U.S. patent application number 15/443524 was filed with the patent office on 2017-06-15 for sinus stent.
This patent application is currently assigned to RAINBOW MEDICAL LTD.. The applicant listed for this patent is RAINBOW MEDICAL LTD.. Invention is credited to Hadar BETTER, Gideon FOSTICK, Yossi GROSS, Ilan UCHITEL.
Application Number | 20170165459 15/443524 |
Document ID | / |
Family ID | 47597874 |
Filed Date | 2017-06-15 |
United States Patent
Application |
20170165459 |
Kind Code |
A1 |
GROSS; Yossi ; et
al. |
June 15, 2017 |
SINUS STENT
Abstract
Paranasal sinus apparatus is provided, including a hole-forming
member configured to form a hole through a bone wall of a paranasal
sinus of a subject. An implant is provided, having a proximal end
and a distal end, and which is shaped to define a lumen. The
implant is couplable to the hole-forming member, and is securable
to the wall and extendable through the hole, such that the proximal
end is disposed external to the paranasal sinus and the distal end
is disposed within the paranasal sinus. The implant includes a
biodegradable material. Other applications are also described.
Inventors: |
GROSS; Yossi; (Moshav Mazor,
IL) ; BETTER; Hadar; (Tel Aviv, IL) ; FOSTICK;
Gideon; (Givat Shmuel, IL) ; UCHITEL; Ilan;
(Kefar Saba, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
RAINBOW MEDICAL LTD. |
Herzliya |
|
IL |
|
|
Assignee: |
RAINBOW MEDICAL LTD.
Herzliya
IL
|
Family ID: |
47597874 |
Appl. No.: |
15/443524 |
Filed: |
February 27, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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14636886 |
Mar 3, 2015 |
9597179 |
|
|
15443524 |
|
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|
13189896 |
Jul 25, 2011 |
8998985 |
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14636886 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 11/00 20130101;
A61M 27/002 20130101; A61F 2/186 20130101; A61B 2018/00327
20130101; A61F 2210/0004 20130101; A61B 18/1485 20130101; A61B
18/14 20130101; A61M 2210/0681 20130101; A61B 2018/00595 20130101;
A61B 2018/00017 20130101; A61F 2/958 20130101; A61F 11/002
20130101; A61F 2/82 20130101 |
International
Class: |
A61M 27/00 20060101
A61M027/00; A61B 18/14 20060101 A61B018/14 |
Claims
1-105. (canceled)
106. The method according to claim 112, wherein inserting the
medical instrument into the paranasal sinus comprises inserting a
stent into the paranasal sinus via the artificial hole in the wall
of the sinus, and wherein using the medical instrument to open the
natural ostium of the sinus comprises: placing the stent in the
ostium from inside of the sinus; and securing the stent in the
ostium by expanding the stent.
107. The method according to claim 106, wherein inserting the stent
into the paranasal sinus comprises inserting the stent into a
maxillary sinus of the subject.
108. The method according to claim 106, wherein inserting the stent
into the sinus via the artificial hole comprises inserting the
stent into the sinus via a lumen of an implant secured in the
hole.
109-110. (canceled)
111. A method for treating a paranasal sinus of a subject, the
method comprising: forming an artificial hole in a wall of the
paranasal sinus; and via the artificial hole, opening a natural
ostium of the paranasal sinus.
112. The method according to claim 111, wherein opening the natural
ostium of the paranasal sinus via the artificial hole comprises:
inserting a medical instrument into the paranasal sinus, via the
artificial hole; and using the medical instrument to open the
natural ostium of the sinus.
113. The method according to claim 111, further comprising
cauterizing tissue in an area of the hole.
114. The method according to claim 113, wherein cauterizing the
tissue comprises cauterizing the tissue by using a radio frequency
electrode to apply energy to the tissue.
115. The method according to claim 106, wherein securing the stent
in the ostium by expanding the stent comprises inflating a balloon
within a lumen of the stent.
116. The method according to claim 108, further comprising securing
the implant in the hole.
117. The method according to claim 116, wherein securing the
implant in the hole comprises securing the implant such that a
first end of the lumen of the implant is in the paranasal sinus,
and a second end of the lumen is out of the sinus.
Description
FIELD OF THE INVENTION
[0001] Applications of the present invention relate generally to
treatment of sinus disorders, and specifically to implantable
medical devices for treating sinus disorders.
BACKGROUND
[0002] Sinusitis is a common condition, characterized by symptoms
such as nasal discharge, facial and ear pressure and pain,
headache, loss of smell, fever, cough and fatigue. Physiological
clearing of paranasal sinuses is via mucociliary transport through
the ostia (natural sinus openings into a nasal cavity). Disruption
of this function, often associated with partial blockage of an
ostium, allows stagnation of mucous secretions and alteration of pH
and other physiologic parameters, making the sinus conditions more
favorable to microbiological growth and, therefore, susceptible to
sinusitis. Treatment of chronic sinusitis typically includes
antibiotics, steroids, decongestants and, in some cases, surgical
procedures such as lavage.
SUMMARY OF THE INVENTION
[0003] In some applications of the invention, a hole-forming member
is coupled to an implant. The hole-forming member forms a hole in a
bone wall of a sinus, and facilitates implantation of the implant
in the formed hole. The apparatus disclosed according to these
applications of the invention allows hole-forming and implantation
to be performed conveniently. Several versions of the implant are
described, each being shaped to define a lumen which, following
implantation, provides communication between the sinus and the
nasal cavity of the subject. This allows drainage from the sinus,
access to the sinus by medical instruments, and the possibility of
administering therapeutic substances to the sinus. Typically, the
implant is left in place for at least several days, allowing
repeated access to the sinus without the need for repeated
hole-forming.
[0004] In some applications of the invention, the paranasal sinus
implant is self-tapping. In these applications, no separate
hole-forming member is used.
[0005] In some applications of the invention, a stent is implanted
in a natural sinus ostium in order to treat sinusitis. The stent is
typically implanted using a balloon catheter, which is inserted
into the sinus ostium, typically via an artificial hole in the bone
wall of the sinus. For example, the insertion of the stent into the
sinus ostium is performed following implantation of an implant with
a lumen, as described above. The stent is positioned in the ostium
while in a compressed configuration on the balloon of the balloon
catheter. Inflation of the balloon expands the stent, which remains
expanded after the balloon is deflated and removed, thereby holding
the ostium in an open configuration. Alternatively, the stent may
be delivered to the ostium in a contracted form, such as within a
sheath, expanding upon removal of the sheath.
[0006] In some applications of the invention, a rivet implant is
implanted in an anatomical wall or other tissue of a subject. The
rivet implant typically acts as a blind rivet. Deformation of a
distal portion of the implant secures the implant in the
tissue.
[0007] In some applications of the invention, a cauterizing
hole-forming member is used to form the hole in the wall of the
sinus. The wall of the sinus includes a bone layer and membranous
layers. In these applications of the invention, the hole-forming
member comprises a drill bit slidably coupled to at least one radio
frequency (RF) electrode, the drill bit being configured to
penetrate the bone layer and the RF electrodes being configured to
penetrate and cauterize the membranous layers. Axially sliding the
drill bit and RF electrodes with respect to each other allows
penetration of the appropriate layer with the respective
appropriate component of the hole-forming member.
[0008] There is therefore provided, in accordance with an
application of the present invention, paranasal sinus apparatus
including: [0009] a hole-forming member configured to form a hole
through a wall of a paranasal sinus of a subject; and [0010] an
implant having a proximal end, a distal end, and shaped to define a
lumen, the implant: [0011] being couplable to the hole-forming
member, [0012] being securable to the wall and extendable through
the hole, such that the proximal end is disposed external to the
paranasal sinus and the distal end is disposed within the paranasal
sinus, and [0013] including a biodegradable material.
[0014] In an application, at least part of the hole-forming member
is disposable within the lumen of the implant, and the implant is
slidably movable over at least part of the hole-forming member.
[0015] In an application, the apparatus includes a tube, disposable
within the lumen of the implant, and the implant is slidably
movable over the tube.
[0016] In an application, at least part of the implant is
disposable within a void defined by the hole-forming member, and
the implant is slidably movable through at least part of the
hole-forming member.
[0017] In an application, the apparatus includes a tube, disposable
within the lumen of the implant, and the hole-forming member is
disposable within the tube, and the hole-forming member is slidably
movable within the tube.
[0018] In an application, the hole-forming member is configured to
form the hole in a wall that is a part of a maxilla of the subject
that divides a nasal cavity of the subject and a maxillary sinus of
the subject, and the implant has a length appropriate to extend
through the hole in the bone wall.
[0019] In an application, the hole-forming member includes a drill
bit.
[0020] In an application, the hole-forming member includes a
piercing device.
[0021] In an application, the hole-forming member includes an
ultrasonic drill.
[0022] In an application, the hole-forming member includes a water
jet cutter.
[0023] In an application, the hole-forming member includes a laser
cutter.
[0024] In an application, the implant is securable to the wall in
an irreversible manner.
[0025] In an application, the implant is securable to the wall in a
reversible manner.
[0026] In an application, the hole-forming member is coupled to the
implant.
[0027] In an application, the hole-forming member is decouplable
from the implant.
[0028] In an application, the implant is shaped to define the
lumen, the lumen having a diameter sufficient to allow flow of
liquid secretions from the distal end to the proximal end of the
implant.
[0029] In an application, the implant is shaped to define the
lumen, the lumen having a diameter of between 0.5 mm and 15 mm
(e.g., at least 0.5 mm and/or less than 2 mm; at least 2 mm and/or
less than 6 mm; or at least 6 mm and/or less than 15 mm).
[0030] In an application, the implant has a length of between 1 mm
and 30 mm (e.g., at least 1 mm and/or less than 4 mm; at least 4 mm
and/or less than 12 mm; or at least 12 mm and/or less than 30
mm).
[0031] In an application, the apparatus includes a medical
instrument, passable through the lumen of the implant.
[0032] In an application, the apparatus includes a control unit and
a radio frequency electrode, wherein:
[0033] the hole-forming member is couplable to the radio frequency
electrode,
[0034] the radio frequency electrode is couplable to the control
unit, and
[0035] the control unit is configurable to drive a radio frequency
current through the electrode.
[0036] In an application, the control unit is configured to
configure the current to reduce bleeding from tissue in a vicinity
of the hole formed by the hole-forming member.
[0037] In an application:
[0038] the apparatus further includes a control unit,
[0039] the hole-forming member includes a radio frequency
electrode, couplable to the control unit, and
[0040] the control unit is configured to drive a radio frequency
current through the electrode.
[0041] In an application, the control unit is configured to
configure the current to form the hole through at least a part of
the wall of the paranasal sinus of the subject.
[0042] In an application, the hole-forming member further includes
a drill bit, slidably coupled to the radio frequency electrode.
[0043] In an application, the apparatus further includes a cooling
element, configured to apply cooling in conjunction with forming
the hole by the hole-forming member.
[0044] In an application, the cooling element is configured to
apply the cooling at least prior to the forming of the hole by the
hole-forming member.
[0045] In an application, the cooling element is configured to
apply the cooling to a site of forming of the hole by the
hole-forming member.
[0046] In an application, the cooling element includes a compressed
gas.
[0047] In an application, the cooling element includes a cooled
liquid.
[0048] In an application, the cooling element is configured to
apply the cooling to the hole-forming member.
[0049] In an application, the cooling element is coupled to the
hole-forming member.
[0050] There is further provided, in accordance with an application
of the present invention, paranasal sinus apparatus including:
[0051] an implant, the implant: [0052] having a length of between 1
mm and 30 mm (e.g., at least 1 mm and/or less than 4 mm; at least 4
mm and/or less than 12 mm; or at least 12 mm and/or less than 30
mm), [0053] being shaped to define a lumen, and the lumen has a
diameter of between 0.5 mm and 15 mm (e.g., at least 0.5 mm and/or
less than 2 mm; at least 2 mm and/or less than 6 mm; or at least 6
mm and/or less than 15 mm), [0054] having a proximal portion, a
middle portion and a distal portion, each portion has an external
diameter, and the external diameter of the middle portion is
between 1 mm and 20 mm (e.g., at least 1 mm and/or less than 4 mm;
at least 4 mm and/or less than 10 mm; and/or at least 10 mm and/or
less than 20 mm); and [0055] a hole-forming member, couplable to
the implant and configured to form a hole in a wall of a paranasal
sinus of a subject.
[0056] In an application, at least part of the hole-forming member
is disposable within the lumen of the implant, and the implant is
slidably movable over at least part of the hole-forming member.
[0057] In an application, the apparatus includes a tube, disposable
within the lumen of the implant, and the implant is slidably
movable over the tube.
[0058] In an application, the hole-forming member is coupled to the
implant.
[0059] In an application, the hole-forming member is decouplable
from the implant.
[0060] In an application, the implant is securable to the wall of
the paranasal sinus of a subject.
[0061] In an application, the implant is securable to a wall that
is a part of a maxilla of the subject that divides a nasal cavity
of the subject and a maxillary sinus of the subject.
[0062] In an application, the implant is securable to the wall in
an irreversible manner.
[0063] In an application, the implant is securable to the wall in a
reversible manner.
[0064] In an application, the implant includes a biodegradable
material.
[0065] In an application, the implant is entirely
biodegradable.
[0066] In an application, the apparatus includes a tube, disposable
within the lumen of the implant, the hole-forming member is
disposable within the tube, and the hole-forming member is slidably
movable within the tube.
[0067] In an application, the hole-forming member includes a drill
bit.
[0068] In an application, the hole-forming member includes a
piercing device.
[0069] In an application, the hole-forming member includes an
ultrasonic drill.
[0070] In an application, the hole-forming member includes a water
jet cutter.
[0071] In an application, the hole-forming member includes a laser
cutter.
[0072] In an application, the apparatus includes a control unit and
a radio frequency electrode, wherein:
[0073] the hole-forming member is couplable to the radio frequency
electrode,
[0074] the radio frequency electrode is couplable to the control
unit, and
[0075] the control unit is configurable to drive a radio frequency
current through the electrode.
[0076] In an application, the control unit is configured to
configure the current to reduce bleeding from tissue in a vicinity
of the hole formed by the hole-forming member.
[0077] In an application:
[0078] the apparatus further includes a control unit,
[0079] the hole-forming member includes a radio frequency
electrode, couplable to the control unit, and
[0080] the control unit is configured to drive a radio frequency
current through the electrode.
[0081] In an application, the control unit is configured to
configure the current to form the hole through at least part of the
wall of the paranasal sinus of the subject.
[0082] In an application, the hole-forming member further includes
a drill bit and
[0083] In an application, the apparatus further includes a cooling
element, the cooling element being configured to apply cooling in
conjunction with formation of the hole by the hole-forming
member.
[0084] In an application, the cooling element is configured to
apply the cooling at least prior to formation of the hole by the
hole-forming member.
[0085] In an application, the cooling element is configured to
apply the cooling to a site of formation of the hole by the
hole-forming member.
[0086] In an application, the cooling element includes a compressed
gas.
[0087] In an application, the cooling element includes a cooled
liquid.
[0088] In an application, the cooling element is configured to
apply the cooling to the hole-forming member.
[0089] In an application, the cooling element is coupled to the
hole-forming member.
[0090] There is further provided, in accordance with an application
of the present invention, paranasal sinus apparatus including:
[0091] a blind rivet implant, shaped to define a lumen and having a
proximal end and a distal end, the implant: [0092] having a length
appropriate to extend through a hole in a wall of a paranasal sinus
of a subject so that the proximal end is disposed external to the
paranasal sinus and the distal end is disposed within the paranasal
sinus, [0093] being securable to the wall, and [0094] including at
a distal region of the implant a buck-tail, being deformable from a
first shape to a second shape, the geometry of the first shape
permitting passage of the distal region through the hole in the
wall of the paranasal sinus, and the geometry of the second shape
preventing such passage; and
[0095] an applicator, shaped so that a distal region of the
applicator is disposable within the lumen of the implant, the
applicator being removable from the implant.
[0096] In an application, the apparatus includes a restraint
disposable within the lumen of the implant, wherein:
[0097] the applicator is couplable to the restraint,
[0098] the first shape of the buck-tail is a constrained shape and
the second shape of the buck-tail is an unconstrained shape,
[0099] the restraint is configured to retain the buck-tail in the
first shape when the restraint is disposed within the lumen of the
implant, and
[0100] the buck-tail is configured such that it moves from the
first shape to the second shape upon removal of the restraint from
the implant.
[0101] In an application:
[0102] the first and second shapes of the buck-tail are
unconstrained shapes, and
[0103] the buck-tail and the distal region of the applicator are
configured such that a force applied to the buck-tail by the distal
region of the applicator deforms the buck-tail from the first shape
to the second shape.
[0104] In an application, the length appropriate to extend through
the hole in the wall of the paranasal sinus of the subject is a
length appropriate to extend through an artificial hole in a wall
that is a part of a maxilla of the subject that divides a nasal
cavity of the subject and a maxillary sinus of the subject.
[0105] In an application, the implant is securable to the wall of
the subject in an irreversible manner.
[0106] In an application, the implant is securable to the wall of
the subject in a reversible manner.
[0107] In an application, the lumen of the implant has a diameter
sufficient to allow flow of liquid secretions from the distal end
to the proximal end of the implant.
[0108] In an application, the lumen of the implant has a diameter
of between 0.5 mm and 15 mm.
[0109] In an application, the implant has a length of between 1 mm
and 30 mm.
[0110] In an application, the implant includes a biodegradable
material.
[0111] In an application, the implant is entirely
biodegradable.
[0112] In an application, the apparatus includes a medical
instrument, passable through the lumen of the implant.
[0113] In an application, the medical instrument includes at least
one instrument selected from the group consisting of: an endoscope,
an aspirator, and a syringe.
[0114] There is further provided, in accordance with an application
of the present invention, paranasal sinus apparatus including:
[0115] An implant, implantable in a wall of a paranasal sinus of a
subject, and shaped to define a lumen;
[0116] a catheter slidable through the lumen of the implant;
[0117] a balloon, couplable to a distal portion of the catheter;
and
[0118] an expandable stent, slidable through the lumen of the
implant, shaped to define a lumen, and configured such that it may
be expanded from a first shape to an expanded shape by an applied
force,
[0119] the balloon being inflatable via the catheter, and
disposable within the lumen of the expandable stent such that
inflation of the balloon expands the expandable stent, and
[0120] the expandable stent being maintainable in the expanded
shape when the balloon is deflated.
[0121] In an application, the balloon is coupled to the distal
portion of the catheter.
[0122] In an application, the stent includes a biodegradable
material.
[0123] In an application, the apparatus further includes a
guidewire, and the catheter is advanceable over the guidewire.
[0124] There is further provided, in accordance with an application
of the present invention, a method for implanting an implant in a
wall of a paranasal sinus of a subject, the implant being shaped to
define a lumen, the method including:
[0125] coupling a hole-forming member to a portion of a body of the
subject;
[0126] forming a hole at a site on the wall of the paranasal sinus
using the hole-forming member, while the hole-forming member is
coupled to the implant; and
[0127] while the hole-forming member is coupled to the portion of
the body of the subject, inserting at least part of the implant
into the hole.
[0128] In an application, at least part of the hole-forming member
is disposable within the lumen of the implant and the implant is
slidably couplable to the hole-forming member, and inserting at
least part of the implant into the hole includes sliding the
implant along at least part of the hole-forming member.
[0129] In an application, at least part of the implant is
disposable within a void defined by the hole-forming member, and
inserting at least part of the implant into the hole includes
sliding the implant through at least part of the hole-forming
member.
[0130] In an application, forming the hole at the site on the wall
of the paranasal sinus includes forming a hole at a site on a wall
that is between a nasal cavity and a maxillary sinus of the
subject.
[0131] In an application, forming the hole at the site on the wall
of the paranasal sinus includes forming the hole at a site that is
inferior to an inferior turbinate of a lateral nasal wall.
[0132] In an application, the implant has a proximal end and a
distal end, and inserting at least part of the implant into the
hole includes inserting the implant such that the proximal end is
disposed external to the paranasal sinus and the distal end is
disposed within the paranasal sinus.
[0133] In an application, the method includes facilitating drainage
of material from the sinus via the lumen of the implant.
[0134] In an application, the method includes administering a
substance to the sinus via the lumen of the implant.
[0135] In an application, inserting at least part of the implant
into the hole includes inserting at least part of an implant that
includes a biodegradable material into the hole.
[0136] In an application, inserting at least part of the implant
into the hole includes advancing the hole-forming member
distally.
[0137] In an application, inserting at least part of the implant
into the hole includes pushing the implant using the hole-forming
member.
[0138] In an application, the method further includes applying
cooling in conjunction with forming the hole using the hole-forming
member.
[0139] In an application, applying cooling includes applying
cooling to the hole-forming member.
[0140] In an application, applying cooling includes applying
cooling at least prior to the forming of the hole using the
hole-forming member.
[0141] In an application, applying cooling includes applying
cooling to the site on the wall.
[0142] In an application, applying cooling includes applying
cooling at least prior to the forming of the hole using the
hole-forming member.
[0143] In an application, applying cooling includes expanding a
compressed gas.
[0144] In an application, applying cooling includes applying a
liquid.
[0145] There is further provided, in accordance with an application
of the present invention, a method for implanting an implant in a
subject, the method including:
[0146] inserting the implant through a hole in a tissue of the
subject, the implant being configured to act as a blind rivet and
including a buck-tail at a distal region of the blind rivet;
and
[0147] deforming the buck-tail from a first shape that allows
passage of the buck-tail through the hole into a second shape that
does not allow passage of the buck-tail through the hole.
[0148] In an application, deforming the buck-tail includes applying
a deforming force.
[0149] In an application, deforming the buck-tail includes removing
a restraint.
[0150] In an application, the implant is shaped to define a lumen,
and the method further includes facilitating drainage of the sinus
via the lumen of the implant.
[0151] In an application, the implant is shaped to define a lumen,
and the method further includes administering a substance to the
sinus via the lumen of the implant.
[0152] In an application, inserting the implant through the hole
includes inserting the implant through a hole in an anatomical wall
of the subject.
[0153] In an application, inserting the implant through the hole in
the anatomical wall of the subject includes inserting the implant
through a hole in a wall of a hollow organ of the subject.
[0154] In an application, inserting the implant through the hole in
the anatomical wall includes inserting the implant through a hole
in a wall of a maxillary sinus of the subject.
[0155] In an application, the method further includes forming the
hole.
[0156] In an application, forming the hole includes forming the
hole with the implant.
[0157] There is further provided, in accordance with an application
of the present invention, a method for implanting a stent in a
natural ostium of a paranasal sinus of a subject, the method
including:
[0158] inserting the stent into the paranasal sinus via an
artificial hole in a wall of the sinus,
[0159] placing the stent in the ostium from inside of the sinus;
and
[0160] securing the stent in the ostium by expanding the stent.
[0161] In an application, inserting the stent into the paranasal
sinus includes inserting the stent into a maxillary sinus of the
subject.
[0162] In an application, inserting the stent into the sinus via
the artificial hole includes inserting the stent into the sinus via
a lumen of an implant implanted in the hole.
[0163] There is further provided, in accordance with an application
of the present invention, a method for forming a hole in a
multilayered tissue of a subject, the method including:
[0164] forming a hole in one layer of the tissue of the subject
with a drill bit, the drill bit being slidably coupled to a radio
frequency electrode;
[0165] forming a hole in another layer of the tissue of the subject
with the radio frequency electrode; and
[0166] axially sliding the radio frequency electrode with respect
to the drill bit.
[0167] In an application, the multilayered tissue of the subject
includes a bone layer and at least one membrane layer, and forming
the hole in the one layer includes forming a hole in the bone
layer, and wherein forming the hole in the other layer includes
forming a hole in the membrane layer.
BRIEF DESCRIPTION OF THE DRAWINGS
[0168] FIGS. 1A-B are schematic illustrations of apparatus for
forming a hole in a wall of a paranasal sinus and implanting a
paranasal sinus implant in the hole, in accordance with respective
applications of the invention;
[0169] FIG. 2 is a schematic illustration of a paranasal sinus
implant, secured in the hole in the wall of the paranasal sinus, in
accordance with an application of the invention;
[0170] FIG. 3 is a schematic illustration of access of a medical
instrument to the paranasal sinus via the paranasal sinus implant,
in accordance with an application of the invention;
[0171] FIGS. 4A-E are schematic illustrations of the hole-forming
member used to form a hole in the bone wall of a paranasal sinus,
in accordance with respective applications of the present
invention;
[0172] FIGS. 5A-E are schematic illustrations of a paranasal sinus
implant, in accordance with respective applications of the present
invention;
[0173] FIGS. 6A-B are schematic illustrations of two sequential
steps in the implantation of a rivet implant, in accordance with an
application of the invention;
[0174] FIG. 7 is a schematic illustration of the implantation of an
expandable stent in a sinus ostium, in accordance with an
application of the invention; and
[0175] FIGS. 8A-C are schematic illustrations of sequential steps
in the formation of a hole in the wall of the paranasal sinus with
a cauterizing hole-forming member, in accordance with an
application of the invention.
DETAILED DESCRIPTION OF EMBODIMENTS
[0176] Reference is made to FIG. 1A, which illustrates a
therapeutic approach, in accordance with one application of the
invention. The figure includes an anatomical representation showing
paranasal sinuses located within the head of a subject. Between the
eyes are ethmoid sinuses 22. Located behind the cheek are maxillary
sinuses 24. Within nasal cavity 38 are middle turbinate 28 and
inferior turbinate 30. Separating nasal cavity 38 from maxillary
sinus 24 is bone wall 32, which is part of the maxilla bone of the
skull. The sinus cavities have a mucosal lining 36 over the bone.
The figure illustrates pus 34 present in sinuses due to sinusitis.
The maxillary sinus ostia 26 are located high on the wall of the
sinus cavity. Therefore drainage of the sinuses is not aided by
gravity, making the maxillary sinuses particularly susceptible to
sinusitis.
[0177] A hole-forming member 50 is inserted through nasal cavity 38
at an angle such that it contacts bone wall 32, and is operated to
form a hole 40 in bone wall 32, below the inferior turbinate. Hole
40 thereby becomes an opening into maxillary sinus 24. For some
applications, hole-forming member 50 itself enters bone wall 32. As
hole-forming member 50 is advanced into hole 40, an implant 52 is
pushed into the hole, optionally accompanied by sliding of the
implant along the hole-forming member, typically until a shoulder
102 of the implant meets the surface of the bone wall. For other
applications, hole-forming member 50 does not itself penetrate the
bone wall. In such a case, implant 52 is typically inserted into
hole 40 by sliding it along hole-forming member 50.
[0178] Reference is made to FIG. 1B, which illustrates an
alternative application of the invention. Hole-forming member 50 is
disposed within a sleeve 54 which, itself, fits within the lumen of
implant 52. Sleeve 54 is placed in contact with bone wall 32; this
contact is maintained throughout some or all of the procedure. For
example, sleeve 54 may be pressed against the bone, and may have
anchors (e.g., sharp protrusions) which enter the bone.
Hole-forming member 50 is extended through sleeve 54 and forms hole
40. Alternatively, hole-forming member 50 is disposed at a fixed
position within sleeve 54. (Examples of versions of hole-forming
member 50 are included in FIGS. 5A-E.)
[0179] FIG. 2 illustrates implant 52 secured in bone wall 32 of
maxillary sinus 24, following the removal of hole-forming member
50, in accordance with an application of the present invention.
Implant 52 is shaped to define a lumen. A distal end of the implant
is disposed in maxillary sinus 24, and a proximal end is disposed
in nasal cavity 38, thus providing communication between the sinus
and the nasal cavity. An application of the invention is the
implantation of implant 52 in order to facilitate passage of
secretions and gaseous exchange between the sinus and nasal
passage. Such passage may be passive, such as by circulation of a
gas, or by gravity-driven drainage, or the passage may be actively
induced by a medical practitioner, using a medical device, for
example as described with reference to FIG. 3.
[0180] In some applications of the invention, implantation of
implant 52 is performed in combination with other procedures such
as functional endoscopic sinus surgery (FESS), orthognathic
surgery, and treatment of facial fractures and nasal polyps.
Implant 52 may be used to facilitate the procedure (e.g., by
improving access), or to facilitate pre- or post-procedure
treatments, such as the application of therapeutic substances.
[0181] In some applications of the invention, hole-forming member
50 (e.g., drill 150) is hollow, or shaped to define a void. Implant
52 is typically disposed within the hollow or void while hole 40 is
formed by the hole-forming member. Implant 52 is then moved out of
the void, distally, typically by sliding the implant through
hole-forming member 50. Implant 52, or a part thereof (e.g., wings
104, described with reference to FIG. 5A) expands within hole 40,
securing the implant in place.
[0182] In some applications of the invention, implant 52 is
self-tapping, comprising a self-tapping screw-thread. In these
applications of the invention, no independent hole-forming member
is required. Rather, implant 52 is pushed against bone wall 32 and
rotated such that it cuts into, and becomes implanted in, the bone
wall.
[0183] Reference is now made to FIG. 3, which is a schematic
illustration of a medical instrument 70 being inserted through the
lumen of implant 52, in accordance with an application of the
present invention. The implantation of implant 52 may allow
repeated access by medical instruments 70 to maxillary sinus 24. In
the application illustrated in FIG. 3, an endoscope 72 is used to
examine the sinus cavity. Similarly, medical instruments 70 may be
used to aspirate the sinus or to introduce a drug or other
substance to the sinus. In some applications of the invention,
medical instrument 70 may be used to prepare the maxillary sinus
for a sinus lift operation (e.g., by delivery of a drug to the
sinus), in order to reduce inflammation (such as inflammation of
mucosal lining 36, e.g., the Schneiderian membrane). Alternatively
or additionally, medical instrument 70 may be used to treat pain
and/or swelling following a sinus lift operation.
[0184] Reference is made to FIGS. 4A-E, which illustrate
hole-forming member 50, in accordance with five respective
applications of the present invention.
[0185] FIG. 4A illustrates hole-forming member 50, comprising a
drill 150. The hole-forming function of drill 150 is imparted, as
per a classical drill, by rotation of a drill bit 160. FIG. 4A
further illustrates a cooling element 151 for use in conjunction
with hole-forming member 50. Cooling element 151 may be used to
administer cooling to hole-forming member 50 prior to formation of
hole 40. Alternatively or additionally, cooling element 151 may be
used to administer cooling to bone wall 32 at the site of hole
formation, prior to formation of hole 40. Alternatively or
additionally, cooling element 151 is used to administer cooling to
hole-forming member 50 and/or bone wall 32 during and/or after
formation of hole 40. Cooling element 151 typically utilizes the
expansion of a compressed gas to apply its cooling effect. For
example, a compressed gas may be applied to drill bit 160 via
nozzle 153, whereby expansion of the gas cools the drill bit.
Alternatively, cooling element 151 utilizes a cooled liquid (e.g.,
saline) to apply its cooling effect. Cooling of hole-forming member
50 and/or bone wall 32 is hypothesized to reduce pain and/or the
damage caused to tissue in the area of hole formation.
[0186] FIG. 4B illustrates hole-forming member 50, comprising a
piercing device 152. The hole-forming function of piercing device
152 is imparted by distal movement of a piercing element 162.
[0187] FIG. 4C illustrates hole-forming member 50, comprising an
energy applicator 154, typically comprising a control unit 155, a
handle 166 and a tip 164. For some applications, energy applicator
154 comprises an ultrasonic drill, for example, an ultrasonic/sonic
driller/corer (USDC). The hole-forming function of the ultrasonic
drill is imparted by ultrasonic vibration of the tip 164 in contact
with bone wall 32. The ultrasonic vibration is typically provided
by a piezoelectric actuator in handle 166.
[0188] For some applications, energy applicator 154 comprises a
radio frequency (RF) electrode. In this example, tip 164 comprises
the RF electrode, typically driven by the control unit 155 to apply
a current having a frequency and amplitude suitable for forming a
hole in bone wall 32. The control unit may also drive the electrode
to apply a current having a frequency and amplitude suitable for
cauterizing the area of hole-formation. A cauterizing RF electrode
may also be employed in combination with other embodiments of
hole-forming member 50 (e.g., those described with reference to
FIGS. 4A, 4B, 4D and 4E), in order to reduce bleeding during and
after formation of hole 40 (see FIGS. 8A-C for an example of such a
combination).
[0189] FIG. 4D illustrates hole-forming member 50, comprising a
laser cutter 156. A laser 170 generates a laser beam 168 which
imparts energy sufficient to form hole 40 in bone wall 32. The
laser is controlled by control unit 157.
[0190] FIG. 4E illustrates hole-forming member 50, comprising a
water jet cutter 158. A pump 174 forces water at high pressure
through the water jet cutter where it is optionally mixed with an
abrasive 176. Abrasive 176 typically comprises particles of a solid
substance such as a mineral, a polymer or a frozen aqueous solution
(e.g., frozen saline). A water jet 172 is ejected, forming hole 40
in bone wall 32.
[0191] Both laser cutter 156 and water jet cutter 158 function by
formation of an energetic stream (laser beam 168 and water jet 172,
respectively). These applications of the invention may comprise
multiple converging streams which focus their energy at a specific
distance, reducing the risk of damage to the inside of the sinus
due to inadvertent entry of the stream immediately following
successful formation of the hole 40. Alternatively, laser cutter
156 generates a straight beam 168, and/or water jet cutter 158
generates a straight water jet 172 (as shown).
[0192] Cooling element 151 is illustrated in FIG. 4A in conjunction
with drill 150, but may be used in conjunction with numerous
embodiments of hole-forming member 50 including, but not limited
to, piercing device 152, energy applicator 154, laser cutter 156
and water jet cutter 158, as well as other hole-forming
members.
[0193] Reference is now made to FIGS. 5A-D, which illustrate four
versions of implant 52, in accordance with respective applications
of the present invention. Each version of implant 52 is shaped to
define a lumen 100. Each version features a shoulder 102 which,
being wider than more distal regions of implant 52, inhibits
implant 52 from entering the sinus cavity entirely. Alternatively,
versions of implant 52 may not include shoulder 102. Each version
of implant 52 illustrated in this figure has a fastener which,
together with, or independently from, shoulder 102, fastens implant
52 in hole 40 formed in bone wall 32. Optionally, implant 52 may
comprise a biodegradable material such as (but not limited to)
polyglycolide (PGA), polylactide (PLA) or another biodegradable
material known in the art. Implant 52 may be entirely
biodegradable.
[0194] FIG. 5A is a schematic illustration of implant 52, embodied
as a push-in implant 90. The fastener of this implant is one or
more extendable members, such as wings 104. Due to their
flexibility and angle, wings 104 are able to flex inwardly and pass
through the formed hole 40 in bone wall 32 when implant 52 is
inserted through the bone wall. Wings 104 return to their original
position once on the sinus side of bone wall 32, fastening implant
52 in place.
[0195] FIG. 5B is a schematic illustration of implant 52, embodied
as a push-in implant 92. Implant 92 comprises a fastener comprising
one or more extendable members, such as wings 106. Wings 106 are
similar to wings 104 of implant 90, but are coupled to the body of
the implant by a support 107 at an additional longitudinal site
along the implant, and provide greater contact with the sinus-side
of bone wall 32, compared to contact provided by wings 104 of
implant 90.
[0196] FIG. 5C is a schematic illustration of implant 52, embodied
as a screw-in implant 94. The fastener of this implant is a screw
thread 108. Following positioning of implant 94 at hole 40, the
implant is fastened into the hole by rotation, as per a classical
screw. For some applications, this rotation may be imparted by the
hole-forming member 50. In applications in which hole-forming
member 50 forms hole 40 by rotation, implant 94 may be fastened
using the same rotational force that is used to form the opening in
bone wall 32. In these applications of the invention, implant 94
may be reversibly coupled to hole-forming member 50 in a manner
that prevents independent rotation (e.g., using a hex socket). For
example, screw-in implant 94 may be reversibly coupled to drill 70,
such that, after formation of hole 40, continued rotation of drill
70 fastens implant 94 into the hole. Alternatively or additionally,
rotational force may be applied separately, after hole 40 has been
formed.
[0197] As described hereinabove, in some applications of the
invention, implant 52 (or screw-in implant 94) is self-tapping,
comprising a self-tapping screw-thread. In these applications of
the invention, no independent hole-forming member is required.
Rather, implant 52 is pushed against bone wall 32 and rotated such
that it cuts into, and becomes implanted in, the bone wall.
[0198] Reference is made to FIG. 5D, which illustrates implant 52,
embodied as a rivet implant 96. Rivet implant 96 has a
configuration similar to a blind rivet. The fastener of this
version is buck-tail 112. The implant is supplied in a restrained
first configuration (left drawing) and is maintained in this
configuration by a restraint, such as splint 114. Upon removal of
splint 114, buck-tail 112 moves to a relaxed second configuration
(right drawing). The relaxed configuration of buck-tail 112 is
wider than the hole 40 formed in bone wall 32 and therefore fastens
the implant in place.
[0199] Reference is now made to FIG. 5E, which illustrates a rivet
implant 98, according to an application of the invention. Rivet
implant 98 is similar to rivet implant 96 but does not comprise a
restraint; rather the buck-tail is distorted from a first
configuration to a second configuration by a force applied by an
applicator. FIG. 6 illustrates such an applicator, according to an
application of the invention.
[0200] FIGS. 6A-B are schematic illustrations, showing two
sequential steps in the implantation of rivet implant 98, in
accordance with an application of the invention. Reference is made
to FIG. 6A. Rivet assembly 74, comprising an applicator 76 and
rivet implant 98, is inserted into hole 40 in the direction of
arrow 77, until a shoulder 102 of the rivet implant abuts the
proximal surface of bone wall 32. As described with reference to
FIG. 5E, rivet implant 98 is configured so as to act as a blind
rivet. Correspondingly, applicator 76 is configured so as to act as
an appropriate mandrel.
[0201] Reference is now made to FIG. 6B. Applicator 76 is withdrawn
in the direction of arrow 79, driving a mandrel head 78 into and
then out of buck-tail 112. Mandrel head 78 deforms buck-tail 112 of
rivet implant 98 into a configuration that fastens the implant in
place.
[0202] Although FIGS. 6A-B illustrate rivet implant 98 being
implanted in a hole in bone wall 32 of a paranasal sinus, rivet
implant 98 may be implanted in a hole in other tissues (e.g., an
anatomical wall, such as a wall of a hollow organ, for example, a
bone wall) of a subject. Alternatively or additionally, rivet
implant 98 is solid, i.e., not shaped to define a lumen.
[0203] Reference is made to FIG. 7, which is a schematic
illustration of an application of the invention. After implantation
of implant 52, a medical instrument 70, which in this application
comprises a balloon catheter 134, is used to implant an expandable
stent 130 in a natural sinus ostium 26. In its initial form,
balloon 132 is disposed within the lumen of stent 130 in a deflated
form. Catheter 134 is used to insert stent 130 and balloon 132
through hole 40, through sinus 24 and finally into ostium 26. The
balloon 132 is then inflated, expanding stent 130 and opening the
ostium. Balloon 132 is then deflated and removed using balloon
catheter 134. Due to its configuration, stent 130 remains expanded,
supporting ostium 26 in an open configuration. Alternatively,
expandable stent 130 may be delivered to ostium 26 in a contracted
form and configured to expand passively when a force contracting
the stent is removed. For example, stent 130 may be delivered
within a sheath. Upon removal of the sheath, the stent expands,
supporting ostium 26 in an open configuration.
[0204] Such implantation of stent 130 in a sinus ostium may also be
performed without passage through a formed hole in a sinus wall.
For example, stent 130 could be advanced through the nasal cavity,
between inferior turbinate 30 and middle turbinate 28 and into
ostium 26. Implantation of stent 130 may be assisted by the use of
a guidewire and/or an endoscope. Stent 130 may comprise a
biodegradable material such as (but not limited to) polyglycolide
(PGA), polylactide (PLA) or another biodegradable material known in
the art. Implant 130 may be entirely biodegradable.
[0205] Reference is made to FIGS. 8A-C, which are schematic
illustrations of a hole being formed in bone wall 32, in accordance
with an application of the invention. In this application of the
invention, hole-forming member 50 comprises one or more RF
electrodes 180 and drill bit 160. As described hereinabove,
hole-forming member 50 is used to create hole 40 in bone wall 32
that divides nasal cavity 38 from maxillary sinus 24. In this
application of the invention, electrodes 180 are configured to
penetrate soft tissue 37 of the nasal cavity and mucosal lining 36
of the sinus, and to cauterize these tissues.
[0206] Reference is now made to FIG. 8A. Hole-forming member 50 is
advanced toward bone wall 32. The distal tips of electrodes 180 are
disposed distal to the distal tip of drill bit 160. Electrodes 180
penetrate and cauterize soft tissue 37.
[0207] Reference is now made to FIG. 8B. Drill bit 160 is extended
distally through the hole formed in soft tissue 37, and is rotated
in order to drill through bone wall 32.
[0208] Reference is now made to FIG. 8C. Electrodes 180 are
extended distally through the hole formed in bone wall 32, and
penetrate and cauterize mucosal lining 36. FIG. 8C shows drill bit
160 as retracted prior to this extension of electrodes 180.
Alternatively, electrodes 180 may slide over drill bit 160, drill
bit 160 remaining in the hole in bone wall 32 until after mucosal
lining 36 has been penetrated.
[0209] It is noted that the cauterization described with reference
to FIG. 8A may be performed without the step of cauterization
described with reference to FIG. 8C, and that the cauterization
described with reference to FIG. 8C may be performed without the
step of cauterization described with reference to FIG. 8A.
[0210] In an alternative application of the invention, hole-forming
member 50 does not comprise RF electrodes 180; rather, RF
electrodes 180 are coupled to hole-forming member 50, and are
configured to cauterize. Typically, RF electrodes 180 are
controlled by a control unit (such as control unit 155, described
with reference to FIG. 4C). In this application of the invention,
hole-forming member 50 (e.g., drill bit 160) penetrates soft tissue
37 and mucosal lining 36, in addition to bone wall 32. Electrodes
180 cauterize soft tissue 37 and mucosal lining 36 following the
penetration of these tissues by the hole-forming member. Typically,
RF electrodes 180 are fixed in position with respect to drill bit
160, such that the tips of electrodes 180 are slightly proximal to
the tip of drill bit 160 (e.g., less than 3 mm from the tip).
Alternatively, RF electrodes 180 may be slidable with respect to
hole-forming member 50.
[0211] It will be appreciated by persons skilled in the art that
the present invention is not limited to what has been particularly
shown and described hereinabove. Rather, the scope of the present
invention includes both combinations and subcombinations of the
various features described hereinabove, as well as variations and
modifications thereof that are not in the prior art, which would
occur to persons skilled in the art upon reading the foregoing
description.
* * * * *