U.S. patent application number 11/349045 was filed with the patent office on 2006-09-21 for system and method for percutaneous palate remodeling.
Invention is credited to Erik van der Burg, Michael Dineen, Andrew Frazier, Mark Hirotsuka, Jasper Jackson, Chad C. Roue.
Application Number | 20060207607 11/349045 |
Document ID | / |
Family ID | 36764327 |
Filed Date | 2006-09-21 |
United States Patent
Application |
20060207607 |
Kind Code |
A1 |
Hirotsuka; Mark ; et
al. |
September 21, 2006 |
System and method for percutaneous palate remodeling
Abstract
Methods and devices are disclosed for manipulating the tongue.
An implant is positioned within at least a portion of the tongue
and may be secured to other surrounding structures such as the
mandible and/or hyoid bone. In general, the implant is manipulated
to displace at least a portion of the posterior tongue in an
anterior or lateral direction, or to alter the tissue tension or
compliance of the tongue. Methods and devices are also disclosed
for manipulating other soft tissue structures, including the soft
palate and pharyngeal airway.
Inventors: |
Hirotsuka; Mark; (San Jose,
CA) ; Jackson; Jasper; (Newark, CA) ; Frazier;
Andrew; (Sunnyvale, CA) ; Burg; Erik van der;
(Los Gatos, CA) ; Roue; Chad C.; (San Jose,
CA) ; Dineen; Michael; (Portola Valley, CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
36764327 |
Appl. No.: |
11/349045 |
Filed: |
February 7, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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60650867 |
Feb 8, 2005 |
|
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60726028 |
Oct 12, 2005 |
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Current U.S.
Class: |
128/848 |
Current CPC
Class: |
A61B 2017/0462 20130101;
A61B 2017/0403 20130101; A61B 2017/0433 20130101; A61B 2017/00814
20130101; A61B 17/0401 20130101; A61B 2017/0437 20130101; A61B
2017/0451 20130101; A61B 2017/0417 20130101; A61B 2017/0454
20130101; A61B 2017/0435 20130101; A61B 2017/0422 20130101; A61B
2017/0409 20130101; A61B 2017/044 20130101; A61B 2017/0458
20130101; A61B 2017/0496 20130101; A61B 17/24 20130101; A61B
2017/042 20130101; A61B 17/0487 20130101; A61B 2017/00862 20130101;
A61F 5/56 20130101; A61B 17/02 20130101; A61B 2017/00986 20130101;
A61B 2017/0427 20130101; A61B 2017/0438 20130101; A61B 2017/00004
20130101; A61B 2017/0461 20130101; A61B 2017/0412 20130101; A61B
2017/0464 20130101; A61B 2017/0414 20130101 |
Class at
Publication: |
128/848 |
International
Class: |
A61F 5/56 20060101
A61F005/56 |
Claims
1. A method for treating a patient, comprising: providing a palate
remodeling system, the system comprising at least one tether
support and at least one palate element, the at least one palate
element having at least one expandable tissue anchor joined to at
least one tether; accessing a region about a hard palate; inserting
the at least one expandable tissue anchor through a first pathway
along the region about the hard palate to a soft palate; attaching
the at least one tether of the at least one palate element to the
at least one tether support; positioning the at least one tether
support about the hard palate; and fixing the at least one tether
support about the hard palate.
2. The method for treating a patient as in claim 1, wherein fixing
the at least one tether support about the hard palate comprises
fixing the at least one tether support to the hard palate.
3. The method for treating a patient as in claim 1, wherein fixing
the at least one tether support about the hard palate comprises
fixing the at least one tether support to mucosal tissue overlying
the hard palate.
4. A method for treating a patient, comprising: providing a soft
palate element having an attachment end and an expandable
tissue-anchoring end; inserting the expandable tissue-anchoring end
into the soft palate; securing the attachment end of the palate
element to a body structure.
5. The method for treating a patient as in claim 4, wherein the
body structure is a palatine bone.
6. The method for treating a patient as in claim 5, wherein the
body structure is a hard palate.
7. The method for treating a patient as in claim 4, wherein the
body structure is a nasal turbinate.
8. A method for treating a patient, comprising: accessing a tissue
anchor implanted in a soft palate, the tissue anchor having a
deployment configuration and a removal configuration; deforming the
tissue anchor to the removal configuration; and withdrawing the
tissue anchor from the soft palate.
9. A method for treating a patient, comprising: accessing an
adjustment assembly of a patient with an implanted adjustable soft
palate remodeling system comprising the adjustment assembly and one
or more soft palate elements inserted into the soft palate; wherein
at least one soft palate element comprises an anchor and a tether
secured to the adjustment assembly at a securing point on the
adjustment assembly; and adjusting one or more soft palate elements
by manipulating the adjustment assembly.
Description
RELATED APPLICATION DATA
[0001] This application claims priority under 35 U.S.C. .sctn.
119(e) from provisional application Ser. No. 60/650,867 filed Feb.
8, 2005, and provisional application Ser. No. 60/726,028 filed Oct.
12, 2005, the disclosures of which are incorporated in their
entirety herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates generally to a system and method for
treating upper airway obstruction, sleep disordered breathing,
upper airway resistance syndrome and snoring by manipulating the
structures of the oropharynx, including the tongue.
[0004] 2. Description of the Related Art
[0005] Respiratory disorders during sleep are recognized as a
common disorder with significant clinical consequences. During the
various stages of sleep, the human body exhibits different patterns
of brain and muscle activity. In particular, the REM sleep stage is
associated with reduced or irregular ventilatory responses to
chemical and mechanical stimuli and a significant degree of muscle
inhibition. This muscle inhibition may lead to relaxation of
certain muscle groups, including but not limited to muscles that
maintain the patency of the upper airways, and create a risk of
airway obstruction during sleep. Because muscle relaxation narrows
the lumen of the airway, greater inspiratory effort may be required
to overcome airway resistance. This increased inspiratory effort
paradoxically increases the degree of airway resistance and
obstruction through a Bernoulli effect on the flaccid pharyngeal
walls during REM sleep.
[0006] Obstructive Sleep Apnea (OSA) is a sleep disorder that
affects up to 2 to 4% of the population in the United States. OSA
is characterized by an intermittent cessation of airflow in the
presence of continued inspiratory effort. When these obstructive
episodes occur, an affected person will transiently arouse, regain
muscle tone and reopen the airway. Because these arousal episodes
typically occur 10 to 60 times per night, sleep fragmentation
occurs which produces excessive daytime sleepiness. Some patients
with OSA experience over 100 transient arousal episodes per
hour.
[0007] In addition to sleep disruption, OSA may also lead to
cardiovascular and pulmonary disease. Apnea episodes of 60 seconds
or more have been shown to decrease the partial pressure of oxygen
in the lung alveoli by as much as 35 to 50 mm Hg. Some studies
suggest that increased catecholamine release in the body due to the
low oxygen saturation causes increases in systemic arterial blood
pressure, which in turn causes left ventricular hypertrophy and
eventually left heart failure. OSA is also associated with
pulmonary hypertension, which can result in right heart
failure.
[0008] Radiographic studies have shown that the site of obstruction
in OSA is isolated generally to the supralaryngeal airway, but the
particular site of obstruction varies with each person and multiple
sites may be involved. A small percentage of patients with OSA have
obstructions in the nasopharynx caused by deviated septums or
enlarged turbinates. These obstructions may be treated with
septoplasty or turbinate reduction procedures, respectively. More
commonly, the oropharynx and the hypopharynx are implicated as
sites of obstruction in OSA. Some studies have reported that the
occlusion begins with the tongue falling back in an
anterior-posterior direction (A-P) to contact with the soft palate
and posterior pharyngeal wall, followed by further occlusion of the
lower pharyngeal airway in the hypopharynx. This etiology is
consistent with the physical findings associated with OSA,
including a large base of tongue, a large soft palate, shallow
palatal arch and a narrow mandibular arch. Other studies, however,
have suggested that increased compliance of the lateral walls of
the pharynx contributes to airway collapse. In the hypopharynx,
radiographic studies have reported that hypopharyngeal collapse is
frequently caused by lateral narrowing of the pharyngeal airway,
rather than narrowing in the A-P direction.
[0009] OSA is generally diagnosed by performing overnight
polysomnography in a sleep laboratory. Polysomnography typically
includes electroencephalography to measure the stages of sleep, an
electro-oculogram to measure rapid eye movements, monitoring of
respiratory effort through intercostal electromyography or
piezoelectric belts, electrocardiograms to monitor for arrhythmias,
measurement of nasal and/or oral airflow and pulse oximetry to
measure oxygen saturation of the blood.
[0010] Following the diagnosis of OSA, some patients are prescribed
weight loss programs as part of their treatment plan, because of
the association between obesity and OSA. Weight loss may reduce the
frequency of apnea in some patients, but weight loss and other
behavioral changes are difficult to achieve and maintain.
Therefore, other modalities have also been used in the treatment of
OSA, including pharmaceuticals, non-invasive devices and
surgery.
[0011] Among the pharmaceutical treatments, respiratory stimulants
and drugs that reduce REM sleep have been tried in OSA.
Progesterone, theophylline and acetozolamide have been used as
respiratory stimulants, but each drug is associated with
significant side effects and their efficacy in OSA is not well
studied. Protriptyline, a tricyclic antidepressant that reduces the
amount of REM sleep, has been shown to decrease the frequency of
apnea episodes in severe OSA, but is associated with
anti-cholinergic side effects such as impotence, dry mouth, urinary
retention and constipation.
[0012] Other modalities are directed at maintaining airway patency
during sleep. Oral appliances aimed at changing the position of the
soft palate, jaw or tongue are available, but patient discomfort
and low compliance have limited their use. Continuous Positive
Airway Pressure (CPAP) devices are often used as first-line
treatments for OSA. These devices use a sealed mask which produce
airflow at pressures of 5 to 15 cm of water and act to maintain
positive air pressure within the pharyngeal airway and thereby
maintain airway patency. Although CPAP is effective in treating
OSA, patient compliance with these devices is low for several
reasons. Sleeping with a sealed nasal mask is uncomfortable for
patients. Smaller sealed nasal masks may be more comfortable to
patients but are ineffective in patients who sleep with their
mouths open, as the air pressure will enter the nasopharynx and
then exit the oropharynx. CPAP also causes dry nasal passages and
congestion.
[0013] Surgical treatments for OSA avoid issues with patient
compliance and are useful for patients who fail conservative
treatment. One surgery used for OSA is uvulopalatopharyngoplasty
(UPPP). UPPP attempts to improve airway patency in the oropharynx
by eliminating the structures that contact the tongue during sleep.
This surgery involves removal of the uvula and a portion of the
soft palate, along with the tonsils and portions of the tonsillar
pillars. Although snoring is reduced in a majority of patients who
undergo UPPP, the percentage of patients who experience reduced
frequency of apnea episodes or improved oxygen saturation is
substantially lower. Postoperatively, many patients that have
undergone UPPP continue to exhibit oropharyngeal obstruction or
concomitant hypopharyngeal obstruction. Nonresponders often have
physical findings of a large base of tongue, an omega-shaped
epiglottis and redundant aryepiglottic folds. UPPP is not a
treatment directed at these structures. UPPP also exposes patients
to the risks of general anesthesia and postoperative swelling of
the airway that will require a tracheostomy. Excessive tissue
removal may also cause velo-pharyngeal insufficiency where food and
liquids enter into the nasopharynx during swallowing.
[0014] Laser-assisted uvulopalatopharyngoplasty (LAUP) is a similar
procedure to UPPP that uses a CO2 laser to remove the uvula and
portions of the soft palate, but the tonsils and the lateral
pharyngeal walls are not removed.
[0015] For patients who fail UPPP or LAUP, other surgical
treatments are available but these surgeries entail significantly
higher risks of morbidity and mortality. In genioglossal
advancement with hyoid myotomy (GAHM), an antero-inferior portion
of the mandible, which includes the attachment point of the tongue
musculature, is repositioned forward and in theory will pull the
tongue forward and increase airway diameter. The muscles attached
to the inferior hyoid bone are severed to allow the hyoid bone to
move superiorly and anteriorly. Repositioning of the hyoid bone
expands the retrolingual airspace by advancing the epiglottis and
tongue base anteriorly. The hyoid bone is held in its new position
by attaching to the mandible using fascia. Variants of this
procedure attach the hyoid bone inferiorly to the thyroid
cartilage.
[0016] A laser midline glossectomy (LMG) has also been tried in
some patients who have failed UPPP and who exhibit hypopharyngeal
collapse on radiographic studies. In this surgery, a laser is used
to resect the midline portion of the base of the tongue. This
involves significant morbidity and has shown only limited
effectiveness.
[0017] In some patients with craniofacial abnormalities that
include a receding mandible, mandibular or maxillomandibular
advancement surgeries may be indicated for treatment of OSA. These
patients are predisposed to OSA because the posterior mandible
position produces posterior tongue displacement that causes airway
obstruction. In a mandibular advancement procedure, the mandible is
cut bilaterally posterior to the last molar and advanced forward
approximately 10 to 14 mm. Bone grafts are used to bridge the bone
gap and the newly positioned mandible is wire fixated to the
maxilla until healing occurs. Mandibular advancement may be
combined with a Le Fort I maxillary osteotomy procedure to correct
associated dental or facial abnormalities. These procedures have a
high morbidity and are indicated only in refractory cases of
OSA.
[0018] Experimental procedures described in the clinical literature
for OSA include the volumetric radiofrequency tissue ablation and
hyoidplasty, where the hyoid bone is cut into several segments and
attached to a brace that widens the angle of the U-shaped hyoid
bone. The latter procedure has been used in dogs to increase the
pharyngeal airway lumen at the level of the hyoid bone. The canine
hyoid bone, however, is unlike a human hyoid bone because the
canine hyoid bone comprises nine separate and jointed bones, while
the human hyoid bone comprises five bones that are typically fused
together.
[0019] Notwithstanding the foregoing, there remains a need for
improved methods and devices for treating obstructive sleep
apnea.
SUMMARY OF THE INVENTION
[0020] Methods and devices for manipulating soft tissue are
provided. A tissue-engaging member is used to engage a region of
soft tissue. The tissue-engaging member is attached to another site
that is less mobile than the soft-tissue engaged by the
tissue-engaging member. The less mobile site may be a bone or
connective tissue attached to bone.
[0021] In further embodiments, methods and devices are disclosed
for manipulating the tongue. An implant is positioned within at
least a portion of the tongue and may be secured to other
surrounding structures such as the mandible and/or hyoid bone. In
general, the implant is manipulated to displace at least a portion
of the posterior tongue in an anterior or lateral direction, or to
alter the tissue tension or compliance of the tongue.
[0022] In one embodiment of the invention, a method for treating a
patient is provided, comprising the steps of providing a tongue
remodeling system, the system comprising at least one tether
support and at least one tongue element, the at least one tongue
element having at least one anchor joined to at least one tether;
accessing a region about the mandible; inserting the at least one
anchor through a first pathway along the region about the mandible
to a tongue; attaching at least one tether of the at least one
tongue element to at least one tether support; positioning at least
one tether support against the surface of the mandible; and fixing
the at least one tether to the at least one tether support. The
term "glossoplasty", as used herein, shall be given its ordinary
meaning and shall also mean any change in the configuration and/or
characteristics of the tongue and is also used interchangeably with
the term "tongue remodeling". In some embodiments, at least a
portion of the first pathway passes through the mandible. The
method may further comprise the step of adjusting the tension of
the at least one tether. The step of adjusting the tension of the
at least one tether may comprise decreasing the tension or
increasing the tension. In some instances, the at least one tether
support of the providing step comprises an adjustable tether
tension interface. In one embodiment, the method further comprises
the steps of accessing the adjustable tether tension interface; and
adjusting the tension of the at least one tether. In some
embodiments, the first anchor of the providing step may comprise a
wire coil, a T-tag, a polymer plug, or a fibrous or porous polymer
plug. The first anchor of the providing step may also comprise a
slotted tube having a distal end, a proximal end, and a plurality
of expandable middle bands between the distal end and proximal end.
The first tether may be secured to the distal end of the slotted
tube or the proximal end of the slotted tube. In one embodiment,
the slotted tube of the providing step may be self-expandable or
expandable by shortening the slotted tube along its longitudinal
length. The method may also further comprise the step of pulling
the first tether to expand the slotted tube.
[0023] In embodiment of the invention, another method for treating
a patient is provided, comprising the steps of providing a patient
with an implanted adjustable tongue remodeling system, comprising
an adjustment assembly and one or more tongue elements inserted
through the tongue; wherein at least one tongue element comprises
an anchor and a tether secured to the adjustment assembly at a
securing point on the adjustment assembly; accessing the adjustment
assembly; and adjusting the tension of one or more tongue elements
by manipulating the adjustment assembly. The adjusting step may
comprise altering the relative configuration of the adjustment
assembly, moving the securing point relative to the adjustment
assembly, releasing the tether from the adjustment assembly and
resecuring the tether to the adjustment assembly, or altering the
length of the tether.
[0024] In another embodiment, a method for treating a patient is
provided, comprising the steps of providing a patient with an
implanted tongue remodeling system comprising one or more tongue
elements inserted through the tongue; wherein at least one tongue
element comprises a first tissue anchor implanted within the tongue
and a tether attached to the first tissue anchor; accessing the at
least one tongue element; and withdrawing the tissue anchor from
the tongue. The method may further comprise the step of deforming
the tissue anchor.
[0025] In another embodiment, a method for treating a patient
comprises engaging a first portion of the tongue and attaching said
portion of the tongue to a bone using a tension element having a
variable length, wherein the variable length of the tension element
varies with the tension of the tension element.
[0026] In one embodiment, the invention comprises a method for
treating a patient, the method comprises compressing tongue tissue,
said compression being conducted by inserting a spiral structure
into the tongue tissue. The spiral structure may comprise at least
one tissue engagement structure.
[0027] In another embodiment, a method for treating a patient is
provided, comprising changing tongue tissue compliance, said change
being conducted by inserting a spiral structure into the tongue
tissue.
[0028] In still another embodiment, a method for treating a patient
is provided, comprising engaging a first portion of the tongue;
engaging a second portion of the tongue; and altering the tissue
compliance at least between the first portion and the second
portion. The step of altering tissue compliance may comprise
increasing the tissue tension. The method may also further comprise
altering the tissue compliance about the first portion.
[0029] In another embodiment of the invention, a method for
treating a patient is provided, comprising engaging a first portion
of the tongue; engaging a second portion of the tongue; and
changing the tissue compliance at least between the first portion
and the second portion.
[0030] In another embodiment, a method for remodeling the tongue is
provided, comprising the steps of providing a rigid elongate body
having a shape; defining a non-linear pathway through the tongue;
and inserting the rigid elongate body through the pathway. The
rigid elongate body of the providing step may have a linear
configuration. The method may further comprise the step of
remodeling the tongue by reorienting the non-linear pathway with
respect to the shape of the elongate body.
[0031] In one embodiment, a method for remodeling the tongue is
provided, comprising the steps of providing an elongate body having
a first configuration and a second configuration; inserting the
elongate body in its first configuration through a pathway having a
first configuration; and changing the elongate body from its first
configuration to its second configuration. The method may further
comprise the step of redistributing the tongue tissue about the
pathway by changing the pathway to a second configuration. The
first configuration of the pathway may be linear, non-linear, may
comprise a curve or at least one convex segment and at least one
concave segment.
[0032] In one embodiment of the invention, an implantable device
for manipulating soft tissue is provided, comprising at least one
tissue anchor; an elongate member attached to the at least one
tissue anchor; and a securing assembly comprising a bony attachment
structure and an elongate member securing structure, wherein the
elongate member securing structure is adapted to be movable
relative to the bony attachment structure while the elongate member
is secured to the elongate member securing structure. The bony
attachment structure may be adapted for insertion into the
mandible. In some instances, the bony attachment structure has a
cylindrical configuration and a threaded outer surface. The
securing assembly may further comprise a moving interface component
adapted to move the elongate member securing structure. In some
embodiments, the bony attachment structure comprises an internal
sealable cavity and the elongate member securing structure
comprises a fluid seal adapted to provide a sliding seal within the
internal sealable cavity of the bony attachment structure. The bony
attachment structure may further comprise a pierceable membrane for
accessing the internal sealable cavity. The bony attachment
structure may also comprise a threaded cylindrical internal cavity
and the elongate member securing structure may comprise a cylinder
having outer threads complementary to the threaded cylindrical
internal cavity of the bony attachment structure and a rotatably
attached securing interface. The bony attachment structure may also
further comprise a longitudinal groove and the rotatably attached
securing interface comprises a protrusion having a complementary
configuration to the longitudinal groove of the bony attachment
structure. The bony attachment structure may comprise an internal
friction cavity and the elongate member securing structure may
comprise a friction surface configured to provide a frictional fit
within the internal friction cavity of the bony attachment
structure. In some embodiments, the elongate member securing
structure is adapted to provide a sliding frictional fit within the
internal friction cavity of the bony attachment structure. In other
embodiments, the elongate member securing structure further
comprises a manipulation interface adapted to reversibly engage a
manipulation tool. In still other embodiments, the bony attachment
structure comprises an internal tapered cavity and the elongate
member securing structure comprises a base with at least two
radially inwardly deflectable prongs adapted to engage the elongate
member.
[0033] In one embodiment of the invention, a device for
manipulating the tongue is provided, comprising a variable pitch
spiral having a first portion with a first pitch and a second
portion with a second pitch, the spiral comprising a biocompatible
material dimensioned to fit within a tongue. The first portion may
have a wide pitch and the second portion may have a narrow pitch.
In other embodiments, the first portion has a narrow pitch and the
second portion has a wide pitch.
[0034] In one embodiment, a device for manipulating the tongue is
provided, comprising an elongate member having a first end, a
second end, an middle section between the first end and the second
end having at least one enlarged segment, wherein the first end is
adapted to attach to a bony structure and the second end is adapted
to attach to either a bony structure, the first end or the middle
section, and wherein the at least one enlarged segment is adapted
for positioning in the tongue. In some embodiments, the at least
one enlarged segment may be at least partially formed in situ in
the tongue, a tissue anchor, a sleeve or a coating.
[0035] In one embodiment, a method for manipulating the tongue is
provided, comprising the steps of providing a tongue implant having
a first portion with a first configuration and a second portion
with a second configuration, the implant comprising a biocompatible
material dimensioned to fit within a tongue; creating a pathway in
the tongue by passing the first portion of the tongue implant;
passing the second portion of the tongue implant into the pathway;
and conforming the pathway in the tongue to the second portion of
the tongue implant. The providing step may comprise providing a
tongue implant that is a variable pitch spiral having a first
portion with a first spiral pitch configuration and the second
portion has a second spiral pitch configuration. The method may
further comprise the steps of compressing the tissue about the
pathway and/or stretching the tissue about the pathway.
[0036] In one embodiment, a method for treating a patient is
provided, comprising: providing a tongue remodeling system, the
system comprising at least one tether support and at least one
tongue element, the at least one tongue element having at least one
expandable tissue anchor joined to at least one tether; accessing a
region about the mandible; inserting the at least one expandable
tissue anchor through a first pathway along the region about the
mandible to a tongue; attaching the at least one tether of the at
least one tongue element to the at least one tether support;
positioning the at least one tether support against the mandible;
and fixing the at least one tether support to the mandible. The
method may further comprise expanding the at least one expandable
tissue anchor joined to the at least one tether. The expandable
tissue anchor of the providing step may be self-expandable, may
comprise a plurality of expandable elongate members, may comprise a
plurality of expandable elongate piercing members, or may comprise
a plurality of expandable tissue-grasping members. The fixing step
may be performed before the attaching step. In some embodiments, at
least a portion of the first pathway may pass through the
mandible.
[0037] In another embodiment, a method for treating a patient is
provided, comprising: providing a tongue element having an
attachment end and an expandable tissue-anchoring end; inserting
the expandable tissue-anchoring end into the tongue; and securing
the attachment end of the tongue element to a body structure. The
securing of the attachment end of the tongue element to the body
structure may be performed with an adjustment assembly. The
adjustment assembly may comprise a moving part, a non-moving part
and a movement interface between the moving part and the non-moving
part. The expandable tissue-anchoring end may comprise one or more
tissue-grasping members. The expandable tissue-anchoring end may
comprise at least two tissue-piercing members. In some embodiments,
one or more tissue-grasping members may be metallic, and/or may be
radially expandable elongate members. The expandable
tissue-anchoring end of the providing step may comprise a wire
coil, a T-tag, an expandable polymer plug, and/or a fibrous or
porous expandable polymer plug. The expandable tissue-anchoring end
may comprise a slotted tube having a distal end, a proximal end,
and a plurality of expandable middle bands between the distal end
and proximal end. The at least one tether may be secured to the
distal end of the slotted tube the proximal end of the slotted
tube. The slotted tube of the providing step may be
self-expandable. The slotted tube may be expandable by shortening
the slotted tube along its longitudinal length. The method may
further comprise the step of pulling the at least one tether to
expand the slotted tube.
[0038] In another embodiment, a method for treating a patient is
provided, comprising: accessing a tissue anchor implanted in a
tongue, the tissue anchor having a deployment configuration and a
removal configuration; deforming the tissue anchor to the removal
configuration; and withdrawing the tissue anchor from the tongue.
The tissue anchor may further comprise a proximal tether. The
method may further comprise exposing the proximal tether. Accessing
the tissue anchor implanted in the tongue may comprise passing a
tubular member along the proximal tether, the tubular member
comprising a distal opening, a proximal opening and a lumen
therebetween. Deforming the tissue anchor to the removal
configuration may comprise collapsing the tissue anchor into the
lumen of the tubular member. Withdrawing the tissue anchor from the
tongue may comprise withdrawing the tubular member from the tongue.
The tubular member may further comprise a longitudinal slot
contiguous with the lumen of the tubular member. The longitudinal
slot of the tubular member may be contiguous with the distal
opening of the tubular member. The tubular member further may
comprise a movable slot blocking member capable of blocking the
distal portion of the longitudinal slot of the tubular member. The
movable slot blocking member may be a slidable slot blocking member
or a rotatable slot blocking member. The movable slot blocking
member may be located within the lumen of the tubular member.
[0039] In one embodiment, a method for treating a patient is
provided, comprising: providing a tongue remodeling system, the
system comprising at least one tether support and at least one
tongue element, the at least one tongue element having at least one
tissue engaging structure joined to at least one tether having a
length and a tension; accessing a region about the mandible;
positioning the tissue engaging structure within a tongue; and
attaching the at least one tether support to the mandible; wherein
the at least one tether of the at least one tongue element may be
attached to the at least one tether support, the at least one
tether support comprising an adjustable tether interface. The
method may further comprise: accessing the adjustable tether
interface; and adjusting the length of the at least one tether
between the tissue engaging structure and the adjustable tether
interface. Adjusting the length of the at least one tether may
comprise decreasing the tension of the at least one tether,
increasing the tension of the at least one tether, or adjusting the
dynamic response of the at least one tether. The at least one
tether of the at least one tongue element may be releasably
attached to the at least one tether support.
[0040] In another embodiment, a method for treating a patient is
provided, comprising: accessing an adjustment assembly of a patient
with an implanted adjustable tongue remodeling system comprising
the adjustment assembly and one or more tongue elements inserted
through the tongue; wherein at least one tongue element may
comprise an anchor and a tether secured to the adjustment assembly
at a securing point on the adjustment assembly; and adjusting one
or more tongue elements by manipulating the adjustment assembly.
Said adjusting may comprise altering the relative configuration of
the adjustment assembly, moving the securing point of the
adjustment assembly and/or altering the length of the tether
between the anchor and the securing point of the adjustment
assembly. Said adjusting may be performed without unsecuring the
tether from the securing point of the adjustment assembly. The may
further comprise securing the adjustment assembly to a mandible.
The adjustment assembly may comprise a rotational component. The
rotational component may comprise a spool.
[0041] In another embodiment, a method for treating a patient is
provided, comprising: providing a tongue element having an
attachment end and a tissue-engaging end; inserting the
tissue-engaging end into the tongue; and securing the attachment
end of the tongue element to a body structure using an adjustment
assembly. The tongue element may comprise a tether having a length
between the tissue-engaging end and the adjustment assembly,
wherein the length is adjustable by the adjustment assembly. The
adjustment assembly may be a rotation assembly, a spool assembly, a
helical assembly, a slide assembly, a pivot assembly, or a
combination thereof. The patient's tongue may be engaged with a
tissue engaging structure attached about the first portion of the
tether, or a tissue anchor that pierces through tongue tissue.
Tension between the first and second portions of the tether may be
adjustable while the first portion of the tether remains engaged
with the patient's tongue and the second portion of the tether
remains attached relative to the body structure. The body structure
may be the mandible. The attachment end of the tongue element may
be secured through a bone screw. The adjustment assembly may
comprise a moving part, a non-moving part and a movement interface
between the moving part and the non-moving part. The adjustment
assembly may comprise a positionable tongue element attachment
site. The adjustment assembly may comprise a locking member.
[0042] In another embodiment, a method for manipulating soft tissue
is provided, comprising: accessing an adjustment structure attached
to at least one tissue anchor by a connector, the at least one
tissue anchor engaging the soft tissue and the adjustment structure
being fixed relative to a body structure, the connector having a
length between the at least one tissue anchor and the adjustment
structure; and changing the length of the connector between the at
least one tissue anchor and the adjustment structure by
manipulating the adjustment structure without detaching the at
least one tissue anchor from the adjustment structure. The tissue
anchor may be at least partially located within the tongue. The
adjustment structure may be fixed relative to a mandible. The
tissue anchor may be at least partially located within the soft
palate. The adjustment structure may be fixed relative to a hard
palate.
[0043] In one embodiment, an implantable device for manipulating
soft tissue is provided, comprising: at least one tissue engaging
structure; an elongate member attached to the at least one tissue
anchor; and a securing assembly comprising a bony attachment
structure and a movable securing member, wherein the movable
securing member may be adapted to be movable relative to the bony
attachment structure while the elongate member may be secured to
the movable securing member. The tissue engaging structure may be
an anchor adapted to pierce the soft tissue. The movable securing
member may be rotatable, slidable, and/or pivotable. The movable
securing member may be a rotatable hub, or a spool. The bony
attachment structure may be adapted for attachment to the mandible
and/or for insertion into the mandible. The bony attachment
structure has a cylindrical configuration and a threaded outer
surface. The securing assembly further may comprise a moving
interface component adapted to move the movable securing member.
The bony attachment structure may comprise an internal sealable
cavity and the movable securing member may comprise a fluid seal
adapted to provide a sliding seal within the internal sealable
cavity of the bony attachment structure. The bony attachment
structure may further comprise a pierceable membrane for accessing
the internal sealable cavity. The bony attachment structure may
comprise a threaded cylindrical internal cavity and the movable
securing member may comprise a cylinder having outer threads
complementary to the threaded cylindrical internal cavity of the
bony attachment structure and a rotatably attached securing
interface. The bony attachment structure further may comprise a
longitudinal groove and the rotatably attached securing interface
may comprise a protrusion having a complementary configuration to
the longitudinal groove of the bony attachment structure. The bony
attachment structure may comprise an internal friction cavity and
the movable securing member may comprise a friction surface
configured to provide a frictional fit within the internal friction
cavity of the bony attachment structure. The movable securing
member may be adapted to provide a sliding frictional fit within
the internal friction cavity of the bony attachment structure. The
movable securing member further may comprise a manipulation
interface adapted to reversibly engage a manipulation tool. The
bony attachment structure may comprise an internal tapered cavity
and the movable securing member may comprise a base with at least
two radially inwardly deflectable prongs adapted to engage the
elongate member.
[0044] In another embodiment, an implantable device for
manipulating soft tissue is provided, comprising: at least one
tissue anchor; an elongate member attached to the at least one
tissue anchor; and a securing assembly comprising a bony attachment
structure and a rotational securing structure. The rotational
securing structure may be a spool.
[0045] In another embodiment, a device for manipulating the tongue
is provided, comprising a variable pitch spiral having a first
portion with a first pitch and a second portion with a second
pitch, the spiral comprising a biocompatible material dimensioned
to fit within a tongue. The first portion may have a wide pitch and
the second portion has a narrow pitch, or the first portion may
have a narrow pitch and the second portion has a wide pitch.
[0046] In another embodiment, an implantable device for
manipulating soft tissue is provided, comprising: at least one
tissue anchor; a securing assembly comprising a bony attachment
structure; an elongate member attached to the at least one tissue
anchor and having a length between the at least one tissue anchor
and the securing assembly; and a means for adjusting the length of
the elongate member. The securing assembly may further comprise the
means for adjusting the length of the elongate member.
[0047] In another embodiment, a tissue anchoring system for
engaging soft tissue is provided, comprising: at least one
deformable hook element, the at least one hook element comprising
an elongate body having a proximal portion and a sharp distal end,
wherein the at least one hook element when unrestrained curls to
form an arcuate structure; and a tether attached about the proximal
portion of the at least one hook element. The at least one
deformable hook element may be a plurality of deformable hook
elements. The plurality of deformable hook elements may be arranged
circumferentially, or in a generally planar configuration. The hook
elements when unrestrained may curl back toward themselves to form
a loop-like structure. The tissue anchoring system may further
comprise a band about the proximal portions of the hook elements.
The tissue anchoring system may further comprise a proximal group
of hook elements and a distal group of hook elements. The hook
elements may comprise symmetrical U-shaped planar structures with
sharp distal tips on each end. The tissue anchoring system may
further comprise a delivery device having a lumen adapted to
receive and restrain the hook elements in a generally linear
configuration, wherein the hook elements when advanced out of the
delivery device curl back toward themselves to engage tissue.
[0048] In another embodiment, a tissue anchoring system for
engaging soft tissue is provided, comprising: at least one means
for expandable curled tissue engagement; and a tether attached to
the at least one means for expandable curled tissue engagement.
[0049] In another embodiment, a tissue anchoring system for
engaging soft tissue is provided, comprising: a plurality of
deformable hook elements spaced circumferentially about each other,
each of the hook element comprising an elongate body having a
proximal portion and a sharp distal end, wherein the hook elements
when unrestrained curls to form an arcuate structure; and a tether
attached about the proximal portion of the hook elements. The
plurality of deformable hook elements may comprise at least two
pairs of deformable hooks elements joined together about the
proximal portions of their elongate bodies. The at least two pairs
of deformable hook elements may be joined proximally by a band. The
at least two pairs of deformable hook elements may comprise four
pairs of deformable hook elements. The at least two pairs of
deformable hook elements may be arranged circumferentially, or in a
generally planar configuration. The generally planar configuration
may be a generally planar nested configuration or a generally
planar stacked configuration.
[0050] In one embodiment, a method for treating a patient is
provided, comprising: providing a palate remodeling system, the
system comprising at least one tether support and at least one
palate element, the at least one palate element having at least one
expandable tissue anchor joined to at least one tether; accessing a
region about a hard palate; inserting the at least one expandable
tissue anchor through a first pathway along the region about the
hard palate to a soft palate; attaching the at least one tether of
the at least one palate element to the at least one tether support;
positioning the at least one tether support about the hard palate;
and fixing the at least one tether support about the hard palate.
Fixing the at least one tether support about the hard palate may
comprise fixing the at least one tether support to the hard palate,
or to mucosal tissue overlying the hard palate.
[0051] In another embodiment, a method for treating a patient is
provided, comprising: providing a soft palate element having an
attachment end and an expandable tissue-anchoring end; inserting
the expandable tissue-anchoring end into the soft palate; securing
the attachment end of the palate element to a body structure. The
body structure may be a palatine bone, a hard palate, or a nasal
turbinate.
[0052] In another embodiment, a method for treating a patient is
provided, comprising: accessing a tissue anchor implanted in a soft
palate, the tissue anchor having a deployment configuration and a
removal configuration; deforming the tissue anchor to the removal
configuration; and withdrawing the tissue anchor from the soft
palate.
[0053] In still another embodiment, a method for treating a patient
is provided, comprising: accessing an adjustment assembly of a
patient with an implanted adjustable soft palate remodeling system
comprising the adjustment assembly and one or more soft palate
elements inserted into the soft palate; wherein at least one soft
palate element may comprise an anchor and a tether secured to the
adjustment assembly at a securing point on the adjustment assembly;
and adjusting one or more soft palate elements by manipulating the
adjustment assembly.
BRIEF DESCRIPTION OF THE DRAWINGS
[0054] The structure and method of using the invention will be
better understood with the following detailed description of
embodiments of the invention, along with the accompanying
illustrations, in which:
[0055] FIG. 1 is a schematic sagittal view of the pharynx.
[0056] FIG. 2 is a schematic elevational view of one embodiment of
a tongue element.
[0057] FIGS. 3A and 3B illustrate anterior and side elevational
views of one embodiment of a mandible securing assembly.
[0058] FIGS. 4A through 4D are cross sectional views through the
oropharynx and mandible depicting implantation of one embodiment of
the invention.
[0059] FIGS. 5A through 5C are cross sectional views through the
oropharynx and mandible depicting another embodiment of the
invention wherein the tongue elements are engaged to the lateral
portions of the mandible.
[0060] FIGS. 6A and 6B are cross sectional views through the
oropharynx and mandible illustrating another embodiment of the
invention comprising a dual-anchor device.
[0061] FIGS. 7A through 7F are cross sectional views through the
oropharynx and mandible depicting transmandibular implantation of
one embodiment of the invention.
[0062] FIGS. 7G through 7J are schematic cross sectional views
depicting the removal of an embodiment of the invention. FIGS. 7I
and 7J are detailed views of the distal anchors and removal tool in
FIGS. 7G and 7H.
[0063] FIGS. 8A and 8B depict one embodiment of the invention
comprising a glossoplasty device with a T-shaped tissue anchor.
[0064] FIGS. 9A and 9B depict one embodiment of the invention
comprising a glossoplasty device with a spiral tissue anchor.
[0065] FIGS. 10A and 10B depict one embodiment of the invention
comprising a glossoplasty device with a flat pronged tissue
anchor.
[0066] FIG. 11 illustrates one embodiment of the invention
comprising a glossoplasty device with a pointed prong tissue
anchor.
[0067] FIG. 12 illustrates one embodiment of the invention
comprising a glossoplasty device with a dual pointed prong tissue
anchor.
[0068] FIG. 13 illustrates another embodiment of the invention
comprising a glossoplasty device with an umbrella tissue
anchor.
[0069] FIGS. 14A and 14B depict embodiments of the invention
comprising a distal anchor having a foam plug and T-tag core. The
foam plug fully encapsulates the T-tag in FIG. 14A and partially
encapsulates the T-tag in FIG. 14B.
[0070] FIGS. 15A through 15C depict another embodiment of the
invention comprising a glossoplasty device with a radially
expandable slotted tissue anchor.
[0071] FIG. 16 depicts one embodiment of the invention where the
proximal end of the tissue anchor comprises barbs for engaging
tissue.
[0072] FIGS. 17A and 17B depict another embodiment of the invention
comprising a glossoplasty device with a dual radially expandable
slotted tissue anchor.
[0073] FIGS. 18A and 18B depict another embodiment the invention
comprising a radially expandable tissue anchor before and after
expansion.
[0074] FIG. 19 depicts still another embodiment the invention
comprising a radially expandable tissue anchor.
[0075] FIG. 20 depicts still another embodiment the invention
comprising a radially expandable tissue anchor with barbs.
[0076] FIGS. 21A and 21B depict another embodiment the invention
comprising a radially expandable tissue anchor before and after
expansion.
[0077] FIGS. 22A and 22B depict another embodiment the invention
comprising a radially expandable tissue anchor before and after
expansion.
[0078] FIGS. 23A and 23B depict one embodiment the invention
comprising a splayed tissue anchor before and after expansion.
[0079] FIGS. 24A and 24B depict one embodiment the invention
comprising a dual splayed tissue anchor before and after
expansion.
[0080] FIGS. 25A through 25C illustrate one embodiment of the
invention comprising an in situ formed anchor or plug.
[0081] FIGS. 26A through 26D illustrate one embodiment of the
invention comprising a fillable anchor or plug.
[0082] FIG. 27 represents one embodiment of the invention
comprising an elastomeric tether.
[0083] FIG. 28 represents one embodiment of the invention
comprising a wound wire.
[0084] FIG. 29 represents one embodiment of the invention
comprising a spring coil.
[0085] FIG. 30 represents one embodiment of the invention
comprising one-sided pneumatic tension assembly.
[0086] FIG. 31 represents another embodiment of the invention
comprising two-sided pneumatic tension assembly.
[0087] FIG. 32 represents one embodiment of the invention
comprising a beaded tether.
[0088] FIG. 33 represents one embodiment of the invention
comprising a barbed tether.
[0089] FIG. 34 depicts one embodiment of a tether having a serial
arrangement of anchors.
[0090] FIG. 35 illustrates one embodiment of a branched tether with
anchors.
[0091] FIG. 36 depicts a tether having two proximal ends.
[0092] FIG. 37 is a cross sectional view of one embodiment of the
invention comprising a tether loop with an enlarged section.
[0093] FIG. 38 is a cross sectional view of one embodiment of the
invention comprising a tether loop with tissue anchors along the
tether loop.
[0094] FIG. 39 illustrates one embodiment of the invention
comprising a mandible securing assembly with a lumen.
[0095] FIGS. 40A through 40C represents one embodiment of the
invention comprising a mandible securing assembly with a clipping
interface.
[0096] FIGS. 41A and 41B illustrate one embodiment of the invention
comprising a mandible securing assembly with a tether securing
bolt.
[0097] FIGS. 42A through 42D illustrate one embodiment of the
invention comprising an adjustable mandible securing assembly with
a non-rotating tether interface.
[0098] FIGS. 43A through 43E illustrate another embodiment of the
invention comprising a keyed tether interface.
[0099] FIGS. 44A and 44B illustrate an embodiment of an adjustable
mandible securing assembly with a keyed interface usable with the
keyed tether interface in FIGS. 41A through 41E.
[0100] FIGS. 45A and 45B are cross sectional views of the
adjustable mandible securing assembly of FIGS. 42A and 42B before
and after an adjustment.
[0101] FIGS. 46A and 46B illustrate an embodiment of an adjustable
mandible securing assembly with a keyed interface.
[0102] FIGS. 47A through 47D illustrate an embodiment of an
adjustable mandible securing assembly with a pierceable
membrane.
[0103] FIGS. 48A and 48B illustrate an embodiment of a mandible
securing assembly with a resistance plug.
[0104] FIGS. 49A through 49D illustrate an embodiment of a mandible
securing assembly usable with a beaded tether.
[0105] FIGS. 50A through 50F illustrate another embodiment of a
mandible securing assembly comprising an inner resistance surface
and tether interface.
[0106] FIGS. 51A through 51E illustrate another embodiment of a
mandible securing assembly comprising an expandable tether
interface.
[0107] FIGS. 52A through 52F represent one embodiment of the
invention comprising a rigid tongue splint.
[0108] FIGS. 53A and 53B represent another embodiment of the
invention comprising a semi-rigid tongue splint.
[0109] FIGS. 54A and 54B represent one embodiment of the invention
comprising a variable pitch tissue compression screw.
[0110] FIGS. 55A and 55B represent another embodiment of the
invention comprising a tissue compression coil.
[0111] FIG. 56 represents another embodiment of the invention
comprising a barbed tissue compression coil.
[0112] FIG. 57 represents another embodiment of the invention
comprising a barbed tissue compression coil positioned on an
implantation needle.
[0113] FIG. 58 represents another embodiment of the invention
comprising a barbed tissue compression coil positioned on a fitted
groove implantation needle.
[0114] FIGS. 59A and 59B represent one embodiment of the invention
for implantation of a tissue compression coil.
[0115] FIGS. 60A and 60B are perspective views of another
embodiment of a distal anchor in the delivery and deployed
configurations, respectively. FIGS. 60C and 60D are rear and
frontal views of the distal anchor in FIG. 60B. FIG. 60E depicts a
subcomponent of the distal anchor in FIGS. 60B to 60D. FIG. 60F
illustrates a tether looped through the distal anchor and FIG. 60G
illustrates the tether knotted to the distal anchor and the tether
ends attached to a securing assembly.
[0116] FIGS. 61A and 61B are inferior and superior perspective
views of another embodiment of the securing assembly, respectively.
FIG. 61C is an exploded superior perspective view of the securing
assembly in FIG. 61B. FIGS. 61D to 61F are inferior, superior and
side elevational views of the securing assembly, respectively. FIG.
61G is a side elevational isolation view of the spool assembly.
FIGS. 61H and 61I are a longitudinal cross sectional views of the
securing assembly in FIG. 61F in the locked and rotation
configurations, respectively. FIGS. 61J and 61K illustrate an
implanted distal anchor and securing assembly before and during
adjustment of the securing assembly, respectively.
[0117] FIG. 62A is a superior isometric view of one embodiment of a
delivery tool system with a partial cut-away of the delivery tube
of the delivery tool. FIGS. 62B and 62C are left elevational views
of the delivery tool without the delivery tool housing and delivery
tube in the loaded and deployed configurations, respectively. FIG.
62D is an exploded view of the actuator handle and safety lock of
the delivery tool.
[0118] FIGS. 63A and 63B are perspective and exploded views,
respectively, of one embodiment of a palate anchor.
[0119] FIGS. 64A to 64D are axial cross sectional views of various
embodiments of a delivery tube of the delivery tool for the palate
anchor in FIG. 64A.
[0120] FIG. 65 is a perspective view of a push rod for the palate
anchor in FIG. 64A.
[0121] FIG. 66 is a schematic sagittal cross sectional view of the
implantation of a palate anchor through the oral cavity.
[0122] FIG. 67 is a schematic sagittal cross sectional view of the
implantation of a palate anchor through the nasal cavity.
[0123] FIG. 68 is a schematic sagittal cross sectional view of the
soft and hard palate with a palate anchor anchored to the hard
palate.
[0124] FIG. 69 is a schematic sagittal cross sectional view of the
soft and hard palate with a palate anchor anchored to the mucosal
tissue overlying the hard palate.
[0125] FIG. 70A is a perspective view of one embodiment of a
recapture tool. FIG. 70B is an exploded view of the recapture tool
in FIG. 70A. FIG. 70C is a superior exploded view of the distal end
of the recapture tool. FIG. 70D is an axial cross sectional view of
the recapture tool in the open position as identified in FIG. 70A.
FIG. 70E is an axial cross sectional view of the recapture tool in
the closed position
[0126] FIGS. 71A to 71I are schematic views of one embodiment for
recapturing an implanted anchor. FIG. 71C is a detailed view of
FIG. 71B. FIG. 71E is a detailed view of FIG. 71D.
[0127] FIG. 72 illustrates another embodiment of a recapture tool
with a circumferentially closed distal end.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
A. Anatomy of the Pharynx
[0128] FIG. 1 is a sagittal view of the structures that comprise
the pharyngeal airway and may be involved in obstructive sleep
apnea. The pharynx is divided, from superior to inferior, into the
nasopharynx 1, the oropharynx 2 and the hypopharynx 3. The
nasopharynx 1 is a less common source of obstruction in OSA. The
nasopharynx is the portion of the pharynx above the soft palate 4.
In the nasopharynx, a deviated nasal septum 5 or enlarged nasal
turbinates 6 may occasionally contribute to upper airway resistance
or blockage. Only rarely, a nasal mass, such as a polyp, cyst or
tumor may be a source of obstruction.
[0129] The oropharynx 2 comprises structures from the soft palate 4
to the upper border of the epiglottis 7 and includes the hard
palate 8, tongue 9, tonsils 10, palatoglossal arch 11, the
posterior pharyngeal wall 12 and the mandible 13. The mandible
typically has a bone thickness of about 5 mm to about 10 mm
anteriorly with similar thicknesses laterally. An obstruction in
the oropharynx 2 may result when the tongue 9 is displaced
posteriorly during sleep as a consequence of reduced muscle
activity during REM sleep. The displaced tongue 9 may push the soft
palate 4 posteriorly and may seal off the nasopharynx 1 from the
oropharynx 2. The tongue 9 may also contact the posterior
pharyngeal wall 12, which causes further airway obstruction.
[0130] The hypopharynx 3 comprises the region from the upper border
of the epiglottis 7 to the inferior border of the cricoid cartilage
14. The hypopharynx 3 further comprises the hyoid bone 15, a
U-shaped, free floating bone that does not articulate with any
other bone. The hyoid bone 15 is attached to surrounding structures
by various muscles and connective tissues. The hyoid bone 15 lies
inferior to the tongue 9 and superior to the thyroid cartilage 16.
A thyrohyoid membrane 17 and a thyrohyoid muscle 18 attaches to the
inferior border of the hyoid 15 and the superior border of the
thyroid cartilage 16. The epiglottis 7 is infero-posterior to the
hyoid bone 15 and attaches to the hyoid bone by a median
hyoepiglottic ligament 19. The hyoid bone attaches anteriorly to
the infero-posterior aspect of the mandible 13 by the geniohyoid
muscle 20.
B. Tongue Remodeling
[0131] Embodiments of the present invention provide methods and
devices for manipulating the airway. It is hypothesized that the
laxity in pharyngeal structures contributes to the pathophysiology
of obstructive sleep apnea, snoring, upper airway resistance and
sleep disordered breathing. This laxity may be intrinsic to the
oropharyngeal structures and/or may be affected by
interrelationships between pharyngeal structures and other body
structures. For example, in some studies, the cure rates in
selected patients undergoing UPPP is as low as 5% to 10%. (Sher A E
et al., "The efficacy of surgical modifications of the upper airway
in adults with obstructive sleep apnea syndrome" Sleep, 1996
February; 19(2):156-77, herein incorporated by reference). These
low cure rates may be affected by continued occlusion of the airway
by structures unaffected by the surgery, such as the tongue. By
biasing at least a portion of the posterior tongue or base of the
tongue in at least a generally anterior and/or lateral direction,
functional occlusion of the oropharynx may be prevented or reduced.
Typically, this bias may be created by altering a distance or
tension between a location in the tongue and an anchoring site,
such as the mandible. In other instances, the bias may be created
by altering the length or amount of a structure located in the
tongue. In some instances, the bias provided to the tongue may only
affect the mechanical characteristics tongue during tongue movement
or in specific positions or situations. Thus, the dynamic response
of the tongue tissue to mechanical forces or conditions may or may
not occur with static changes, although static changes typically
will affect the dynamic response of the tongue tissue. The
embodiments of the invention described herein, however, are not
limited to this hypothesis.
[0132] Although surgical and non-surgical techniques for biasing
the tongue anteriorly are currently available, these techniques
suffer from several limitations. For example, the Repose.RTM.
system (InfluENT.RTM. Medical, New Hampshire) utilizes a bone screw
attached to the lingual cortex of the mandible and a proline suture
looped through the posterior tongue and bone screw, where the
suture ends are tied together at some point along the suture loop
to prevent posterior tongue displacement. In one study of 43
patients, four patients developed infections of the floor of the
mouth and required antibiotics. One patient developed dehydration
caused by painful swallowing, requiring intravenous fluids, and
another patient developed delayed GI bleeding requiring
hospitalization. (Woodson B T, "A tongue suspension suture for
obstructive sleep apnea and snorers", Otolaryngol Head Neck Surg.
2001 March; 124(3):297-303). In another study of 19 patients
undergoing combined UPPP and Repose.RTM. implantation, two patients
developed submandibular infection requiring antibiotics, and one
patient developed a hematoma in the floor of the mouth requiring
drainage. In addition, one patient extruded the suture four weeks
after implantation and another patient developed a persistent
lump/globus sensation at the base of the tongue requiring removal
of the Repose.RTM. system. (Miller F R et al., "Role of the tongue
base suspension suture with The Repose.RTM. System bone screw in
the multilevel surgical management of obstructive sleep apnea",
Otolaryngol Head Neck Surg. 2002 April; 126(4):392-8).
[0133] By developing a tongue remodeling system that can be
adjusted before, during and/or after the initial implantation
procedure, a device and method for treating a patient with
breathing problems may be better tolerated and less prone to
treatment failure. For example, by adjusting the tension or bias of
the implant, suture migration, suture extrusion, and/or dysphagia
may be avoided or corrected. In another embodiment of the
invention, the tongue remodeling system alters the structural
characteristics of the tongue with an anterior or lateral bias
force rather than a fixed length anchoring of the tongue to a body
structure. This bias may reduce dysphagia or odynophagia associated
with existing tongue suspension devices and procedures. In other
embodiments, the tongue may be remodeled by altering the tissue
compliance of at least a portion of the tongue. By inserting a
prosthesis into the tongue tissue, tongue tissue compliance is
changed and may alter the tongue response to forces acting during
obstructive sleep apnea. The change in compliance may or may not be
associated with a change in the position of the tongue. In some
instances, embodiments of the tongue remodeling system can be
implanted through an antero-inferior access site of the mandible.
Implantation of the system that avoids the transoral route may
improve infection rates that occur with other tongue related
devices and procedures.
C. Tissue Anchor
[0134] In one embodiment, depicted in FIGS. 2, 3A and 3B, the
invention comprises a tongue remodeling system having one or more
tongue elements 22 and at least one securing assembly 24. As
depicted in FIG. 2, at least one tongue element 22 comprises a
distal tissue anchor 26 attached to a proximal tether 28. The
distal anchor 26 typically is a soft tissue anchor adapted for
implantation within the tongue 9. The soft tissue anchor 26 may
comprise any of a variety of structures capable of engaging the
surrounding tissue. These structures may have pointed, sharp or
blunt tissue engagement structures 30. In some instances, the
distal anchor 26 has a first reduced diameter configuration for
delivery into the tongue tissue and a second expanded diameter
configuration for engaging the surrounding tissue. In other
embodiments, the distal anchor 26 has a fixed configuration.
[0135] The securing assembly 24 is configured to provide a stable
position about the mandible 13 or other structure adjacent to the
mandible 13 and comprises one or more securing interfaces 32 to
which one or more proximal tethers 28 may be secured. In some
embodiments, the securing assembly 24 may comprise a bone anchor or
bone screw, a clip, or a staple for attaching the proximal tether
28 to the bone. In other embodiments, as illustrated in FIGS. 3A
and 3B, the securing interface 32 may provide a friction fit or
mechanical interfit with the proximal tether 28 that may be
reversed or altered without disengaging or loosening the securing
assembly 24 from the bone. The securing assembly in turn is
attached to the bone using bone screws or anchors 34. In some
embodiments, the friction fit or mechanical interfit is adjustable
in one direction. In other embodiments, the friction fit or
mechanical interfit is capable of bidirectional adjustment. In some
embodiments, the proximal tether 28 and the securing assembly 24
may be integrated together. Various embodiments of the securing
assembly 24 are described in further detail below. Preferably, the
remodeling system comprises one securing assembly 24 and one to
three tongue elements 22, but one skilled in the art may select
other combinations of securing assemblies and tongue elements,
depending upon the patient's anatomy and the desired result.
[0136] By implanting one or more tongue elements 22 within the
tongue 9, creating tension in the proximal tethers 28, and
attaching the proximal tethers 28 to a securing assembly 24 located
peripherally to the distal anchors 26, a directional bias may be
created in the tongue 9 to resist posterior displacement. There
need not be continuous tension present in the proximal tethers 28.
In some embodiments, tension is generated in one or more proximal
tethers 28 only when the tongue 9 has been displaced a particular
distance and/or a range of directions. The peripheral site of the
securing assembly is typically located about an anterior portion of
the mandible 13 and may involve the external, internal or inferior
surface of the mandible 13 or a combination of these surfaces. In
some embodiments, a lateral or anterolateral location about the
mandible 13 may be used.
[0137] FIGS. 4A to 4D depict one embodiment of the invention where
the tongue elements 22 are inserted into the tongue 9 through an
insertion site inferior to the mandible 13, preferably but not
always about the anterior portion of the mandible 13. In other
embodiments, the implantation pathway may originate from a location
anterior or lateral to the mandible 13, and in still other
embodiments, may also pass through the mandible 13. The tongue
elements 22 may be implanted percutaneously into the tongue 9 using
a hypodermic needle 36 or other piercing delivery tool known in the
art. In some instances, the distal anchors 26 of the tongue
elements are positioned about the base of the tongue, which is the
portion of the tongue posterior to the circumvallate papillae (not
shown), but other locations within the tongue 9, such as the
anterior portion 39, may also be used. For example, the distal
anchors 26 may also be positioned in the dorsal region 38 of the
tongue 9. This position may have a better effect on resisting
posterior tongue displacement against the pharyngopalatine arch.
Once positioned, the distal anchor 26 is released from the delivery
tool 36. As shown in FIG. 4C, additional anchors 26 may be
deployed, if desired. The delivery tool 36 is then withdrawn,
leaving the proximal tether 40 trailing from the distal anchor 26
and accessible by the physician. A securing assembly 24 may be
attached to the mandible 13 using minimally invasive techniques and
the proximal tethers 40 of the tongue elements 22 are adjusted to
an initial tension and secured to the securing structures 32 on the
securing assembly 24. In some embodiments, the initial tension is
zero but increases with changes in tongue position. In some
embodiments, the securing assembly 24 is preferably secured to the
inferior or inner surface of the mandible 13 to reduce visibility
of the securing assembly beneath the skin 42. The securing assembly
24 may be adapted to penetrate and attach to the mandible 13, as
depicted in FIG. 4D, or attach to the mandible surface with the use
of an adhesive or tissue welding. In some embodiments, the securing
structures may also be adjusted through an adjustment interface,
described below, to further alter the tension in the proximal
tether.
[0138] FIGS. 5A through 5C are inferior schematic views of an
embodiment of the invention where the tongue elements 22 have been
inserted into the posterior tongue bilaterally and attached to
securing assemblies 42 located on the inferior surface of the
bilateral mandible 13. Continuous or intermittent tension created
within the tongue elements 22 causes remodeling of the posterior
tongue not only in an anterior direction but also a lateral
direction. This may be advantageous by increasing tissue tension in
the posterior tongue with less limitation of tongue movement in the
antero-posterior direction.
[0139] FIGS. 6A and 6B depict another embodiment of the invention
comprising a tongue element 44 having a distal tissue anchor 46 and
a proximal tissue anchor 48 joined by a tether 50. This device can
be inserted into the tongue tissue using a single cutaneous
delivery device 52 and access point without accessing or inserting
into the mandible or other bone. To implant a dual-ended tongue
element 44, the needle or delivery tool 52 is inserted
percutaneously into the tongue 9 to a desired distal location and
in a direction along the desired tension pathway. The distal anchor
46 is released from the delivery tool 52 into the tongue tissue.
The delivery tool 52 is withdrawn, gradually exposing the tether
50. By applying proximal force to the delivery tool 52, tension may
be formed within the tether 50. In some embodiments, the release
mechanism for the proximal tissue anchor 48 further comprises a
force measurement component that may assist the physician in
determining the appropriate release position for the proximal
tissue anchor 48. The measurement component may comprise a
calibrated spring or a piezoelectric crystal with an analog or
digital readout. When the desired tension and/or location for the
proximal tissue anchor 48 are reached, the proximal tissue anchor
48 may be released from the delivery tool by withdrawal of an outer
sheath on the delivery tool 52 to expose the proximal tissue anchor
48, or by release of an engagement structure, such as a suture or
deflection of one or more biased prongs, that are engaged to the
proximal tissue anchor 48. The tether tension allows the distal and
proximal tissue anchors 46, 48 to come closer together, thereby
compressing the tongue tissue between the anchors 46, 48 and
altering the tongue configuration. In other embodiments, the
dual-ended tongue element 44 is implanted within the tongue 9 and
creates intermittent rather than continuous tissue compression,
depending on tongue position.
[0140] FIGS. 7A through 7F depict another embodiment of the
invention, where the implantation pathway passes through the
mandible 13 to access the tongue 9. A pathway or conduit through
the mandible 13 or other bone may be created using a bone drill 54
or other device known in the art. As illustrated in FIGS. 7A and
7B, in some instances, the inferior skin 56 of the lower jaw is
drawn toward the anterior chin prior to accessing the anterior
mandible 13. Displacing the skin anteriorly provides access through
skin that normally faces inferiorly, thereby hiding the skin access
site 59 at the inferior surface of the mandible 13 once the
procedure is complete. Referring to FIGS. 7C and 7D, once a pathway
is created through the mandible 13, the delivery tool 36 may be
used to insert one or more tongue elements 22 into the tongue 9. A
sheath or retractors may be inserted through the skin and bone
conduit to maintain access and/or exposure to the bone during the
procedure. In one embodiment, a delivery tool 36 with a tongue
element 22 is inserted generally through the mandible 13 to a
desired location in the tongue 9, deployed and released from the
delivery tool 36. Deployment of the distal anchor 26 may also
include expansion of the distal anchor 26, if needed. In FIG. 7E,
the delivery tool 36 is then withdrawn, leaving the proximal tether
40 trailing from the distal anchor 26 and accessible by the
surgeon. Additional anchors 26 may be deployed, if desired. In some
embodiments, an intra-mandible securing assembly 60, shown in FIG.
7F, may be attached or partially attached to the bone before,
during and/or after the implantation of the tongue elements 22. In
one embodiment, the proximal tethers 40 are attached to a securing
assembly 60 and the tension of the proximal tether 40 is adjusted
as needed and secured to the securing assembly 60. In some
embodiments, the securing assembly 60 may be engaged to the
mandible surface or conduit surface. In other embodiments, the
tension of the tongue element(s) 22 alone is sufficient to keep the
securing assembly against the mandible 13. In some embodiment, a
portion of the securing assembly may be inserted prior to
implantation of the tongue elements 22. In FIG. 7C, for example, a
conduit portion 61 of the securing assembly 60 is inserted through
the mandible 13 prior to use of the delivery tool 36.
[0141] In addition to securing the proximal tethers 40 of the
tongue elements 22 to the anterior portion of the mandible 13,
other securing sites are also envisioned, including the lateral
portions of the mandible 13, the hyoid bone 15, the occiput, the
thyroid cartilage 16, the tracheal rings and any other structure
about the head or neck.
[0142] The embodiments of the invention described above may be
combined with other treatments for OSA, sleep disordered breathing,
upper airway resistance syndrome and snoring. These other
treatments may also include external devices such as CPAP,
medications such as modafinil, other surgical procedures, as well
as other treatments of the tongue, including various forms of
tongue debulking using RF ablation such as Coblation.RTM. by
ArthroCare.RTM. ENT.
[0143] 1. Distal Anchor
[0144] The distal anchor may have any of a variety of shapes
adapted for implantation within the tongue 9 and to resist
migration, typically comprising one or more tissue engaging
structures 30. Expandable anchors may include expandable slotted
tubes, fibrous or porous polymer plugs or structures, coilable
wires, expandable barb structures or any other deformable or
expandable structure or combinations thereof. In other embodiments,
the distal anchor 26 has a fixed configuration but is adapted to
facilitate its insertion in one direction through the tongue 9 or
other soft tissue and to resist migration or displacement in at
least the opposite direction. Distal anchors 26 with a fixed
configuration may have barbs, angled pins, hooks or other angled or
ramped structures capable of engaging surrounding tissue. The
distal anchors may also be self-expandable or may require the
application of force to expand in size or surface area. For
instance, in some embodiments of the invention, the distal anchor
may have one or more deformable tissue engagement structures that
self-expand upon release of the distal anchor from the delivery
tool to engage the surrounding tissue. In other embodiments, the
distal anchor may engage or expand into the surrounding tongue
tissue upon the application of tension to the proximal tether of
the tongue element.
[0145] In some embodiments, the distal anchor has a first
configuration with a reduced cross-sectional profile to facilitate
implantation of the distal anchor within the tongue, and a second
configuration with an expanded cross-sectional profile to engage
the surrounding tissue and/or resist migration of the anchor within
or out of the tongue. In further embodiments of the invention, the
distal anchor may have a third configuration to facilitate removal
of the distal anchor from the tongue. The third configuration may
result from deformation of the distal anchor to facilitate
disengagement from the surrounding tongue tissue and/or to reduce
the cross-sectional profile. Deformation of the distal anchor may
occur at one or more pre-engineered failure points or deformation
points on the distal anchor. One skilled in the art can design a
failure point to deform with a force greater than the upper limit
of forces generally acting on the distal anchor in its intended
use.
[0146] FIGS. 7G through 7J depict the removal of an anchor
previously inserted in FIGS. 7A through 7F. In FIG. 7G, the
proximal tether 40 is disengaged from the securing assembly 60 and
a removal tool 62 is passed along the proximal tether 40 to the
distal anchor 26. In FIG. 7H, the distal anchor 26 is deformed such
that the distal anchor 26 has a reduced cross sectional profile
and/or disengages the surrounding tongue tissue. The deformation
may occur by stabilizing or pulling on the proximal tether and
distal anchor while pushing and/or stabilizing the removal tool
against the distal anchor. FIG. 7I depicts a cross sectional
expanded view of the distal anchor 26 and removal tool 62 from FIG.
7G as the removal tool 62 abuts the distal anchor 26. FIG. 7J
depicts the distal anchor and removal tool from FIG. 71 following
deformation of the distal anchor. After deformation, the removal
tool 62 may be withdrawn from the tongue separately from the distal
anchor 26 or together with the distal anchor 26. In some
embodiments, the removal tool 62 surrounds the distal anchor 26 to
reduce the risk of breakage or snagging of the distal anchor 26
during withdrawal from the tongue. The removal tool may include any
of a variety of structures capable of exerting sufficient force
against the distal anchor 26 to cause deformation. In some
instances, the removal tool 62 may be a catheter or large gauge
needle. Preferably, the removal tool 62 is further adapted to slide
or interface with the proximal tether 40 of the distal anchor to
guide the removal tool 62 to the distal anchor 26. The adaptation
may include a groove, channel or a lumen that can be placed about
the proximal tether 40.
[0147] In some embodiments of the invention, the distal anchor may
resist migration by having an enlarged surface area that creates a
frictional or mechanical interface with the surrounding tissue, but
is not limited to this sole mechanism to resist migration. Examples
of such distal anchors include a T-shaped anchor 64 depicted in
FIGS. 8A and 8B, a coil-shaped anchor 66 in FIGS. 9A and 9B, and
the flat-ended prong anchor 68 illustrated in FIGS. 10A and 10B.
Tissue anchors having an enlarged surface area may be advantageous
by reducing or avoiding tissue laceration that may be associated
with piercing-type anchors. In other embodiments of the invention,
the distal anchor comprises one or more coils that are drawn taut
during the implantation procedure and resume a coiled configuration
upon release of tension on the wire coil. In embodiments of the
distal anchor comprising multiple coils, the coils lengths may be
distinct or intertwined with other coils of the same or different
anchor. The ends of each coil may be attached to the same or
different point on the tether or coils of the tether. However, a
piercing anchor 70 with hooks or barbs 72, as shown in FIG. 11, may
also be used. The piercing structures need not be arranged on the
distal anchor about the same circumference. FIG. 12 illustrates
another embodiment of the invention where the piercing structures
72 are located at two separate circumferences of the distal anchor
70, but in other embodiments, the piercing structures may be
staggered anywhere along the length of the distal anchor.
[0148] In some embodiments of the invention, the distal anchor 74
may further comprise one or more polymeric sheets 76 between or
engaged to the tissue engagement structures 78 of the distal anchor
74. In one example depicted in FIG. 13, the polymeric sheets 76 may
be attached to the tissue engagement structures 78 generally about
one end of the distal anchor 74, thereby forming an umbrella-like
structure upon expansion that provides an increased surface area
for resisting the migration of the distal anchor 74. In other
embodiments, the polymeric sheets may span from one end of the
distal anchor to the other end, thereby forming a generally
enclosed shape.
[0149] Referring to FIGS. 14A and 14B, in one embodiment of the
invention, at least a portion of the distal anchor 80 may comprise
a plug structure 82. The term plug is used to describe any of a
variety of space-occupying structures, including lattice,
reticular, fibrous or porous plugs, discs or other structures. The
plug 82 may comprise a polymer, a metal, a ceramic or combination
thereof. The polymer may optionally be a resorbable polymer. The
plugs may be expandable or non-expandable. Expandable plugs may be
self-expandable through the use of a shape memory material, a
compressible material such as a foam, or an absorptive material
that may expand in the presence of liquid. The plugs may or may not
be filled or saturated with one or more therapeutic agents that may
alter tissue ingrowth, scarring or other physiological effect,
either systemically or locally about the tongue 9. These agents may
include but are not limited to an antibiotic, a sclerosing agent,
an anti-proliferative agent, growth factors, hormones and other
therapeutic agents known in the art. The plug structure 82 may also
be combined with other distal anchor designs discussed herein.
FIGS. 14A and 14B represent embodiments of a distal anchor 80
comprising an expandable foam plug 82 with a T-tag core 84. The
T-tag 84 may be fully encapsulated by the foam 82 as shown in FIG.
14A, or some portions 86 of the T-tag 88 may protrude from the foam
plug 82, as shown in FIG. 14B.
[0150] Other distal anchor designs that may be used are shown in
FIGS. 15A though 22B. FIGS. 15A and 15B depict one embodiment of
the invention comprising a tubular distal anchor 90 having a
proximal end 92, a distal end 94 and at least one deformable zone
96 between the proximal end 92 and the distal end 94. The
deformable zone 96 is configured to deform radially outward and may
comprise any of a variety of deformable structures, including but
not limited to struts 98, prongs, lattice, reticular, coiled or
spiral structures. The deformation may occur as a result of elastic
deformation of the distal anchor 90, shape memory effects, or
particular mechanical effects of the distal anchor configuration in
response to applied force. In some embodiments, when the distal end
94 and/or proximal end 92 of the distal anchor 90 are pushed or
pulled closer together, the deformable zone 96 bends in a radially
outward direction. In one embodiment, the tether 28 is located
through a lumen in the proximal end 92 of the distal anchor 90 and
the deformable zone 96 and attaches to the distal end 94 of the
distal anchor 90. Referring to FIG. 15B, by pulling on the tether
28, the tether 28 moves in a proximal direction and brings the
distal end 94 of the distal anchor 90 closer to the proximal end
92, causing radial expansion of the deformable zone 96. In one
embodiment, shown in FIG. 15C, the position of the proximal end 92
is maintained during the expansion of the deformation zone 96, by
abutting a portion of the delivery tool 36 against the proximal end
92 of the distal anchor 90 to provide leverage and to resist
proximal displacement during the expansion process. The delivery
tool 36 may comprise a sheath 102 for retaining the proximal end 92
of the distal anchor 90 during expansion to prevent angular
displacement of the anchor 90 as force is applied through the
tether 28. In other embodiments, sufficient resistance is provided
by the contact between the proximal end 92 of the distal anchor 90
and the tongue tissue to limit displacement of the proximal end 92
with tension of the tether 28 and thereby allow deformable zone
expansion. Referring to FIG. 16, resistance between the proximal
end 92 of the anchor 90 and the tongue tissue may be enhanced by
tissue engagement members 104 on the proximal end, such as small
hooks, barbs, or any of a variety of ramped surfaces inclined
radially outwardly from a distal to proximal direction.
[0151] One skilled in the art can configure the deformable zone to
provide any of a variety of desired expanded anchor shapes. In
addition to a plurality of longitudinally oriented
circumferentially spaced slots 106 depicted in FIGS. 15A and 15B,
the slots 106 may also be arranged serially along the longitudinal
axis of the distal anchor 108, as depicted in FIGS. 17A and 17B, to
create two or more deformable zones 110, 112. Each deformable zone
110, 112 need not have the same deformation characteristics. The
first deformable zone, for example, may be configured for a larger
expanded diameter compared to the second deformable zone.
[0152] Referring to FIG. 18A, in another embodiment, the deformable
zone 114 comprises angled circumferential slots 116, which, when
expanded as shown in FIG. 18B, result in a spirally oriented
deformation zone 118. FIG. 19 illustrates a spirally oriented
deformable zone 120 of an anchor 124 configured to maintain the
position of the one end of the anchor 124 while rotating the other
end of the anchor. In one embodiment, the proximal end 126 of the
distal anchor 124 is held in position by a delivery tool or
catheter while the distal end 128 of the distal anchor 124 is
pulled and rotated proximally. In some instances, the tether 28 has
sufficient stiffness such that rotation of a tether 28 joined to
the distal end 128 of the anchor 124 is sufficient to cause
twisting of the anchor 124. In other instances, the tether 28
attached to the distal anchor 124 may lack sufficient stiffness to
transmit sufficient torque to the distal anchor 124. To facilitate
torque transmission to the distal anchor 124, a stiff inner core of
the delivery tool may extend into the distal anchor to form a
mechanical interfit with the distal end 128 of the anchor 124 and
that is adopted to rotate and deploy the anchor 124 with rotation
in one direction of the delivery tool and disengage from the anchor
124 when rotated in the other direction. After expansion, the inner
core may be disengaged from the distal anchor 124 and
withdrawn.
[0153] One or more surfaces of an anchor may also be further
configured with protrusions, indentations or one or more porous
layers to further engage the surrounding tissue. FIG. 20 is a
further embodiment of the invention comprising teeth or pointed
members 130 protruding from the struts 98 of the distal anchor 90
that may further enhance the tissue engagement characteristics of
the distal anchor 90. In another embodiment, one or more surfaces
of a strut 98 may be polished by methods known in the art. In still
another embodiment, portions of the distal anchor 90 may comprise a
drug-eluting surface. Preferably, the drug-eluting anchor may be
used to release agents that alter the tissue and scar formation
about the anchor. In some embodiments, fibrous tissue growth is
encouraged to reduce the friability of the tissue surrounding the
anchor. In other embodiments, anti-proliferative agents such as
rapamycin or corticosteroids may be used to limit tissue growth.
Other therapeutic agents may also be used, including
antimicrobials, clot inhibitors, sclerosants, growth factors,
hormones and other therapeutic agents known in the art. More than
one therapeutic agent may be eluted from the drug-eluting surface,
if desired. As mentioned previously, the distal anchor may also be
covered with a bioabsorbable coating. The bioabsorbable coating may
result in inflammation and/or fibrous tissue formation about the
distal anchor. The fibrous tissue formation may also alter the
tension or compliance characteristics of the tongue element or
surrounding tongue tissue, and may be beneficial in reducing the
risk of anchor extrusion or migration.
[0154] Although a distal anchor having a circular cross-sectional
shape may be used in some embodiments of the invention, other
cross-sectional shapes of distal anchors may also be used,
including, triangular, rectangular, oval, polygonal or any other
shape. The distal anchor need not have the same cross-sectional
shape or size along its length. FIG. 21A depicts one embodiment of
the distal anchor 132 comprising a square cross-sectional shape
with slots 134 between each surface 136 of the anchor 132. When
expanded, the anchor forms an X-shaped anchor as shown in FIG. 21B.
The slots, however, may be positioned in a variety of
configurations on the anchor as desired to achieve a particular
expanded shape. In other embodiments, slots may be located within a
surface 136 of the anchor 132, in addition to or in lieu of slots
between the surfaces 136.
[0155] The shape of the slot and/or strut of the deformable zone
need not be constant along the length of the slot or strut, or
between the slots and/or struts of the same anchor. The struts may
also be configured to control the shape of the deformation by
varying the strut dimensions along the length of the strut. In some
embodiments, indentations or creases in the struts may be used to
cause an angular deformation of the strut with expansion. In other
embodiments, the struts may deform in a curved or looped fashion.
For example, variations in the cross-sectional shape, thickness and
width of the struts may be used to provide a distal anchor that
deforms asymmetrically in as least one dimension. This may be
advantageous for resisting migration of the anchor in a particular
direction. In FIGS. 22A and 22B, for example, struts 138 of the
deformable zone 140 expands with a proximal bias because of
proximal regions 142 of narrower widths, which may be beneficial in
resisting migration from the proximal tension exerted through the
tether 28.
[0156] In some embodiments of the invention, the deformable zone
may comprise at least one prong with one end that is not joined to
either the distal end or proximal end of the tube segment. When the
distal end and proximal end of the tube segment is brought closer
together, the free end of the prong is able to splay outward and
engage the tongue tissue. The strut may or may not have an
intrinsic outward bias. FIGS. 23A and 23B depict one embodiment of
the invention comprising prongs 144 attached to the distal end 146
of the anchor 148. When proximal tension is placed upon the tether
28, the prongs 144 contact and slide away from the proximal end 150
of the anchor 146, thereby splaying in a radially outward direction
to engage the tongue tissue. In other embodiments, the anchor 152
comprises an alternating or other arrangement of multi-directional
prongs 154, 156. In FIGS. 24A and 24B, alternating distal end and
proximal end prongs 154, 156 are provided to engage the surrounding
tissue from multiple directions. Although the prongs depicted in
FIGS. 23A through 24B are flat prongs 144, 154, 156, the prongs may
have any of a variety of cross-sectional shapes, including
triangles, circles, square or any of a variety of other shapes. The
end of each prong may be also configured with additional structures
to modify the tissue engagement characteristics of the anchor. In
some embodiments, the prong ends may be configured with spheres or
other smooth surfaces to reduce the risk of tissue laceration from
chronic tension exerted by the tether. In other embodiments, the
prong ends are configured with barbs or hooks to further enhance
tissue engagement. One skilled in the art can configure or select
the prongs with the desired features for a given patient's anatomy
and pathophysiology.
[0157] In another embodiment of the invention, the distal anchor
500 comprises at least one deformable hook element, and preferably
a plurality of deformable hook elements 502, 504. The plurality of
hook elements 502, 504 may be spaced circumferentially and/or
longitudinally on the distal anchor 500 in any of a variety of
configurations, at regular or irregular positions. The hook
elements 502, 504 may be arranged individually about the distal
anchor or placed in one or more groups about the distal anchor 500.
A tether is typically attached to the distal anchor 500 about its
proximal end 521. In the specific embodiment illustrated in FIGS.
60A to 60D, the distal anchor 500 comprises a proximal group 506 of
four hook elements 502 and a distal group 508 of four hooks 504.
The hook elements 502, 504 within each group 506, 508 are spaced
about 90 degrees apart and the proximal group 506 is offset from
the distal group 508 by about forty-five degrees. In other
embodiments, one or more of the angles between the hook elements
502, 504 and/or hook groups 506, 508 may be different. For example,
the hook elements may be spaced such that the distal anchor has a
left/right symmetry but a smaller vertical profile than horizontal
profile when fully deployed into tissue. In still other
embodiments, the hook elements may or may not have a left/right
symmetry, and/or may have similar or dissimilar sizes, shapes
and/or lengths. The hook elements 502, 504 may be provided with
sharp or tapered distal ends 510, 512 as depicted in FIGS. 60A to
60E, but in other embodiments, the ends may have blunt or have
other configurations. Each end of the hook element need not have
the same configuration. The distal anchor 500 illustrated in FIGS.
60A to 60D may also be combined with other features and structures
described herein, including but not limited to biocompatible or
biodegradable coatings.
[0158] The distal anchor 500 in FIGS. 60A to 60D comprise groups
506, 508 of symmetrical U-shaped planar structures 514 with one
hook element on each end, as depicted in FIG. 60E, and restrained
by a band 516 and an inner core 518 about their proximal ends 520,
522, as depicted in FIGS. 60C and 60D. One of skill in the art can
produce any of a variety of expandable hook structures for
deployment in the tongue without undue experimentation and will
understand that the embodiments of the invention are not limited to
the arrangements of U-shaped symmetrical hook element structures.
For example, in other embodiments, the distal anchor may have a
unibody construction, or may comprise a plurality of
non-symmetrical and/or multi-planar components. In one specific
embodiment, the plurality of piercing or grasping elongate members
may be provided using one or more X-- or asterisk-like structure
formed into a multi-planar structure. Each group may be formed from
the same or a different X or asterisk-like structure.
[0159] As shown in FIG. 60A, the distal anchor 500 may comprise a
low-profile delivery configuration to facilitate minimally invasive
implantation of the distal anchor 500 and, as shown in FIG. 60B, an
expanded deployment configuration to engage the surrounding soft
tissue. In the low-profile delivery configuration, each hook
element 502, 504 generally has a straighter configuration to
facilitate insertion of the distal anchor 500 into the soft tissue
using a delivery device. The delivery device may be configured to
restrain the hook elements in the straighter low-profile
configuration until the distal anchor is deployed. As illustrated
in FIG. 62A, one embodiment of the delivery device 700 for
deploying a distal anchor comprises a tubular body 702 with a
pushrod 704, spring structure or other structure for displacing a
distal anchor out of the distal opening 706 of the tubular body
702. In other embodiments, the tubular structure may be retracted
or withdrawn relative to the pushrod. One embodiment of a delivery
device is discussed in greater detail below.
[0160] As each hook element is exposed relative to the distal
opening 706 of the tubular body 702, the distal tip of each hook
element is no longer restrained and can revert back to its
deployment configuration to engage the surrounding tissue. In the
embodiment depicted in FIG. 60B, the distal ends 510, 512 of the
hook elements 502, 504 are configured to curl back onto themselves
to form a loop-like structure 524. In other embodiments, the hook
elements may curl to a greater or lesser extent, have a tighter or
looser curl, and/or may have a more angular configuration when
deployed. In some embodiments, due to the expansion bias of the
hook elements 502, 504 in the deployment configuration, as the
distal ends 510, 512 of the hook elements 502, 504 are partially
exposed from the delivery tool, the expansion of the hook elements
502, 504 may cause the proximal portions 520, 522 of the distal
anchor 500 to be quickly pulled out of the delivery tool unless
restrained or controlled in some manner. In some instances, the
rapid expansion of the hook elements 502, 504 out of the delivery
tool may facilitate its engagement of the surrounding tongue tissue
by virtue of the rate with which the hook elements pierces or grabs
the surrounding soft tissue. With a slower deployment speed, the
soft tissue may get pushed away or displaced from the curling hook
elements 502, 504, rather than being engaged, captured, pierced or
grasped. Additional features on the hook elements, including but
not limited to tissue ingrowth surfaces or barbs, may be used to
enhance engagement of the tissue anchor to the surrounding tissue
in some instances when a slower delivery speed is desirable but
provides inadequate tissue engagement. Preferably, the deformable
or expandable piercing or grasping members of the distal anchor
comprise a metal such as Nitinol or superelastic Nitinol, but other
materials may also be used and are described in greater detail
below.
[0161] Although the distal anchor structure shown in FIGS. 60A to
60D and in other figures are described in the context of tongue
manipulation, such structures may be applicable to a variety of
other tissue structures, anatomical locations and treatments. Other
tissue structures may include bone, fat, ligament, tendon, liver,
striated and smooth muscle. Other anatomical locations may include
the nasopharynx, soft palate, hard palate, pharyngeal wall, GI
tract, bronchial tree, biliary tree, and genitourinary tract.
[0162] Referring to FIGS. 25A through 25C, in another embodiment of
the invention, the anchor or plug 157 may be at least partially
formed in situ within the tongue 9. As shown in FIG. 25C, an
injectable material 159 may be formulated to set in situ, to form
the anchor 157 or plug, possessing the desired shape, position and
mechanical properties to engage or resist migration from the
surrounding tongue 9 or other soft tissue. A tether 28 may be
positioned at the site of formation before, during or after the
injection of the material 159. The portion of the tether embedded
in the anchor or plug 157 may be configured to resist separation
from the material 159, typically by one or more transverse
elements, but one skilled in the art will understand that any of a
variety of protrusions or other three-dimensional structures may be
used.
[0163] The anchor 157 may comprise an injectable material 159
having one or more biocompatible liquid components, or one or more
solid biocompatible components carried in one or more liquid
biocompatible components. As depicted in FIG. 25B, the material 159
may be injected as a liquid or slurry into the tongue 9 or other
soft tissue region by a syringe or other delivery tool 161. Upon
mixing, the components cross-link, polymerize, or otherwise
chemically react to create the in situ biocompatible, non-liquid,
static mechanical anchor 157 or plug, as shown in FIG. 25C. In one
embodiment, the delivery tool 161 has at least two injection lumens
for delivering the components separately to the target site to
prevent premature reaction of the components within the delivery
tool 161 or elsewhere.
[0164] Referring to FIG. 25A, in some embodiments, prior to
injection of the material 159, the targeted tissue region may be
dilated by use of a trocar, balloon catheter or other expandable
structure, to open a tissue space 163 in the tongue 9 to receive
the injectable material 159. During dilation, the tissue space 163
may be deliberately sized and shaped, so that the resulting
material 159 injected into the tissue space 163 will possess the
size, shape, and physical characteristics to resist migration
within the surrounding soft tissue.
[0165] The biocompatible liquid component may comprise, e.g., an
Elastin.TM. media. Alternatively, the liquid component may comprise
an oil or low viscosity liquid that is biocompatible to impart the
desired features and/or shape to the anchor 157. The solid
component may be a polyvinyl acetate (PVA) or foam that is
appropriately sealed to provide biocompatibility. Other materials
such as silicone rubber, elastomeric polymers and
polytetrafluoroethylene (Teflon.RTM. Material, from DuPont) may
also be selected. Alternatively, a powder, small spheres,
microtubules or shavings of solid material can be mixed with a
slurry or liquid.
[0166] Referring to FIGS. 26A and 26B, alternatively, the
injectable material 159 may be injected into a fillable structure
165 that is itself implanted in a targeted tissue region. The
fillable structure is preferably pre-shaped, expandable to assume
the desired inflated shape, position, and mechanical properties. A
tether 28 may or may not be integrated with the fillable structure
165.
[0167] As illustrated in FIGS. 26C and 26D, once suitably
implanted, the fillable structure 165 is inflated by infusion of
the injectable material 159, which is dispensed from a syringe or
other delivery tool 161. In one embodiment, the injectable material
159 may be formulated to set in situ within the fillable structure
165, the fillable structure 165 and its contents serving as an
anchor 157 or plug, possessing the shape, position and mechanical
properties to resist migration. It should be appreciated that, when
an expandable fillable structure 165 is used to house the
injectable material 159, a fluid (e.g. saline) or slurry that does
not set or cure in situ may be also used to form an anchor 157 or
plug. Furthermore, the injectable material 159 may be formulated to
be injected as a gel that need not set or cure to perform its
desired function.
[0168] The fillable structure 165 may comprise a bioresorbable
material, such as polyglycolic acid, a polymer used for resorbable
sutures and other devices within the body. In this arrangement,
once expandable fillable structure 165 is resorbed, only the core
of injectable material 159 will remain to serve as the anchor or
plug. The fillable structure 165 may also have one or more porous
regions. Each porous region may be full thickness or partial
thickness porous regions. One or more full thickness porous regions
may allow escape of trapped air, if any, during the injection
procedure. Depending on the pore size, the full thickness porous
regions may also allow partial extrusion of one or more components
of the injectable material 159 from the fillable structure 165 to
interface with the surrounding tissue.
[0169] One or more partial thickness porous regions on the outer
surface of the fillable structure 165 may allow tissue ingrowth
into the fillable structure 165 or increase the frictional
resistance between the fillable structure 165 and the surrounding
tissue to further resist migration. One or more porous regions may
also be provided on the inner surface of the fillable structure 165
to allow the injectable material 159 to form an interlocking
configuration with fillable structure 165 which can resist
separation or movement at the interface between the fillable
structure 165 and the core formed in situ by the injectable
material.
[0170] In one embodiment of the invention, the anchor is integral
with a tether and comprises a tubular elastic member wherein one or
more regions of the elastic member are configured to expand and
occupy a larger space when the tubular elastic member is filled or
pressurized with the injectable material. In one embodiment the
anchor portion of the tubular elastic member comprises a thin
walled region configured to expand to a greater size than other
portion of the tubular elastic member.
[0171] 2. Tether
[0172] In some embodiments of the invention, the tethers of the
tongue elements comprise sutures or wires that are well known in
the art. Such materials are generally inelastic and may be useful
to fix the distance between the distal anchor and the proximal
anchor or securing assembly. For reasons previously mentioned,
however, a tether with elastic properties or comprising structures
that provide a length/tension relationship may be preferred in some
instances. A tether capable of lengthening in response to increased
load or tension may be optimized to provide sufficient bias to
reduce the effects of oropharyngeal occlusion while providing a
more physiologic range of tongue motion than that produced by fixed
length tethers. Fixed length glossoplasty or suspension of the
tongue may be the cause of odynophagia, dysphagia and deglutition
problems seen with existing tongue remodeling devices, but the
current invention is not limited to this purpose. A tether with
elastomeric properties may be provided by using materials such as
but not limited to urethane or silicone. One skilled in the art can
select the particular material, tether length, diameter,
cross-sectional shape and other features based upon the desired
effect, tolerances, and the particular patient's anatomical
characteristics. Other materials that may comprise the tether
include but are not limited to Nitinol, spring steel, tantalum,
polyethylene, polyester, silk, polypropylene, polyolefin or a
combination thereof.
[0173] Other tether configurations that may be used include passive
and active variable length or bias structures such as braided or
woven structures, electropolymers, springs, coils, magnets or
solenoids. Thus, in some of the embodiments, the tether
configuration may actively change in length in length or
configuration resulting from the application of external energy or
force such as electrical current or magnets. These active tether
configurations may be further configured with local or distal
sensor components that may modulate the activity of the external
energy or force acting on the active tether. The modulation may be
influenced or triggered by detection of diaphragm movement or
depolarization activity, nerve depolarization, pressure changes
and/mechanical contact in the airway.
[0174] The tether may also be covered by a lubricious biocompatible
coating. In another embodiment, the tether comprises a
bioabsorbable coating that may cause scar or connective tissue
formation about the tether. Scar tissue formation may further
enhance the effect of the glossoplasty implant by tightening the
tongue tissue and/or to resist migration of the implant.
[0175] In some embodiments, the proximal tether of the tongue
element may be configured with one or more structures or surfaces
capable of engaging at least a portion of the tongue tissue
surrounding the tether so that a distal anchor is not required, or
to distribute the tissue engagement. In still other embodiments,
the tongue element may comprise multiple distal anchors and
multiple tethers arranged in a serial or branching fashion.
[0176] FIG. 27 depicts one embodiment of the invention comprising
an elastomeric cord that may be used for the tether 28. The
elastomeric cord 154 may comprise single or multiple tightly wound
elastomeric members 156, as shown in FIG. 28. Referring to FIG. 29,
in other embodiments, the tether may comprise a structure having
spring-like or resilient properties, such as a braided structure, a
woven structure, or a metallic or polymeric coil 158.
[0177] The tether may also comprise a variety of other tension
structures that provide length/tension relationships. FIG. 30
depicts one embodiment of the invention comprising a pneumatic
casing 160 with a first tether 162 fixed to one end of the
pneumatic casing 160 and a second tether 164 attached to a movable
piston 166 within the casing 160 which is capable of reversible
movement within the pneumatic casing 160 depending upon tension
exerted through the first and second tethers 162, 164. A vacuum
chamber 168 provides a shortening bias to the second tether 164. In
another embodiment of the invention, shown in FIG. 31, the
pneumatic casing 170 comprising a first movable piston 166 attached
to a first tether 164 and a second movable piston 172 attached to
the second tether 174. By having two movable pistons 166, 172
incorporated into the pneumatic casing 190, the casing 170 can
remain in a fixed position within the tongue 9 while distributing
changes in distance between both the first and second tether 164,
174, which may reduce the irritation and inflammation caused by
excessive movement of any one part of the tether system.
[0178] The tether may be further configured to provide one or more
structures for adjustable mechanical interfacing with the securing
structure of the implant. These structures may include bead
structures 176, as shown in FIG. 32, or ramped structures 178 as
shown in FIG. 33. The particular structure on the tether 28 can be
selected by one skilled in the art based upon particular interface
characteristics desired with the securing assembly.
[0179] Although in some embodiments of the invention, the tongue
element comprises a single elongate tether having one proximal end,
one distal end, and a single distal anchor attached to the distal
end of the tether, other configurations of the tongue element are
also envisioned. In one embodiment, depicted in FIG. 34, the tongue
element 179 comprises a tether 181, a distal anchor 183, and at
least one additional anchor 185, 187 along the length of the tether
181, arranged serially. The multiple anchors 183, 185, 187 need not
be of the same configuration and need not be spaced regularly along
the segment or length of tether 181. In another embodiment,
depicted in FIG. 35, the tether 189 may have one or more branches,
191, 193, 195. The branches 191, 193, 195 may originate from the
main tether trunk 197, or may branch from other branches 191, 193,
195 of the tether 189. In one embodiment, the branching tether 189
had a single proximal end 199 and two or more distal ends 201, 203,
205. Tissue anchors 207, 209 may be located along a branching
tether 189 at the distal ends 201, 203, 205, a branch point 211, or
any other position along the branching tether 189. The branches
201, 203, 205 of the tether 189 need not be symmetrical in branch
length, diameter, elasticity, branch configuration or other
characteristics.
[0180] In another embodiment, shown in FIG. 36, the tether 213 may
comprise two or more proximal ends 215, 217, that are attachable to
the same or different anatomical structures. A tongue element 219
having two or more proximal attachments 221, 223 may be beneficial
in limiting tongue movement or distal anchor 225 movement in more
than one direction. The various features of the tongue element
described above may be used in various combinations to achieve the
desired effect from the glossoplasty system.
[0181] FIG. 37 depicts another embodiment comprising a tether loop
227 having two ends 229, 231 wherein the two ends 229, 231 are
joined and the tether loop 227 is engaged to a securing assembly
24. The tether loop 227 may comprise one or more regions 233 of an
expanded diameter or size to reduce the risk of the loop 227
cutting through the tongue 9 due to chronic tether tension and with
tongue movement. The tether loop 227 may have a fixed region of
increased diameter, a self-expanding region, a balloon or fluid
expanding region or an in situ formed expanded region.
[0182] FIG. 38 illustrates another embodiment of the invention
comprising a tether 235 with two ends 237, 239 and at least one
tissue anchor 241 attached to the tether 235 between the two ends
237, 239. The two ends 237, 239 of the tether 235 may be attached
to the same site or same securing assembly, or at two different
sites 243, 245. Although the relative locations of the two sites
243, 245 as shown in FIG. 38 are symmetrical with respect to the
midline of the tongue 9 and mandible 13, in other embodiments the
location may be asymmetrical.
[0183] FIG. 60F depicts another embodiment of the invention,
comprising a tether 28 that is looped or threaded through the
proximal end 521 of the distal anchor 500 from FIG. 60B. Typically,
the proximal end of the distal anchor 500 is positioned about
halfway between the first end 23 and second end 25 of the tether
28, but may also be positioned at other locations between the first
and second ends 23, 25. Referring to FIG. 60G, one or more knots 27
are optionally provided to resist slippage of the distal anchor 500
along the length of the tether 28. One or more knots 27 and/or
other securing methods (e.g. gluing or melting the elongate member
to itself) may also be used to prevent the distal anchor 500 from
separating from the tether 28 should a section of the tether 2
between the knot(s) 27 and one of the ends 23, 25 be severed. The
optional knot(s) 27 will keep the distal anchor 500 secured to the
tether 28 and allow the remaining intact section of the tether 28
to maintain its connection to the securing assembly 600. The
connection of the tether 28 to the distal anchor 500 is typically
performed at the point of manufacture, but in other embodiments of
the invention, one or more attachments may be performed at the
point of use to allow customization of the tongue element. As
mentioned previously, the distal anchor 500 is preferably implanted
into the tongue prior the attachment of the first and second ends
23, 25 of the tether 28 to the securing assembly 500, but in other
embodiments, the distal anchor 500 and tether 22 are pre-attached
to the securing assembly 600 when the distal anchor 500 is
implanted.
[0184] 3. Securing Assembly
[0185] As mentioned previously, bone anchors or screws, clips,
staples and other devices well known in the art may be used for
directly attaching a tongue element 22 to a mandible 13 or other
rigid structure. Preferably, however, a tether securing assembly 24
is provided to facilitate attachment, removal and/or adjustment of
the tether 28 to an attachment structure. More preferably, tether
securing structures 24 that allow adjustment in a minimally
invasive manner are used. In some embodiments, one tether securing
structure is provided for each tongue element 22 of the
glossoplasty system. In other embodiments, more than one tongue
element 22 may be secured to each retaining structure.
[0186] FIG. 39 depicts one embodiment of an attachment structure
180. The attachment structure 180 comprises one or more bone
engaging elements to attach the attachment structure to a bone or
other structure such as a bone screw or anchor 34. Angled
protrusions or tabs 182 projecting from the attachment structure
180 provide securing interfaces 32 may be used to lodge and retain
one or more tethers 28 through frictional resistance. The tether 28
may be wound between the two angled protrusions 182 to further
enhance the frictional resistance between the protrusions 182 and
tether 28, and also to localize excess tether material for access
at a later date. If the tongue element 22 was secured with
excessive tension, the excess tether material may be unwound,
loosened to a desired tension and rewound onto the protrusions 182.
Once the desired tension is determined over the course of days,
weeks or months post-implantations, any excess tether material not
required to secure the tether 28 to the attachment structure 180
may be removed to reduce the infection risk from unnecessary
foreign body material. In some embodiments of the invention, a
conduit or bore hole is provided in the mandible 13 or other bone,
an access hole 184 may be provided in the attachment structures 180
and the attachment structure 180 may be positioned directly over
the conduit or bore hole.
[0187] FIGS. 40A through 40C depict another embodiment of
attachment structure comprising a bone screw 186 with a clamping
interface 188 for retaining tethers 28. The clamping interface 188
comprises two opposing surfaces 190, 192 or structures that are
adapted to provide a frictional or mechanical interface with
tethers 28 or other elongate members inserted within the clamping
interface 188. The clamping interface 188 has an open configuration
depicted in FIGS. 40B and 40C to allow positioning of one or more
tethers 28 within the interface 188 and a closed configuration
shown in FIG. 40A for retaining the tethers 28. The closed
configuration may be achieved by crimping the two opposing surfaces
190, 192 or by further structures of the clamping interface, such
as complementary clasps or clip structures that are well known in
the art to fix the opposing surfaces 190, 192 together. Referring
to FIG. 40C, the clamping interface 188 may further comprise
complementary indentations 194 and protrusions 196 to further
enhance the frictional resistance of the interface in the closed
configuration. The opposing surfaces or structures of the clamping
interface may also be configured with frictional surfaces that are
well known in the art through the use of various materials, surface
treatments or configurations. Frictional surface configurations may
also include cross hatched surfaces or irregular porous
surfaces.
[0188] FIGS. 41A and 41B illustrate another embodiment of the
attachment structure 198 comprising a retaining lumen 200 for
inserting one or more tethers 28 and accepting a retaining bolt 202
for securing the tethers 200 within the retaining lumen 200.
Typically the retaining bolt 202 will comprise a threaded surface
204 that is complementary to a threaded surface 206 of the
retaining lumen 200.
[0189] In some embodiments of the invention, the securing assembly
is capable of adjusting the tension acting on the tether without
directly accessing and manipulating the tether. This may reduce the
need to perform an open procedure to access the securing assembly
and locate small, hard-to-find tether ends. Preferably, the tension
adjustment may be facilitated through an adjustment tool interface
that can be accessed in a minimally invasive manner.
[0190] As previously illustrated in FIGS. 7A through 7F, in some
embodiments of the invention, the securing assembly 60 is adapted
for insertion into a conduit created through the mandible 13 or
other bone. A securing assembly 60 with a reduced or flush profile
may be beneficial by minimizing or eliminating any palpability or
visibility of the implant. Some patients may find that palpable or
visible surface landmarks of the implant are psychologically or
cosmetically unacceptable. Although the securing assemblies
described below are described in the context of insertion into a
conduit through the mandible, these securing assemblies may adapted
for attachment to the exterior of the bone by providing an
attachment structure with an aperture on the exterior surface of
the securing structure capable of accepting a bone screw.
[0191] Referring to FIGS. 42A through 42D, in one embodiment of the
invention, a securing assembly 217 comprises an elongate body 208
with a lumen 210 and an inner threaded surface 212, and a core 214
with external surface threads 216 complementary to the threaded
lumen surface 212 of the lumen 210 and capable of forming a
rotational interface with the elongate body 208. The core 214 may
be directly attached or attachable to one or more tethers 216 of
the glossoplasty system. After implantation of the distal anchor in
the tongue, tether tension can be adjusted by rotating the core 214
within the threaded lumen 210 which in turn adjusts the distance
between the distal anchor and the core 214 within the lumen 210 of
the elongate body 208. In one embodiment, where the tether 216 is
directly attached to the core 214, rotation of the core 214 with a
rotation tool 240 will adjust the tether tension and result in
translation of the core rotation into torque acting on the tether
216 and distal anchor, which may or may not result in unacceptable
rotation of the tether 216 and distal anchor. This torque effect
may cause increased tension in the tether 216 from twisting causing
further reduction in the distance between the core and the distal
anchor. The torque effect may cause rotational laceration of the
tongue tissue about the distal anchor. In other embodiments,
however, the torque effect may be advantageous in taking up excess
slack in the tether.
[0192] The securing assembly 217 may be threaded on its external
surface 222 to allow secure positioning of the elongate body 208
within the bone conduit of a bone. Although the lumen 210 is
generally circular in cross section, the cross sectional shape of
the external surfaces 222 of the elongate body 208 need not be
circular, and could be oval, rectangular, square, polygonal or any
other of a variety of cross sectional shapes. The external surface
222 may also have other surface characteristics or structures to
resist migration, including but not limited to ridges, barbs,
hooks, and/or porous surfaces for bone ingrowth. The elongate body
208 may also comprise a flange on the proximal end 218 to resist
migration of the elongate body 208 in the distal direction. The
proximal end 218 of the elongate body 208 is typically open ended
to allow insertion of the threaded core 214 after implantation of
the elongate body 208. In other embodiments, the proximal end 218
of the elongate body 208 is partially closed and is configured to
accept the threaded core 214 at the distal end 220. In still other
embodiments, the elongate body 208 is open at both ends.
Preferably, the distal end 220 of the elongate body 208 is
partially closed to prevent accidental release and loss of the
threaded core if the core is overadjusted while still open
sufficiently to allow passage of one or more tethers into the
elongate body. In some embodiments of the invention, a slip
interface is provided at the attachment of the tether to the distal
anchor to resist rotation of the distal anchor with adjustment of
tether tension.
[0193] As shown in FIG. 42A, the threaded core 214 is a cylindrical
component with a proximal end 224, distal end 220, and a threaded
external surface 228 complementary to the threaded inner lumenal
surface 212 of the elongate body 208. The threaded core 214 further
comprises a first partial slot 230 that is generally perpendicular
to the longitudinal axis of the core 214 and a second slot 232 that
is generally between the first slot, the external surface and the
distal end of the core. The second slot 232 is dimensioned to allow
passage of at least the diameter of one tether 216 but to resist
passage of the tether 216 when the external surface of the core 214
is in contact with the inner lumenal surface 212 of the elongate
body 208 and where the proximal end 234 of the tether 216 is
configured to with an increased diameter, in some examples, by
tying the tether end 234 into one or more knots, or to attach the
tethers end 234 to an enlarged surface area slippage component,
such as a rod, disc 236 or plate. The first and second slots 230,
232 are generally dimensioned to align the center of the disc 236
with the center of the distal end 226 of the core 214, but it is
not required. Alignment of the centers allows the tether 216 to
maintain a generally stable position while the core 214 is rotated.
If either the first or second slot 230, 232 does not include the
center of the core 214, the tether may wobble eccentrically when
the core 214 is rotated. FIG. 42B illustrates one embodiment of the
securing assembly where the tether 216 is attached to a disc 236,
which is then passed through the second slot 232 and into the first
slot 230. Although it is preferred that the first slot 230 be
generally perpendicular to the longitudinal axis of the core 214 to
evenly distribute frictional forces between the core and tether
end, this is not required. In some embodiments, the first slot 230
may be oriented within the range of about zero degrees to about 180
degrees with respect to the longitudinal axis of the core 214. In
other embodiments, the first slot 230 is oriented between about 45
degrees and 135 degrees, and in still other embodiments to about 75
degrees to about 110 degrees. The core 214 further comprises a
mechanical interface 238 on its proximal end 224 for engaging a
rotational tool 240. As shown in FIGS. 42C and 42D, when the core
214 is rotated within the lumen 210, the position of the core 214
with respect to the lumen 210 is changed, thereby adjusting the
tension in the tether 216. The first slot 230, second slot 232,
and/or slippage component 236 may be covered with PTFE or another
lubricious coating to minimize rotation of the tether 216 from
rotation of the core 214 due to friction between the
tether/slippage component 236 and core 214.
[0194] FIGS. 43A through 43E depict another embodiment of the
invention for restricting rotation of the tether. Here, the core
242 is rotatably attached to an intermediate tether interface 244
by a rod 246 or other structure. The intermediate tether interface
244 may be any structure that is rotatably attached to the core 242
and comprises one or more keyed structures 248 that form a partial
mechanical interfit with a complementary groove or track 250 on the
inner threaded surface 252 of the elongate body 254 that allows
sliding of the intermediate tether interface 244 along the
longitudinal axis of the elongate body 254 while restricting
rotation of the intermediate tether interface 244. The groove 250
typically has a generally linear configuration oriented parallel to
the longitudinal axis of the elongate body 254, but the groove 250
may also have other configurations and orientations. In some
embodiments, the groove may have a spiral configuration within the
inner threaded surface 252 of the elongate body, thereby allow some
torque transmission to the tether. The pitch of the spiral
configuration may be constant or variable. For example, in some
embodiments, the groove may have a tighter pitch proximally, so
that it the keyed structure can impart greater rotation to the
tether as the longitudinal displacement range limit is reached. The
keyed structure 248 may comprise any of a variety of shapes
sufficient to restrict rotation and need not be exactly matched in
cross sectional shape and/or surface area to the groove or tract.
The keyed structure 248 and/or the groove of the elongate body 250
may be coated with PTFE and/or other lubricious coating to reduce
friction and promote sliding of the keyed structure 248 long the
groove 250. The keyed structure 248 depicted FIGS. 43B and 43C are
square shaped, while the keyed structures 256 depicted in FIGS. 43D
and 43E are triangular. FIGS. 44A and 44B are cross sectional and
end elevational views of one embodiment of the securing assembly
257 configured with a keyed groove 250 and inner threaded surface
252 to accept a threaded core 242 attached to a keyed intermediate
tether interface 244.
[0195] The intermediate tether interface 244 may be configured with
a variety of structures to which one or more tethers may be
attached. FIG. 43B depicts a tether interface 244 configured with a
single hole 258 to accept a single tether, while FIG. 43C depicts
another tether interface 260 configured with three holes 256
capable of accepting up to three tethers. FIG. 43D depicts still
another tether interface 262 with three eyelet attaching sites 264,
while FIG. 43E illustrates a tether interface 266 with circular
post 268 capable of engaging a number of attached tethers.
[0196] FIGS. 45A and 45B depict one embodiment of the invention
utilizing the core 242 and tether interface 244 depicted in FIG.
43A and the securing assembly 257 shown in FIGS. 44A and 44B. The
keyed structure 248 of the tether interface 244 remains in the
groove 250 or tract of the elongate body 254 to restrict rotation
of the interface 244. The rod 246 of the threaded core 242 and/or
the rod lumen 290 of the tether interface 244 may be coated with
PTFE and/or other lubricious coating to reduce friction at the rod
rotation site.
[0197] In another embodiment of the invention, shown in FIGS. 46A
and 46B, a securing assembly 292 comprises an elongate body 294
with an unthreaded lumen 296 containing a drive screw 298 and a
keyed tether interface 300. The drive screw 298 is supported within
the unthreaded lumen 296 by threadless supports 302, 304 that allow
the drive screw 298 to remain in the same general location when
rotated. The keyed tether interface 300 is manipulable using a
drive screw 298. The keyed tether interface 300 has a threaded
opening 306 that is complementary to the threads 308 of the drive
screw 298. Rotation of the drive screw 298 causes movement of the
keyed tether interface 300 along the longitudinal axis of the
unthreaded lumen 296 of the securing assembly 292. Although the
embodiment shown in FIGS. 46A and 46B depict a drive screw 298
located off-center from the longitudinal axis of the elongate body
294, the drive screw 298 may be configured with respect to the
elongate body 294 and tether interface 300 at any of a variety of
locations relative to the central longitudinal axis. One skilled in
the art can select the diameter of the drive screw 298 and the
thread pitch of the drive screw 298 and threaded lumen 306 of the
tether interface 300 to achieve the desired adjustment
characteristics.
[0198] Referring to FIGS. 47A through 47D, in one embodiment of the
invention, the securing assembly 310 comprises a sealed cavity 312
wherein one section of the sealed cavity 312 comprises a sealed
access interface 314 and a second portion of the sealed cavity
comprises a sliding seal 316 attached to a tether 28. The sealed
cavity 312 may be filled with a volume of gas or preferably a
liquid 316 that can be changed by adding or removing the fluid
through the access interface 314. The sliding seal 316 is
configured to move with changes in fluid volume of the sealed
cavity 312. As shown in FIGS. 47B and 47C, the access interface 314
is preferably configured as a self-sealing pierceable membrane 318
so that the sealed cavity may be accessed with a hypodermic needle
320 that is percutaneously inserted through the membrane 318 in a
minimally invasive fashion. Alternatively, the access interface 314
may comprise any of a variety of sealed mechanical valves or other
interfaces that are well known in the art. The securing assembly
310 shown in FIGS. 47A through 47C further comprise a flange 322 at
the proximal end of the securing assembly to restrict further
distal migration of the securing assembly. FIG. 47D depicts an
alternative embodiment of the securing assembly 324 lacking a
flange and comprising a threaded or frictional surface 326 on at
least a portion of the external surface 328. Limiting the threaded
or frictional surface 326 to only a portion of the external surface
328 may facilitate insertion of the securing assembly 310 into a
bony conduit while still providing sufficient friction to resist
migration of the assembly 310. Although the tether 330 depicted in
FIGS. 47A through 47D is embedded into the sliding seal 316 of the
securing assembly 310, the sliding seal 316 may also be configured
with any of a variety of attachment structures to allow attachment
of one or more tethers to the sliding seal 316.
[0199] In one embodiment of the invention, illustrated in FIGS. 48A
and 48B, a securing assembly 332 comprises a tapered elongate body
334 through which one or more tethers 336 may be passed into or
through the lumen 338 of the elongate body 334. The tethers 336 may
be secured to the securing assembly 332 by a frictional core 340
that can be snugly inserted into the tapered lumen 338 of the
tapered elongate body 334. The frictional core 340 may comprise any
of a variety of frictional materials, including silicone, rubber,
metal, polymers or a combination thereof. While the frictional core
338 forms a friction fit with the tether 336, the fit to the
tapered lumen 338 may be frictional or mechanical. The surface of
the lumen 338 may or may not be coated with frictional materials to
further enhance the frictional securing of the tethers 336 between
the core 340 and lumen 338. The frictional core 340 may be inserted
and removed through a recessed interface 342 that is configured to
accept a complementary core attachment tool. Alternatively or
additionally, the frictional core 340 may also comprise a
patterned, rough or porous surface, such as a knurled or grooved
surface. Alternatively, the frictional core 340 may comprise a
protruding structure with can be engaged with forceps or other
grasping tool for insertion and/or removal.
[0200] In one embodiment of the invention, shown in FIGS. 49A
through 49D, a securing assembly 344 comprises an elongate body
346, a tapered lumen 348, and a pronged core 350 capable of forming
a mechanical stop or frictional surface to restrict movement of one
or more tethers 352. The tapered lumen 348 comprises a proximal
threaded lumen 352 and a distal tapered lumen 354 through which a
tether 356 may be passed. The pronged core 350 comprises a proximal
threaded external surface 358 that is complementary to the proximal
threaded lumen 352 of the elongate body 346, and one or more distal
prongs 360 that are capable of inward deflection. When the pronged
core 350 is inserted into the elongate body 346, as depicted in
FIG. 49C, as the pronged core 350 is rotated and advanced distally,
the prong or prongs 360 are deflected radially inward by the
tapered lumen 354. In some embodiments, shown in FIGS. 49B through
49D, the distal ends 362 of at least some prongs may be curved or
angled inward to form a mechanical stop interface capable of
restricting a beaded tether 356 or other similarly configured
tethers with segments of increased cross sectional area. In other
embodiments, the distal ends 362 of the prongs 360 are capable of
reducing sufficiently to form a frictional aperture that is capable
of resisting sliding of a tether about the prong ends 362.
[0201] Referring to FIGS. 50A through 50F, another embodiment of
the invention comprises an elongate body 364 with a frictional
internal lumenal surface 366 and a frictional core 368. The
frictional core 368 is configured to resist movement within the
internal lumenal surface 366 by exertion of force within the broad
range of force expected by physiologic activities acting on one or
more attached tongue elements, but is also capable of movement with
the application of supraphysiologic forces through a frictional
core movement tool 370. One embodiment of the movement tool 370 is
depicted in FIG. 50B. The interface 372 between the movement tool
370 and the frictional core 368 may comprise any of a variety of
mechanical interfaces known in the art sufficient to transmit
adequate pulling and pushing force to the frictional core. The
interface 372 shown in FIGS. 50A and 50C though 50F allow
engagement of the frictional core 368 following insertion and
rotation of the movement tool 370 with one or more arms 374 capable
of resisting dislodgement from the frictional core 368 when in the
rotated position.
[0202] In still another embodiment of the invention, illustrated in
FIGS. 51A to 51E, the securing assembly 376 comprises an elongate
body 378 with a lumen 380 and an expandable tether core 382. The
expandable tether core 382 is configured to allow attachment of one
or more tethers 384 and to also reversibly radially expand and
contract such that the expanded radius of the core 382 is capable
of forming a frictional and/or mechanical fit with the lumen wall
386 of the elongate body 378. In one embodiment of the invention,
depicted in FIGS. 51A through 51E, the expandable core 382
comprises a proximal end 388 and a threaded distal end 390, a
threaded drive screw 392 through the proximal end 388 and
threadably engaged to the threaded distal end 390, and one or more
expandable members 394 between the proximal end 388 and distal end
390. When the drive screw 392 is rotated, as shown in FIG. 51C, the
distal end 390 of the expandable core 382 is brought closer to the
proximal end 388, causing deformation of the expandable members 394
which can then engage the lumen wall 386, as shown in FIG. 51E. The
proximal end 388 of the expandable tether core 382 may have a
flange 396 to facilitate engagement by a deployment tool 398. The
deployment tool 398 have grasper 400 adapted to engage and hold the
flange 396 while an extendable shaft 402 can form an interfit with
the drive screw 392 and rotate the drive screw 392.
[0203] In another embodiment of the invention, the securing
assembly comprises a spool or rotation assembly for adjusting the
tether length or tether tension between the securing assembly and
distal anchor. Referring to FIGS. 61A to 61I, in one embodiment of
the invention, the securing assembly 600 comprises a fastener
interface 602 for attaching the securing assembly 600 to a bone or
other tissue and a spool assembly 604, the spool assembly 604
comprising a spool 606 and a spool lock 608. The spool lock 608
allows the rotation of the spool 606 to take up or release a
portion of the tether when desired, while resisting unintentional
uptake or release of the tether at other times. In the specific
embodiment depicted in FIGS. 61A to 61I, the spool 606 comprises
one or more spool hubs 610 onto which one or more tethers may be
wound or unwound. Optionally, one or more flange structures 612,
614 are provided on the spool 606 to help maintain the tether on
the spool hub 610. In other embodiments, grooves or a
slip-resistant surface on the spool hub may be used to maintain the
tether on the spool hub, with or without spool flanges. Typically,
two flange structures 612, 614 are provided, but in other
embodiments of the invention, only one flange structure is needed
as other portions of the securing assembly housing 616 may act to
maintain the tether on the spool hub 610. The spool hub 610
typically has a circular cross-section, but any of a variety of
other cross-sectional shapes may also be used. Furthermore,
although the spool hub 610 described, for example, in FIG. 61G
comprises a cylindrical surface, the spool hub may be any structure
capable of winding a tether about it, e.g. in some embodiments, the
spool hub may be the region where two flanges are joined.
[0204] The spool may further comprise one or more engagement
structures for engaging the tether or elongate element. For
example, in FIG. 61D, the inferior flange 612 of the spool 606
comprises one or more holes 618 for attaching the tether. One of
skill in the art will understand that any of a variety of
alternative engagement structures may be provide on the spool,
spool flange or spool hub, including hooks, clips, clasps, crimp
structures or any combination thereof.
[0205] In a further embodiment of the invention, the spool assembly
may comprise two or more spools for winding the tether. Use of
multiple spools may allow the use of smaller spools and/or use of
non-circular tether uptake paths, which may allow the construction
of securing assemblies having a reduced profile compared to
securing assemblies comprising a single large spool.
[0206] The spool assembly 604 may further comprise a spool
adjustment interface 620. Referring to FIGS. 61H and 61I, the spool
adjustment interface 620 is typically located at the center of the
spool 606 and is configured to form an interfit with an adjustment
tool 621 for rotating the spool 606. The adjustment tool 621 may
optionally have a sharp distal end so that the adjustment tool may
also be used to provide direct access to the spool 606 without the
preforming the access pathway, or having to use a cannula,
introducer, trocar or access needle first. In further embodiments,
the adjustment tool 621 may also be used to displace the spool 606
in one or more directions. Spool displacement, whether
perpendicular to its rotation axis or longitudinally along its
rotation axis, as depicted in FIGS. 61H and 61I, may be used to
switch the spool between its locking and rotation configurations.
In other embodiments, spool displacement may be used to wind the
tether onto a secondary spool hub of the spool having a different
diameter to provide a different rate of tether winding per
rotation, for example, on a frusta-conical spool hub.
[0207] To facilitate the insertion of the adjustment tool 621 into
the spool adjustment interface 620, the adjacent flange 612 may
have a tapered or conical surface 623 to help guide an adjustment
tool 621 into the spool adjustment interface 620. Other tapered or
grooved structures 623 on the securing assembly 600 may also be
provided to guide the adjustment tool 621 from other locations
about the securing assembly 600.
[0208] In other embodiments, the spool adjustment interface may be
provided on a cog or disc, which in turn is configured to rotate
the spool for adjusting the tether. Likewise, the cog may also be
reversibly displaceable along its rotation axis and/or off its
rotation axis to lock rotation of the spool.
[0209] The interface between the spool and the spool housing may be
configured in a number of ways. As depicted in FIG. 61C, spool
rotation is provided by a generally cylindrical or circular
rotation surface 622 that rotates in or about a hole 624, lumen or
other arcuate surface of the spool housing 616 to provide rotation.
The circular rotation surface 622 may be located on the spool hub
610, spool flanges 612, 614 or other section of the spool 606. In
other embodiments, the spool may comprise a tubular lumen which
rotates about a pin or an axle structure of the spool housing. The
tubular lumen may be concentric or eccentric with the spool
hub.
[0210] In some embodiments of the invention, the interface between
the spool and the spool housing provides sufficient mechanical or
frictional force to generally resist undesired rotation, in one or
both directions, related to physiological forces acting on the
distal anchor, tether and/or securing assembly. In other
embodiments of the invention, the securing assembly may further
comprise a reversibly engageable spool lock to resist undesirable
spool rotation. Referring to the embodiment shown in FIGS. 61A to
61I, the spool lock 608 may comprise a four-sided locking flange
626 that prevents rotation of the spool 606 when the locking flange
626 is positioned within a corresponding four-sided locking cavity
628 of the spool housing 616. In some embodiments of the invention,
the locking flange may also serve the function of a spool flange.
To rotate the spool 606 when desired, the four-sided locking flange
626 may be displaced out of the four-sided locking cavity 628 of
the spool housing 616, longitudinally along the rotation axis of
the spool 606. Longitudinal displacement along the rotation axis of
the spool 606 is provided because the cylindrical rotation surface
622 of the spool 606 has an axial length that is greater than the
axial length of arcuate rotation surface or hole 624 of the spool
housing 616. The spool 606 may be biased to its locked position by
a bias structure 630 that applies an axial force on the spool to
maintain or push the four-sided locking flange 626 into the
four-sided locking cavity 628 of the spool housing 616. This bias
structure 630 may be a coil or leaf spring, an elastically
deformable wire or other similar structures known in the art. The
bias may be attached or retained in the spool housing in any of a
variety of ways, including bonding, or retention within a cavity
631, with or without a retaining plate 632, as illustrated in FIGS.
61A to 61I. To move the spool 606 from the locked position to the
adjustment position, in the embodiment depicted in FIGS. 61H and
61I, the adjustment tool 621 is inserted into the spool adjustment
interface 620 with sufficient force to overcome the force exerted
by the bias structure 630.
[0211] In the specific embodiment of the invention shown in FIG.
61E, the spool 606 may optionally comprise indentations, detents
634, or other surface structures that provide auditory and/or
tactile feedback to the user of the adjustment tool 621. As the
spool 606 is rotated, the interaction between the bias structure
630 and indentations 634 will cause a clicking that can convey to
the user that the adjustment tool 621 is properly inserted into the
spool adjustment interface 620 and is properly rotating.
[0212] Although one specific embodiment of the invention is
depicted in FIGS. 61A to 61I, one of skill in the art will
understand that many locking structures or configurations may be
used with a spool-based securing assembly. In another embodiment,
the bias structure, such as a protruding prong or tab, may be
located on the spool itself near the spool adjustment interface and
forms a mechanical interfit with a complementary structure about
the spool. When the adjustment tool is inserted into the spool
adjustment interface, the bias structure is displaced from the
complementary structure about the spool. Alternatively, the
complementary structure, such as a groove or detent, may be located
on the spool about the adjustment interface while the bias
structure is located adjacent to the spool and projects into the
complementary structure of the spool. In this alternate embodiment,
when the adjustment tool is inserted into the spool adjustment
interface, the projecting bias structure is displaced form the
complementary structure of the spool to allow rotation.
[0213] In still another embodiment, the spool is not axially
displaceable but comprises an interface with a lock assembly that
resists spool rotation in at least one direction using a ratchet
element. The ratchet element or mechanical lock may be deactivated
independently or as a result of the application of the spool
adjustment tool. In another embodiment, the lock assembly may be a
resistance lock provided by a rubber resistance pad. The position
of the pad may be fixed or mobile.
[0214] Although the tether may be taken up or released from the
spool directly, in other embodiments the securing assembly may
comprise a lumen, ring or bushing to facilitate adjustment of the
tether and/or to resist snagging of the tether. FIG. 61B depicts a
bushing 636 located on the posterior region of the securing
assembly 600. When the curved surface 638 of the securing assembly
600 is attached in a typical fashion to the inferior surface of the
mandible, the adjustment interface 620 of the spool 606 will be
positioned for access from the inferior chin surface while the
bushing 636 will protect the tether as the tether passes in or out
of the securing assembly 600.
[0215] The use of a spool or rotational assembly for the adjustment
of the tether is generally preferred, because it allows a
substantial range of tether adjustment in a limited amount of
space. Other embodiments of a movable securing assembly that do not
use rotational assemblies or are not purely rotational, however,
are also contemplated, including those with helical, slide or pivot
assemblies for tether manipulation. These alternative mechanisms
have a limited movement range compared to a rotational assembly,
but can be configured with a broader range of adjustment by
incorporating a ratchet and release subassembly with the slide or
pivot assembly. One benefit of a movable securing assembly is that
it may allow the adjustment of an attached tether without the risks
or complications associated with having to detach the tether in
order to adjust it. Such risks may occur when using an eyelet or
crimping-type securing device. Furthermore, the articulation or
joint between the moving and non-moving components of the securing
assembly are configured to withstand the stress of repeated
adjustment, in comparison to crimp structures, which may fail with
repeated crimp/uncrimp adjustment procedures.
[0216] FIGS. 61J and 61K depict one particular embodiment of the
invention wherein the distal anchor 500 and tether 28 are implanted
into the tongue 9, either the base of the tongue or, preferably the
anterior tongue. With the first and second ends (not shown) of the
tether 28 protruding from the inferior chin region after
implantation, the first and second ends of the tether are attached
to the spool of the securing assembly. Excess tether length, if
any, may be cut before, during or after the attachment of the
tether to the spool. Preferably, the securing assembly 600 is
attached to its anchoring site, such as the mandible 13, after the
attachment of the tether 28, as this reduces the degree of surgical
exposure required to attach the tether 28 after the securing
assembly 500 is attached to its anchoring site. In other
embodiments of the invention, attachment of the securing assembly
to its anchoring site prior to attachment of the tether, or even
implantation of the distal anchor, may be desirable.
[0217] 4. Delivery Systems
[0218] Referring to FIG. 62A to 62D, in a preferred embodiment of
the invention, the delivery system 711 for the distal anchor 500
comprises a delivery tool 700 with a tubular body 702, a pushrod
704 within the tubular body 702, a movable handle 708 for altering
the relative position between the tubular body 702 and pushrod 704,
and an optional retraction assembly 710 for loading the implant
into the tubular body. The delivery system 711 may optionally
comprise an introducer 712 dimensioned to allow insertion of the
delivery tool 700 into its lumen 714. The proximal end 716 of the
introducer 712 may be provided with a mechanical fit, such as a
male Luer adapter 718, which can be attached to the base 720 of the
delivery tool 700 provided with a female Luer adapter 722, to lock
the tubular body 702 to the introducer 712 and enhance the accuracy
of inserting the distal tip of the delivery tool 700 into the
tissue. The delivery system 711 may also comprise a trocar 724 for
creating an insertion pathway from the skin insertion site to the
desired soft tissue site. The trocar 724 is preferably, but not
necessarily, dimensioned to also fit within the lumen 714 of the
introducer 712, such that the trocar 724 is insertable into the
patient together with the introducer 712 and then removed from the
introducer 712 to allow placement of the delivery tool 700. The
base 726 of the trocar 724 may also be provided with a female Luer
adapter 722 or other complementary interface to engage the
introducer. In other embodiments, the locations of the male and
female Luer adapters may be reversed, or other mechanical interfit
configurations may be used.
[0219] In the particular embodiment of the invention illustrated in
FIGS. 62B and 62C, the delivery tool 700 comprises a pushrod 702
attached to an actuator handle 708, the pushrod 702 having a distal
position and a proximal position which can be manipulated by a user
through the actuator handle 708. In an alternate embodiment, rather
than moving the pushrod within the tubular body, the actuator
handle is attached to a movable tubular to allow withdrawal of the
overlying tubular body to expose the distal anchor to the tissue,
rather than pushing the distal anchor out of the delivery tube and
into the tissue. The alternate embodiment may be advantageous in
some instances because it maintains a constant distal anchor
position as the distal anchor is deployed, rather than pushing the
distal anchor forward during deployment
[0220] Referring to FIGS. 62B and 62C, the distal anchor and tether
may be loaded into the delivery tool by attaching the end(s) of the
tether to tether attachment site 727 on a spool 728 located within
the delivery tool 700. When the tether is attached to the spool 728
and the dial 730 attached to the spool 728 is rotated, the tether
and distal anchor are pulled into the tubular body 702 as the
tether is wound around the spool 728. The proximal pulling of the
distal anchor into the delivery tube causes the expanded hook
elements of the distal anchor to straighten and retract into their
delivery profile and into the tubular body 702. In some instances,
rotation resistance is provided for the spool 728, for example by
using a biased resistance structure 732 with the retraction
assembly 710. Rotational resistance may be useful to prevent
inadvertent unspooling of a tether during packaging, storage or
implantation of the device. FIGS. 62B and 62C depict one embodiment
of the biased resistance structure 732 comprising a cantilever 734
biased by a spring 736, the cantilever comprising a rubber grommet
738 or other resistance surface or structure
[0221] When the actuator handle 708 is moved from the loading
position to the deployed position, the actuator handle 708
overcomes the bias of the resistance structure to release the
rotation resistance. This allows the spool 728 to freely rotate and
to quickly deploy the distal anchor into the tissue. As mentioned
previously, the speed with which the distal anchor is deployed may
affect the degree of tissue engagement by the distal anchor. In
some instances, it is desirable to reduce rotation resistance in
the delivery phase compared to the loading phase of the delivery
tool usage.
[0222] To avoid inadvertent actuation or deployment of a distal
anchor loaded into the delivery tool, the actuator handle 708,
spool 728, and/or pushrod 704 may be provided with a safety catch
or pin that must first be manipulated before the one or more of
these components can be moved. Referring to FIG. 62D, the actuator
handle 708 has an indentation 740 or other configuration which can
form a mechanical interfit with a movable pin 742 that can resist
or prevent movement of the actuator handle 708 when the pin 742.
The movable pin 742 can be moved or slid between a safety position
wherein a portion of the pin 742 interferes with the movement of
the actuator handle 708, and a release position that removes the
mechanical interfit and allows movement of the actuator handle
708.
[0223] 5. Soft Palate
[0224] As mentioned previously, the methods and devices described
herein may be used to manipulate other body structures besides the
tongue. For example, a tissue anchor may be implanted into the soft
palate and attached to the hard palate using a tether. Referring to
FIG. 63A, in one embodiment, the soft palate anchor 800 comprises
one or more expandable hooks 802 that are preferably arranged in a
generally planar configuration for insertion into the similarly
planar-shaped soft palate tissue. A planar configuration reduces
the risk that the tissue anchor 800 forms a palpable nodule or
protrudes from the superior or inferior surfaces of the soft
palate. However, the expandable hooks 802 need not to lie in the
same plane to have a generally planar configuration. A planar
configuration may be characterized by an anchor having a maximum
dimension as measured perpendicular to the longitudinal axis of the
anchor that is greater than its orthogonal dimension also measured
perpendicular to the longitudinal axis. For example, FIGS. 63A and
63B illustrate two pairs of hooks 804, 806 that are stacked with
the side by side of one pair 806 stacked against the side 814 of
the other pair 804 while still having a generally planar
configuration. In other embodiments, one pair may be nested within
the inside surface of the other pair.
[0225] The soft palate anchor 800 may have a unibody design or may
comprise a multiple components joined together. As illustrated in
FIGS. 63A and 63B, the soft palate anchor 800 may comprise a pair
804 of expandable distal hooks 802 joined with a pair 806 of
expandable proximal hooks using a central core 808 and band
810.
[0226] The soft palate anchor 800 may be inserted into the soft
palate using a delivery tool similar to that depicted in FIG. 62A.
In other embodiments, as shown in FIGS. 64A to 64D, the delivery
tube 702, 816 of the delivery tool may be further configured to
control the planar orientation of the tissue anchor 800, by a
planar-configured delivery lumen 818. The planar-configured
delivery lumen 818 may be achieved using a unibody delivery tube
816, as depicted in FIG. 64A, or with one or more additional
delivery tube confining structures 820, as depicted in FIGS. 64B
and 64C. The planar-configured delivery lumen 818 may be
concentrically or eccentrically located along the axis of the
delivery tube 702, as illustrated in FIGS. 64B and 64C,
respectively. Although the cross-sectional shape of the delivery
tube is typically different from the cross-sectional shape of the
delivery lumen in order to facilitate rotation of the delivery tool
during implantation, in other embodiments, as shown in FIG. 64D,
the cross sectional shape of both the delivery lumen 818 and the
delivery tube 826 may also has a planar outer shape.
[0227] As shown in FIG. 65, the rotational position of the planar
tissue anchor may also be controlled in the delivery lumen using a
push rod 820 with a distal end 824 configured with a slot 822.
[0228] The soft palate anchor 800 may be inserted through the oral
cavity 826, as shown in FIG. 66, or through the nasal cavity 828,
as shown in FIG. 67. Insertion of the soft palate anchor 800 may be
facilitated by manipulating the soft palate 4 to align it and the
delivery tube 816. One of skill in the art will understand that any
of a variety of surgical tools and techniques may be used to
manipulate the soft palate 4, including but not limited to forceps
manipulation or the use temporary sutures for applying traction to
the soft palate 4. In other embodiments, soft palate alignment
structures or tools may be integrated into the delivery tube 816.
In still other embodiments, the delivery tube 816 may comprise a
curved delivery tube to reduce the amount of soft palate
manipulation. The curved delivery tube may comprise a curved or
flexible push rod with sufficient column strength to resist axial
compression when pushed distally.
[0229] FIGS. 68 and 69 depict further embodiments of the expandable
soft palate anchor 800 system using different insertion and
anchoring methods. FIG. 68 depicts the tether 830 of the expandable
soft palate anchor 800 attached to the hard palate 8 by a fixation
member 832, such as a bone anchor or screw. The tether 830 may also
be optionally attached using an adjustment structure 834 that
allows adjustment of tether tension or length. These adjustment
structures may include those depicted in FIGS. 40A to 51E, and 61A,
but are preferably configured with a reduced profile to accommodate
the anatomical limitations of the palate. In another embodiment,
FIG. 69 depicts the tether 830 with a flat tissue anchor 800 at
each end, with one anchor 800 in the soft palate 4 and the other
anchor 800 attached to the mucosal tissue 836 overlying the hard
palate 8. This mucosal tissue 836 is less mobile than the soft
palate tissue and therefore may also be used as an anchoring
structure. Alternatively, a loop of suture may also be used to
attach the soft palate anchor 800 to the mucosal tissue 836.
[0230] 6. Recapture Systems
[0231] Although FIGS. 7G to 7J depict one embodiment for removing
an implanted tongue anchor using a cannula, other embodiments of
the invention provide additional features and structures to further
facilitate removal of the implanted device.
[0232] Referring to FIGS. 70A to 70E, in another embodiment of the
invention, a recapture tool 840 is provided when removal of the
tissue anchor 800 is desired. The recapture tool 840 comprises a
recapture tube 842 with a longitudinal slot 844 at its distal end
846 and a handle housing 848 at its proximal end 850, a movable
blocking assembly 852 and a movable tether guide 854 with a
longitudinal slot 856. In the preferred embodiment, the blocking
assembly 852 and tether guide 854 are concentrically arranged
inside the lumen 858 of the recapture tube 842, with the blocking
assembly 852 between the tether guide 854 and recapture tube 842.
The longitudinal slots 844, 856 of the recapture tube 842 and
tether guide 854 are aligned, with the tether guide 854 preferably
movable axially, but not rotationally, relative to the recapture
tube 842. In one embodiment, axial mobility and rotational
alignment of the tether guide 854 is achieved by a longitudinal
alignment groove 860 located at the proximal end 861 of the tether
guide 854 that interfaces with an alignment pin 862 inserting into
the groove 860 and held in place by the handle housing 848. The
alignment pin 862 may be further configured to allow locking and
unlocking of the tether guide 854 with respect to the recapture
tube 842. This may be achieved by any of a variety of locking
interfaces known in the art, including but not limited a rotational
screw interface or a spring-biased mechanical fit between the
alignment pin and the groove.
[0233] The blocking assembly 852 typically comprises a tubular body
864 with a keyed longitudinal slot 866 at its distal end 868.
Referring to FIG. 70C, The keyed longitudinal slot 866 comprises a
narrow slot 870 and a blocking surface 872 at its most distal end
868, and a wider slot 874 just proximal to the narrow slot 870 and
blocking surface 872. The blocking assembly 852 has a proximal
handle 876 to facilitate rotation of the blocking assembly 852 to
open and closed positions within the recapture tube 842. The
proximal handle 876 projects from an opening 878 in the handle
housing 848 of the recapture tube 842. In some embodiments, the
opening 878 is configured to limit the range of motion of the
proximal handle 876. Referring to FIG. 70D, in the open position,
the narrow slot 870 of the blocking assembly 852 is generally
aligned with the longitudinal slots 844, 856 of the recapture tube
842 and the tether guide 854. This open position facilitates
threading of the proximal end of a tether 830 of an implanted
anchor 800 into the recapture tool 840. In the closed position, as
shown in FIG. 70E, the blocking surface 872 of the blocking
assembly 852 is located at the longitudinal slot 844 of the
recapture tube 842, effectively forming a circumferentially closed
tube at the distal end 846 of the recapture tube 842. As described
in greater detail below and depicted in FIG. 71H, as the implanted
anchor 800 is pulled into the recapture tool 840, the
circumferentially closed distal end 846 of the recapture tube 842
assures that the expanded members or hooks 802 of the implanted
anchor 800 are at least collapsed back to their unexpanded
configuration and are not accidentally protruding from the
longitudinal slot 844 of the recapture tube 842 in an expanded
state as it is pulled into the recapture tube 842 and removed from
the body. In the closed position, the wider slot 874 of the
blocking assembly 852 remains in general alignment with the
proximal portions of the longitudinal slots 844, 856 of the
recapture tube 842 and the tether guide 854 so that the captured
tether 830 can still slide through the recapture tool 840.
[0234] Referring back to FIG. 70A, the tether guide 854 is
configured to move longitudinally within the recapture tube 842 and
the blocking assembly 852. The tether guide 854 further comprises a
conical distal tip 880. In its distal position, the tether guide
854 extends from the distal end 846 of the recapture tube 842 and
the conical tip 880 assists with separating the tether 830 from the
surrounding ingrown tissue, if any, as the recapture tool 840 is
slid over the tether 830 towards the anchor 800. In its distal
position, the tether guide also facilitates the threading of the
tether 830 into the tether guide 854. Threading is typically
accomplished using a needle hole threader that is well known in the
art and is inserted through the longitudinal slot 856 of the tether
guide 854 and out of the tip lumen 882 of the conical tip 880. Once
the tether 830 is engaged to the needle hole threader, it is pulled
through the conical tip 880 and out through the longitudinal slot
856 of the tether guide 854.
[0235] In the proximal position, the tether guide 854 pulls the
tether 830 more proximally into the recapture tube 842 to allow the
blocking assembly 852 to rotate into its closed position without
snagging the tether 830 with the blocking surface 872. Once the
blocking assembly 852 is moved to the closed position, the tether
guide 854 may be repositioned back in the distal position in order
to allow the conical tip 880 to separate the soft tissue from the
tether 830 as the recapture tool 840 is guided toward the implanted
anchor 800.
[0236] One embodiment for using the above recapture tool 840
comprises achieving anesthesia of the midjaw and anterior tongue
and accessing the proximal attachment site of the implanted device.
Typically, anesthesia is achieved using local or regional
anesthesia, but in other embodiments of the invention, general
anesthesia may be used. The proximal end of the tether 830 is
released from its attachment site or adjustment assembly and pulled
out from the access site. A needle hole threader inserted into the
longitudinal slot 856 of the tether guide 854 and out of the lumen
882 of the conical tip 880. The proximal end of the tether 830 can
then be pulled into the conical tip 880 and out through the
longitudinal slot 856 of the tether guide 854, as depicted in FIG.
71A. In FIG. 71B and 71C, the tether guide 854 is retracted into
the recapture tube 842 to proximally shift the position where the
tether 830 exits the longitudinal slot 844 of the recapture tube
842. This allows the blocking assembly 852 to rotate into the
closed position without snagging the tether 830, thereby blocking
the distal end 846 of the recapture tube's longitudinal slot 844
and forming a circumferentially closed lumen, as shown in FIGS. 71D
and 71E. In FIG. 71F, the tether guide 854 is placed back in the
extended position so the conical tip 880 may be used to separate
the soft tissue from the tether 830 as the recapture tool is passed
over the tether 830 toward the implanted anchor 800. Referring to
FIG. 71G, the conical tip 880 is pushed distally until it generally
abuts the implanted anchor 800. As illustrated in FIG. 71H, tether
position is maintained by pulling on the tether 830 as the
recapture tube 842 is pushed distally against the implanted anchor
800, causing its expandable members 802 to curl or collapse back
into a straighter configuration as it enters the recapture tube
842. Once the anchor 800 is retracted into the recapture tube 842,
as illustrated in FIG. 71I, the entire recapture tool 840 may be
withdrawn from the patient. The existing bone anchor and/or
adjustment assembly may be removed or left in place, depending upon
a variety of factors, such as whether replacement anchors will be
inserted and the functionality of the existing bone anchor and/or
adjustment assembly.
[0237] In another embodiment of the recapture tool, shown in FIG.
72, the longitudinal slot 844 of the recapture tube 842 does not
fully extend through the distal end 846 of the recapture tube 842.
In this embodiment, the blocking assembly may be omitted and a
distal segment 884 of about 0.5 to about 2 cm or more of the
recapture tube 842 is circumferentially intact. To thread the
exposed tether 830 into the recapture device 840, a needle hole
threader is inserted through the longitudinal slot 844 of the
recapture tube 842 and tether guide 854 until it is visible at the
distal end of the recapture tube. The tether guide is optionally
retracted into the recapture tube 842 when the needle hole threader
is initially inserted and re-extended when the free end of the
tether 830 is pulled into the conical tip 880 of the tether guide
854 and out through the slot 844 of the recapture tube 842. The
remaining recapturing steps are similar to the prior embodiment of
the recapture system. Although this alternate embodiment of the
recapture device omits the rotatable blocking assembly, it may be
somewhat more difficult to thread the tether into the device than
with the other embodiment.
[0238] One of skill in art the will also understand that the
recapture tool depicted in FIGS. 71A to 71G may be used or adapted
to remove expandable anchors implanted elsewhere in the body,
including but not limited to the nasopharynx, soft palate, hard
palate, pharyngeal wall, GI tract, bronchial tree, biliary tree,
and genitourinary tract.
[0239] Although the delivery tool for implanting a planar-shaped
tissue anchor depicted in FIG. 63A is preferably configured to
control for rotation of the anchor during the implantation
procedure, rotation control is generally unnecessary for a
recapture of a planar anchor, but may be provided in some
embodiments.
D. Non-Anchored Tongue Remodeling
[0240] In one embodiment of the invention, the glossoplasty device
is implanted in the tongue and does not require attachment or
anchoring to any bone or other organ. One example of a non-anchored
tongue remodeling device is the dual-anchor device described above
and depicted in FIGS. 6A and 6B. Other embodiments are described
below.
[0241] 1. Tongue Splinting
[0242] In one embodiment of the invention, a tongue splint is
provided that is capable of redistributing the mass of the tongue.
The tongue splint may be inserted to displace at least a portion of
the base of the tongue or posterior tongue away from the posterior
pharynx or pharyngopalatine arch to prevent or resist occlusion of
the airway during sleep or other activities.
[0243] As shown in FIGS. 52E and 52F, in one embodiment of the
invention, the tongue splint 404 comprises a rigid linear body 406
that is dimensioned to fit within a hypodermic needle or other
piercing delivery tool 408. Referring to FIG. 52A, beginning on one
side of the posterior tongue 410, the delivery tool 408 is inserted
in a general direction toward the posterior tongue 410 in a
postero-medial direction, then, as shown in FIG. 52B, reoriented
and advanced in an antero-medial direction until generally the
midline is reached. Referring to FIG. 52C, the needle or delivery
tool 408 is then reoriented and advanced in a postero-lateral
direction toward the opposite side of the tongue 9 before a final
reorientation and advancement in an antero-lateral direction.
Advancement may be stopped at a submucosal location of the tongue
9, as illustrated in FIG. 52D, or may pierce the opposite side of
the tongue 9. One skilled in the art can determine the insertion
pathway for the rigid tongue splint 404 based upon the particular
tongue 9 and oropharynx anatomy of a particular patient. In FIG.
52E, the needle or delivery tool 408 is withdrawn to deposit the
splint 404 along a pathway that redistributes the posterior mass
410 of the tongue 9 to reduce occlusion of the airway, as shown in
FIG. 52F. In a further embodiment of the invention comprising the
tongue splint 404, one or both ends 412, 414 of the tongue splint
404 may project from the surface of the tongue and may be
configured to engage a mouthpiece or appliance inserted into the
oral cavity to further displace the tongue mass.
[0244] FIGS. 53A and 53B depict another embodiment of the tongue
splint 404 comprising a semi-rigid non-linear tongue splint 416.
The semi-rigid tongue splint 416 is configured to at least
partially straighten within the lumen of a hypodermic needle or
delivery tool 408, yet regain at least some of its original
configuration upon release from the needle or tool 408 such that
the tongue splint 416 is capable of redistributing the tongue mass
upon return to its original configuration. The tongue splint 416
may be made of a shape memory or superelastic material. A
semi-rigid implant 416 may be advantageous in that it may be
implantable into the tongue 9 with a single linear implantation
pathway, as shown in FIG. 53A. Referring to FIG. 53B, upon release
and regaining of its previous form, the tongue splint 416 will
cause a relative redistribution of tongue tissue. To facilitate
implantation of a semi-rigid implant 416 into the tongue 9, the
delivery tool 408 may have rotational indicators to that allow the
physician to properly orient the tongue splint 416 with respect to
the tongue anatomy.
[0245] 2. Tongue Tissue Compression
[0246] In another embodiment of the invention, a glossoplasty
device capable of compressing tongue tissue is provided. In one
embodiment, illustrated in FIGS. 54A and 54B, the device comprises
a variable pitch tissue screw 418 having a distal end 420 with a
long pitch, a middle section 422 with a shorter pitch, and a
proximal head 424 configured to engage and disengage a rotational
tool 426 for driving the tissue screw 418 into the tongue 9. The
tissue screw 418 is configured to pierce and advance through soft
tissue. As the tissue screw 418 advances, the distal end 420 with
the long pitch defines a spiral pathway through the tissue with a
first tissue volume 428 between turns of the spiral pathway. As the
shorter pitch portions 422 of the tissue screw 418 are advanced
through the pathway defined by the distal end 420, the middle
section 422 of the tissue screw 418 will compress the first tissue
volume 428 defined by the long pitch distal end 420 into a smaller
second volume 430 caused by redefined by the shorter pitched
portions 422 of the tissue screw 418. Compression of the tongue
tissue along the tissue screw 418 will generally bias or displace
the tongue tissue toward the insertion site of the tissue screw
418, and may indirectly bias or displace the base of the tongue 9
or posterior tongue 410 from the posterior pharynx or
pharyngopalatine arch. The compression and displacement of tongue
tissue by the variable pitch tissue screw 418 may be further
augmented by attaching the proximal head 424 or other portion of
the tissue screw to a fixed or variable length tether and attaching
tether to another structure such as the mandible 13 or hyoid bone
15.
[0247] In one embodiment of the invention, shown in FIGS. 55A and
55B, the glossoplasty device comprises a spring or coil 432 that is
advanced into the tongue tissue in a first configuration having a
long pitch w', and then changed to a second configuration with a
shorter pitch w'', thereby compressing the tongue tissue about or
between the turns of the spring or coil 432. In one embodiment, the
coil 432 has a sufficient stiffness to be advanced into the tongue
tissue in its first configuration similar to that of the tissue
screw previously described. If the spring comprises a shape memory
material such as Nitinol, the spring is able to assume the second
configuration with a shorter pitch w'' upon warming up to body
temperature and/or elastic recoil, thereby compressing the tongue
tissue. In another embodiment of the invention, the distal tip 434
of the coil 432 is attached to a suture or wire that is first
inserted into the tongue 9 along the desired insertion path.
Tension is applied to the suture or wire to maintain the coil 432
in its first position as it is advanced into the tongue 9. Once the
spring is positioned, the suture tension is released to allow the
coil 432 to assume its second configuration to engage and compress
the tongue tissue. The suture or wire may be cut to eliminate any
exposed foreign body and to reduce the risk of infection tracking
down the suture path.
[0248] In some instances, the change in configuration from the
first configuration to the second configuration may not cause
tissue compression because the coil 432 failed to engage the
surrounding tissue. In such situations, the coil 432 may axially
contract and radially expand to form a cavity without any tissue
between the spirals. As shown in FIG. 56, to reduce the risk of
non-engagement of the tongue tissue, the coil 432 may be configured
with a series of barbs, hooks, angled pins or other tissue engaging
structures 436 to facilitate engagement and compression of the
tissue as the coil 432 assumes the second configuration. The
location, spacing, orientation and length of the tissue engaging
structures 430 may be determined by one skilled in the art with
routine experimentation. The characteristics of each tissue
engaging structure 436 need not be uniform along the length of the
coil 432. For example, the tissue engaging structures at the
proximal and distal ends of the coil 432 may be configured
differently than the engaging structures 436 in the middle portion
of the coil 432 because rather than compress the tongue tissue, the
ends 434, 438 of the spring may be configured to attach and pull
the surrounding tissue towards the middle section of the coil 432.
To facilitate insertion of a spring or coil 432 comprising tissue
engagement structures 436, the spring or coil 432 may be covered
with a sheath during the insertion process to reduce the risk of
engaging tissue prior to final positioning of the device. The
sheath can be removed to expose the tissue engaging structures 436
upon final positioning.
[0249] In another embodiment of the invention, the spring or coil
432 may be inserted in its first configuration within the lumen of
a needle or other delivery device. In some instances, however,
reducing the diameter of the spring or coil 432 sufficiently to fit
within a lumen device may cause plastic deformation of the spring
or coil 432 such that the spring or coil lack the elastic
properties to assume the second configuration. Alternatively, as
shown in FIG. 57, the spring or coil 432 may be placed around the
outer surface 440 of a needle or other piercing device 442 for
insertion into the tongue 9. In a further embodiment, illustrated
in FIG. 58, the needle or other piercing device 442 may comprise a
fitted spiral groove 444 or tract along the outer surface 440 to
reduce or make flush the profile of the spring or coil 432 on the
delivery device 442. FIGS. 59A and 59B depict the implantation of
the coil-on-needle device 432, 442. FIG. 59A depicts the
positioning the distal end 434 of the coil 432 prior to the
complete release of the implant from the sheath 446, while FIG. 59B
schematically illustrates the resulting tissue compression from the
released coil 432.
[0250] 3. Tongue Tissue Compliance Change
[0251] In another embodiment of the invention, the tongue
remodeling system changes the compliance of the tongue tissue
surrounding the implanted device, but does not require exertion of
a continuous force upon the surrounding tongue tissue. In some
instances, a change in the tissue compliance without placing the
tissue under compression may be sufficient to reduce or eliminate
airway occlusion during apnea episodes. The implantation of the
device without creating tissue compression may simplify the
implantation procedure by eliminating the need to adjust the degree
of tissue tension exerted by the device either during or after the
initial implantation procedure. Many of the embodiments of the
invention mentioned previously may be used without altering the
physical characteristics of the tether and/or splint by implanting
the device and not exerting tension on the device during the
implantation process Thus, although the device exerts reduced or no
force while the tongue is in usual or resting position, but when
the patient is asleep and the musculature of the oropharynx and/or
hypopharynx relaxes, the compliance of the tongue tissue altered by
the device such that greater force is required to cause posterior
displacement of the tongue. One skilled in the art may also select
the materials and/or configurations of the tether and/or splint for
the previously disclosed embodiments to modify the degree of change
in tissue compliance.
E. Materials
[0252] The materials that may be used to construct the tether
component of the glossoplasty device were discussed previously. The
other components of the invention, such as the distal anchor and/or
securing assembly, may be manufactured in accordance with any of a
variety of techniques which are well known in the art, using any of
a variety of medical-grade construction materials. One or more
components can be molded, formed or machined from biocompatible
metals such as Nitinol, stainless steel, titanium, and others known
in the art. One or more components can also be injection-molded
from a variety of medical-grade polymers including high or other
density polyethylene, nylon and polypropylene. Portions of the
system can be separately formed and secured thereto in a
post-molding operation, using any of a variety of securing
techniques such as solvent bonding, thermal bonding, adhesives,
interference fits, pivotable pin and aperture relationships, and
others known in the art.
[0253] Reinforcing fibers suitable for use in the components of the
present invention include ceramic fibers, like bioabsorbable
hydroxyapatite or bioactive glass fibers. Such bioabsorbable,
ceramic fiber reinforced materials are described, e.g., in
published European Patent Application No. 0146398 and in
WO/96/21628, the entire disclosures of which are incorporated
herein by way of this reference. The materials may also include a
bioabsorbable coating previously described.
[0254] As a general feature of the orientation, fiber-reinforcement
or self-reinforcement of the tongue remodeling components, many of
the reinforcing elements may be oriented in such a way that they
can carry effectively the different external loads (such as
tensile, bending and shear loads) that are directed to the
remodeling system as used.
[0255] The components of the invention (or a bioabsorbable
polymeric coating layer on part or all of the implant surface), may
contain one or more bioactive substances, such as antibiotics,
chemotherapeutic substances, angiogenic growth factors, substances
for accelerating the healing of the wound, growth hormones,
antithrombogenic agents, bone growth accelerators or agents, and
the like. Such bioactive implants may be desirable because they
contribute to the healing of the injury in addition to providing
mechanical support.
[0256] In one embodiment, the distal anchor may comprise a
bioabsorbable coating and/or structure. As used herein, terms such
as bioabsorbable, bioresorbable and biodegradable interchangeably
refer to materials which will dissipate in situ, following a
sufficient post-operative period of time, leaving acceptable
byproducts. A variety of polymers which may be useful for the
components of the present invention are identified below. Many of
these polymers have been reported to be biodegradable into
water-soluble, non-toxic materials which can be eliminated by the
body: polycaprolactone, poly (L-lactide), poly (DL-lactide),
polyglycolide, poly (L-Lactide-co-D, L-Lactide), 70:30 poly
(L-Lactide-co -D, L-Lactide), 95:5 poly (DL-lactide-co-glycolide),
90:10 poly (DL-lactide-co-glycolide), 85:15 poly
(DL-lactide-co-glycolide), 75:25 poly (DL-lactide-co-glycolide),
50:50 poly (DL-lactide-co-glycolide), 90:10 Poly
(DL-lactide-co-caprolactone), 75:25 poly
(DL-lactide-co-caprolactone), 50:50 poly
(DL-lactide-co-caprolactone), polydioxanone, polyesteramides,
copolyoxalates, polycarbonates, and poly (glutamic-co-leucine). The
desirability of any one or a blend of these or other polymers can
be determined through routine experimentation by one of skill in
the art, taking into account the mechanical requirements, preferred
manufacturing techniques, and desired reabsorption time.
Optimization can be accomplished through routine experimentation in
view of the disclosure herein. Bodily reaction to the bioabsorbable
materials or byproducts may furnish at least a portion of the
support provided by the device or treatment method. All or portions
of any of the devices herein, as may be appropriate for the
particular design, may be made from allograft material, or
synthetic bone material.
[0257] While this invention has been particularly shown and
described with references to embodiments thereof, it will be
understood by those skilled in the art that various changes in form
and details may be made therein without departing from the scope of
the invention. For all of the embodiments described above, the
steps of the methods need not be performed sequentially.
* * * * *