The
internal tissue puncture sealing apparatus comprises a first thin,
elongated conduit having a first central lumen and first and second
ends. The first end is insertable through the internal tissue
puncture and has an inflation segment in fluid communication with
the central lumen. The first end includes an expandable member that
is selectively inflatable with a fluid via the central lumen. The
apparatus also includes a second thin, elongated conduit having a
second central lumen receptive of the first thin, elongated
conduit. The proximal end of the second conduit has at least one
valved side-port in fluid communication with an annulus between the
first and second conduits. The valved side-port may include a
vacuum communication path and a sealant injection path, which
enable aspiration of a tissue puncture site and sealing of the
puncture.
[0008] Another aspect of the invention provides a method of closing
a hole in a vessel wall. The method may include inserting an
inflatable device through an introducer that is disposed in the
vessel, inflating the inflatable device, sealing the inflatable
device against an inner wall of the vessel, reducing the pressure
inside of the introducer, injecting a sealant into the introducer,
deflating the inflatable device, and removing the inflatable device
through the sealant. Following removal of the inflatable device,
manual pressure may be applied to the hole for a short period of
time to ensure continued hemostasis. According to some aspects of
the invention, a specially designed introducer is swapped with a
standard introducer used to facilitate insertion of vascular tools
used to perform a vascular procedure prior to inserting the
inflatable device.
[0009] The foregoing and other features, utilities and advantages
of the invention will be apparent from the following more
particular description of preferred embodiments of the invention as
illustrated in the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The accompanying drawings illustrate various embodiments of
the present invention and are a part of the specification. The
illustrated embodiments are merely examples of the present
invention and do not limit the scope of the invention.
[0011] FIG. 1 is an exploded assembly view of an introducer sheath
and an associated balloon catheter according to one embodiment of
the present invention.
[0012] FIG. 2 is a perspective view of the balloon catheter
inserted into the introducer sheath.
[0013] FIG. 3 is a sectional side elevation view of a patient with
the introducer sheath of FIG. 1 in place within an arteriotomy and
the associated balloon catheter extending through the introducer
sheath and into a blood vessel according to one embodiment of the
present invention.
[0014] FIG. 4 is a sectional side elevation view of the patient,
introducer sheath, and balloon catheter of FIG. 3 with a balloon of
the balloon catheter inflated and sealing the arteriotomy.
[0015] FIG. 5 is a sectional side elevation view of the patient,
introducer sheath, and balloon catheter of FIG. 4 shown with the
introducer sheath connected to a vacuum apparatus according to one
embodiment of the present invention.
[0016] FIG. 6 is a sectional side elevation view of the patient,
introducer sheath, and balloon catheter of FIG. 5 shown with the
introducer sheath connected to a sealant injector according to one
embodiment of the present invention.
[0017] FIG. 7 a sectional side elevation view of the patient,
introducer sheath, and balloon catheter of FIG. 6 with the balloon
deflated and being withdrawn through the sealant according to one
embodiment of the present invention.
[0018] FIG. 8 is a sectional side elevation view of the patient
following retraction of the introducer sheath and balloon catheter
from the situs of the arteriotomy.
[0019] Throughout the drawings, identical reference numbers
designate similar, but not necessarily identical, elements.
DETAILED DESCRIPTION
[0020] As mentioned above, vascular procedures are commonly
performed throughout the world and require access to a blood vessel
through a puncture or opening in the vessel. Often an introducer
sheath is placed in the opening to facilitate access to the vessel
by one or more vascular instruments, including puncture closure
devices. Proper location of an artery or other lumen is typically
indicated by a flow of blood through the lumen into the introducer
sheath or other instrument as the instrument enters the vessel. The
present invention describes methods and apparatus for sealing the
vessel opening or arteriotomy following completion of a vascular
procedure. The methods and apparatus may also be used, however, to
close punctures caused by accidents or other injuries, and are not
limited to use following a vascular procedure. The principles
described herein may be used to close internal tissue punctures of
any kind in any live body. Therefore, while the description below
is directed primarily to closing arteriotomys, the methods and
apparatus may be used according to principles described herein with
any bodily lumen to close a hole or puncture.
[0021] As used throughout the claims and specification, the term
"sealant" is used broadly to encompass any fluid, foam, or gel that
does not require a biochemical reaction with bodily fluids to set
or cure for sealing purposes. The term "fluid" refers to molecules
of a substance that move freely past one another and have the
tendency to assume the shape of its container, including liquids,
foams, gels, and gasses. A "lumen" refers to any open space or
cavity in a bodily organ, especially in a blood vessel, or a fluid
passageway through a vascular device. "Aspirate" or "aspirating"
means to remove fluids with a suction device. The term "vacuum"
means lower pressure than local atmospheric pressure or a device
that creates a lower pressure. The words "having" and "including"
have the same meaning as the word "comprising."
[0022] Referring now to the drawings, and in particular to FIG. 1,
an internal tissue puncture sealing apparatus 100 according to one
embodiment of the present invention is shown. As shown in FIG. 1,
the internal tissue puncture sealing apparatus 100 includes a first
thin, elongated conduit. According to FIG. 1, the first thin,
elongated conduit is a balloon catheter 102 and includes a first
central lumen 104 and first and second ends 106, 108, respectively.
The first end 106 includes an inflation segment 112. According to
FIG. 1, the inflation segment 112 comprises an expandable member
such as a balloon 114 that is in fluid communication with the
central lumen 104. Therefore, the balloon 114 is selectively
inflatable with a fluid via the central lumen 104. The balloon 114
may be inflated by increasing the pressure of the fluid inside the
central lumen 104. For example, the second end 108 of the balloon
catheter includes a syringe 116 that may be depressed to inflate
the balloon 114 with saline solution. Downstream of the syringe 116
is a valve 118 that selectively isolates the central lumen 104 from
the syringe 116. Accordingly, when the valve 118 is open, the
syringe 116 may be depressed, resulting in expansion or inflation
of the balloon 114. Further, following inflation, the valve 118 may
be closed, maintaining the expansion of the balloon 114. When
uninflated as shown in FIG. 1, the balloon 114 is coaxial and
substantially flush with the central lumen 104.
[0023] The internal tissue puncture sealing apparatus 100 also
includes a second thin, elongated conduit. According to FIG. 1, the
second thin, elongated conduit comprises an introducer assembly or
sheath 120. The introducer sheath 120 has a second central lumen
122 that is receptive of the balloon catheter 102.
[0024] The introducer sheath 120 also has a distal end 124 and a
proximal end 126. The proximal end 126 includes at least one
side-port 128 extending into the second central lumen 122.
According to FIG. 1, the side-port 128 is in fluid communication
with an external valve 130. The external valve 130 branches to a
vacuum port 132 and a sealant injection port 134. However,
according to some embodiments the vacuum port 132 and sealant
injection port 134 are one and the same, and thus there may be no
branching.
[0025] As shown in FIG. 1, the vacuum port 132 is in fluid
communication with a vacuum source or other evacuator, for example
a vacuum syringe 136. Similarly, the sealant injection port 134 is
in fluid communication with a sealant supply, such as a
sealant-containing syringe 138. Therefore, the external valve 130
may comprise a translucent three-way valve positionable between a
first or closed position isolating both the vacuum port 132 and the
sealant injection port 134 from the second central lumen 122, a
second position opening a fluid communication path between the
second central lumen 122 and the vacuum port 132, and a third
position opening a fluid communication path between the second
central lumen 122 and the sealant injection port 134. Details of
the external valve 130 and the associated vacuum port 132 and
sealant injection port 134 are shown in FIGS. 3-7.
[0026] The balloon catheter 102 may be inserted into the introducer
sheath 120 as shown in FIG. 2. When the balloon catheter 102 is
inserted into the introducer sheath 120, an annulus 142 is created
between the balloon catheter 102 and the introducer sheath 120. The
side-port 128 is thus in fluid communication with the annulus
142.
[0027] A stopper sleeve or spacer 140 is shown disposed over the
balloon catheter 102 to limit the insertion distance of the balloon
catheter into the introducer sheath 120. The length of the spacer
140 is chosen such that the first end 106 of the balloon catheter
102 extends beyond the distal end 124 of the introducer sheath 120
by a predetermined distance. According to some embodiments, the
predetermined distances is approximately 2.5-4.0 cm. The
predetermined distance allows for the balloon 114 of the inflation
segment 112 to pass into a vessel as discussed in more detail
below. The spacer 140 may comprise a split tube that can be easily
removed as desired.
[0028] Methods of closing a hole or puncture such as an arteriotomy
144 using the internal tissues puncture sealing apparatus 100 are
next discussed with reference to FIGS. 3-8. Referring first to FIG.
3, the tissue puncture sealing apparatus 100 is shown with the
introducer sheath 120 inserted into the arteriotomy 144. Although
FIG. 3 shows the introducer sheath 120 passing through an incision
tract 146 leading to the arteriotomy 144, according to some methods
the introducer sheath 120 may be swapped with a standard introducer
that may have been used to perform a vascular procedure.
Preferrably, however, the introducer sheath 120 is used both for
introducing instruments used to perform a vascular procedure and
for closing the arteriotomy 144.
[0029] With the introducer sheath 120 inserted into the
arteriotomy, the balloon catheter 102 is introduced through the
second central lumen 122 until the first or distal end 106 of the
balloon catheter 102, including the inflation segment 112, extends
beyond the distal tip 124 of the introducer sheath 120 and into a
blood vessel 148. The balloon 114 is in fluid communication with
the first central lumen 104. Therefore, opening the catheter valve
118 (FIG. 2) and depressing the syringe 116 (FIG. 2) inflates the
balloon 114 of the inflation segment 112 as shown in FIG. 4. To
maintain the balloon 114 in an inflated posture, the catheter valve
118 may be closed. The balloon catheter 102 and the introducer
sheath 120 are retracted until the balloon 114 bears against an
inner wall 150 of the blood vessel 148 and seals the internal
portion of the arteriotomy 144 as shown in FIG. 4.
[0030] With the balloon 114 in place internally sealing the
arteriotomy 144, the side-port valve 130 is opened to allow fluid
communication between the annulus 142 and the vacuum syringe 136 as
shown in FIG. 5. A vacuum is created in the annulus 142 by a
withdrawing a stem 152 of the vacuum syringe 136 or by some other
vacuum device. As the vacuum is created in the annulus 142 and
communicated to the incision tract 146, a situs 154 of the
arteriotomy 144 and is aspirated, removing fluids from the incision
tract 146 via the annulus 142.
[0031] As the arteriotomy 144 is aspirated, a surgeon or other
medical professional may visually inspect the fluid contents
evacuated through the translucent valve 130 to assess blood flow
through the arteriotomy and thereby ensure proper positioning of
the introducer sheath 120 and/or the balloon 114 within the blood
vessel 148. A flow of blood may indicate that the balloon 114 is
not properly sealing the arteriotomy 144.
[0032] When the surgeon is satisfied with the positioning of the
introducer sheath 120 and the balloon 114, the side-port valve 130
is toggled to create a fluid communication path between the annulus
142 and the sealant contained by the sealant-containing syringe 138
or other sealant supply as shown in FIG. 6. The sealant-containing
syringe 138 holds a volume of sealant that is injected into the
introducer sheath 120 via the side-port 128 as a stem 156 is
depressed. As shown in FIGS. 5 and 6, the side-port 128 provides a
single, common access point for supplying the sealant and vacuum
condition to the annulus 142. The sealant flows through the annulus
142 and into the incision tract 146. Further, because the incision
tract 146 has been evacuated and is in a vacuum condition, the
sealant is drawn through the annulus 142 toward the arteriotomy
144. The vacuum condition of the situs 154 external to the
arteriotomy 144 causes the sealant to quickly and efficiently fill
all of the voids around the arteriotomy 144 and in the incision
tract 146. Preferably, the sealing-containing syringe 138 holds a
volume of sealant sufficient to fill the annulus 142 and therefore
the incision tract 146. As the sealant is injected, the sheath 120
is preferably withdrawn with respect to the balloon 114 to allow
the sealant to fill the incision tract 146. Therefore, in order to
facilitate retraction of the sheath 120, the spacer 140 (FIG. 2) is
removed.
[0033] Following injection of the sealant, the sealant may be
optionally activated, cured, or set. The sealant may comprise a gel
or foam made of materials including, but not limited to: collagen,
polyvinyl alcohol, polyethylene glycol, cyanoacrylates, chitosan,
poly-n-acetyl glucosamine. Unlike the materials used in previous
devices, none of the materials recited herein is dependent on a
biochemical reaction with blood or other bodily fluids to create a
hemostatic seal. However, the gels or foams used according to some
aspects of the present invention may in some cases be activated or
cured by, for example, application of a second fluid, UV light, or
other activation mechanisms.
[0034] When the sealant is in place adjacent the exterior of the
arteriotomy 144, the balloon 114 is deflated as shown in FIG. 7.
The balloon 114 is deflated by reopening the catheter valve 118
(FIG. 2). The stem 158 (FIG. 2) of the catheter syringe 116 (FIG.
2) may be retracted to ensure full deflation of the balloon 114.
The balloon catheter 102 and the introducer sheath 120 are
retracted, with the balloon 114 sliding through the sealant and in
contact with the sealant while at least a portion of the sealant
remains positioned in and in contact with the introducer sheath 120
as shown in FIG. 7. According to some embodiments, following
removal of the balloon catheter and the introducer sheath 120,
manual pressure may be applied to the arteriotomy site to
counteract any sealing action disruption caused by the act of
pulling the balloon 114 through the sealant. However, the manual
pressure is applied for only a fraction of the time allocated to
traditional arteriotomy closures. For example, according the
principles described herein, manual pressure may be applied
following retraction of the internal tissue puncture sealing
apparatus 100 for only ten minutes or less. The sealant remains in
the incision tract 146 sealing the arteriotomy 144 as shown in FIG.
8.
[0035] While the invention has been particularly shown and
described with reference to embodiments thereof, it will be
understood by those skilled in the art that various other changes
in the form and details may be made without departing from the
scope of the invention.
* * * * *