U.S. patent application number 16/336445 was filed with the patent office on 2021-11-11 for containers for medical devices.
This patent application is currently assigned to PneumRx, Inc.. The applicant listed for this patent is PneumRx, Inc.. Invention is credited to Jeffrey Etter, David Lehrberg, Mark Mathis, Verna Rodriguez.
Application Number | 20210346143 16/336445 |
Document ID | / |
Family ID | 1000005785013 |
Filed Date | 2021-11-11 |
United States Patent
Application |
20210346143 |
Kind Code |
A1 |
Lehrberg; David ; et
al. |
November 11, 2021 |
Containers for Medical Devices
Abstract
A container for a medical device having a housing defining a
cavity for receiving the device, a coupling zone external to the
cavity, and an exit aperture between the cavity and the coupling
zone; and a bearing surface located within the cavity, the bearing
surface, exit aperture and coupling zone defining an exit path
along which the device can be moved for deployment from the
container. The bearing surface is spaced from the exit aperture and
arranged, together with the coupling zone, such that the exit path
is substantially straight. The cavity is approximately cylindrical,
and the bearing surface, the exit aperture, and the coupling zone
are aligned such that the exit path extends in a direction that is
substantially tangential to the cavity. The housing comprises a two
part structure joined together in a plane substantially orthogonal
to the exit path. The housing defines a substantially unobstructed
cavity for receiving the device. The housing in the coupling zone
defines a slot through which the exit path extends, the slot
defining a restricted space for deployment of a capture device.
Inventors: |
Lehrberg; David; (Santa
Clara, CA) ; Mathis; Mark; (Santa Clara, CA) ;
Etter; Jeffrey; (Santa Clara, CA) ; Rodriguez;
Verna; (Santa Clara, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PneumRx, Inc. |
Santa Clara |
CA |
US |
|
|
Assignee: |
PneumRx, Inc.
Santa Clara
CA
|
Family ID: |
1000005785013 |
Appl. No.: |
16/336445 |
Filed: |
September 8, 2017 |
PCT Filed: |
September 8, 2017 |
PCT NO: |
PCT/IB2017/055431 |
371 Date: |
March 25, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62402730 |
Sep 30, 2016 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/0095 20130101;
A61B 17/12104 20130101; A61B 17/12145 20130101; B65D 11/08
20130101; B65D 85/04 20130101 |
International
Class: |
A61F 2/00 20060101
A61F002/00; B65D 85/04 20060101 B65D085/04; B65D 8/02 20060101
B65D008/02 |
Claims
1-27. (canceled)
28. A container for a medical device comprising an elongate body,
the container comprising: a housing defining a cavity for holding
the medical device in a first configuration, a conduit external to
the cavity, and an exit aperture between the cavity and the
conduit; and a guide element within the cavity comprising a
substantially planar element with a first planar surface and a
second opposing planar surface; wherein the conduit defines a
substantially straight pathway configured to allow the medical
device to exit the cavity through the exit aperture for deployment
from the container.
29. The container of claim 28, wherein when the medical device is
in the first configuration, a first portion of the medical device
is oriented within the cavity to face the first planar surface of
the substantially planar element and a second portion of the
medical device is oriented to face the second planar surface.
30. The container of claim 29, wherein the medical device further
comprises a rounded transition portion between the first portion of
the medical device and the second portion of the medical
device.
31. The container of claim 28, further comprising a coupling zone
configured to allow for an extraction of the medical device through
the conduit, wherein the conduit extends between the cavity and the
coupling zone.
32. The container of claim 31, wherein the conduit comprises a
substantially straight tube structure, the tube structure defining
the exit aperture, a cavity end of the tube structure being located
within the cavity, and a coupling end of the tube structure being
positioned at the coupling zone.
33. The container of claim 32, wherein the medical device is a lung
volume reduction coil (LVRC) having a proximal portion and a distal
portion and having a coiled manufactured shape and a substantially
straight delivery shape, wherein the housing comprises a housing
wall with an outer surface and an inner surface, the inner surface
defining the cavity such that the cavity is suitable for receiving
at least a distal portion of the LVRC in its manufactured shape,
the proximal portion of the LVRC extending through the exit
aperture and into the coupling zone in use such that a proximal end
of the LVRC is disposed in the coupling zone and accessible from
outside the housing; and wherein the guide element is adapted to
guide the LVRC through the exit aperture and the conduit as the
LVRC is extracted from the container, the guide element being
adapted to force the LVRC into the delivery shape as the proximal
end of the LVRC is withdrawn from the housing.
34. The container of claim 33, wherein the housing comprises an
outer chamber and an inner chamber, the exit aperture connecting
the outer chamber with the inner chamber, the inner chamber
comprising the cavity suitable for receiving the distal portion of
the LVRC, the outer chamber comprising the coupling zone, the outer
chamber having a second aperture suitable for receiving an opened
forceps such that the proximal end of the LVRC is accessible with
the opened forceps from outside the housing.
35. The container of claim 34, wherein the outer chamber comprises
a receiving tube for receiving the opened forceps, a distal end of
the receiving tube being contiguous with a rim surrounding the exit
aperture.
36. The container of claim 35, wherein the receiving tube is
configured to constrain the opened forceps so that so that the
opened forceps are forced into being centered on and aligned with
the proximal end of the LVRC.
37. The container of claim 36, wherein the receiving tube is
configured to constrain the opened forceps into only two possible
configurations, a first configuration of the opened forceps being a
180-degree rotation of a second configuration.
38. The container as of claim 37, wherein an inner wall of the
receiving tube encloses an oblong rectangular or oval lumen for
receiving the opened forceps in one of the two possible
configurations.
39. The container as of claim 37, wherein a lumen of the receiving
tube tapers smoothly from a broad diameter at a proximal end of the
receiving tube to a narrower diameter at the distal end of the
receiving tube.
40. The container of claim 33, wherein the first configuration of
the medical device comprises the distal portion of the LVRC in the
manufactured shape.
41. The container of claim 40, wherein the first configuration of
the medical device further comprises the proximal portion of the
LVRC being held in the delivery shape.
42. The container of claim 40, wherein the manufactured shape
comprises a circular or elliptical coil shape.
43. The container of claim 40, wherein the manufactured shape
comprises a U-shape.
44. The container of claim 43, wherein the substantially planar
element is oriented to be substantially perpendicular to a plane
defined by the U-shape.
45. The container of claim 43, wherein the substantially planar
element is oriented to be substantially parallel to a plane defined
by the U-shape.
46. The container of claim 33, further comprising a spool within
the housing, wherein the spool provides a bearing surface against
and around which the distal portion of the LVRC is configured to
pivot as the proximal end of the LVRC is withdrawn from the
housing.
47. The container of claim 46, wherein the spool is secured to a
corner of the guide element.
48. The container of claim 33, wherein a distal end of the
substantially planar element provides a pivot point against and
around which the distal portion of the LVRC is configured to pivot
as the proximal end of the LVRC is withdrawn from the housing.
Description
FIELD OF THE INVENTION
[0001] The invention relates to improved containers or shell
encasings for a medical device, such as an elongate implant that is
produced in a predetermined configuration. The invention aims to
provide the device with protection from physical damage, prevent
snagging of the device during withdrawal or deployment from the
container, provide the possibility of sterile handling, and provide
a convenient presentation for surgical use.
BACKGROUND OF THE INVENTION
[0002] Certain types of medical devices are provided in the form of
elongate implants that are deployed in the body and assume a
predetermined configuration so as to apply force to internal
tissues. One example of such devices is a lung volume reduction
coil (LVRC), for example a nitinol wire that is prepared in a
coiled configuration, stressed into a relatively straight delivery
configuration for delivery into the lung through a catheter, and
allowed to resume its compact coiled shape in the lung. Examples of
LRVCs and their therapeutic uses can be found in WO2007/106495 and
WO2010/030993.
[0003] It has been proposed to provide the LVRC in a rigid
container to protect the LVRC from handling and damage during
shipment, and to provide a relatively sterile packaging in which an
LVRC may be shipped unstrained in its original manufactured coiled
shape. Where such a container is used, it is necessary to be able
to couple the LRVC to a forceps-like device for withdrawing the
LRVC form the container into a delivery cartridge. The spring-like
nature of the LVRC can make grasping the end of the device, and
withdrawing it smoothly from the container difficult in certain
cases.
[0004] It is against this background that the present invention has
been made. Accordingly, improved containers or shell encasings for
medical devices, and particularly LVRC are desired.
SUMMARY
[0005] The various aspects of the invention relate to improved
containers or shell encasings for a medical device, such as lung
volume reducing implants (e g, coils). The container comprises a
housing defining a cavity for receiving the device, a coupling zone
external to the cavity, and an exit aperture between the cavity and
the coupling zone; and a bearing surface located within the cavity,
the bearing surface, exit aperture and coupling zone defining an
exit path along which the device can be moved for deployment from
the container.
[0006] In a first aspect of the invention, the bearing surface is
spaced from the exit aperture and arranged, together with the
coupling zone, such that the exit path is substantially
straight.
[0007] In a second aspect of the invention, the cavity is
approximately cylindrical, and the bearing surface, the exit
aperture, and the coupling zone are aligned such that the exit path
extends in a direction that is substantially tangential to the
cavity.
[0008] In a third aspect of the invention, the housing comprises a
two part structure joined together in a plane substantially
orthogonal to the exit path.
[0009] In a fourth aspect of the invention, the housing defines a
substantially unobstructed cavity for receiving the device.
[0010] In a fifth aspect of the invention, the housing in the
coupling zone defines a slot through which the exit path extends,
the slot defining a restricted space for deployment of a capture
device.
[0011] Embodiments of the invention comprise combinations of one or
more of the first to fifth aspects of the invention.
[0012] The housing can comprise a substantially straight tube
structure extending between the cavity and the coupling zone, the
tube structure defining the exit aperture, a cavity end of the tube
structure being located within the cavity and providing the bearing
surface, and a coupling end being positioned at the coupling zone.
In this case, the cavity can extend into a region intermediate the
cavity end and coupling end of the tube structure.
[0013] The housing can comprise a substantially straight tube
structure extending in a substantially tangential direction between
the cavity and the coupling zone, the tube structure defining the
exit aperture, a cavity end of the tube structure being located
within the cavity and providing the bearing surface, and a coupling
end being positioned at the coupling zone. In this case, the cavity
can extend into a region intermediate the cavity end and coupling
end of the tube structure.
[0014] The housing can comprise a body part and a cap part, wherein
the aperture defined when the cap part is separated from the body
part provides an inlet opening though which a device can be loaded
into the cavity for withdrawal through the exit aperture.
[0015] When the housing in the coupling zone defines a slot through
which the exit path extends, the slot defining a restricted space
for deployment of a capture device, the housing on the side of the
slot opposite to the cavity can define a substantially circular
section tubular structure, and a transition section between the
tubular structure and the slot is provided with smoothly sloping
surfaces inner surfaces for directing a capture device so as to be
aligned with the slot as it introduced into the coupling zone.
[0016] A further aspect of the invention comprises a container
according to any of the preceding aspects, further containing a
lung volume reduction coil (LVRC) having a proximal portion and a
distal portion and having a coiled manufactured shape and a
substantially straight delivery shape, wherein the LVRC is in its
coiled manufactured shape and the proximal portion lies in the exit
path with a proximal end in the coupling zone.
[0017] The invention also comprises the use of a container
according to any of the preceding claims for dispensing a lung
volume reduction coil.
[0018] In one particular aspect, the invention comprises a housing
for dispensing a lung volume reduction coil (LVRC), comprising a
housing wall with an outer surface and an inner surface, the inner
surface defining a cavity suitable for receiving the distal portion
of the LVRC in its manufactured shape, the wall having an aperture
extending therethrough from the inner surface of the wall to the
outer surface of the wall, through which the LVRC may be withdrawn,
the proximal end of the LVRC extending through the aperture in use
such that the proximal end of the LVRC is accessible from outside
the housing; and a guide element having an elongate body with a
length defined by a proximal end and a distal end, and a guiding
surface along its length, the guiding surface adapted to guide the
LVRC between the distal end of the elongate body of the guide
element and the aperture; the elongate body extending from a
proximal end adjacent the aperture, projecting from the inner
surface of the wall adjacent the aperture into the cavity and
terminating in a distal end, the guide element being adapted to
tension the LVRC into a straightened form as the proximal end of
the LVRC is withdrawn from the housing.
[0019] The guide element may define a guide path that directs the
LVRC to the aperture. Preferably, the housing comprises an outer
chamber and an inner chamber, the aperture being shared between and
connecting the outer chamber with the inner chamber, the inner
chamber comprising the cavity suitable for enclosing the distal end
of the LVRC, the outer chamber suitable for receiving the proximal
end of the LVRC, the outer chamber having a larger second aperture
suitable for receiving open forceps such that the proximal end of
the LVRC is accessible with forceps from outside the housing.
Although the outer chamber is not necessary, the two-chambered
housing is preferable because the outer chamber protects the
proximal portion of the LVRC, thus minimizing handling of the LVRC
and maintaining relative sterility, while still permitting access
to the LVRC with forceps.
[0020] The housing or the outer chamber of the housing may comprise
a receiving tube for receiving the open forceps, the distal end of
the inner surface of which is contiguous with the rim surrounding
the aperture.
[0021] The guiding surface may be planar or the guiding surface may
be concave and contiguous with the rim surrounding the aperture.
The guide element may be a tube with an inner surface, outer
surface and a lumen, the inner surface of the tube being concave
and providing the guiding surface.
[0022] The guide element may function both to keep the distal end
of the LVRC away from the aperture as the proximal end is guided
through the aperture, and also to serve as a pivot point around
which the curved distal portion of the LVRC will pivot as it is
straightened. Depending on the nature and orientation of the guide
element and particularly if the guide element may also serve as a
pivot for the distal portion of the LVRC, the housing may contain a
spool or may be spoolless.
[0023] Preferably, the receiving tube is configured to constrain
opened forceps of a delivery device into only two possible
orientations/configurations, the first configuration of the forceps
being a 180 degree rotation of the second configuration, so that
the opened forceps are forced into being centered on and aligned
with a ball at the proximal end of the LVRC. Optionally, the inner
wall of the receiving tube encloses a lumen which is oblong
rectangular or oval in cross-section for receiving the open forceps
in one of the two configurations.
[0024] The housing may be formed of two sections, each section
having a rim, and wherein the rims of the sections do not intersect
the rim of the aperture in the housing through which the LVRC may
be withdrawn. The rims of the sections may be fitted together in an
interference fit.
[0025] In a yet further aspect of the invention, in a method of
dispensing a lung volume reduction coil, the LVRC may be further
tensioned into a straightened form by a receiving tube as the
proximal end is withdrawn from the housing, wherein the receiving
tube is for receiving open forceps, the distal end of the inner
surface of which is contiguous with the rim surrounding the
aperture. The LVRC may also be further tensioned into a
straightened form by a loading cartridge prior to delivery into the
delivery catheter, or may be further tensioned to be delivered from
the housing directly to the delivery catheter without first being
tensioned into a straightened form by a loading cartridge.
[0026] Various changes may be made within the scope of the various
aspects of the invention as defined by the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] FIG. 1 shows a lung volume reduction coil (LVRC);
[0028] FIG. 2 shows a cutaway view of a delivery cartridge
system;
[0029] FIG. 3 shows the delivery of an LVRC to a patient's
airway;
[0030] FIGS. 4 a-c show a housing for dispensing an LVRC;
[0031] FIG. 5 shows a partial view of the device of FIGS. 4 a-c
with the distal ball of the LVRC becoming caught and stuck on the
inner surface of the wall of the housing;
[0032] FIG. 6 shows tangling of an LVRC in the device of FIGS. 4
a-c on the side of the spool proximal to the user;
[0033] FIGS. 7 a-b show sticking of an LVRC in the device of FIGS.
4 a-c between rims of sections of the housing;
[0034] FIG. 8 shows the proximal end of an LVRC in the device of
FIGS. 4 a-c in the receiving area of the housing;
[0035] FIGS. 9 a-b show an embodiment of the container of the
present invention;
[0036] FIG. 10 shows a cutaway close-up view of the guide element
of the container of FIGS. 9 a-b;
[0037] FIGS. 11 a-b show cutaway close-up views of alternative
embodiments of the invention;
[0038] FIG. 12 shows an embodiment comprising a two part
construction for a container the of the invention; and
[0039] FIGS. 13 a-c show the proximal end of an LVRC in the
coupling zone of an embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0040] FIG. 1 shows a lung volume reduction coil (LVRC). For
patients with severe emphysema, treatment with LVRCs is designed to
help improve exercise capacity, lung function and quality of life.
The LVRC 10 comprises a preformed shape memory coil of a metal such
as nitinol, with atraumatic ends 11, typically in the form of ball
structures. The preformed shape of the LVRC can be a coil, a
baseball seam shape, a saddle-shape, a U-shape having the base of
the U curved about an axis parallel to the plane of the U and
perpendicular to the axis of the U, a shape that is pre-programmed
so that its distal portion approximately circumscribes the volume
of a sphere, or (using knot tying terms, see The Ashley Book of
Knots, Faber & Faber, 1.sup.st published 1944, reprinted with
amendments 1993, p 13) a shape comprising a closed loop with the
central bight 12 looped back so as to lie over the legs 14, 16. Any
of these shapes can be used as an alternative to any particular
shape mentioned in this document, unless otherwise indicated.
[0041] The LVRC is delivered to a patient's lung in a straightened
form using a catheter procedure (FIG. 3). Subsequent recovery of
the device to its original manufactured shape when the device is in
contact with the inner wall surrounding the lumen of a patient's
airway supplies force that urges the patient's airway into a bent,
folded or rolled configuration. This effectively shortens the
airway structure within the lung. Since the airways are well
anchored into lung tissue, the shortened airway provides tension on
the surrounding lung tissue. The bending, folding and rolling of
the airways resulting from the implantation of LVRCs rolls up
diseased tissue and reduces air trapping; the volume of diseased
tissue in the lung is thus reduced. By compressing the lung tissue,
implantation of one or more LVRCs can result in an increase in
elastic recoil and tension in the lung. Additionally, in some
instances, lung function can be at least partially restored
regardless of the amount of collateral ventilation. Further, the
patient's diaphragm may, in some instances, move up once greater
tension is created, which enables the lung cavity to operate more
effectively. The implantation of LVRCs is described in further
detail in WO2007/106495 and WO2010/030993.
[0042] PneumRx, Inc. (Santa Clara, Calif., USA, a BTG international
group company) presently manufactures nitinol LVRCs and ships them
in their unstrained, original manufactured shape. During
preparation for implant, the LVRCs are typically reshaped into a
delivery configuration by a cartridge that straightens the LVRC,
prior to the LVRC being drawn into a bronchoscope or a catheter for
delivery into a patient's lung in a straightened form. Such a
cartridge 18 containing an LVRC 10 is shown in FIG. 2. PneumRx.TM.
LVRCs are not shipped in a straightened form, because of the risk
of reprogramming a straightened LVRC if it is exposed to heat, i.e.
temperatures in excess of approximately 100.degree. C. During
manufacture, the nitinol shape memory LVRCs are programmed into
their manufactured shape through a heat treating process, which
results in coils of a specified strength, the strength being
dependent on the manner in which the LVRC is heat processed. In the
austenite phase, the nitinol metal recovers to its preprogrammed
shape. The temperature at which the nitinol has fully recovered is
known as the A.sub.f temperature (austenite final), and typically
the strength of a given coil is expressed in terms of its A.sub.f
temperature.
[0043] PneumRx.TM. LVRCs are typically produced with an A.sub.f
lower than both room and body temperature, so that they are elastic
at both room and body temperature and perform as springs at these
temperatures. In the straightened or strained form the austenite to
martensite phase transition occurs at a much lower temperature than
would otherwise occur if the LVRC is unstrained. Were the LVRCs to
be shipped in their strained or straightened form, care would need
to be taken to ensure that the coils were not heated to
temperatures in excess of approximately 100.degree. C. so as to
prevent their reprogramming and possible loss of functionality. (In
the case of unstrained LVRCs, the temperature is much higher at
around 300.degree. C.) Thus, if LVRCs were to be shipped in their
straightened form, their packaging would need to indicate that
temperatures in excess of approximately 100.degree. C. had not been
reached. Manufacturing such packaging would require additional
validation and expense.
[0044] PneumRx.TM. LVRCs are typically e-beam sterilized prior to
shipment, and although patients are typically receiving
prophylactic antibiotics, it is preferable to minimize handling to
maintain the relative sterility of the LVRCs prior to and during
their implantation, particularly since severe emphysema patients
may also be immunocompromised. Presently each LVRC is shipped in a
container functioning to maintain the relative sterility of the
LVRC and to protect the LVRC from handling and damage during
shipment.
[0045] The present invention relates to improvements to containers
for the LVRC. The container 42 shown in FIGS. 4 a-c, comprises a
housing wall 46 with an outer surface and an inner surface, the
inner surface defining a cavity 48 suitable for enclosing the LVRC
10 in its manufactured shape. The housing further comprises a spool
50 for receiving and holding the preformed curved distal end 52 of
the LVRC. This spool provides a bearing surface against and around
which the preformed curved distal end pivots as the coil is
withdrawn; this provides the necessary tension to straighten the
coil so that the coil may be withdrawn through an aperture in the
housing. The housing further comprises an exit aperture 54
extending through the housing wall through which the LVRC may be
withdrawn, the proximal end 56 of the LVRC extending through the
aperture in use such that the proximal end is accessible from
outside the housing. The housing further comprises a housing wall
with an inner and outer surface surrounding a bell-shaped receiving
area 58 for receiving the forceps used to withdraw the LVRC, the
bell-shaped receiving area being roughly spherical 60 in the area
adjacent the aperture outside the enclosed cavity, and opening into
a frustoconical void 62 at a wider end that is more distant to the
aperture. In use, the forceps may be inserted into the void for
withdrawal of the proximal end of the LVRC. The housing wall
surrounding the receiving area protects the LVRC while enabling
access to and withdrawal of the proximal end of the LVRC from the
housing through the void in the receiving area. In other words, the
housing comprises an outer chamber and an inner chamber, the
aperture being shared between and connecting the outer chamber with
the inner chamber, the inner chamber comprising the cavity suitable
for enclosing the distal end of the LVRC, the outer chamber
suitable for receiving the proximal end of the LVRC, the outer
chamber having a larger second aperture suitable for receiving open
forceps such that the proximal end of the LVRC is accessible with
forceps from outside the housing.
[0046] Several shortcomings of the container shown in FIGS. 4 a-c
involve difficulties faced as a user is withdrawing the LVRC from
the housing using forceps. The LVRC may stick or tangle in the
housing in various ways as the coil is withdrawn from the housing
or the user may have difficulty grasping the proximal end of the
LVRC with the forceps within the void in the receiving area. In
addition, the housing includes a central spool around which the
LVRC is wrapped when loaded into the housing. The LVRC will bear
against this spool, as well as the inside wall of the housing as it
is withdrawn from the container, the friction arising from this
contact impeding smooth withdrawal of the LVRC from the
container.
[0047] The proximal and distal ends of the LVRC have balls 11
positioned thereon. When a user withdraws the LVRC through the
aperture 54 in the housing, due to the stiffness of the LVRC, in
some instances instead of moving freely around the inner surface of
the housing wall, the distal ball of the LVRC may become caught and
stuck on the inner surface 64 of the wall of the housing adjacent
the aperture as shown in FIG. 5. This may result in kinking of the
LVRC. The LVRC generally recoils with a snapping motion and the
distal end eventually exits the aperture as the user continues to
pull the proximal end with the forceps, but there is increased
difficulty for the user to withdraw the LVRC from the housing and
the user must apply a greater amount of force than if the movement
of the LVRC were more smooth.
[0048] Additionally, LVRCs come in several sizes for use in the
bronchoscopic procedure. WO2010/030993 relates to selection of an
LVRC from a plurality of alternatively selectable LVRCs, wherein
the length of the elongate body of the LVRC varies between the
LVRCs. This is accomplished using an indexed guidewire extendable
distally along the delivery catheter suitable for selecting an LVRC
of appropriate length for implantation. When a relatively large
guidewire is used (typically being over 5 Fr, such as a 51/2 Fr
guidewire), the cross-section of the guidewire may limit
advancement to a region of the airway having a lumen size
appropriate for receiving the LVRC. To select an LVRC of
appropriate length, the radiopaque indices on the guidewire are
counted using fluoroscopy or remote imaging to measure the length
of guidewire between the distal end of the guidewire and the distal
end of the broncoscope or catheter. Usually in a procedure, one
individual in a surgical team measures a patient's airway while
another technician selects an LVRC of appropriate length and
prepares it for implantation by using forceps to draw the LVRC into
a cartridge for straightening. The technician typically hands the
forceps/coil/cartridge system to the physician--the Luer lock on
the cartridge is fitted to that on the catheter, and then the
straightened coil is pushed out into the catheter for delivery--the
catheter at this point is already in the patients lung, guidewire
has been removed after the airway has been measured. Each LVRC, if
or when selected, can be loaded into the catheter by straightening
the associated elongate body toward the axis and inserting the
elongate body into the lumen so that the catheter maintains the
elongate body in the delivery configuration. Occasionally, the
measurement of the patient's airway is different than expected, an
inappropriate LVRC is chosen to be drawn from the housing into a
cartridge prematurely, or the physician changes his or her mind
regarding which length of LVRC to use. With the housing of FIGS. 4
a-c, if an LVRC is partially withdrawn from the aperture beyond a
certain point and then released, the LVRC will fail to pass over
the spool and recover its shape in front of the spool. The LVRC may
then no longer be usable, as it will be difficult to adequately
tension the LVRC for efficient withdrawal of the LVRC from the
housing for straightening in the cartridge and catheter. This is
shown in FIG. 6.
[0049] The container of FIGS. 4 a-c is made from two injection
molded halves of polycarbonate plastic, one of which is shown in
FIG. 4c. The external surface of the housing, the internal surface
of which forms the spool portion 50, contains threading for a screw
such that a screw may be used to hold the halves together;
additionally locating dowels 70 and bores 72 are provided in the
matching surfaces of the two halves, which fit together to keep the
halves held stably in position. However, occasionally as the LVRC
is withdrawn through the aperture 54 between the inner and outer
chambers, the LVRC may become stuck in the joint 74 between the
halves of the housing, as is shown in FIGS. 7 a-b. Also, the fact
that the proximal end of the LVRC exits the cavity at an angle and
so must be bent around the edge of the exit aperture for it to be
withdrawn in the correct direction for loading into the cartridge
means that the LVRC tends to be dragged into the joint.
[0050] The container of FIGS. 4 a-c comprises an inner chamber and
an outer chamber with an exit aperture connecting the inner chamber
with the outer chamber. The inner chamber of the housing comprises
the cavity suitable for enclosing the distal end of the LVRC, the
outer chamber is suitable for receiving the proximal end of the
LVRC. The outer chamber has a larger second aperture suitable for
receiving open forceps such that the proximal end of the LVRC is
accessible with forceps from outside the housing. In the container
of FIGS. 4 a-c, the outer chamber defines an exit path comprising a
bell-shaped receiving or coupling area for receiving the forceps
80, the bell-shaped receiving zone 58 being roughly spherical in
shape 60 and opening into a wider, second region having a
substantially frustoconical section 62, as shown in FIG. 8. In use,
the receiving/coupling zone and the second region are relatively
large compared to the ball 11 at the proximal end 56 of the LVRC,
and it may take a technician or physician several attempts to grasp
the ball at the proximal end of the LVRC with forceps.
[0051] FIG. 1 shows an LVRC 10 suitable for use with the containers
of the invention. The LVRC is shown in its manufactured, coiled
shape. The LVRC comprises a shape memory nitinol wire with balls 11
positioned thereon to form the proximal and distal atraumatic ends
of the LVRC device. In its manufactured shape, the shape memory
nitinol wire is preprogrammed so that its distal portion roughly
circumscribes the volume of a sphere; in use after implantation the
distal portion of the LVRC gathers and rolls up diseased lung
tissue into a roughly spherical volume. The preprogrammed shape of
the wire at the distal end may also be described as the contour of
a baseball seam or a saddle. The LVRC also has a straight proximal
portion which remains straight after implantation, and around
which, in use in the lung, lung tissue is not rolled, thus
facilitating recapture and removal or in situ adjustment of the
LVRC if necessary. The individual LVRC implants may vary in length
from one to another and have any suitable length for treating
target lung tissue. The LVRC may have a length of over 70 mm, often
having a length in a range from about 120 mm to about 250 mm. LVRCs
are currently available in lengths of 200, 175, 150, 125, 100, 85,
70 mm. The diameter of the nitinol wire of the LVRC is typically
from 0.2 to 0.7 mm, preferably 0.3 to 0.5 mm. The atraumatic
proximal and distal balls minimize scraping or gouging of the lung
tissue and facilitate manipulation of the LVRC with the forceps for
implantation as well as for recapture, removal or in situ
adjustment of the LVRC if necessary. The atraumatic proximal and
distal balls may typically be formed by melting back a portion of
the nitinol wire, and typically have a cross-sectional diameter
between 1 and 3 mm, preferably 1 mm.
[0052] FIG. 2 illustrates a cutaway view of a delivery cartridge
system 18 that constrains the LVRC 10 in a deliverable shape. The
cartridge may be used as a tool to more easily load the implant
into a desired shape before being installed into the bronchoscope
or a catheter delivery device and into the patient. The cartridge
may be terminated with open ends or one or more hubs such as the
Luer lock hub 19 that is shown. If a Luer lock hub is present it
may be used to connect the cartridge to the bronchoscope or
catheter delivery device so that the LVRC may be more easily
advanced from the cartridge into the bronchoscope or catheter
delivery device.
[0053] FIG. 3 illustrates a delivery system that may be used to
deliver the implant device into the human lung. The many components
of the system may be needed to guide the bronchoscope 20 to a site
that is appropriate for implant delivery. The catheter 22 is
designed to constrain the device in a deliverable shape while it is
advanced through the system and into the patient. The distal end 24
may be configured from a floppier polymer or braid than the
proximal end 26 and the distal tip 28 may further include a
radiopaque material associated with the tip, either integral or
adjacent, to identify the position of the tip. Providing one or
more radiopaque markers facilitates using x-ray guidance system to
position the distal end of the device in situ relative to a target
anatomy. The proximal termination of the delivery catheter may
further be adapted to incorporate a lockable hub to secure the
loading cartridge with a smooth continuous lumen. The delivery
catheter 22 is shown introduced into the bronchoscope side port 30
and out from the distal end 32 of the scope. A camera is shown
attached to the end of the scope with a cable to transmit the image
signal to a processor and monitor 34. The monitor shows a typical
visual orientation on the screen of a delivery catheter image just
ahead of the optical element in the scope. The distal end 24 of the
delivery catheter 22 protrudes out of the scope 20 in an airway 36
where the user will place an implant device 38. The implant is
loaded into a loading cartridge that is coupled to the proximal end
of the delivery catheter via locking hub connection. A pusher
grasper device 40 is coupled to the proximal end of the implant
with a grasper coupler that is locked to the implant using an
actuation plunger, handle and pull wire that runs through the
central lumen in the pusher catheter. By releasably coupling the
pusher to the implant device, the user may advance the implant to a
position in the lung in a deployed configuration. The user can
survey the implant placement position and still be able to retrieve
the implant back into the delivery catheter, with ease, if the
delivery position is less than ideal. The implant and pusher has
been advanced through the delivery catheter to a location distal to
the scope into the airway. The pusher grasping jaws are still
locked onto the proximal end of the implant but the implant has
recovered to a pre-programmed shape that has also bent the airway
into a folded configuration. By folding the airway, the airway
structure has been effectively shortened within the lung. Since the
airways are well anchored into the lung tissue, the airway provides
tension on the surrounding lung tissue which is graphically
depicted by showing the pulled (curved inward) floor of the lung.
The image from the camera is transmitted through the signal
processor to the monitor to show the distal tip of the delivery
catheter, distal grasper of the pusher and proximal end of the
implant. Alternatively, when the distal end of the delivery
catheter is beyond the field of view of the camera, a fluoroscopic
guidance system may be used. The grasper may be used to locate,
couple to and retrieve devices that have been released in the
patient. It is easy to envision how the implant performs work on
the airways and lung tissue without blocking the entire lumen of
the airway. This is a benefit in that fluid or air may pass either
way through the airway past the implant device.
[0054] FIGS. 9 a-b show an embodiment of the container 100 of the
present invention. The container may be made of any suitable
material, but is typically made of polycarbonate plastic. The
container defines a housing 102 of a size suitable for dispensing
an individual LVRC 10. The individual LVRCs come in various sizes;
typically the various sizes for the housing may be approximately 5
to 7 cm in length, approximately 1 to 2 cm in width at their widest
points, and approximately 1 to 2 cm in height at their highest
points. The container comprises a housing wall 104 with an outer
surface and an inner surface, the inner surface defining a cavity
102 suitable for enclosing the distal end portion of the LVRC in
its manufactured shape, the wall having an exit aperture 106
extending through which the LVRC may be withdrawn, the proximal end
of the LVRC extending through the aperture in use such that the
proximal end is in a coupling zone 108 external to the cavity and
is accessible from outside the housing. The housing further
comprises a guide element 110 having a guiding/bearing surface 112
extending from the inner surface of the wall adjacent the exit
aperture and projecting into the cavity, the guide element/bearing
surface being adapted to tension the LVRC into a straightened form
as the proximal end is withdrawn from the housing. This guide
element is in the form of a tube structure 114, which projects from
the inner surface of the wall adjacent the aperture into the cavity
of the housing. The inner wall of the tube forms a concave guiding
surface which guides the LVRC to the exit aperture through which it
may be withdrawn. The housing shown comprises an outer chamber
(coupling zone) 108 and an inner chamber (cavity) 102, the exit
aperture 106 connecting the outer chamber with the inner chamber.
The inner chamber comprises the cavity suitable for enclosing the
distal end portion of the LVRC, the outer chamber comprises the
coupling zone suitable for receiving the proximal end portion of
the LVRC. The outer chamber has a larger second aperture 116
suitable for receiving open forceps such that the proximal end of
the LVRC is accessible with forceps from outside the housing. The
outer chamber shown further comprises a receiving tube 118 for
receiving the open forceps, the distal end of the inner surface of
which is contiguous with the rim surrounding the exit aperture. In
the embodiment shown, both the receiving tube for receiving the
forceps and the guide element tube are contiguous with the rim
surrounding the aperture. As will be appreciated, the exit path
formed by the guiding/bearing surface 112, exit aperture 106, and
coupling zone 108 extends in a substantially straight tangential
direction with respect to the approximately cylindrical cavity 102.
Thus the distal portion of the LVRC is left free to rotate in the
cylinder-like cavity as the LVRC is progressively fed through the
tube. In addition, the LVRC does not need to be further distorted
once it has passed through the exit aperture before it is loaded in
to a cartridge.
[0055] The shape of the housing generally corresponds to the shape
of the LVRC and only has one mirror axis of symmetry as opposed to
two in the container of FIG. 4. It thereby minimises plastic use.
The shape of the housing in FIG. 9a also avoids difficulties
encountered in tensioning the coil if the chamber is tilted in use
by the physician or assistant. When the chamber of FIG. 4 is
tilted, the LVRC is able to move freely within the chamber 48 in
the direction of the tilt, which exacerbates difficulties
tensioning the LVRC as discussed with reference to FIG. 5. In FIG.
9a, because outer chamber 108 is tangentially offset from chamber
102 and chamber 102 is appropriately sized for the LVRC, i.e., not
so small that the LVRC rubs against the inner surface as it is
withdrawn nor so large that the LVRC moves freely within chamber
102, and because the distal portion of the LVRC is constrained
within guide element 110, this difficulty when the housing is
tilted in use is avoided. One piece 120 connects the guide tube to
the inner surface of the wall of the housing and abuts the distal
portion of the coil, the distal portion of the coil sliding against
it as it is withdrawn. Piece 120 also prevents the coil from
jamming against the inner surface of the housing as the coil is
withdrawn. The other piece 130 keeps the distal end of the coil
from becoming stuck between the tube and the housing as it is
withdrawn.
[0056] FIG. 10 shows a cutaway close-up view of the guide element
of FIGS. 9 a-b. This guide element is in the form of a tube 110,
which projects from the inner surface of the wall adjacent the exit
aperture into the cavity 102 of the housing. The inner surface 112
of the wall of the tube forms a guiding/bearing surface which
guides the LVRC 10 to the exit aperture through which it may be
withdrawn. The guide element separates the proximal and distal ends
of the LVRC from one another as the proximal end is pulled away
from the aperture and out of the housing, keeping the distal end of
the LVRC away from the aperture as the proximal end is guided
through the aperture. That is to say, the proximal portion of the
LVRC is initially inside the lumen of the tube while the distal end
of the LVRC is adjacent to the outer surface of the tube before the
LVRC is withdrawn. As the LVRC is withdrawn, the distal end of the
LVRC is eventually pulled inside the lumen of the tube--this occurs
after the proximal portion of the LVRC has been withdrawn from and
has exited the housing. Thus the problem shown in FIG. 5, in which
the distal ball becomes caught on the inner surface of the wall of
the housing adjacent the aperture resulting in kinking of the LVRC
and increased difficulty in withdrawal, is avoided, and the LVRC
may be withdrawn from the housing in a motion that is more smooth
and continuous.
[0057] Referring again to FIG. 10, the distal end 122 of the upper
inner surface of the wall of the tube provides a bearing pivot
point around which the curved distal end of the LVRC may pivot as
it is withdrawn from the housing; this provides the necessary
tension to straighten the LVRC so that the LVRC may be withdrawn
through the exit aperture in the housing. Thus the housing may of
the invention may be spoolless or otherwise unobstructed, as shown.
If an inappropriate LVRC is chosen or if the physician changes his
or her mind regarding which length of LVRC to use, an LVRC that is
partially withdrawn from the aperture and then released will be
guided by the guide element (in this case, the inner surface of the
wall of the tubular guide element) back into the housing as it
recovers its original manufactured shape. The LVRC will still be
usable following its release back into the housing, as it will
again be possible to adequately tension the LVRC for efficient
withdrawal from the housing. Additionally, in the case of a
spoolless housing, as shown, the LVRC will not be stuck in front of
a spool. Thus, the problem shown in FIG. 6 will be avoided.
[0058] FIG. 11a shows schematically an alternative embodiment of
the present invention wherein the guide element 146 has two
opposing planar surfaces. The guide element separates the proximal
and distal ends of the LVRC from one another as the proximal end is
pulled away from the aperture and out of the housing, keeping the
distal end of the LVRC away from the aperture as the proximal end
is guided through the aperture 148. The proximal portion of the
LVRC is shown in front of the guide element, while the distal end
of the LVRC is shown behind the guide element. As the LVRC is
withdrawn, the distal end of the LVRC is eventually pulled in front
of the guide element--this occurs after the proximal portion of the
LVRC has been withdrawn from and has exited the housing. Thus the
problem shown in FIG. 5, in which the distal ball becomes caught on
the inner surface of the wall of the housing adjacent the aperture
resulting in kinking of the LVRC and increased difficulty in
withdrawal, is avoided. When the guide element is a planar element
in a substantially vertical orientation, relative to the rest of
the housing, in use, shown in FIG. 11a, the housing can contain a
spool 150 as shown. This spool provides a bearing surface against
and around which the preformed curved distal end pivots as the LVRC
is withdrawn; as the user pulls the proximal end of the LVRC the
spool this provides tension to straighten the coil so that the coil
may be withdrawn through the aperture in the housing. FIG. 11b
shows a guide element that is a planar element 152 in a
substantially horizontal orientation, relative to the rest of the
housing, in use. The distal end of this guide element provides a
single pivot point around which the LVRC may pivot as it is
withdrawn. In alternative substantially vertical and substantially
horizontal embodiments, instead of a planar surfaces as shown the
guide element may have a concave surface.
[0059] FIG. 12 shows an embodiment of the invention comprising a
two-part structure having an interference or press fit by which two
sections of the housing of the present invention may be snapped
together. The two parts comprise a body part 200, defining the main
part of the cavity, and a cap part 202. When the cap part is
removed from the body part, it provides an inlet or loading
aperture 204 through which the LVRC can be loaded into the
container. Protrusions 206 on the rim of one section of the housing
are met with corresponding indentations 208 on the rim of other
section of the housing, and the sections are snap-fitted and held
together with friction. The problem of FIGS. 7 a-b is thereby
avoided for two reasons. Firstly, the interference fit of the two
sections forms a tight junction, there is therefore no space or gap
as in FIGS. 7 a-b into which the LVRC is able to fit to become
stuck. Secondly, because the rims of the sections lie in a plane
that is orthogonal to the exit path of the LVRC, they do not
intersect the rim of the exit aperture in the housing through which
the LVRC may be withdrawn, nor do the rims of the sections
intersect the perimeter of the receiving tube. Therefore the LVRC
will not become stuck between the two sections of housing as it is
pulled through the aperture and withdrawn from the housing.
Preferably, the two sections of housing may be joined at the widest
portion of the cavity, so that the LVRC may be easily loaded into
the housing following its manufacture.
[0060] FIGS. 13 a-c shows a cutaway view of the outer
chamber/coupling zone 108 of the embodiment of FIGS. 9 a-b in two
perpendicular orientations, along the width and along the depth of
the housing. The outer chamber shown further comprises a receiving
tube 118 for receiving the open forceps 80, the distal end of the
inner surface of which is contiguous with the rim surrounding the
exit aperture 106. In the embodiment shown, both the receiving tube
for receiving the forceps and the guide element tube are contiguous
with the rim surrounding the aperture. The receiving tube is
configured as a slot 210 to constrain opened forceps 80 of a
delivery device into only two possible orientations/configurations,
the one configuration of the forceps being a 180 degree rotation of
the other configuration, so that the opened forceps are forced into
being centered on and aligned with the ball at the proximal end of
the LVRC. Because the opened forceps are forced into one of two
configurations, and because the proximal ball 11 is centered in the
receiving tube by the tubular guide element it is ensured that the
ball at the proximal end of the LVRC will be grasped with the
center of the open forceps. Thus, the problem discussed with
reference to FIG. 8, in which it may take a technician several
attempts to grasp the proximal ball of the LVRC has been avoided,
and the proximal ball of the LVRC may even be grasped with the
forceps blindly. Additionally, as shown, preferably the lumen of
the receiving tube tapers smoothly from a broad diameter tube to a
narrower diameter slot so as to guide the forceps to the proximal
ball of the LVRC.
[0061] Other variations are within the spirit of the present
invention. Thus, while the invention is susceptible to various
modifications and alternative constructions, certain illustrated
embodiments thereof are shown in the drawings and have been
described above in detail. It should be understood, however, that
there is no intention to limit the invention to the specific form
or forms disclosed, but on the contrary, the intention is to cover
all modifications, alternative constructions, and equivalents
falling within the spirit and scope of the invention, as defined in
the appended claims.
[0062] In the previous description, various embodiments of the
present invention are described. For purposes of explanation,
specific configurations and details are set forth in order to
provide a thorough understanding of the embodiments. However, it
will also be apparent to one skilled in the art that the present
invention may be practiced without the specific details.
Furthermore, well-known features may be omitted or simplified in
order not to obscure the embodiment being described.
[0063] The use of the terms "a" and "an" and "the" and similar
referents in the context of describing the invention (especially in
the context of the following claims) are to be construed to cover
both the singular and the plural, unless otherwise indicated herein
or clearly contradicted by context. The terms "comprising,"
"having," "including," and "containing" are to be construed as
open-ended terms (i.e., meaning "including, but not limited to,")
unless otherwise noted. The term "connected" is to be construed as
partly or wholly contained within, attached to, or joined together,
even if there is something intervening. Recitation of ranges of
values herein are merely intended to serve as a shorthand method of
referring individually to each separate value falling within the
range, unless otherwise indicated herein, and each separate value
is incorporated into the specification as if it were individually
recited herein. All methods described herein can be performed in
any suitable order unless otherwise indicated herein or otherwise
clearly contradicted by context. The use of any and all examples,
or exemplary language (e.g., "such as") provided herein, is
intended merely to better illuminate embodiments of the invention
and does not pose a limitation on the scope of the invention unless
otherwise claimed. No language in the specification should be
construed as indicating any non-claimed element as essential to the
practice of the invention.
[0064] Preferred embodiments of this invention are described
herein, including the best mode known to the inventors for carrying
out the invention. Variations of those preferred embodiments may
become apparent to those of ordinary skill in the art upon reading
the foregoing description. The inventors expect skilled artisans to
employ such variations as appropriate, and the inventors intend for
the invention to be practiced otherwise than as specifically
described herein. Accordingly, this invention includes all
modifications and equivalents of the subject matter recited in the
claims appended hereto as permitted by applicable law. Moreover,
any combination of the above-described elements in all possible
variations thereof is encompassed by the invention unless otherwise
indicated herein or otherwise clearly contradicted by context.
[0065] All references, including publications, patent applications,
and patents, cited herein are hereby incorporated by reference to
the same extent as if each reference were individually and
specifically indicated to be incorporated by reference and were set
forth in its entirety herein.
* * * * *