Note: Descriptions are shown in the official language in which they were submitted.
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SYSTEM OF MEDICAL DEVICES AND METHOD FOR PERICARDIAL PUNCTURE
FIELD:
[0001]This document relates to medical devices. More specifically, this
document relates
to systems of medical devices that can be used in pericardial puncture, and
related
methods.
SUMMARY:
[0002]The following summary is intended to introduce the reader to various
aspects of
the detailed description, but not to define or delimit any invention.
[0003]Systems of medical devices are disclosed. According to some aspects, a
system
of medical devices includes a puncture device extending from a puncture device
proximal
end to a puncture device distal end. The puncture device includes a puncturing
tip at the
puncture device distal end. The system further includes an introducer
extending from an
introducer proximal end to an introducer distal end. The introducer has a
lumen extending
therethrough from the introducer proximal end to the introducer distal end.
The puncture
device is advanceable through the lumen from the introducer proximal end
towards the
introducer distal end to position the puncturing tip proud of the introducer
distal end. The
puncture device is engageable with the introducer to limit advancement of the
puncturing
tip out of the introducer distal end beyond a predetermined distance.
[0004] In some examples, the puncture device includes a first catch, the
introducer
includes a second catch, and the first catch is engageable with the second
catch to limit
advancement of the puncturing tip out of the introducer distal end beyond the
predetermined distance.
[0005]In some examples, the puncture device has a puncture device distal
portion
defining the puncture device distal end, and the first catch is in the
puncture device distal
portion. In some examples, the introducer has an introducer distal portion
defining the
introducer distal end, and the second catch is in the introducer distal
portion.
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[0006] In some examples, the puncture device is stepped to define a distally
facing
shoulder, and the first catch includes the distally facing shoulder. In some
examples, the
lumen is stepped to define a proximally facing internal edge, and the second
catch
includes the proximally facing internal edge. The distally facing shoulder can
abut the
proximally facing internal edge to limit advancement of the puncturing tip out
of the
introducer distal end beyond the predetermined distance.
[0007] In some examples, the predetermined distance is between about 1 mm and
about
3 mm.
[0008] In some examples, the puncture device distal end is sharpened to
provide the
puncturing tip.
[0009] In some examples, the introducer has an introducer length between the
introducer
proximal end and the introducer distal end, the puncture device has a puncture
device
length between the puncture device proximal end and the puncture device distal
end, and
the introducer length is less than the puncture device length.
[0010] In some examples, the introducer distal end is blunt.
[0011]In some examples, the introducer includes a metallic tube embedded in a
polymeric sheathing.
[0012] In some examples, at least one of the introducer and the puncture
device includes
a radiopaque marker.
[0013] Methods for pericardial puncture are also disclosed. According to some
aspects,
a method for pericardial puncture includes: a. positioning a distal end of an
introducer
adjacent a pericardium; b. advancing a puncturing tip of a puncture device out
of the
introducer to puncture the pericardium with the puncturing tip; and c.
engaging the
introducer with the puncture device to prevent advancement of the puncturing
tip out of
the introducer beyond a predetermined distance.
Date Recue/Date Received 2021-07-26
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[0014] In some examples, step c. includes engaging a first catch of the
puncture device
with a second catch of the introducer. Step c. can include abutting a shoulder
of the
puncture device with an edge of the introducer.
[0015] In some examples, the predetermined distance is between about 1 mm and
about
3 mm.
[0016]In some examples, step b. includes advancing a sharpened distal end of
the
puncture device out of the introducer.
[0017] In some examples, the method further includes, prior to step b.,
confirming the
position of the distal end of the introducer using fluoroscopy.
[0018] In some examples, the method further includes, after step c.,
withdrawing the
puncture device from the introducer.
[0019] BRIEF DESCRIPTION OF THE DRAWINGS:
[0020]The accompanying drawings are for illustrating examples of articles,
methods, and
apparatuses of the present disclosure and are not intended to be limiting. In
the drawings:
[0021] Figure 1 is a perspective view of an example system of medical devices;
[0022] Figure 2 is a perspective view of the puncture device of the system of
Figure 1;
[0023] Figure 3 is a cross-section taken along line 3-3 in Figure 2;
[0024] Figure 4 is a perspective view of the introducer of the system of
Figure 1;
[0025] Figure 5 is a cross-section taken along line 5-5 in Figure 4; and
[0026] Figure 6 is a cross-section taken along line 6-6 in Figure 1
DETAILED DESCRIPTION:
[0027]Various apparatuses or processes or compositions will be described below
to
provide an example of an embodiment of the claimed subject matter. No example
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described below limits any claim and any claim may cover processes or
apparatuses or
compositions that differ from those described below. The claims are not
limited to
apparatuses or processes or compositions having all of the features of any one
apparatus
or process or composition described below or to features common to multiple or
all of the
apparatuses or processes or compositions described below. It is possible that
an
apparatus or process or composition described below is not an embodiment of
any
exclusive right granted by issuance of this patent application. Any subject
matter
described below and for which an exclusive right is not granted by issuance of
this patent
application may be the subject matter of another protective instrument, for
example, a
continuing patent application, and the applicants, inventors or owners do not
intend to
abandon, disclaim or dedicate to the public any such subject matter by its
disclosure in
this document.
[0028]Generally disclosed herein is a system of medical devices that includes
an
introducer and a puncture device. The system can be used, for example, in
pericardial
puncture procedures. In such procedures, the introducer can be advanced
towards a
patient's heart, with the puncture device received in the introducer. When the
introducer
is in contact with the patient's heart, the puncture device can be advanced
out of the
introducer, in order to puncture the pericardium. The system disclosed herein
is
configured such that the extent to which the puncture device can be advanced
out of the
introducer is limited. For example, the puncture device can in some examples
be
advanced out of the introducer by only up to 3 mm. By limiting the extent to
which the
puncture device can be advanced out of the introducer, the risk of
inadvertently
puncturing tissues deeper within the heart, such as the epicardium, is
reduced. The
system disclosed herein can thus enhance ease of use and can enhance patient
safety
[0029] Referring now to Figure 1, an example system 100 of medical devices is
shown.
The system 100 generally includes a puncture device 102 and an introducer 104.
The
puncture device 102 is receivable in and advanceable through the introducer
104. The
introducer 104 can serve to atraumatically guide the puncture device 102
towards a target
location in a patient's body (e.g. the heart), and the puncture device 102 can
then
puncture the target location (e.g. puncture the pericardium).
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[0030] Referring now to Figures 2 and 3, the puncture device 102 extends along
a
longitudinal axis 106 and has a proximal portion 108 (also referred to herein
as a 'puncture
device proximal portion'), which defines a proximal end 110 (also referred to
herein as a
'puncture device proximal end'), and a distal portion 112 (also referred to
herein as a
'puncture device distal portion'), which defines a distal end 114 (also
referred to herein as
a 'puncture device distal end). The puncture device 102 has a length (also
referred to
herein as a 'length length') between the proximal end 110 and the distal end
114.
[0031 ] Referring still to Figures 2 and 3, the puncture device 102 includes a
shaft 116
(e.g. a stainless-steel shaft) and a hub 118. The hub 118 defines the puncture
device
proximal end 110, while the shaft 116 defines the puncture device distal end
114. The
hub 118 can be used to grasp and manipulate the puncture device 102.
[0032] Referring still to Figures 2 and 3, the puncture device 102 has a
puncturing tip 117
at the distal end 114. In the example shown, the puncture device 102 is a
mechanical
puncture device, and the distal end 114 is sharpened to provide the puncturing
tip 117.
For example, the distal end 114 can be conical (as shown), beveled, or
pyramidal. In
alternative examples, the puncture device can be a radiofrequency puncture
device, and
the puncturing tip can include a radiofrequency electrode.
[0033] Referring now to Figures 4 and 5, the introducer 104 extends along a
longitudinal
axis 120 and has a proximal portion 122 (also referred to herein as an
'introducer proximal
portion'), which defines a proximal end 124 (also referred to herein as an
'introducer
proximal end'), and a distal portion 126 (also referred to herein as an
'introducer distal
portion'), which defines a distal end 128 (also referred to herein as an
'introducer distal
end). The introducer 104 has a length (also referred to herein as an
'introducer length')
between the proximal end 124 and the distal end 128, and the introducer length
is less
than the puncture device length. A lumen 130 (shown in Figure 5) extends
through the
introducer 104 from the proximal end 124 to the distal end 128, for receiving
the puncture
device 102.
[0034] Referring still to Figures 4 and 5, in the example shown, the
introducer 104 includes
a shaft 132 (also referred to herein as an 'introducer shaft') and a hub 134
(also referred
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to herein as an 'introducer hub'). The hub 134 defines the introducer proximal
end 124
while the shaft 132 defines the introducer distal end 128. The hub 134 may
include various
features, such as fluid ports and hemostatic valves, etc. (not shown). As
shown in Figure
5, the shaft 132 includes a metallic tube 136 (e.g. a stainless steel
hypotube), and a
polymeric sheathing 138 (e.g. a high-density polyethylene sheathing) on the
tube 136. In
use, the hub 134 may be grasped and manipulated by the user, while the distal
portion
126 is directed to a target site within a patient's body (e.g. the heart). The
distal end 128
is blunt, to avoid damaging tissue in contact with the distal end 128.
[0035] Referring now to Figures 1 and 6, the puncture device 102 is
advanceable through
the lumen 130 (not labelled in Figure 6) of the introducer 104, from the
introducer proximal
end 124 towards the introducer distal end 128, to position the puncturing tip
117 proud of
the introducer distal end 128. When the introducer distal end 128 is in
contact with a
tissue (e.g. the pericardium), the puncturing tip 117 can be advanced proud of
the
introducer distal end 128 in order to puncture the tissue. However, it may be
desired to
advance the puncturing tip 117 proud of the introducer distal end 128 by only
a limited
distance, in order to avoid puncturing of deeper tissue (e.g. the epicardium).
Accordingly,
the introducer 104 and puncture device 102 are configured to engage to limit
advancement of the puncturing tip 117 out of the introducer distal end 128
beyond a
predetermined distance (e.g. a distance of up to 3 mm, or a distance of
between about 1
mm and about 3 mm). For example, the puncture device 102 can include a first
catch, the
introducer 104 can include a second catch, and the first catch can be
engageable with
the second catch to limit advancement of the puncturing tip 117 out of the
introducer distal
end 128 beyond a predetermined distance. More specifically, referring to
Figure 3, in the
example shown the shaft 116 of the puncture device 102 is stepped to define a
distally
facing shoulder 140 in the puncture device distal portion 112. The distally
facing shoulder
140 serves as a first catch. Furthermore, referring to Figure 5, the lumen 130
of the
introducer 104 is stepped to define a proximally facing internal edge 142 in
the introducer
distal portion 126. The proximally facing internal edge 142 serves as a second
catch. As
shown in Figure 6, as the puncture device 102 is advanced through the
introducer 104 to
position the puncturing tip 117 proud of the introducer distal end 128, the
distally facing
shoulder 140 abuts the proximally facing internal edge 142 to limit
advancement of the
Date Recue/Date Received 2021-07-26
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puncturing tip 117 out of the introducer distal end 128 beyond a predetermined
distance
D.
[0036] In any of the above examples, the introducer 104 and/or the puncture
device 102
can include one or more radiopaque markers (not shown), to facilitate viewing
of the
system 100 under fluoroscopy.
[0037] In one particular example of use, the introducer 104 can be
percutaneously
advanced towards a target location in a patient's body (e.g. towards the
pericardium via
the subxiphoid approach). The puncture device 102 can be advanced together
with the
introducer 104, with the puncture device 102 in the lumen 130 and with
puncturing tip 117
proud of the introducer distal end 128, so that the puncture device 102
facilitates piercing
of adipose tissue etc. (however, in alternative examples, the puncture device
102 may be
advanced after the introducer 104). The puncture device 102 and introducer 104
can be
advanced until the introducer 104 and puncture device 102 are proximate the
pericardium. The puncture device 102 can then be retracted slightly, so that
the
puncturing tip 117 is shy of or flush with the introducer distal end 128.
Advancement can
then continue until the introducer distal end 128 is positioned adjacent the
pericardium,
so that the introducer distal end 128 first contacts the pericardium.
Optionally, fluoroscopy
can be used to confirm the position of the distal end 128 of the introducer
104 and/or the
distal end 114 of the puncture device 102.
[0038] With the distal end 128 of the introducer 104 positioned adjacent the
pericardium,
the puncturing tip 117 of the puncture device 102 can be advanced out of the
introducer
104 to puncture the pericardium with the puncturing tip 117. As the puncturing
tip 117 is
advanced, the introducer 104 will engage with the puncture device 102, to
prevent
advancement of the puncturing tip 117 out of the introducer 104 beyond the
predetermined distance D (e.g. beyond up to 3 mm, or between about 1 mm and
about 3
mm). More specifically, the shoulder 140 of the puncture device 102 will abut
the edge
142 of the introducer 104, to prevent advancement of the puncturing tip 117
out of the
introducer 104 beyond the predetermined distance D.
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[0039]Abutting of the shoulder 140 of the puncture device 102 with the edge
142 of the
introducer 104 can provide tactile feedback to the user, to indicate that the
puncture
device 102 is fully advanced and the pericardium has been punctured. When the
pericardium has been punctured, the puncture device 102 can be withdrawn from
the
introducer 104, and a subsequent medical procedure can be carried out (e.g.
various
other medical devices (e.g. a guidewire and/or an ablation catheter) can be
advanced
through the introducer 104).
[0040] While the above description provides examples of one or more processes
or
apparatuses or compositions, it will be appreciated that other processes or
apparatuses
or compositions may be within the scope of the accompanying claims.
[0041]To the extent any amendments, characterizations, or other assertions
previously
made (in this or in any related patent applications or patents, including any
parent, sibling,
or child) with respect to any art, prior or otherwise, could be construed as a
disclaimer of
any subject matter supported by the present disclosure of this application,
Applicant
hereby rescinds and retracts such disclaimer. Applicant also respectfully
submits that any
prior art previously considered in any related patent applications or patents,
including any
parent, sibling, or child, may need to be re-visited.
Date Recue/Date Received 2021-07-26
