U.S. patent application number 13/160469 was filed with the patent office on 2011-10-06 for delivery tools for sleep disorders treatment implant and methods of implantation.
Invention is credited to Casidy Hallsten, Anant V. Hegde, Phil Houle, Kasey Kai-Chi Li, Chris D. Owen.
Application Number | 20110240037 13/160469 |
Document ID | / |
Family ID | 41507398 |
Filed Date | 2011-10-06 |
United States Patent
Application |
20110240037 |
Kind Code |
A1 |
Hegde; Anant V. ; et
al. |
October 6, 2011 |
Delivery Tools for Sleep Disorders Treatment Implant and Methods of
Implantation
Abstract
Methods and tools are disclosed for inserting an implant device
that treats snoring and apnea of a patient by altering the position
of a soft palate. Methods and tools can make an incision in
patient's soft and hard palate to create a cavity that can house
the implant. The tools can have visually observable markings that
can be aligned with the incision, thus controlling the depth of the
cavity. A needle having an incision edge can be used to make an
incision in patient's soft palate. The needle can be bent into a
suitable longitudinal shape to allow easier access and
visualization of the process. A blade that makes the cavity in the
tissue can be housed inside a channel in the needle. The tools may
have stoppers to prevent excessive extension and retraction of the
blade thus preventing an excessive cavity depth. Some tools may
also house the implant device, which may be implanted after the
cavity is formed.
Inventors: |
Hegde; Anant V.; (Hayward,
CA) ; Li; Kasey Kai-Chi; (Palo Alto, CA) ;
Houle; Phil; (Sunnyvale, CA) ; Hallsten; Casidy;
(San Mateo, CA) ; Owen; Chris D.; (Manteca,
CA) |
Family ID: |
41507398 |
Appl. No.: |
13/160469 |
Filed: |
June 14, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12168820 |
Jul 7, 2008 |
7980248 |
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13160469 |
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10946435 |
Sep 21, 2004 |
7836888 |
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12168820 |
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11233493 |
Sep 21, 2005 |
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10946435 |
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Current U.S.
Class: |
128/848 |
Current CPC
Class: |
A61B 17/320016 20130101;
A61B 2017/248 20130101; A61F 5/56 20130101; A61B 17/3209 20130101;
A61F 2/00 20130101 |
Class at
Publication: |
128/848 |
International
Class: |
A61F 5/56 20060101
A61F005/56 |
Claims
1-8. (canceled)
9. A cavitation tool for creating a cavity in a palate comprising:
a posterior end; an anterior end; a needle adapted and configured
to incise and lift tissue, wherein the needle comprises a posterior
end, an anterior end, and a channel extending from the posterior
end of the needle to the anterior end of the needle and an incising
edge at the posterior end of the needle for incising tissue; a
blade comprising a posterior end, an anterior end, and a cutting
element at the posterior end of the blade for creating a tissue
cavity in which an implant device may be deployed, wherein the
blade slides in the posterior and anterior directions within the
channel of the needle and can extend out the posterior end of the
needle and anterior end of the needle; a first handle connected to
the needle adapted and configured to control the position of the
needle; and a second handle connected to the blade at the anterior
end of the blade, wherein the handle is adapted and configured to
slide the blade within the channel of the needle and into the
tissue to create the cavity.
10. The cavitation tool of claim 9 comprising a stopper connected
to the blade at the anterior end of the blade, wherein the stopper
is adapted and configured to stop the posterior motion of the
blade.
11. The cavitation tool of claim 10 comprising a marking on the
needle, wherein the marking indicates where to align the tool with
the incision to create the cavity appropriately sized for the
implant device.
12. The cavitation tool of claim 11 wherein the posterior motion of
the blade is stopped by the stopper when the cutting element of the
blade extends about 2.5 centimeters posterior to the needle
marking.
13. The cavitation tool of claim 9 wherein the cavitation tool is
curved to aid in procedure visualization.
14. The cavitation tool of claim 9 wherein the first handle can be
injection molded around the needle.
15. The cavitation tool of claim 9 wherein the needle comprises at
least one of stainless steel, a shape memory metal (e.g. Nitinol),
and a plastic.
16. The cavitation tool of claim 9 wherein the incising edge is
beveled to aid in incising tissue, to aid in moving the needle
through the tissue, and to aid in lifting the tissue.
17. The cavitation tool of claim 9 wherein the blade comprises at
least one of stainless steel, a shape memory metal (e.g. Nitinol),
and a plastic.
18. The cavitation tool of claim 9 wherein the cutting element of
the blade is rounded.
19. The cavitation tool of claim 9 wherein the blade is more
flexible at the posterior end of the blade than at the anterior end
of the blade.
20. The cavitation tool of claim 9 wherein the blade comprises a
first cutting layer and a second layer, wherein the cutting first
layer is adapted and configured to extend posterior to the second
layer, and wherein the layers are joined.
21. The cavitation tool of claim 9 wherein the blade comprises a
single layer and a taper at the posterior end of the blade.
22. The cavitation tool of claim 21 wherein the taper of the blade
is made by a process chosen from a group consisting of a grinding,
chemical etching, or a combination thereof.
23. The cavitation tool of claim 9 wherein the blade comprises a
heat shrink material and wherein the heat shrink material forms the
external surface of the blade and extends up to the cutting element
of the blade.
24. The cavitation tool of claim 9 wherein the cavitation tool can
be sterilized.
25. An implant delivery tool for deploying an implant device
comprising: a sheath; a support tube within a portion of the sheath
wherein the support tube and sheath are joined and wherein the
support tube comprises a cutout section to limit range of motion
for an implant support; a sheath retractor joined to the support
tube; the implant support within the sheath and within the support
tube, wherein the implant support comprises a posterior end, an
anterior end, and a third handle fastening element aligning with
the cutout section of the support tube, wherein the implant support
supports the implant device during deployment into a cavity in the
palate; and a third handle having an implant support fastening
element adapted and configured to mate with the third handle
fastening element, wherein the third handle has a channel through
which the support tube and the sheath slide anteriorly and
posteriorly relative to the handle and implant support.
26. The delivery tool of claim 25 wherein the sheath is clear or
translucent.
27. The delivery tool of claim 25 wherein the implant support
comprises at least one cutout to increase flexibility.
28. The delivery tool of claim 25 wherein the posterior end of the
implant support is more flexible than is the anterior end of the
implant support.
29. The delivery tool of claim 25 wherein the implant support
tapers down in thickness from the anterior end of the implant
support to the posterior end of the implant support.
30. The delivery tool of claim 25 wherein the implant support
comprises at least one of stainless steel, a shape memory metal
(e.g. Nitinol), and a plastic.
31. The delivery tool of claim 25 wherein the implant support
comprises an abutting portion against which the implant device
abuts during insertion into the cavity for alignment of the implant
device during deploymnent.
32. The delivery tool of claim 31 wherein the abutting portion is a
flap on the implant support.
33. The delivery tool of claim 25 wherein the sheath comprises a
dimple adapted and configured to align the implant device on the
implant support until delivery into the cavity.
34. The delivery tool of claim 25 wherein the sheath comprises a
sheath flap adapted and configured to laterally support the implant
device during insertion into the cavity.
35. The delivery tool of claim 25 wherein the delivery tool is
adapted and configured to be sterilized.
36. A delivery and cavitation tool for deploying an implant device
comprising: a cavitation element for creating a cavity in a palate
comprising a posterior end, a anterior end, a needle adapted and
configured to incise and lift tissue, wherein the needle comprises
a posterior end, an anterior end, and a channel extending from the
posterior end of the needle to the anterior end of the needle and
an incising edge at the posterior end of the needle for incising
tissue, a blade comprising a posterior end, an anterior end, and a
cutting element at the blade posterior end for creating a tissue
cavity in which the implant device may be deployed, wherein the
blade slides in the posterior and anterior directions within the
needle channel and can extend out the posterior end of the needle
and anterior end of the needle, a first handle connected to the
needle adapted and configured to control the position of the
needle, and a second handle connected to the blade at the anterior
end of the blade, wherein the handle is adapted and configured to
slide the blade within the channel of the needle and into the
tissue to create the cavity; and a delivery element for delivering
the implant device into the cavity created by the cavitation
element comprising a sheath, a support tube within a portion of the
sheath wherein the support tube and sheath are joined and wherein
the support tube comprises a cutout section, a sheath retractor
joined to the support tube, an implant support within the sheath
and within the support tube, wherein the implant support has a
third handle fastening element aligning with the cutout section of
the support tube, and wherein the implant support supports the
implant device during deployment into a cavity in the palate, and a
third handle having an implant support fastening element adapted
and configured to mate with the third handle fastening element,
wherein the third handle has a channel through which the support
tube and the sheath slide anteriorly and posteriorly relative to
the handle and implant support.
37. The tool of claim 36 wherein the tool can be sterilized.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a continuation in part of U.S. patent
application Ser. Nos. 10/946,435, filed Sep. 21, 2004, and
11/233,493 filed Sep. 21, 2005, which are incorporated herein by
reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] Snoring is very common among mammals including the humans.
Snoring is a noise produced while breathing during sleep due to the
vibration of the soft palate and uvula. If the snoring gets worst
overtime and goes untreated, it could lead to apnea.
[0003] Those with apnea stop breathing in their sleep, often
hundreds of times during the night. Usually apnea occurs when the
throat muscles and tongue relax during sleep and partially block
the opening of the airway. When the muscles of the soft palate at
the base of the tongue and the uvula relax and sag, the airway
becomes blocked, making breathing difficult and noisy and even
stopping it altogether. Sleep apnea also can occur in obese people
when an excess amount of tissue in the airway causes a narrowing of
the airway. In a given night, the number of involuntary breathing
pauses or "apneic events" may be as high as 20 to 60 or more per
hour. These breathing pauses are almost always accompanied by
snoring between apnea episodes. Sleep apnea can also be
characterized by choking sensations.
[0004] Sleep apnea is diagnosed and treated by the primary care
physicians, pulmonologists, neurologists, or other physicians with
specialty training in sleep disorders. Diagnosis of sleep apnea is
not simple because there can be many different reasons for
disturbed sleep. The specific therapy for sleep apnea is tailored
to the individual patient based on medical history, physical
examination, and the results of polysomnography. Medications are
generally not effective in the treatment of sleep apnea. Oxygen is
sometimes used in patients with central apnea caused by heart
failure. It is not used to treat obstructive sleep apnea.
[0005] Nasal continuous positive airway pressure (CPAP) is the most
common treatment for sleep apnea. In this procedure, the patient
wears a mask over the nose during sleep, and pressure from an air
blower forces air through the nasal passages. The air pressure is
adjusted so that it is just enough to prevent the throat from
collapsing during sleep. The pressure is constant and continuous.
Nasal CPAP prevents airway closure while in use, but apnea episodes
return when CPAP is stopped or it is used improperly. Many
variations of CPAP devices are available and all have the same side
effects such as nasal irritation and drying, facial skin
irritation, abdominal bloating, mask leaks, sore eyes, and
headaches. Some versions of CPAP vary the pressure to coincide with
the person's breathing pattern, and other CPAPs start with low
pressure, slowly increasing it to allow the person to fall asleep
before the full prescribed pressure is applied.
[0006] Dental appliances that reposition the lower jaw and the
tongue have been helpful to some patients with mild to moderate
sleep apnea or who snore but do not have apnea. A dentist or
orthodontist is often the one who fits the patient with such a
device.
[0007] Some patients with sleep apnea may need surgery. Although
several surgical procedures are used to increase the size of the
airway, none of them is completely successful or without risks.
More than one procedure may need to be tried before the patient
realizes any benefits. Some of the more common procedures include
removal of adenoids and tonsils (especially in children), nasal
polyps or other growths, or other tissue in the airway as well as
correction of structural deformities. Younger patients seem to
benefit from these surgical procedures more than older
patients.
[0008] Uvulopalatopharyngoplasty (UPPP) is a procedure used to
remove excess tissue at the back of the throat (tonsils, uvula, and
part of the soft palate). The success of this technique may range
from 30 to 60 percent. The long-term side effects and benefits are
not known, and it is difficult to predict which patients will do
well with this procedure.
[0009] Laser-assisted uvulopalatoplasty (LAUP) is done to eliminate
snoring but has not been shown to be effective in treating sleep
apnea. This procedure involves using a laser device to eliminate
tissue in the back of the throat. Like UPPP, LAUP may decrease or
eliminate snoring but not eliminate sleep apnea itself. Elimination
of snoring, the primary symptom of sleep apnea, without influencing
the condition may carry the risk of delaying the diagnosis and
possible treatment of sleep apnea in patients who elect to have
LAUP. To identify possible underlying sleep apnea, sleep studies
are usually required before LAUP is performed.
[0010] Somnoplasty is a procedure that uses RF to reduce the size
of some airway structures such as the uvula and the back of the
tongue. This technique helps in reducing snoring and is being
investigated as a treatment for apnea.
[0011] Tracheostomy is used in persons with a severe,
life-threatening sleep apnea. In this procedure, a small hole is
made in the windpipe and a tube is inserted into the opening. This
tube stays closed during waking hours and the person breathes and
speaks normally. It is opened for sleep so that air flows directly
into the lungs, bypassing any upper airway obstruction. Although
this procedure is highly effective, it is an extreme measure that
is rarely used.
[0012] Patients whose sleep apnea is caused by the deformities of
the lower jaw may benefit from surgical reconstruction. Surgical
procedures to treat obesity are sometimes recommended for sleep
apnea patients who are morbidly obese. Behavioral changes are an
important part of the treatment program, and in mild cases
behavioral therapy may be all that is needed. Overweight persons
can benefit from losing weight. Even a 10 percent weight loss can
reduce the number of apneic events for most patients. Individuals
with apnea should avoid the use of alcohol and sleeping pills,
since they make the airway more likely to collapse during sleep and
prolong the apneic periods. In some patients with mild sleep apnea,
breathing pauses occur only when they sleep on their backs. In such
cases, using pillows and other devices that help them sleep in a
side position may be helpful.
[0013] Recently, Restore Medical, Inc., Saint Paul, Minn. has
developed a new treatment for snoring and apnea, called the Pillar
technique. Pillar System is a procedure where 2 or 3 small
polyester rods are placed in the patient's soft palate. The Pillar
System stiffens the palate thus reducing the vibration of the soft
palate, and possibly prevents the airway collapse. Stiff implants
in the soft palate, however, could hinder patient's normal
functions like speech, ability to swallow, coughing and sneezing.
Puncturing the tissue with a stiff implant is another long-term
concern. Other implants have been disclosed, such as those in U.S.
patent application Ser. No. 11/613,027, which is incorporated
herein by reference in its entirety.
[0014] Thus, there exists a need for methods and devices to create
a cavity and to insert an implant that can treat apnea or snoring
of a patient.
BRIEF SUMMARY OF THE INVENTION
[0015] The present invention relates to methods and tools for the
insertion of an implant device that treats snoring and apnea of a
patient by altering the position of a soft palate. The tools and
methods can make an incision in patient's soft and hard palate to
create a cavity that can house the implant device. A needle having
an incision edge can be used to make an incision in patient's soft
palate. The needle can be bent into a suitable longitudinal shape
to allow easier access and visualization of the process. A blade
that makes the cavity in the tissue can be housed inside a channel
of the needle. The tools may have stoppers to prevent excessive
extension of the blade, thus preventing an excessive cavity depth.
The tools can have visually observable markings that can be aligned
with the incision, thus controlling the depth of the cavity. Some
tools may also house the implant device, which may be implanted
after the cavity is formed.
[0016] In one embodiment, a method for treating snoring and/or
apnea of a patient includes: incising a periosteum inferior to the
hard palate with a cavitation tool, where the incising creates an
incision, and where the cavitation tool has a needle having a
posterior end, an anterior end, a channel extending the length of
the needle from the posterior end of the needle to the anterior end
of the needle, a blade that is adapted and configured to slide
through the channel and out the posterior end of the needle, and an
incising edge at the posterior end of the needle for incising the
periosteum inferior to the hard palate and/or for incising the soft
palate; creating a cavity within the periosteum inferior to the
hard palate and within a soft palate using the cavitation tool, the
creating of the cavity having the steps of entering with the needle
the periosteum inferior to the hard palate through the incision
created by the cavitation tool, extending the blade through the
channel of the needle whereby the blade extends posterior to the
posterior end of the needle, and cutting a cavity in the hard and
soft palate such that the cutting comprises separating the
periosteum from the hard palate and advancing the blade into the
soft palate tissue; entering the cavity created within the
periosteum inferior to the hard palate and the soft palate with an
airway implant device loaded on an implant delivery tool that has
an implant support upon which the device rests and a retractable
sheath extending over at least a portion of the device and at least
a portion of the implant support; and deploying the implant device
into the cavity created within the periosteum inferior to the hard
palate and within the soft palate, such that the deploying includes
positioning the implant device within the cavity, such that the
implant device is loaded on the implant delivery tool, retracting
the delivery tool sheath while keeping the implant device and the
implant support fixed relative to each other and in a substantially
fixed position within the cavity, removing the delivery tool from
the cavity, and leaving the implant device within the cavity.
[0017] In one aspect, deploying the device includes closing the
incision.
[0018] In another aspect, deploying the device includes securing
the airway implant device within the cavity.
[0019] In another aspect, securing the device includes suturing the
device to a tissue.
[0020] In one embodiment, a cavitation tool for creating a cavity
in a palate includes: a posterior end; an anterior end; a needle
adapted and configured to incise and lift tissue, where the needle
has a posterior end, an anterior end, and a channel extending from
the posterior end of the needle to the anterior end of the needle
and an incising edge at the posterior end of the needle for
incising tissue; a blade having a posterior end, an anterior end,
and a cutting element at the posterior end of the blade for
creating a tissue cavity in which an implant may be implanted, such
that the blade slides in the posterior and anterior directions
within the channel of the needle and can extend out the posterior
end of the needle and anterior end of the needle; a first handle
connected to the needle adapted and configured to control the
position of the needle; and a second handle connected to the blade
at the anterior end of the blade, such that the handle is adapted
and configured to slide the blade within the channel of the needle
and into the tissue to create the cavity.
[0021] In another embodiment, a delivery tool for implanting an
airway implant includes: a sheath; a support tube within a portion
of the sheath such that the support tube and sheath are joined and
such that the support tube has a cutout section; a sheath retractor
joined to the support tube; an implant support within the sheath
and within the support tube, such that the implant support has a
posterior end, an anterior end, and a third handle fastening
element aligning with the cutout section of the support tube, such
that the implant support supports the implant during implantation
into a cavity in the palate; and a third handle having an implant
support fastening element adapted and configured to mate with the
third handle fastening element, such that the third handle has a
channel through which the support tube and the sheath slide
anteriorly and posteriorly relative to the handle and implant
support.
[0022] For a further understanding of the nature and advantages of
the invention, reference should be made to the following
description taken in conjunction with the accompanying figures. It
is to be expressly understood, however, that each of the figures is
provided for the purpose of illustration and description only and
is not intended as a definition of the limits of the embodiments of
the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 illustrates the terminology used to describe object
position with reference to a patient's head.
[0024] FIG. 1B is a cross sectional view of a patient's head
showing the hard and soft palate.
[0025] FIG. 2 illustrates an implant device in the soft palate.
[0026] FIG. 3 is a perspective view of an embodiment of the
cavitation tool.
[0027] FIG. 4 is a perspective view of the distal end of a needle
of the cavitation tool.
[0028] FIG. 5 is a planar view showing a blade and a second handle
of the cavitation tool.
[0029] FIGS. 5A and 5B show top planar views of a rounded and an
angled cutting elements of the cavitation tool blade,
respectively.
[0030] FIGS. 6A and 6B show side planar views of a blade of the
cavitation tool.
[0031] FIG. 7 is an exploded view of an embodiment of the
cavitation tool.
[0032] FIG. 8 is a partial view of the anterior end of the needle
and needle stopper of the cavitation tool.
[0033] FIG. 9 shows an isometric view of an embodiment of an
implant delivery tool.
[0034] FIG. 10 shows a partial cross-sectional view of an
embodiment of the implant delivery tool.
[0035] FIG. 11 shows an isometric view of the posterior end of an
embodiment of the implant delivery tool.
[0036] FIG. 12 shows an exploded view of an embodiment of the
implant delivery tool.
[0037] FIG. 13 illustrates an embodiment of a combined delivery and
cavitation tool.
DETAILED DESCRIPTION OF THE INVENTION
[0038] The embodiments of the present invention are directed toward
tools and methods for inserting an implant device that treats
snoring and apnea. The tools and methods can make a cavity in
patient's soft and hard palate and can insert the implant device in
the cavity. The tools and methods have numerous advantages. For
example, the tools can have visually observable markings that can
be aligned with the incision edge, thus controlling the depth of
the cavity. The tools may have stoppers to prevent excessive
extension and retraction of the blade. In some embodiments, the
same tool may be used for the tissue cutting and implant insertion.
The details of the exemplary embodiments of the present invention
are explained with reference to FIGS. 1-13.
[0039] FIG. 1 illustrates the terminology used in describing
position of an object with reference to the patient's head. As
shown by the arrows in FIG. 1, the position of an object can be
anterior or posterior, superior or inferior, and left or right.
Anterior 100 refers to an area toward the front of the head or the
invention, or in front of another part of the body or invention, or
represents the front view of the invention. Conversely, posterior
102 refers to a part of the head or the invention toward the back
of the invention or body, or behind another part of the invention
or body, or represents the rear view of the body or the invention.
Analog sets of definitions apply to superior 106 or inferior 108
and left 104 or right 105, as shown by the arrows in FIG. 1.
[0040] FIG. 1B shows a cross-sectional view of patient's palate
having soft palate 84 and hard palate 74. Periosteum 118 is a
membrane that lines the outer surface of hard palate 74. The tools
that are described below are inserted through the mouth of the
patient. An incision is made in soft palate 84, and a cavity is
formed in the soft palate, and may also extend to a portion of hard
palate 74.
[0041] FIG. 2 shows a partial cross-sectional view of a patient's
mouth. Tooth 64 is on the anterior side of the mouth. Implant
device 2 is inserted into cavity 94 in soft palate 84. In some
embodiments of the invention, the cavity may partially extend to
hard palate 74. If the cavity extends to the hard palate, then
Periosteum 118 has to be separated from or lifted off hard palate
74. Implant device 2 may take different shapes and sizes. Thus, the
implant device shape shown in FIG. 2 is illustrative, not
restrictive.
[0042] FIG. 3 shows a perspective view of cavitation tool 134 which
may be used to make incision and cavity in patient's soft and hard
palate. Cavitation tool 134 has blade 144 that is partially housed
in needle 140. First handle 166 can be injection molded around
needle 140. A channel can extend along the interior of needle 140
thus allowing blade 144 to slide inside the needle. Blade 144 can
be attached to stopper 160. The movement range of blade 144 within
the channel of needle 140 can be limited by stopper 160. When the
posterior end of stopper 160 and the anterior end of first handle
166 make contact, the posterior end of blade 144 extends out of
needle 140 to the maximum extent. Stopper 160 can be attached to
second handle 168. In some embodiments the posterior end of blade
144 may extend up to about 2.5 cm from needle 140, but other
dimensions are possible depending on the required depth of the
cavity. Blade 144 may be made of stainless steel, a shape memory
metal (e.g. Nitinol), plastic, or other suitable material.
[0043] Needle 140 may be bent to allow easier access to the
patient's palate and also to aid procedure visualization. Needle
140 can be made more rigid than blade 144, thus blade 144 having to
conform to the shape of needle 140. Needle 140 can have markings
156, which may be aligned with the incision to evaluate the depth
of the cavity. The needle may be made of stainless steel, a shape
memory metal (e.g. Nitinol), or plastic. Other suitable materials
are available.
[0044] FIG. 4 shows a perspective view of the posterior end of
needle 140. One or more markings 156 can be placed near the
posterior side of needle 140 to help evaluate the depth of the
cavity by lining the markings against the incision in soft palate
84. Markings 156 can have several lines or other indicators of the
distance to the posterior tip of blade 144, thus indicating a depth
of cavity 94. Markings 156 can also be used to indicate the
location on patient's palate where the needle incision should be
made. Needle 140 can have incising edge 157 to make an incision in
the tissue, to help move the needle through the tissue, and to lift
the tissue. Incising edge 157 can also be used for separating and
elevating periosteum 118 from hard palate 74. Incising edge 157 can
be beveled.
[0045] FIG. 5 shows a top planar view of blade 144 and second
handle 168. Stopper 160 and second handle 168 can attach with blade
144. Stopper 160 is shown as a surface on second handle 168, but
the stopper can also be a separate part. As explained in reference
to FIG. 3, the location of stopper 160 determines how far first
handle 166 can slide in the anterior direction relative to blade
144. Because first handle 166 is attached with needle 140, the
contact between stopper 160 and first handle 166 also determines
how far can blade 144 extend out of needle 140.
[0046] FIGS. 5A and 5B show detail views of cutting element 164 at
the posterior side of blade 144. Rounded and angled cutting
elements 164 are shown in FIGS. 5A and 5B, respectively. Many other
shapes are possible. Cutting element 164 can be used to create a
cavity in soft palate 84 and hard palate 74.
[0047] FIG. 6A shows a side planar view of an embodiments of blade
144. In this embodiment, blade 144 can be configured by joining
first cutting layer 182 and second layer 184. Due to smaller
thickness of blade 144 at its posterior end, blade 144 is more
flexible at the posterior end than at its anterior end. An increase
in blade flexibility can make the blade more maneuverable.
[0048] FIG. 6B shows another embodiment of blade 144 that also has
variable thickness and, hence, different flexibility at its
posterior and anterior ends. Blade 144 can be made of a single
layer material. The posterior end of blade 144 can be tapered by
grinding, chemical etching, or other processes that remove
material, thus making taper 186 on the blade. The reduction of
thickness of the blade 144 at its posterior end results in the
increased blade flexibility at that end.
[0049] FIG. 7 shows an exploded view of an embodiment of cavitation
tool 134. In this embodiment, the external surface of blade 144 can
be partially covered by heat shrink 178 from the anterior end of
blade 144 to cutting element 164. Other coverage of blade 144 by
heat shrink 178 is also possible. A contact between needle stopper
180 and blade stopper 160 limits the maximum extension of the
posterior end of blade 144 relative to the posterior end of needle
140. The cavitation tool can be sterilized.
[0050] FIG. 8 shows the anterior end of needle 140 and needle
stopper 180 in an embodiment of the cavitation tool. Needle 140 can
extend through first handle 166 and needle stopper 180, ending at
the anterior end of needle stopper 180. Needle 140 can have needle
channel 142 that can house blade 144.
[0051] FIG. 9 shows an isometric view of one embodiment of delivery
tool 136. Implant device 2 (not shown) can be supported by implant
support 148 and covered by sheath 150. Delivery tool 136 can be
used for deploying the implant into the cavity. The implant device
can be loaded on the delivery tool and deployed into the cavity by
advancing the posterior end of the delivery tool into the cavity,
followed by retracting sheath 150 towards the anterior end of the
delivery tool while keeping the delivery tool in a substantially
fixed position within the cavity. Implant device 2, which is
covered by sheath 150 at the posterior end of the delivery tool,
can thus be freed from the contact with sheath 150, and left in the
cavity. Sheath 150 can be clear or translucent to visually aid the
deployment of the implant device. After deploying the implant
device in the cavity and removing the delivery tool, the incision
can be closed by, for example, suturing or other methods. The
deployed implant device can be secured in the cavity by, for
example, adhering the device to the tissue using a tissue adhesive,
or by suturing the device to the tissue, or by other methods.
[0052] FIG. 10 shows a partial side view of implant device 2,
implant support 148, sheath 150, and support tube 192. Implant
device 2 can be held in place by implant support 148 and sheath
150. The anterior end of implant device 2 can be in contact with
abutting portion 212 on implant support 148. Abutting portion 212
can be made by joining with implant support 148, but it can also be
made by, for example, stamping a suitable portion of implant
support 148 in the superior direction, thus creating a flap against
which implant device 2 can abut. Thus, implant device 2 can be
partially or fully supported on its inferior and anterior ends by
implant support 148 and abutting portion 212, respectively. Implant
support 148 may be made of stainless steel, a shape memory metal
(e.g. Nitinol), plastic, or other suitable material. Furthermore,
implant device 2 can be partially supported on its left and right
ends by sheath 150. The superior end of implant device 2 can also
be supported by sheath 150 which may have dimple 216 to hold the
implant device in place.
[0053] Support for implant device 2 is illustrated in FIG. 11 which
shows an isometric view of the posterior end of one embodiment of
the delivery tool. Implant support 148 supports the inferior side
of implant device 2 (not shown). Implant support 148 can have
cutout section 206 with one or more cutouts which make implant
support 148 more flexible, hence easier to maneuver. Cutout section
206 shown in FIG. 11 has the cutouts that are smaller in the
vicinity of the posterior side of the implant support, and larger
away from the posterior side, but other arrangements are also
possible. An embodiment of abutting portion 212 that is a flap is
shown, but other types of abutting portion 212 are also possible,
for example an abutting portion that is joined with implant support
148. Sheath 150 has sheath flaps 218 to support the left and right
lateral ends of the implant device. Dimple 216 can be configured to
align the implant device on implant support 148 by pressing against
the superior side of the implant device.
[0054] FIG. 12 shows an exploded view of one embodiment of implant
delivery tool 136. The anterior end of sheath 150 and the posterior
end of support tube 192 can be joined. Sheath retractor 196 can be
attached with the anterior end of support tube 192. Therefore, a
movement of sheath retractor 196 in the anterior direction causes
support tube 192 to move in the same direction, which, in turn,
causes sheath 150 to follow, too. The retraction of sheath 150
along implant support 148 does not cause implant device 2 to move
in the anterior direction because abutting portion 212 prevents
implant device 2 from sliding along implant support 148.
[0055] Implant support 148 can slide inside sheath 150 and support
tube 192. Implant support 148 can attach with third handle 200
using fastening element 202 which is positioned on the superior
side of third handle 200. The superior and inferior sections of
third handle 200 can be connected on their outside edges thus
forming third handle channel 204 through the interior of third
handle 200. Support tube 192 and sheath 150 can slide inside third
handle channel 204. Thus, in the embodiment shown in FIG. 12,
implant support 148 can slide inside support tube 192 and sheath
150, which, in turn, can slide inside third handle channel 204.
When support tube 192 and sheath 150 slide inside third handle
channel 204, the range of their anterior-posterior motion is
limited by the length of cutout section 194 on the superior side of
support tube 192, because the sliding stops when the posterior end
of cutout section 194 reaches fastening element 202 on third handle
200. The range of anterior-posterior motion for support tube 192
and sheath 150 can be selected such that implant device 2 is
secured when sheath 150 is in its posterior position and is
released when sheath 150 is moved to the anterior position. The
implant delivery tool can be sterilized.
[0056] FIG. 13 illustrates an embodiment of combined cavitation and
delivery tool 250. The combined cavitation and delivery tool can
have first handle 166 connected to and controlling the position of
needle 140, second handle 168 connected to blade 144, and a
delivery element for delivering the implant into the cavity created
by the tool.
[0057] As will be understood by those skilled in the art, the
present invention may be embodied in other specific forms without
departing from the essential characteristics thereof. For example,
the lateral support for the implant device may be provided by the
implant support, and not by the sheath. Also, a needle may take
many different longitudinal shapes, including a straight needle.
The implant delivery tool may be used to deliver medications or
diagnostic instruments or similar to the cavity. Many other
embodiments are possible without deviating from the spirit and
scope of the invention. These other embodiments are intended to be
included within the scope of the present invention, which is set
forth in the following claims.
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