U.S. patent application number 14/639774 was filed with the patent office on 2015-09-10 for systems and methods for tissue suspension and compression.
The applicant listed for this patent is Siesta Medical, Inc.. Invention is credited to Christopher Feezor, Peter Martin, Erik van der Burg, Jason van Tassel.
Application Number | 20150250476 14/639774 |
Document ID | / |
Family ID | 54016218 |
Filed Date | 2015-09-10 |
United States Patent
Application |
20150250476 |
Kind Code |
A1 |
Feezor; Christopher ; et
al. |
September 10, 2015 |
SYSTEMS AND METHODS FOR TISSUE SUSPENSION AND COMPRESSION
Abstract
Suture passer systems for tissue suspension and tissue
compression are described. The system can include a shaft and a
needle, wherein the needle is freely rotatable with respect to the
shaft. The suture may include an overmolded segment. Methods of
placing one or more implants, sutures, fastener, bone anchors and
other devices are also described. The methods include moving
tissue, including the superior pharyngeal constrictor muscle,
palatopharyngeal arch, and palatoglossal arch. The methods include
hyoid bone suspension.
Inventors: |
Feezor; Christopher; (San
Jose, CA) ; van der Burg; Erik; (Los Gatos, CA)
; Martin; Peter; (Mountain View, CA) ; van Tassel;
Jason; (Los Altos, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Siesta Medical, Inc. |
Los Gatos |
CA |
US |
|
|
Family ID: |
54016218 |
Appl. No.: |
14/639774 |
Filed: |
March 5, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61948473 |
Mar 5, 2014 |
|
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|
Current U.S.
Class: |
606/144 ;
606/228 |
Current CPC
Class: |
A61B 17/0469 20130101;
A61F 2/0059 20130101; A61B 17/0401 20130101; A61B 2017/0496
20130101; A61B 17/06166 20130101; A61B 2017/0641 20130101; A61B
2017/0647 20130101; A61B 2017/00814 20130101; A61B 17/0482
20130101; A61B 2017/06009 20130101; A61B 2017/06023 20130101; A61B
2017/00991 20130101; A61B 2017/0618 20130101; A61B 17/24 20130101;
A61B 2017/06176 20130101; A61B 17/0485 20130101; A61B 2017/0414
20130101; A61B 2017/044 20130101; A61B 2017/061 20130101; A61B
2017/06042 20130101; A61B 2017/0649 20130101; A61F 2250/0007
20130101; A61B 17/064 20130101 |
International
Class: |
A61B 17/06 20060101
A61B017/06; A61B 17/04 20060101 A61B017/04 |
Claims
1. A suture passer comprising: a proximal handle; an elongate shaft
having a proximal end, a distal end, and a longitudinal axis; a
suture passing element coupled to the distal end of the shaft,
wherein the a suture passing element is movable with respect to the
shaft, and configured to swivel with respect to the shaft in an arc
of at least about 90 degrees.
2-20. (canceled)
21. A suspension line for tensioning tissue, comprising: a suture
having a first thickness dimension; an elastomer surrounding a
portion of the suture having a second thickness dimension greater
than the first thickness dimension; and at least one bearing
element configured to allow the suture to move with respect to the
elastomer while maintaining the flexibility of the suture.
22. The suspension line of claim 21, wherein the at least one
bearing element is at least partially covered by the elastomer.
23. The suspension line of claim 21, wherein the at least one
bearing element comprises a knot.
24. The suspension line of claim 21, wherein the at least one
bearing element comprises a bead.
25. The suspension line of claim 21, wherein the at least one
bearing element comprises a coil.
26. The suspension line of claim 25, wherein the coil comprises
polypropylene.
27. The suspension line of claim 21, wherein the elastomer
comprises silicone.
28. The suspension line of claim 21, wherein the elastomer is at
least partially radiopaque.
29. The suspension line of claim 28, wherein the elastomer is
compounded with a radiopacifier.
30-54. (canceled)
55. An method comprising: providing a suture having a first strand,
a second strand, and an arc between the first strand and the second
strand; placing the arc on one side of the hyoid bone; placing the
first strand and the second strand on the other side of the hyoid
bone; forming a girth hitch around the hyoid bone; and securing the
first strand and the second strand to a bone anchor
56. The method of claim 55, wherein the bone anchor is located on
the mandible.
57. The method of claim 55, further comprising a second suture
comprising a third strand, a fourth strand, and a second arc
between the third strand and the fourth strand.
58. The method of claim 57, further comprising coupling the third
strand to the first strand.
59. The method of claim 58, further comprising pulling the third
strand to form the girth hitch.
60. The method of claim 57, further comprising placing the second
arc under the first arc
61. The method of claim 57, further comprising pulling the suture
such that the second arc is on one side of the hyoid bone and both
the third and fourth strands are on other side of the hyoid
bone.
62. The method of claim 55, further comprising an elastomer
surrounding a portion of the suture.
63. The method of claim 55, further comprising at least one bearing
element on the suture.
64. The method of claim 63, wherein the at least one bearing
element is at least partially covered by the elastomer.
Description
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS
[0001] Any and all applications for which a foreign or domestic
priority claim is identified in the Application Data Sheet as filed
with the present application are hereby incorporated by reference
under 37 CFR 1.57. This application claims the priority benefit
under 35 U.S.C. .sctn.119(e) as a nonprovisional application of
U.S. Provisional Application No. 61/948,473, filed on Mar. 5, 2014,
which is hereby incorporated by reference in its entirety Also
incorporated by reference in their entireties is U.S. Pat. No.
8,460,322 issued on Jun. 11, 2013, and U.S. Pat. Pub. No.
2014/0074518 A1 published on Mar. 13, 2014.
BACKGROUND
[0002] 1. Field
[0003] In some aspects, the invention relates generally to suture
passer systems and methods for tissue suspension and tissue
compression. Disclosed herein are systems and methods for tissue
suspension using one or more sutures, implants, fasteners and/or
bone anchors for treating obstructive sleep apnea.
[0004] 2. Description of the Related Art
[0005] In many surgical procedures, there is a need to pass a
suture deep into tissue. Sometimes, a surgeon needs to pass a
suture deep into tissue to suspend the tissue by fixing the suture
to bone. In particular, one such surgical procedure is suspension
of tissues for treating conditions such as obstructive sleep apnea
(OSA).
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] Laser-assisted uvulopalatopharyngoplasty (LAUP) is a similar
procedure to UPPP that uses a CO.sub.2 laser to remove the uvula
and portions of the soft palate, but the tonsils and the lateral
pharyngeal walls are not removed.
[0016] 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.
[0017] 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.
[0018] 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.
[0019] 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.
[0020] Another surgical procedure performed to treat OSA is suture
based tongue suspension. However, current techniques for suture
based tongue suspension require the passage of suture through the
tongue and into the oral space. This technique carries with it
significant risks of infection as well as difficulty in accessing
the optimal placement for the suspension suture.
[0021] Notwithstanding the foregoing, there remains a need for
improved methods and devices for treating various conditions,
including but not limited to obstructive sleep apnea. There is also
a need for improved devices and methods for delivering suture into
tissue. Specifically with respect to current methods for tissue
suspension and compression, there is a need to reduce infection
risk due to suture exposure to the oral cavity, to improve the
surgeon's range and ability to precisely locate and orient the
suture, and to improve the ability of surgeons to properly tension
the suture by eliminating the need to perform knot-tying while
simultaneously controlling the final tension of the suture.
SUMMARY
[0022] The present disclosure provides suture passer system and
methods for tissue suspension or compression.
[0023] In some embodiments, a suture passer is provided. The suture
passer can comprise a proximal handle. The suture passer can
comprise an elongate shaft having a proximal end, a distal end, and
a longitudinal axis. The suture passer can comprise a suture
passing element coupled to the distal end of the shaft. In some
embodiments, the suture passing element is movable with respect to
the shaft, and configured to swivel with respect to the shaft in an
arc of at least about 90 degrees. In some embodiments, the suture
passing element comprises a feature to engage the suture. In some
embodiments, the suture passing element comprises a tube.
[0024] In some embodiments, a suture passer is provided. The suture
passer can comprise an elongate shaft. The suture passer can
comprise a suture passing element coupled to the elongate shaft. In
some embodiments, the suture passing element is configured to
swivel with respect to the elongate shaft. The suture passer can
comprise a second stage element carried within the suture passing
element. In some embodiments, the second stage element can be
configured to extend from and retract into the suture passing
element. In some embodiments, the second stage element can be
configured to exit an opening at or near a distal end of the suture
passing element and form a path through tissue. The suture passer
can comprise a suture carried by the second stage element. In some
embodiments, the second stage element comprises a grasping element
operably connected to the suture. In some embodiments, the grasping
element comprises a snare. In some embodiments, the grasping
element comprises movable jaws.
[0025] In some embodiments, a suspension line is provided. The
suspension line can comprise a suture. The suspension line can
comprise an overmolded segment. The suspension line can comprise a
feature between the suture and the overmolded segment which serves
as a bearing.
[0026] In some embodiments, a method is provided. The method can
include the step of providing an implant having a first end and a
second end. The method can include the step of securing the first
end of the implant to the palatopharyngeal arch. The method can
include the step of tensioning the implant. The method can include
the step of securing the second end of the implant to a tissue
selected from the group consisting of: the superior pharyngeal
constrictor muscle, palatopharyngeal arch, and palatoglossal
arch.
[0027] In some embodiments, the implant comprises barbs. In some
embodiments, the implant comprises suture loops. The method can
include the step of securing the implant to a bone anchor. The
method can include the step of adjusting the tension of the implant
post-operatively.
[0028] In some embodiments, a method is provided. The method can
include the step of moving a portion of a tissue selected from the
group consisting of: the superior pharyngeal constrictor muscle,
palatopharyngeal arch, and palatoglossal arch. The method can
include the step of securing a fastener to a tissue selected from
the group consisting of: the superior pharyngeal constrictor
muscle, palatopharyngeal arch, and palatoglossal arch.
[0029] In some embodiments, a method is provided. The method can
include the step of forming a loop around the hyoid bone. The
method can include the step of securing the loop to a bone anchor,
wherein the bone anchor is located on the mandible. In some
embodiments, the loop is a girth hitch. In some embodiments, the
loop is formed by an implant comprising a longitudinally extending
tail and an implant head. In some embodiments, the implant
comprises a ratchet for tensioning the loop.
[0030] In some embodiments, a method is provided. The method can
include the step of forming a hole in the hyoid bone. The method
can include the step of passing an implant through the hole in a
collapsed configuration. The method can include the step of
expanding the implant to an expanded configuration, wherein the
implant is unable to pass through the hole in the expanded
configuration. In some embodiments, the implant comprises
expandable barbs.
[0031] In some embodiments, a suspension line for tensioning tissue
is provided. The suspension line can comprise a suture having a
first thickness dimension. The suspension line can comprise an
elastomer surrounding a portion of the suture having a second
thickness dimension greater than the first thickness dimension. The
suspension line can comprise at least one bearing element
configured to allow the suture to move with respect to the
elastomer while maintaining the flexibility of the suture.
[0032] In some embodiments, the at least one bearing element is at
least partially covered by the elastomer. In some embodiments, the
at least one bearing element comprises a knot. In some embodiments,
the at least one bearing element comprises a bead. In some
embodiments, the at least one bearing element comprises a coil. In
some embodiments, the coil comprises polypropylene. In some
embodiments, the elastomer comprises silicone. In some embodiments,
the elastomer is at least partially radiopaque. In some
embodiments, the elastomer is compounded with a radiopacifier.
[0033] In some embodiments, a suture passer is provided. The suture
passer can comprise a first section with a first distal tip and a
first proximal handle. The suture passer can comprise a second
section with a second distal tip and a second proximal handle. The
suture passer can comprise a slot on the sidewall of the first
section. The suture passer can comprise a first interior lumen
extending through a portion of the first section and in
communication with the slot. The suture passer can comprise a
plunger configured to enter the slot and the first interior lumen
and move a suture toward the second section.
[0034] In some embodiments, the plunger comprises a feature to
engage the suture. The suture passer can comprise a second interior
lumen extending through a portion of the second section. In some
embodiments, the plunger is configured to enter the second interior
lumen. In some embodiments, the second section comprises a snare.
In some embodiments, the first section is configured to pivot
relative to the second section. In some embodiments, the plunger
comprises a head, wherein the head has at least one dimension
larger than a corresponding dimension of the plunger. In some
embodiments, the first distal tip is curved. In some embodiments,
the second distal tip is curved. In some embodiments, the first
interior lumen is open at the first distal tip. In some
embodiments, the second interior lumen is open at the second distal
tip.
[0035] In some embodiments, a method of using a suture passer is
provided. The method can include the step of providing a suture
passer comprising a first section with a first distal tip, a second
section with a first distal tip, and a first interior lumen
extending through a portion of the first section. The method can
include the step of advancing the suture passer around a hyoid
bone. The method can include the step of passing a plunger into the
first interior lumen.
[0036] The method can include the step of engaging the plunger with
a suture. The method can include the step of engaging the suture
with a snare. The method can include the step of engaging the
suture with a feature of the second section. The method can include
the step of disengaging the suture as the plunger is retracted
through the first interior lumen. The method can include the step
of protruding the plunger from the first interior lumen toward the
second distal tip. In some embodiments, the suture passer comprises
a second interior lumen extending through a portion of the second
section, further comprising passing the plunger into the second
interior lumen. The method can include the step of engaging the
suture with a snare coupled to the second section. The method can
include the step of engaging the suture with a feature coupled to
the second section. The method can include the step of engaging a
suture with the second section. The method can include the step of
advancing the plunger toward the suture. The method can include the
step of engaging the suture with the plunger. The method can
include the step of moving the suture through the first interior
lumen as the plunger is retracted. The method can include the step
of moving the suture through the first interior lumen as the first
section is pivoted.
[0037] In some embodiments, a method is provided. The method can
include the step of providing a suture having a first strand, a
second strand, and an arc between the first strand and the second
strand. The method can include the step of placing the arc on one
side of the hyoid bone. The method can include the step of placing
the first strand and the second strand on the other side of the
hyoid bone. The method can include the step of forming a girth
hitch around the hyoid bone. The method can include the step of
securing the first strand and the second strand to a bone anchor.
In some embodiments, the bone anchor is located on the mandible. In
some embodiment, the system further includes a second suture
comprising a third strand, a fourth strand, and a second arc
between the third strand and the fourth strand. The method can
include the step of coupling the third strand to the first strand.
The method can include the step of pulling the third strand to form
the girth hitch. The method can include the step of placing the
second arc under the first arc. The method can include the step of
pulling the suture such that the second arc is on one side of the
hyoid bone and both the third and fourth strands are on other side
of the hyoid bone. In some embodiments, the system further
comprises an elastomer surrounding a portion of the suture. In some
embodiments, the system further comprises an at least one bearing
element on the suture. In some embodiments, the at least one
bearing element is at least partially covered by the elastomer.
[0038] In some embodiments, an apparatus is provided having a shaft
for passing a suture and a needle coupled to the shaft. The needle
is freely rotatable with respect to the shaft. The needle can
include a feature to engage the suture. The needle can include a
tube. The apparatus can have a second stage element configured to
extend from the needle.
[0039] In some embodiments, an apparatus is provided having a
suture, an overmolded segment, and a feature between the suture and
the overmolded segment which serves as a bearing.
[0040] In some embodiments, a method is provided which comprises
the steps of providing an implant having a first end and a second
end, securing the first end of the implant to the palatopharyngeal
arch, tensioning the implant, and securing the second end of the
implant to a tissue selected from the group consisting of: the
superior pharyngeal constrictor muscle, palatopharyngeal arch, and
palatoglossal arch. The implant can include barbs. The implant can
include suture loops. The method can include the step of securing
the implant with a bone anchor. The method can include the step of
adjusting the tension of the suture loops post-operatively.
[0041] In some embodiments, a method is provided which comprises
the steps of moving a portion of a tissue selected from the group
consisting of: the superior pharyngeal constrictor muscle,
palatopharyngeal arch, and palatoglossal arch; and securing a
fastener to a tissue selected from the group consisting of: the
superior pharyngeal constrictor muscle, palatopharyngeal arch, and
palatoglossal arch.
[0042] In some embodiments, a method is provided which comprises
the steps forming a loop around the hyoid bone, and securing the
loop to a bone anchor, wherein the bone anchor is located on the
mandible. The loop can be a girth hitch. The loop can be formed by
an implant comprising a longitudinally extending tail and an
implant head. The implant can include a ratchet.
[0043] In some embodiments, a method is provided which comprises
the steps of forming a hole the hyoid bone; passing an implant
through the hole in a collapsed configuration; and expanding the
implant to an expanded configuration, wherein the implant is unable
to pass through the hole. The implant can include expandable
barbs.
[0044] Also disclosed herein is a suture passer comprising one or
more of: a proximal handle; an elongate shaft having a proximal
end, a distal end, a tubular body, and a longitudinal axis; a
needle coupled to the distal end of the shaft, the needle having an
arcuate deployed configuration, wherein the needle is movable with
respect to the shaft, and configured to swivel with respect to the
shaft in an arc of at least about 90 degrees; and a control on the
proximal handle configured to swivel the needle with respect to the
shaft. The needle can comprise a feature to engage the suture, and
comprise a tube in some embodiments.
[0045] In some embodiments, disclosed herein is a suture passer
comprising one or more of: a proximal handle having a first
actuator control and a second actuator control; a first elongate
shaft extending distally from the handle; a first needle carried
within the first elongate shaft, the first needle configured to
extend from and retract into the first elongate shaft, the first
needle having a straight configuration when located within the
first elongate shaft, the first needle configured to exit an
opening at or near a distal end of the first elongate shaft and
form a curved or lateral path through tissue upon actuation of the
first actuator control; and a second needle carried within the
first needle, the second needle configured to extend from and
retract into the first needle, the second needle having a straight
configuration when located within the first elongate shaft, the
first needle configured to exit an opening at or near a distal end
of the first needle and form a curved or lateral path through
tissue upon actuation of the second actuator control, the second
needle having an extended geometry that is different from that of
the first needle; and a suture carried by the second needle. The
second needle can comprise a grasping element operably connected to
the second needle, such as, for example, a snare or movable
jaws.
[0046] Also disclosed herein is a suspension line comprising a
suture; an overmolded segment; and a feature between the suture and
the overmolded segment which serves as a bearing.
[0047] In another embodiment, disclosed is a method comprising
providing an implant having a first end and a second end; securing
the first end of the implant to the palatopharyngeal arch;
tensioning the implant; and securing the second end of the implant
to a tissue selected from the group consisting of: the superior
pharyngeal constrictor muscle, palatopharyngeal arch, and
palatoglossal arch. The implant can comprises barbs and/or suture
loops. The implant can also be secured with a bone anchor. The
tension of the suture loops can be adjusted during the procedure,
or post-operatively, such as 1 hour, 6 hours, 1 day, 1 week, 1
month, or more post-operatively.
[0048] Also disclosed is a method comprising moving a portion of a
tissue selected from the group consisting of: the superior
pharyngeal constrictor muscle, palatopharyngeal arch, and
palatoglossal arch; and securing a fastener to a tissue selected
from the group consisting of: the superior pharyngeal constrictor
muscle, palatopharyngeal arch, and palatoglossal arch.
[0049] Also disclosed is a method comprising: forming a loop around
the hyoid bone; and securing the loop to a bone anchor, wherein the
bone anchor is located on the mandible. The loop can be a girth
hitch. The loop can be formed by an implant comprising a
longitudinally extending tail and an implant head. The implant can
also comprise a ratchet for tensioning the loop.
[0050] In some embodiments, disclosed is a method comprising:
forming a hole in the hyoid bone; passing an implant through the
hole in a collapsed configuration; and expanding the implant to an
expanded configuration, wherein the implant is unable to pass
through the hole. The implant can comprise expandable barbs.
[0051] Further disclosed herein is a suspension line for tensioning
tissue, comprising: a suture having a first thickness dimension; a
elastomer surrounding a portion of the suture and defining a
central segment of the suspension line having a second thickness
dimension greater than the first thickness dimension; and at least
one bearing element on the central segment of the suspension line,
the bearing element configured to provide a rigid bearing to allow
the suture to move with respect to the elastomer (e.g., silicone)
while maintaining the flexibility of the suture. The at least one
bearing element can be at least partially covered by the elastomer.
The bearing element can include, for example, a knot, a bead,
and/or a coil. The coil can comprise polypropylene, for example.
The elastomer can be at least partially radiopaque, and/or
compounded with a radiopacifier, such as barium sulfate for
example.
BRIEF DESCRIPTION OF THE DRAWINGS
[0052] FIGS. 1A-1C illustrate an embodiment of a suture passer with
a suture passing element.
[0053] FIGS. 2A-2C illustrate a method of using the suture passer
of FIG. 1A.
[0054] FIGS. 3A-3D illustrate an embodiment of a suture passer with
a suture passing element.
[0055] FIGS. 4A-4D illustrate embodiments of a suture passing
element.
[0056] FIG. 5 illustrates the inability of a suture passer to reach
a target location.
[0057] FIGS. 6A-6C illustrate an embodiment of a suture passer with
a second stage element.
[0058] FIGS. 7A-7B illustrate an embodiment of a suture passer with
a second stage element.
[0059] FIGS. 8A-8B illustrate an embodiment of a suture passer with
a second stage element.
[0060] FIGS. 9A-9B illustrate an embodiment of a suture passer
system with a second stage element.
[0061] FIGS. 10A-10B illustrates an embodiment of a suture passer
with a second stage element.
[0062] FIGS. 11A-11E illustrate embodiments of a suture.
[0063] FIGS. 12A-12B illustrate a method of making a suture.
[0064] FIGS. 13A-D illustrates a method of delivering a plurality
of suture loops into tissue.
[0065] FIG. 14 illustrates a method of narrowing the lateral
pharyngeal wall, according to one embodiment of the invention.
[0066] FIGS. 15A-15B illustrate the anatomy with and without an
implant.
[0067] FIGS. 16A-16D illustrate an embodiment of a method of
inserting an implant.
[0068] FIGS. 17A-17B illustrate an embodiment of an implant with a
tissue ingrowth portion.
[0069] FIGS. 18A-18B illustrate an embodiment of a method of
inserting an implant.
[0070] FIGS. 19A-19E illustrate an embodiment of a method of
inserting a suture.
[0071] FIG. 20 illustrates an embodiment of a method of inserting a
suture.
[0072] FIGS. 21A-21B illustrate an embodiment of a method of using
a bone anchor.
[0073] FIGS. 22A-22B illustrate an embodiment of an apparatus and
method of securing a tissue.
[0074] FIGS. 23A-23C illustrate embodiments of a fastener.
[0075] FIGS. 24A-24D illustrate an embodiment of a method of hyoid
bone suspension.
[0076] FIGS. 25A-25B illustrate an embodiment of a suture
passer.
[0077] FIGS. 26A-26B illustrate an embodiment of a method of hyoid
bone suspension.
[0078] FIGS. 27A-27D illustrate an embodiment of a method of hyoid
bone suspension.
[0079] FIG. 28 illustrates an embodiment of a method of hyoid bone
suspension.
[0080] FIGS. 29A-29C illustrate an embodiment of an implant and a
method of hyoid bone suspension.
[0081] FIG. 30 illustrates an embodiment of an implant.
[0082] FIG. 31 illustrates a method of hyoid bone suspension using
an implant.
[0083] FIGS. 32A-32B illustrate an embodiment of an implant.
[0084] FIGS. 33A-33B illustrate an embodiment of an implant.
[0085] FIGS. 34A-34F illustrate an embodiment of a suture
passer.
DETAILED DESCRIPTION
[0086] In some embodiment, disclosed is a suture passer system and
method for passing a suture (e.g., a suspension line, a tether, a
tether loop, a suture, a suture loop, suture tape, an implant,
etc.) through tissue to suspend or compress the tissue. The term
"suture" as used herein, unless otherwise specified or limited, is
intended to have its ordinary meaning and is also intended to
include all structures, including any of the aforementioned or
later-described examples, that can be passed through tissue using
the devices described herein.
[0087] As illustrated in FIG. 1A, the suture passer 100 can include
a first elongate tubular body or shaft 102. The shaft 102 can
releasably couple to a suture passing element 104. The suture
passing element 104 can be a flexible needle. The suture passing
element 104 can pass one, two, or more sutures therethrough.
Portions of the one or more sutures can reside outside of the first
shaft 102. The distal end of the suture passing element 104 can be
sharpened to facilitate tissue penetration. In other embodiments,
the distal end of the suture passing element 104 can be blunt to
prevent distal penetration through the mucosa, thus preventing a
through-and-through puncture. The shaft 102 can have a length of
between about 4 cm to about 30 cm in some embodiments.
[0088] The suture passer 100 can include a second elongate tubular
body or shaft (not shown). The second shaft can couple to a suture
receiving element (not shown). The suture receiving element can be
a snare, for example. The second shaft and the suture passer 100
can be substantially similar to suture passer system described in
commonly owned U.S. Pat. No. 8,460,322, the entire disclosure of
which is incorporated by reference. The suture passer 100 can
include any feature described in commonly owned U.S. Pat. No.
8,460,322.
[0089] The shaft 102 can extend distally from a proximal handle
108. As illustrated in FIG. 1A, the proximal end of the shaft 102
can be coupled to the handle 108. In some embodiments, the shaft
102 rotates when the handle 108 rotates. The shaft 102 can rotate
about the longitudinal axis 114 of the proximal handle 108. In some
embodiments, the shaft 102 can rotate independently from the handle
108. The shaft 102 can rotate about the longitudinal axis 112 of
the shaft 102.
[0090] As illustrated in FIG. 1A, the suture passing element 104
can be coupled to the distal end of the shaft 102. The suture
passing element 104 can rotate relative to the distal end of the
shaft 102. The shaft 102 can include one, two, or more slots or
apertures 105 on the sidewall of the distal end of the shaft 102.
The suture passing element 104 can be located within the slot 105.
In some embodiments, the suture passing element 104 is formed as an
independent component from the shaft 102. The suture passing
element 104 can rotate relative to the slot 105 (e.g., 0.degree.,
10.degree., 20.degree., 30.degree., 40.degree., 50.degree.,
60.degree., 70.degree., 80.degree., 90.degree., 100.degree.,
110.degree., 120.degree., 130.degree., 150.degree., 160.degree.,
170.degree., 180.degree., 190.degree., 200.degree., 210.degree.,
220.degree., 230.degree., 240.degree., 250.degree., 260.degree.,
270.degree., 280.degree., 290.degree., 300.degree., 310.degree.,
320.degree., 330.degree., 340.degree., 350.degree., 360.degree., at
least 90.degree., at least 180.degree., at least 270.degree., etc.,
or a range including any two of the foregoing values, such as
between about 0.degree. and about 180.degree. for example).
[0091] The suture passing element 104 can function as a hook. The
suture passing element 104 can be moved in position relative to the
shaft 102. The shaft 102 can be rotated relative to the suture
passing element 104 after the suture passing element 104 hooks, or
passes an elongate element around a bone. The suture passing
element 104 can rotate when the shaft 102 is held stationary. The
shaft 102 can rotate when the suture passing element 104 is held
stationary. The suture passing element 104 and the shaft 102 can
rotate at the same time, in the same directions and/or orientations
or a different directions and/or orientations. The suture passing
element 104 can rotate relative to the longitudinal axis 112 of the
shaft 102. The suture passing element 104 can rotate relative to
the longitudinal axis 114 of the proximal handle 108. The suture
passing element 104 can rotate about an axis 116, wherein axis 116
is perpendicular to the longitudinal axis 112 of the shaft 102. The
suture passing element 104 can rotate about one, two, or more axes.
In some embodiments, the suture passing element 104 while rotating
in an arc, offset from the longitudinal axis of the shaft 102,
during at least one point during rotation the path of the arc
intersects the longitudinal axis 112 of the shaft 102. The degree
of rotation of the suture passing element 104 can be, in some
embodiments, at least about 45.degree., 90.degree., 135.degree.,
180.degree., 225.degree. or more, or between about 90.degree. and
180.degree., 135-225.degree., or different ranges including two of
the foregoing values thereof for example.
[0092] The suture passing element 104 can include a longitudinal
axis 118. In some orientations, the longitudinal axis 118 of the
suture passing element 104 is aligned with the longitudinal axis
112 of the shaft 102, as shown in FIGS. 1A and 2A. In some
orientations, the longitudinal axis 118 of the suture passing
element 104 is not aligned with the longitudinal axis 112 of the
shaft 102, as shown in FIGS. 1B, 1C, and 2C as well as the
schematic of FIG. 1C clarifying certain features. The suture
passing element 104 can be rotated relative to the slot 105 as
shown in FIG. 1C.
[0093] In some embodiments, a mechanism (not shown) can control the
rotation of the suture passing element 104 relative to the shaft
102. The mechanism 110 can be housed within the shaft 102. The
suture passing element 104 can be coupled to the shaft 102. The
suture passing element 104 can be retained in the slot 105. The
slot 105 can include a bushing 120 or other device known in the art
to permit free rotation. The distal end of the shaft 102 can be
split to house the bushing 120. A component 130 such as a fastener
can couple the split distal end of the shaft 102 to prevent the
disengagement and/or loosening of the bushing 120. In some
embodiments, the bushing 120 provides friction to hold the suture
passing element 104 relative to the shaft 102. The torque exerted
by rotating the shaft 102 can rotate the shaft 102 relative to the
suture passing element 104.
[0094] As illustrated in FIGS. 2A-2C, a method of using the suture
passer 100 is shown with respect to the hyoid bone. The method
illustrates a generally superior to inferior approach. The
longitudinal axis 118 of the suture passing element 104 can be
generally aligned with the longitudinal axis 112 of the shaft 102.
The suture passing element 104 can extend from the distal end of
the shaft 102. The shaft 102 can be manipulated relative to the
hyoid bone until the suture passing element 104 surrounds, such as
least partially circumscribes a portion of the hyoid bone. FIG. 2B
illustrates the front view of the approach. As shown in FIGS.
2A-2B, the longitudinal axis 118 of the suture passing element 104
is aligned with the longitudinal axis 112 of the shaft 102. The
suture passing element 104 can hook or otherwise pass an elongate
element such as a suture around the hyoid bone. The shaft 102 can
be rotated relative to the suture passing element 104 and/or the
suture passing element 104 can be rotated relative to the shaft.
FIG. 2C illustrates the suture passing element 104 in a position
after a completed pass in some embodiments. The shaft 102 is
rotated relative to the suture passing element 104 a different
position relative to the hyoid bone. The longitudinal axis 118 of
the suture passing element 104 is not aligned with the longitudinal
axis 112 of the shaft 102.
[0095] As illustrated in FIGS. 3A-3D, the suture passing element
104 can rotate relative to the shaft 102. This can be completed by
an internal mechanism to actively rotate the suture passing element
104, overcoming frictional forces between the shaft 102 and the
suture passing element 104. The suture passing element 104 can be
coupled to the shaft 102 via the bushing 120. The suture passing
element 104 can rotate in an arc about, or at least about 15
degrees, 30 degrees, 60 degrees, 90 degrees, 105 degrees, 120
degrees, 135 degrees, 150 degrees, 165 degrees, 180 degrees, 195
degrees, 210 degrees, 225 degrees or more relative to the axis 116.
The axis 116 can be transverse to the longitudinal axis 112 of the
shaft 102.
[0096] The suture 106 can be carried by the suture passing element
104 and thereby passed around the hyoid bone. As illustrated in
FIG. 4A, the suture 106 can form a suture loop including a first
strand 106A, a second strand 106B and an arc (e.g., loop portion)
106C connected to and residing between the first strand 106A and
the second strand 106B. The arc 106C can form a portion of a
circle. The suture 106 can be pre-attached to the suture passing
element 104 prior to the suture passing element 104 being passed
around the hyoid bone. In other embodiments, the suture 106 can be
attached to the suture passing element 104 after the suture passing
element 104 is passed around the hyoid bone. The suture 106 can be
passed around the hyoid bone as the suture passer 100 is retracted.
The suture 106 can remain in place, around the hyoid bone, after
the suture passer 100 is retracted.
[0097] As illustrated in FIGS. 4A-4D, the suture passing element
104 can have a variety of configurations. As shown in FIGS. 4A-4C,
a portion of the suture passing element 104 can include one or more
suture engagement mechanisms. As shown in FIG. 4A, the suture
engagement mechanism can be a slot 124. The suture 106 can be
inserted into the slot 124. For instance, the first strand 106A,
the second strand 106, and/or the arc 106C can be inserted into the
slot. The insertion of the arc 106C into the slot 124 and around
the hyoid bone may facilitate the tying of a knot, as described
herein. As shown, the slot 124 can be a lateral slot extending
through the suture passing element 104. The suture 106 can be
inserted so that the arc 106C is on one side of the suture passing
element 104 and the first strand 106A and the second strand 106B of
the suture 106 are on the other side of the suture passing element
104.
[0098] As shown in FIG. 4B, the suture engagement mechanism can be
a plurality of holes 126, 126' (e.g., two or more holes). While two
holes are shown, other configurations are contemplated (e.g.,
three, four, five, six, etc.). The first strand 106A of the suture
106 can be inserted into a first hole 126, and the second strand
106B of the suture 106 can be inserted into a second hole 126'. As
shown, the holes 126, 126' can be laterally-facing (or
alternatively distal-facing) holes with respect to the distal end
of the suture passing element 104. The holes 126, 126' can extend
through the suture passing element 104. The suture 106 can be
inserted so that the arc 106C is on one side of the suture passing
element 104 and the first strand 106A and the second strand 106B of
the suture 106 are on the other side of the suture passing element
104.
[0099] As shown in FIG. 4C, the suture engagement mechanism can be
a notch 128. The suture 106 can be inserted into the notch 128. As
shown, the notch 128 can be a lateral notch extending along a
surface of the suture passing element 104. The arc 106C of the
suture 106 can be inserted into the notch 128. The first strand
106A is on one side of the suture passing element 104 and the
second strand 106B is on the other side of the suture passing
element 104. The slot 124, the holes 126, and the notch 128 can be
formed in a distal end of the suture passing element 104. The
suture 106 can be coupled to the suture passing element 104 before
or after passing the suture passing element 104 is passed around a
bone or tissue. In some methods, the suture engagement mechanism
can guide the suture 106 around the bone or tissue.
[0100] As shown in FIG. 4D, the suture engagement mechanism can be
a lumen 130. In some embodiments, the lumen 130 extends through a
portion of the entire length of the suture passing element 104. The
lumen 130 can include a distally-facing exit aperture, as opposed
to the laterally-facing suture engagement mechanisms described with
respect to FIGS. 4A-4C. The lumen 130 can extend the entire length
of the suture passing element 104. The lumen 130 can extend along
the length of the curved longitudinal axis 118 of the suture
passing element 104. In other words, the suture passing element 104
can be in the form of a tubular structure.
[0101] In some embodiments, the suture passing element 104 includes
a second stage element 132 as shown in FIG. 6A. The second stage
element 132 can be movable within the central lumen 130 as
illustrated in FIG. 4D. The second stage element 132 can be coaxial
with the suture passing element 104. The suture passing element 104
allows for the passage of the second stage element 132 through the
suture passing element 104. As shown in FIG. 5, the suture passing
element 104 may be unable to reach a target location 302. The
suture passing element 104, in some embodiments, does not penetrate
the soft tissue 300. In some cases, this limitation is caused by
the interference of the shaft 102 with the soft tissue 300. In some
cases, this limitation is caused by the geometry of the suture
passer 100 and/or the geometry of the patient's anatomy.
[0102] This limitation has been observed, for example, in some
cases when attempting to pass the suture passing element 104 close
to the backside (e.g., posterior surface) of a body structure such
as a bone 200, such as the hyoid bone for example. The bone 200 can
be located deep within an incision. The bone 200 can be surrounded
by soft tissue 300. A suture passing element 104 that is agile
enough to start the pass while maintaining proximity to the bone
200 may not be sufficiently long enough to penetrate the soft
tissue on the opposing side of the bone 200 to reach the target
location 302. In other words, the need for agility of the suture
passing element 104 may limit the length of the suture passing
element 104. In other words, the design constraints of the suture
passer 100 may prevent the suture passing element 104 from reaching
the target location 302.
[0103] The second stage element 132 can be deployed to reach the
target location 302, as shown in FIG. 6A. The second stage element
132 can be deployed through the lumen 130 of the suture passing
element 104. The suture passer 100 with the second stage element
132 can penetrate the soft tissue 300 after passing around the bone
200. The suture passer 100 with the second stage element 132 can
form a complete pass (e.g., a loop) around the bone 200.
[0104] As shown in FIGS. 6A-6B, the second stage element 132 can
extend distally beyond, and from a distal end of the suture passing
element 104. The second stage element 132 can be a linear extension
of the distal end of the suture passing element 104. As shown in
FIGS. 6A-6C, a tool 134 can be used to pass the second stage
element 132 through the suture passing element 104. The tool 134
can insert the second stage element 132 into the lumen 130 of the
suture passing element 104. In some embodiments, the second stage
element 132 can be inserted into the suture passing element 104 at
the proximal end of the suture passing element 104. In some
embodiments, the second stage element 132 can be inserted into the
suture passing element 104 at the location where the suture passing
element 104 couples with the shaft 102.
[0105] The second stage element 132 can include a needle 136, as
shown in FIG. 6B. The needle 136 facilitates the additional tissue
penetration to reach the target location 302. The second stage
element 132 can include a suture engagement mechanism to engage
suture 106. The suture engagement mechanisms can include those
shown in FIGS. 4A-4D. For instance, the distal end of the second
stage element 132 can include a slot, one or more holes, a notch,
or a lumen or other feature.
[0106] As shown in FIGS. 7A-7B, the second stage element 132 can
include a snare 137. The snare 137 can extend through the lumen 130
of the suture passing element 104 as described herein. FIG. 7A
shows the snare 137 retracted and FIG. 7B shows the snare 137
advanced from the distal end of the suture passing element 104. The
snare 137 creates a larger target for the user to place the suture
106. In other words, the snare 137 may be, in some embodiments,
easier to thread with the suture 106 than the suture engagement
mechanisms such as the slot, the holes, and the notch, shown in
FIGS. 4A-4D.
[0107] As shown in FIGS. 8A-8B, the second stage element 132 can
include features of FIGS. 6A-6B and 7A-7B. The second stage element
132 can include both a needle 140 and a snare 142. The needle 140
facilitates the additional tissue penetration to reach the target
location 302. The snare 142 creates a larger target for the user to
place the suture 106 in the suture passer 100. The snare 142 can be
operably attached to the needle 140 as illustrated, such as via
laterally-facing apertures in the needle 140. FIG. 8A shows the
second stage element 132 in a retracted configuration and FIG. 8B
shows the second stage element 132 in an extended configuration and
advanced from the distal end of the suture passing element 104.
[0108] As shown in FIGS. 9A-9B, the second stage element 132 can be
a grasper 144 having a plurality of movable jaws. The grasper 144
can be configured to hold one or more sutures 106 when the grasper
144 is retracted. FIG. 9A shows the grasper 144 retracted. FIG. 9B
shows the grasper 144 advanced from the distal end of the suture
passing element 104. In some embodiments, the grasper 144 can open
when deployed from the distal end of the suture passing element
104, releasing the sutures 106. The sutures 106 can be coupled to
the grasper 144 and/or the suture passer 100 prior to the suture
passer 100 advancing around the bone 200. In some embodiments, the
grasper 144 can close around the sutures 106 and transport the
sutures 106 around the bone 200. The grasper 144 can be retracted
into the suture passing element 104.
[0109] In some embodiments, the suture passing element 104 can have
a complex configuration having a plurality of distal curved regions
having differing radii of curvature, such as a first region having
a first radii of curvature, and a second region having a second
radii of curvature that is greater or less than the first radii of
curvature. The first region and the second region can have convex
curves, concave curves, or one convex and the other concave in some
embodiments. FIGS. 10A-10B show a coiled suture passing element
148, resembling a pig's tail. The coiled suture passing element 148
can have any combination of the characteristics described herein
with reference to suture passing element 104. The coiled suture
passing element 148 can be tubular. The coiled suture passing
element 148 can include a second stage element 132. The second
stage element 132, such as a needle, facilitates the additional
tissue penetration to reach the target location 302. The second
stage element 132, such as a snare, can create a larger target for
the user to place the suture 106. The second stage element 132,
such as grasper, can hold or release sutures 106 during the
pass.
[0110] In some embodiments, the outer or inner diameter of the
shaft of the suture passer 100 can be between about 3/8 inch and
about 1 inch. The diameter can be selected based upon the method to
be performed. The outer or inner diameter of the suture passing
element 104 and the coiled suture passing element 148 can be, for
example, between about 1/16 inch and about 1/8 inch for methods for
passing a suture around the hyoid bone.
[0111] The diameter rod or tube used to make the suture passing
element 104 can depend on a number of factors. In some embodiments,
it may be desirable to have the suture passing element 104 that is
stiff. For instance, the suture passing element 104 may need to be
stiff enough to penetrate tissue, such as tough connective tissues
around the hyoid bone. The suture passing element 104 may need to
be large enough to accommodate features described herein, such as
suture engagement mechanisms. The suture passing element 104 may
need to be large enough to accommodate additional components, such
as the second stage element 132. It may be desirable to design the
suture passer 100 as small as possible, for instance, with as small
diameter as possible. A small diameter may minimize the amount of
injury to the tissue. The diameter of second stage element 132 can
be, for example between about 1/16 inch and about 1/8 inch for
methods for passing a suture around the hyoid bone.
[0112] In some embodiments, the suture passing element 104 is
subjected to torque. For instance, the suture passing element 104
may be subjected to torque loads when pushed through connective
tissue. It can be advantageous, in some embodiments, to minimize
deformations that occur when the suture passing element 104 is
subjected to torque, load and/or force. The suture passing element
104 may be sufficiently stiff to navigate through connective
tissue. The suture passing element 104 can be formed, in some
embodiments, from a material (e.g., stainless steel) that has
adequate characteristics to resist deformation during the intended
use. The second stage element 132 can be formed, in some
embodiments, from a material that is super-elastic (e.g.,
nitinol).
[0113] FIGS. 11A-11E illustrate various embodiments of sutures 106.
The sutures described herein can include a variable-thickness
suspension line for suspending tissue, including a suture 106
having a first thickness dimension. The suture described herein can
include an elastomer surrounding a portion of the suture forming an
overmolded segment 150 and defining a central segment of the
suspension line having a second thickness dimension greater than
the first thickness dimension. The elastomer can be overmolded onto
the suture 106. The elastomer can be, for example silicone. The
suture 106 can be braided. The elastomer can be overmolded over a
plurality of discontinuous segments of the suture 106. The central
segment of the suspension line can include one or more knots and/or
one or more beads for improving adhesion between the suture and the
elastomer. The suspension line could have a rounded, and/or a
rectangular cross-section. As such, the sutures can either be
elastic or inelastic. In some embodiments, elastic sutures can be
stretched to at least about 110%, 120%, 130%, 140%, 150%, 175%,
200%, 250%, 300%, or more of their unstretched length.
[0114] The suture 106 can include at least one transition zone
extending from the central segment of the suspension line to a
lateral end of the suspension line, the transition zones having a
thickness dimension that tapers from the second thickness dimension
to the first thickness dimension. The suture 106 can have any
features described in commonly owned U.S. patent application Ser.
No. 14/020,617, the disclosure of which is incorporated by
reference herein.
[0115] The suture 106 can be a #2 suture, or any other size
depending on the desired clinical result (e.g., #1 to #6). The
suture 106 can be formed from a suitable material (e.g., braided
polyester, braided polyethylene). The suture 106 can include a
longitudinal suture optionally coupled with additional features.
The suture 106 can include two free ends. The suture 106 can
include one, two, or more sections of increased thickness, that can
be overmolded segments 150, or otherwise attached over the suture
106 to increase thickness of the suture. The overmolded segment 150
can be formed from, for example, silicone or other elastomer. The
overmolded segment 150 can be silicone compounded with a
radiopacifier, such as barium sulfate, and as such be radiopaque
under an imaging modality, such as fluoroscopy or CT. In other
embodiments, the suture, e.g., the overmolded segment 150, or a
portion thereof is visible under other imaging modalities, such as
ultrasound for example. As the suture 106 stretches under load, the
overmolded segment 150 will move and stretch with the suture 106,
and can advantageously provide a bearing against wear in some
cases.
[0116] FIG. 11A shows a suture 106 with a series of spaced-apart
knots 152, or areas of increased width and/or surface area. The
knots 152 can be overhand knots in some embodiments. The
longitudinal suture 106 can be knotted to form an integral
structure. The series of knots 152 increase adhesion between the
suture 106 and the overmolded segment 150.
[0117] FIG. 11B shows a suture 106 with a suture braid 154. The
suture braid 154 can be formed with the longitudinal first suture
106 and a second suture 106' having the same size (e.g., #2) or a
different (e.g., larger or smaller) size (e.g., #5) with respect to
the size of the longitudinal first suture 106. The second suture
106' is braided with the longitudinal first suture 106 and forms a
suture sock as shown. The ends of the second suture 106' can be
fixed to the longitudinal first suture 106 to prevent fraying. In
some embodiments, heat is used to fix the second suture 106' to the
longitudinal first suture 106. The suture braid 154 provides some
bulk to the overmolded segment 150. The suture braid 154 can serve
as a bearing.
[0118] FIG. 11C shows a suture 106 with a series of beads 156. The
beads 156 can be rigid or flexible beads. The beads 156 can be
formed from a suitable material (e.g., glass). The beads 156 can
all have the same diameter, as shown in FIG. 11C. The beads 156 can
be retained on the longitudinal suture 106 by knots 152 positioned
at the end of the beads 156. The knots 156 can be overhand knots.
The knots 152 can be adjacent to the first and last beads 156 or
spaced apart from the first and last beads 156. The beads 156 can
serve as a rigid bearing, and in some embodiments advantageously
allow the suture 106 to slide, stretch, or otherwise move within
the overmolded segment 150. The beads 156 allow the suture 106 to
remain flexible due to the discrete nature of the beads 156.
[0119] FIG. 11D shows a suture 106 with a series of beads 158. The
beads 158 can have varying diameters as illustrated in FIG. 11D.
The beads 158 can be formed from a suitable material (e.g., glass).
The suture 156 can have similar characteristics as suture 158. The
beads 158 can have different diameters. The diameter of the beads
158 can be selected to accommodate the shape of the overmolded
segment 150. The suture 106 can have two differing diameters of
beads 158. The smaller diameter beads 158 can be located near the
suture ends, and the larger diameter beads 158 can be located
between the smaller diameter beads 158, or in a different
arrangement.
[0120] FIG. 11E shows suture 106 with a coil 160. The coil 160 can
be formed from a suitable material (e.g., a polymer (e.g.,
polypropylene), suture, (e.g., #2 or other size monofilament
suture), or a metal (e.g., stainless steel)). The coil 160 can be
wrapped around the longitudinal suture 106. The coil 160 can be
threaded around the longitudinal suture 106. The coil 160 can be
retained on the longitudinal suture 106 by knots 152 positioned at
the end of the coil 160. The knots 152 can be overhand knots. The
knots 152 can be adjacent to the ends of the coil 160 or spaced
apart from the ends of the coil 160. The coil 160 can serve as a
bearing. The coil 160 can allow the suture 106 to slide, stretch,
or otherwise move within the overmolded segment 150. The coil 160
allows the suture 106 to remain flexible. The coil 160 of suture
106 may be more flexible than the beads 156, 158 of sutures shown
in FIG. 11C-11D.
[0121] FIG. 12A shows an embodiment of the suture 106 before
overmolding. FIG. 12B shows the suture 106 after overmolding, with
overmolded segment 150. The length, suture size, and/or overall
diameter of the coil 160 can be adjusted depending on the desired
clinical result. The coil 160 of suture 106 may be advantageously
relatively simple to manufacture. The length, suture size, and/or
overall diameter of the overmolded segment 150 can be adjusted
depending on the desired clinical result. The overmolded segment
150 of suture 106 may be advantageously relatively simple to
manufacture.
[0122] In some embodiments, the suture 106 and/or suture 106' could
be USP #2, or about 0.020'' or less in diameter. In some
embodiments, the sections of increased thickness, e.g., the
overmolded sections 150, could be between about 0.080'' to 0.120'',
or 0.020'' to 0.030''.times.0.080'' to 0.120''. In some
embodiments, the lengths of the overmolded sections 150 could be
between about 2 cm and about 3 cm. The suture 106 with the
overmolded section 150 could also include a tapered thickness or
diameter section, such as parts of the overmolded sections 150. The
length of the taper could be, for example, less than 1 cm, or less
than 0.5 cm. In some embodiments, the first suture 106 could be USP
#3, or about 0.024'' or less in diameter. In some embodiments, the
overmolded sections 150 could be between about 0.030'' to 0.200'',
or 0.020'' to 0.030''.times.0.030'' to 0.200'', or have a diameter
that it at least about 20%, 30%, 40%, 50%, 60%, 75%, 100%, 125%,
150%, 200%, or more larger than that of the underlying suture 106
without overmolding. In some embodiments, the lengths of the
overmolded sections 150 could be between about 1 cm and about 5 cm.
The length of the taper on either side of the overmolded section
150 or largest diameter/thickest section could be up to about 20%,
30%, 40%, or 50% of the length of the overmolded section 150 or
entire large diameter/thickest section. In some embodiments,
additional suture 106 and other features that can be used or
modified for use with embodiments disclosed herein can be found,
for example, in U.S. patent application Ser. No. 14/020,617 to
Feezor et al., which is hereby incorporated by reference in its
entirety.
[0123] The surface of any of the disclosed sutures may be
mechanically, chemically, or otherwise modified to improve adhesion
with, for example, muscle cells and other tissues of the
genioglossus. Mechanical modifications create improved adhesion by
modifying the surface texture of the implant and may be achieved as
part of the manufacturing process and may involve the removal of
material from, or the addition of material to the surface of the
implant. Chemical adhesion may be achieved through the
incorporation of chemical (including biological) compounds into the
surface or the bulk material or materials that makes up the implant
in order to improve the affinity between cellular components and
the implant. Compounds may include, but are not limited to
proteins, peptides, antibodies, growth factors, or other molecules
which create an affinity for cellular or tissue components.
[0124] FIGS. 13A-13D illustrate a method of narrowing the lateral
pharyngeal wall. Some surgical procedures indirectly tension the
lateral pharyngeal wall. The technique involves a plurality, e.g.,
two, three, or more suture passes around the superior pharyngeal
constrictor muscle. The sutures are sewn into the palatoglossal
muscle and tied off as shown. The aforementioned technique can
require exposure of muscle with several incisions in the mucosa
layer, and the technical ability to consistently anchor the suture
in the superior pharyngeal constrictor muscle. The technique can
also require the ability to consistently anchor the suture in the
palatoglossal muscle. In some cases, there may be increased pain
and recovery time for patients due to the mucosal incisions.
[0125] In some embodiments, as illustrated in FIG. 14, a barbed
implant 162 can be utilized. The barbed implant 162 can include a
first end 164 and a second end 166. The first end 164 can include
one or more barbs. The second end 166 can include one or more
barbs. The barbs on the first end 164 can point in a first
direction away from the second end 166. The barbs on the second end
166 can point in a second direction away from the first end 164. In
other embodiments, the barbs can point in the same direction. The
barbed implant 162 can have a longitudinally extending portion
between the first end 164 and the second end 166. In some
embodiments, the longitudinally extending portion does not include
barbs as shown in FIG. 14. In other embodiments, the longitudinally
extending portion includes barbs. The barbed implants 162 can be
elastic or inelastic. The longitudinally extending portion can be
elastic or inelastic. The barbs can generally move in one direction
(e.g., to be inserted into tissue). The barbs resist movement in an
opposite direction (e.g., to prevent back out of the barbed implant
162).
[0126] The system can include one or a plurality (e.g., about or at
least about 2, 3, 4, 5, 6, or more) of barbed implants 162. The
barbs can function as proximal and/or distal anchors. The barbed
implant 162 can be implanted into tissue 300. The barbed implant
162 can be horizontally oriented within the body of the patient.
The method of use can include an implant inserter tool 168. The
implant inserter tool 168 can include a proximal handle, an
elongate shaft, and a distal tip. The barbed implant 162 can be
implanted by advancing an implant inserter tool 168 in a generally
horizontal orientation. The implant inserter tool 168 can release
the barbed implant 162 into the tissue 300. In some embodiments,
the barbed implants 162 could be implanted within about 10 degrees
of the horizontal axis. However, in other embodiments, the barbed
implants 162 could be within less than about 15 degrees, 30
degrees, 45 degrees, 60 degrees, 75 degrees of the horizontal axis.
This provides more localized control of tissue suspension,
depending on the desired clinical result.
[0127] In some methods of use, a combination of generally
horizontally-oriented barbed implants 162 can be used as shown in
FIG. 14. In some methods of use, a combination of generally
horizontally oriented barbed implants 162 and generally
vertically-oriented barbed implants 162 can be used. In some
methods of use, a combination of generally vertically-oriented
barbed implants 162 can be used. In some embodiments, the distance
between barbed implants 162 could be irregular or regular. The
distance between the midlines of the barbed implants 162 could be,
for example, between about 0.1 cm and about 3 cm. The barbed
implants 162 can have the same or different orientations within the
tissue 300. In some instances where additional suture strength is
required at a single location within tissue, the multiple barbed
implants 162 may share a midline axis, but be oriented differently
(from -90 to +90 degrees) from each other.
[0128] FIG. 14 illustrates three barbed implants 162 deployed in
the tissue 300. As shown, the barbed implants 162 are used to tack
the superior pharyngeal constrictor muscle to the palatoglossal
muscle. The barbed implants 162 may extend from the palatoglossal
arch to the palatopharyngeal arch. The barbed implants 162 may each
include a longitudinal extending section, the first end 164 and the
second end 166, as described herein. The barbs of the first end 164
may be oriented the same as, or differently from the barbs on the
second end 166. The barbs on the first end 164 may be opposite the
orientation of the barbs on the second end 166. The barbs may be
configured to engage tissue 300 when tensioned from different
directions.
[0129] FIGS. 15A-15B illustrates a cross-sectional view of the
palatoglossal arch and the palatopharyngeal arch. FIG. 15A shows
the barbed implant 162 deployed. The barbed implant 162 compresses
the palatopharyngeal arch toward the palatoglossal arch. FIG. 15B
illustrates a cross-sectional view of the anatomy without the
barbed implant 162. The barbed implant 162 can be deployed at an
angle relative to the horizontal. The angle may be approximately 45
degree. The angle can be determined by the relative anatomy of the
patient.
[0130] FIGS. 16A-D illustrate a method of inserting the barbed
implant 162. FIG. 16A shows the implant inserter tool 168 having
the proximal handle, the elongate shaft, and the distal tip. The
implant inserter tool 168 can be inserted into and extends between
the palatoglossal arch and the palatopharyngeal arch. The implant
inserter tool 168 can be advanced until the distal tip is proximate
a target location. FIG. 16B shows the barbed implant 162 being
deployed from the distal tip of the implant inserter tool 168. This
can be accomplished, for example, by actuating a control on the
proximal handle to actuate a pushrod distally, for example to expel
the barbed implant 162. The first end 164 of the barbed implant 162
engages tissue 300 of the palatopharyngeal arch. In some
embodiments, the barbs may further embed in the tissue 300 as a
force is applied to the barbed implant 162. The barbs of the barbed
implant 162 dig into or otherwise embed in the soft tissue 300. The
tool 168 is retracted from the palatopharyngeal arch.
[0131] FIG. 16C shows the tool 168 being retracted to the
palatoglossal arch. By applying a force (e.g., tension) on the
barbed implant 162, the barbs may further embed in the tissue 300.
The palatopharyngeal arch may be brought toward the palatoglossal
arch. The palatopharyngeal arch may be compressed against the
palatoglossal arch. In some embodiments, the palatopharyngeal arch
may touch the palatoglossal arch. The palatopharyngeal arch may be
pulled laterally and/or anteriorly.
[0132] FIG. 16D shows the implant inserter tool 168 being retracted
from the palatoglossal arch. The second end 166 of the barbed
implant 162 engages tissue 300 of the palatoglossal arch. The
barbed implant 162 may be deployed such that the first end 164
engages the palatopharyngeal arch and the second end 166 engages
the palatoglossal arch. As force is applied to the barbed implant
162, the barbs may further embed into the soft tissue 300, thereby
inhibiting further movement of the barbed implant 162. The method
steps shown in FIGS. 16A-16D can be repeated to deploy one or more
barbed implants 162 on one or more sides of the airway.
[0133] In some cases, the method can include several advantages
depending on the desired clinical result. The technique can leave
the mucosa layer intact. The barbed implants 162 can be anchored to
a larger tissue area than the sutures, in some embodiments. The
technique is a simple, repeatable process providing dependable
results. The technique may produce a large clinical benefit for
minimally invasive intervention.
[0134] FIGS. 17A-17B illustrate embodiments of the barbed implant
162 with tissue ingrowth material 170. The tissue ingrowth material
170 may be located near the first end 164. The tissue ingrowth
material 170 may be located near the second end 166. The tissue
ingrowth material 170 may be located near the first end 164 and
near the second end 166. The tissue ingrowth material 170 may be
located beyond the first end 164. The tissue ingrowth material 170
may be located beyond the second end 166. The tissue ingrowth
material 170 may be located beyond the first end 164 and beyond the
second end 166. The tissue ingrowth material 170 may provide
long-term stability of the barbed implant 162. The tissue ingrowth
material 170 may prevent migration of the barbs out of the tissue.
The tissue ingrowth material 170 can be biocompatible, to prevent
rejection of the barbed implant 162 by the body of the patient. The
tissue ingrowth material 170 and may include one or more drugs or
other therapeutic agents.
[0135] FIGS. 18A-18B illustrate a method of inserting the barbed
implant 162. FIG. 18A shows the implant inserter tool 168 inserted
into the palatopharyngeal arch. The implant inserter tool 168 is
advanced until the distal tip is located at a target location. FIG.
18A shows the barbed implant 162 being deployed from the distal tip
of the implant inserter tool 168. The barbed implant 162 engages
tissue 300 of the palatopharyngeal arch. In some embodiments, the
barbs may further embed in the tissue as a force is applied to the
barbed implant 162. The barbs of the barbed implant 162 dig into or
otherwise embed in the soft tissue. The implant inserter tool 168
is retracted from the palatopharyngeal arch. FIG. 18B shows the
implant inserter tool 168 retracted. The barbed implant 162 spans
from the palatopharyngeal arch to the base of the palatoglossal
arch. The barbed implant 162 compresses the palatoglossal arch. By
applying a force (e.g., tension) on the barbed implant 162, the
barbs may further embed in the tissue. The palatopharyngeal arch
may be brought toward the palatoglossal arch. The palatopharyngeal
arch may be pulled laterally. This technique avoids tacking the
palatopharyngeal arch directly to the palatoglossal arch.
[0136] FIGS. 19A-19E illustrate a method of inserting a suture 106
for a tissue lift procedure. The suture 106 can include the
overmolded segment 150 as described herein. FIG. 19A shows the
method step of making an incision in the skin of the head of a
patient. FIG. 19B shows the method step of making a small surgical
dissection pocket. FIGS. 19C-19E show various non-limiting possible
suture passes. Path A provides neck lift, Path B provides mid-level
cheek lift, and Path C provides eye line lift, as shown in FIG.
19C. Path D, as shown in FIG. 19D, shows the path wherein the
suture passes inferiorly to the mandible. The suture is advanced
until reaching the midline of the neck. The method may include the
step of placing suspension sutures such as suture 106 with the
overmolded segment 150 under the jaw line. Path E, as shown in FIG.
19E illustrates the path of suture 106 forming loops in the neck.
The method may include the step of suspending a suture, trimming
extra skin, and/or closing the incision. The sutures may be placed
using the SMAS, or the sub-muscular aponeurotic system. The system
and methods, such as the use of various suture passers, can be as
disclosed herein and can be, or modified from systems and methods
described in U.S. Pat. No. 8,460,322, the entire disclosure of
which is incorporated by reference.
[0137] FIG. 20 illustrate a method of inserting a suture 106. The
suture 106 can include the overmolded segment 150 as described
herein. The methods can be performed by a suture passer described
herein and in commonly owned U.S. Pat. No. 8,460,322, the entire
disclosure of which is incorporated by reference. The suture passer
can be modified, (e.g., reduced in size). The suture passer can be
used to place suture 106. The suture 106 can form loops within the
tissue instead of single short sections of suture. The suture
passer can place suture 106 into the superior pharyngeal
constrictor muscle. The suture 106 can be placed as shown. The
suture 106 can be placed near the palatopharyngeal arch, the
palatoglossal arch and/or any location between the palatopharyngeal
arch and the palatoglossal arch. The suture 106 can be anchored.
The suture 106 can be anchored into palate tissue and/or the hard
palate. The suture 106 can be tensioned to stabilize the lateral
pharyngeal wall. The method can in some embodiments narrow the
lateral pharyngeal wall and/or provide the lateral
pharyngoplasty.
[0138] FIGS. 21A-21B illustrate a method of using one or more bone
anchors 172 in an adjustable tensioning system. The bone anchors
172 can be knotless bone anchors in some embodiments. The suture
106 can be inserted into the bone anchors 172. In some embodiments,
the suture 106 includes a first strand 106A, a second strand 106B
and an arc connecting the first strand 106A and the second strand
106B. The first strand 106A has a free end and the second strand
106B has a free end. The free ends of the suture 106 can be
inserted into a lumen of the bone anchor 172. The bone anchor 172
can be tightened to secure the first strand 106A and the second
strand 106B. The bone anchor 172 can be loosened to release the
first strand 106A and the second strand 106B and allow for
adjustable tensioning without necessarily requiring untying of the
suture loop.
[0139] The bone anchors 172 can be used to secure the suture 106
within the face or neck, or another desired anatomical location.
The suture 106 can form a loop such that the suture arc 106C is
disposed within the tissue. The sutures 106 may be placed to
provide a face and/or neck lift.
[0140] The bone anchor 172 can provide post-operative adjustability
to the suture 106. For instance, the suture 106 can be adjusted
after the arcs 106C are placed, during the procedure and/or at any
time in the future. The suture 106 could be adjusted days, months,
or years after the suture 106 is placed within the body. The bone
anchor 172 permits adjusting the suture 106 by increasing or
decreasing tension in a minimally invasive manner. In some
embodiments, the bone anchor 172 can selectively release the first
strand 106A. In some embodiments, the bone anchor 172 can
selectively release the second strand 106B. In some embodiments,
the bone anchor 172 can selectively release the first strand 106A
and the second strand 106B. The surgeon can apply tension to the
first strand 106A and/or the second strand 106B. Once adjusted, the
bone anchor 172 can be tightened to retain the first strand 106A
and the second strand 106B. The bone anchor 172 permits adjusting
the face and/or neck lift in a minimally invasive manner. The free
ends of the suture 106 may be pulled, slid, tensioned and/or
manipulated to adjust the suture 106. This movement would then
adjust the tissue, bone, and/or skin coupled to the suture 106
(e.g., adjust the face and neck lift).
[0141] The bone anchor 172 can have lock and unlock capabilities.
The bone anchor 172 can include an opening (e.g., a hexagonal
opening) for the insertion of a tool (not shown). The tool can lock
and unlock the bone anchor 172, allowing for the suture 106 to be
adjusted. The bone anchor 172 may be implanted on a surface of the
skin and/or within the body. The bone anchor 172 can be placed
above the ear (e.g., in the temporal bone), as shown in FIG. 21A.
The bone anchor 172 can be placed under the skin near the ear, as
shown in FIG. 21B. The bone anchor 172 placed under the skin can be
adjusted by making a small incision near the bone anchor 172. The
incision may be near the implantation location for the bone anchor
172. The tool can be inserted into the incision to adjust the bone
anchor 172.
[0142] FIGS. 22A-22B illustrate a tool 176 and method for moving
the superior pharyngeal constrictor or another desired muscle. The
tool 176 can move the superior pharyngeal constrictor muscle in any
direction (e.g., laterally and/or anteriorly). The tool 176 can
stabilize the superior pharyngeal constrictor muscle in the desired
location (e.g., laterally and/or anteriorly). The tool 176 can
insert a fastener 178 (e.g., a tack, staple, cap, suture loop, or
suture). The fastener 178 can be biodegradable or bioabsorbable in
some cases. The tool 176 can include a blunt tip for moving the
tissue. The tool 176 can couple to the fastener 178 for stabilizing
the tissue. FIG. 22A shows the tool 176 moving the superior
pharyngeal constrictor muscle laterally. The tool 176 can move the
superior pharyngeal constrictor muscle via the blunt tip. The
superior pharyngeal constrictor muscle may be moved toward the side
of the airway. The tool 176 can be positioned to discharge (e.g.,
launch, fire) the fastener 178 to stabilize the tissue. The method
can be repeated for the contralateral side of the airway to move
the superior pharyngeal constrictor muscle laterally.
[0143] FIGS. 23A-23C illustrate some embodiments of the fastener
178, with the placement of the fastener 178 shown in relation to
the superior pharyngeal constrictor muscle. FIG. 23A shows the
fastener 178 as a staple, with ends biased toward each other. FIG.
23B shows the fastener 178 as a tack, having a proximal tissue
contacting structure and a distal tissue contracting structure,
both operably connected to a tension element. FIG. 23C shows the
fastener 178 as the suture 106. The suture 106 can form a loop by
bringing the first end 106A to the second end 106B. The suture 106
can be stabilized with anchors as described herein. The suture 106
can be placed with a device like a suture passer as described
herein. The fastener 178 can be a barbed suture 162, as shown in
FIG. 14 for example. The fastener 178 can be bioabsorbable in some
embodiments. The fastener 178 can extend from the superior
pharyngeal constrictor muscle to a location near the
palatopharyngeal arch, the palatoglossal arch and/or any location
between the palatopharyngeal arch and the palatoglossal arch. The
fastener 178 can extend from the fascia behind the superior
pharyngeal constrictor muscle.
[0144] FIGS. 24A-24D illustrate a method of hyoid suspension. The
hyoid bone is located in the anterior midline of the neck and is
anchored by muscles. The hyoid aids in tongue movement and
swallowing. Hyoid suspension involves pulling the hyoid forward in
order to increase the size of the airway. FIG. 24A illustrates the
method step of forming an incision in the neck of a patient. The
incision can be, for example, between 2 cm and 4 cm. The incision
may extend from, for example, the hyoid bone to the mandible. The
surgeon can dissect the tissue and muscle to reach the hyoid
bone.
[0145] FIG. 24B illustrates the method step of using a suture
passer for hyoid suspension. The method may utilize a suture passer
substantially similar to the systems and methods described herein
or in commonly owned U.S. Pat. No. 8,460,322, the entire disclosure
of which is incorporated by reference. The suture passer can be
used to pass a suture loop 106 around the body of the hyoid bone.
The suture 106 can include the overmolded segment 150. The suture
106 has the first strand extending longitudinally 106A, the second
strand extending longitudinally 106B, and the arc 106C connecting
the first strand 106A and the second strand 106B. The arc 106B is
passed around the hyoid bone. The suture loop 106 can be elastic or
inelastic. The suture 106 can be substantially similar to the
sutures described herein, including the sutures shown in FIGS.
11A-12B. The arc 106C can be on one side of the hyoid bone. The
first 106A and second strand 106B can be on the other side of the
hyoid bone. In some methods, the first strand 106A and the second
strand 106B are then passed around the hyoid bone. The first strand
106A and the second strand 106B are passed under the arc 106B. The
suture 106 can form a girth hitch. Other knot configurations are
contemplated. For instance, the suture 106 could be wrapped around
the hyoid bone forming a klemhiest or prusik knot.
[0146] The first suture 106 can be replaced with a second, larger
suture 108. The larger suture 108 can include be a larger diameter
suture, suspension loop, suture tape, etc. The larger suture 108
can be similar to suture 106. The larger suture 108 can prevent
erosion through the bone. The second, larger suture 108 can be
elastic. The larger suture 108 can include the overmolded segment
150 as described herein. The suture 108 has a first strand
extending longitudinally 108A, a second strand extending
longitudinally 108B, and an arc 108C connecting the first strand
108A and the second strand 108B.
[0147] In some methods of use, the first strand 106A is passed
around the hyoid bone. The arc 106C can be in contact with the
hyoid bone. The second strand 106B can be on the other side of the
hyoid bone. The suture 106 can be used to place the suture 108,
akin to a guide suture. In some methods, the arc 108C can be placed
around the first strand 106A. The arc 108C can be operably coupled
to the first strand 106A. The suture 106 can be pulled. In some
embodiments, the second strand 106B of the suture 106 is pulled.
The arc 108C can be on one side of the hyoid bone. The first 108A
and second strand 108B can be on the other side of the hyoid bone.
In some methods, the first strand 108A and the second strand 108B
are then passed around the hyoid bone. The first strand 108A and
the second strand 108B are passed under the arc 108B. The suture
108 can form a girth hitch. Other knot configurations are
contemplated. For instance, the suture 108 could be wrapped around
the hyoid bone forming a klemhiest or prusik knot.
[0148] In some methods of use, the arc 106C is passed around the
hyoid bone as shown in FIG. 24C. The arc 106C is on one side of the
bone and the first strand 106A and the second strand 106B can be on
the other side of the hyoid bone. In some methods, the arc 108C can
be placed under the arc 106C. The suture loop 106 can be pulled. In
some embodiments, the first strand 106A and the second strand 106B
of the suture 106 are pulled. The arc 108C can be on one side of
the hyoid bone. The first 108A and second strand 108B can be on the
other side of the hyoid bone. In some methods, the first strand
108A and the second strand 108B are then passed around the hyoid
bone. The first strand 108A and the second strand 108B are passed
under the arc 108B. The suture 108 can form a girth hitch. Other
knot configurations are contemplated. FIG. 24C shows the method of
pulling the larger suture 108, which can be operably connected to
the smaller guide suture 106 in some embodiments.
[0149] FIG. 24D illustrates the method step of securing the suture
106 and/or larger suture 108 to the mandible. The method may
utilize a bone anchor 178, which can include any or all of the
features of bone anchor 178 described herein. The bone anchor 178
can be a knotless bone anchor. The bone anchor 178 can be a locking
bone screw. The loop of the suture 106 and/or larger suture 108
provides a knotless attachment to the hyoid bone.
[0150] The tension, position, and/or suspension of the hyoid bone
can be adjusted by adjusting the loop of the suture 106 and/or
larger suture 108. For instance, pulling on the first strand 106A
and/or the second strand 106B can change the position of hyoid
bone. For instance, changing the location of the suture 106
relative to the hyoid bone can change position of the hyoid
bone.
[0151] The bone anchor 178 can allow for post-operative adjustment
of the suture 106 and/or larger suture 108. The bone anchor 178 can
release the first strand 108A and or the second strand 108B. The
surgeon can adjust the tension provided by the first strand 108A
and the second strand 108B. The larger suture 108 can be adjusted
after the knot is placed, and/or at any time in the future. The
larger suture 108 could be adjusted days, months, years after the
larger suture 108 is placed within the body. The larger suture 108
can be adjusted acutely or chronically. The method of passing the
suture 106, 108 around the hyoid bone may be simpler, easier, and
more minimally invasive than using a curved needle. Although FIG.
24D shows one larger suture 108, more than one larger suture 108
can be utilized (e.g., two girth hitch knots, three girth hitch
knots, etc.). The thickness, strength, and/or other material
properties may be selected to minimize the number of larger sutures
108. A single larger suture 108 of a sufficiently thick and/or
strong material may be able to stabilize the hyoid bone with
respect to the mandible.
[0152] FIG. 25A-25B illustrate a suture passer, in particular the
distal end of the suture passer. The suture passer 182 can be
modified from the suture passer described in commonly owned U.S.
Pat. No. 8,460,322, the entire disclosure of which is incorporated
by reference. The suture passer 182 can be modified to include one
or more sharpened suture passing needles 184. The sharper needles
184 may be configured for passing through tissues having a greater
inherent resistance to puncture, such as ligaments (e.g.,
hyoepiglottic ligaments, hypothyroid ligaments). The design and/or
material of the needle 184 may be selected to enhance
stiffness.
[0153] The suture passer 182 can be modified to include one or more
sharp tips 186. The sharp tips 186 on the ends of the suture passer
182 may be useful in passing through ligaments as noted above. The
suture passer 182 can include a depth stop 188 which may limit the
forward movement of the suture passer 182. The depth stop 188 may
serve as a safety measure, to prevent the suture passer 182 from
puncturing the airway. Alternatively, the tips could be blunt and
atraumatic in some embodiments.
[0154] FIG. 25B illustrates the placement of the suture passer 182
within the body of the patient. The sharp tips 186 may surround the
hyoid bone. The needle 184 may penetrate the hyoepiglottic
ligament. The needle 184 may extend from one sharp tip 186 to the
other sharp tip 186 in order to pass the suture. Surrounding
structures such as the hypothyroid ligament, thyroid cartilage, and
epiglottis are also shown for reference.
[0155] FIG. 26A-26B illustrate a method of hyoid bone suspension.
FIG. 26A illustrates the method step of forming a girth hitch
around the hyoid bone. FIG. 26A utilizes two sutures 106 (e.g., #2
suture, suture tape (e.g., 2 mm suture tape)). One, two, or more
girth hitch knots may be utilized as shown in FIG. 26A. The first
strand 106A and the second strand 106B pass under the arc 106C. The
first strand 106A and the second strand 106B of the suture 106 are
secured to a bone anchor 178. The bone anchor 178 can be located on
the mandible. The bone anchor 178 can be tightened to securely hold
the first strand 106A and the second strand 106B. The bone anchor
178 can be loosened to release the first strand 106A and the second
strand 106B. The surgeon can alter the tension applied to the hyoid
bone. The bone anchor 178 can be tightened after the adjustment.
FIG. 26A shows a configuration with two side-by-side girth hitch
knots, and two bone anchors 178. FIG. 26B shows a configuration
with one girth hitch knot illustrated using suture tape, and three
bone anchors 178. Additional girth hitch knots utilizing sutures
106 may be utilized in FIG. 26B with respect to the remaining bone
anchors 178. The ratio of girth hitches or other knots to bone
anchors 178 may be greater than 1:1 (2 girth hitches to 1 bone
anchors) or equal to 1:1 (2 girth hitches to 2 bone anchors) in
some embodiments. The ratio of sutures 106 to bone anchors 178 may
be greater than 1:1 (2 girth hitches to 1 bone anchors) or equal to
1:1 (2 girth hitches to 2 bone anchors) in some embodiments.
[0156] FIG. 27A-27D illustrates a method of forming a girth hitch,
in some embodiments. The suture 106 includes the first strand 106A,
the second strand 106B, and the arc 106C. FIG. 27A shows the method
step of conducting a pass with a suture passer. The suture 106 may
be folded, held or otherwise coupled to the suture passer. FIG. 27B
shows the method step of retracting the suture passer and/or the
needle of the suture passer. The arc 106C remains within the body.
FIG. 27C illustrates passing the first strand 106A and the second
strand 106B of the suture 106 through the arc 106C of the suture
106 to form a girth hitch. FIG. 27D illustrates the method step of
tensioning the first strand 106A and the second strand 106B of the
suture 106 to form a girth hitch. The first strand 106A and the
second strand 106B of the suture 106 can be coupled to a bone
anchor 178 as described herein. The bone anchor 178 can be attached
to the mandible. The suture 106 may be either pre-attached to the
bone anchor 178 prior to the procedure, or following formation of
the girth hitch. The suture 106 can be a smaller diameter guide
suture. In some methods, the suture 106 can be coupled with a
larger diameter suture 108, which can follow the path of the guide
suture 106 to create a girth hitch. In some methods, the arc 108C
of the larger diameter suture 108 can be passed under the arc 106C
of the suture 106C to create a girth hitch.
[0157] The method illustrated in FIG. 27A-27D illustrates the
creation of a girth hitch around the hyoid bone at the midline
(e.g., near the midline, substantially near the midline). The girth
hitch may be connected to a bone anchor 178. The bone anchor 178
may be attached to the mandible at the midline (e.g., near the
midline, substantially near the midline).
[0158] Alternatively two girth hitch knots may be deployed. The
girth hitch knots may be coupled to the hyoid bone. The two girth
hitch knots can be around the hyoid bone. The two girth hitch knots
can be placed on either side (e.g., right side, left side) of the
midline of the hyoid bone, as shown in FIGS. 26A and 28. In some
embodiments, the two girth hitch knots can be coupled to two bone
anchor 178. The two bone anchors 178 can be placed on either side
(e.g., right side, left side) of the midline of the mandible, as
shown in FIG. 26A. In some embodiments, the two girth hitch knots
can be coupled to a single bone anchor 178. The single bone anchor
178 can be placed at the midline of the mandible (e.g., near the
midline, substantially near the midline), as shown in FIG. 28. The
single bone anchor 178 can be placed on either side (e.g., right
side, left side) of the midline of the hyoid bone.
[0159] FIGS. 29A-29C illustrate an embodiment of a hyoid suspension
implant 192 (e.g., an alternative to, or can be combined with the
suture). FIG. 29A illustrates an implant 192. The implant 192 can
include an implant head 192A, that can have a relatively larger
width dimension, and a longitudinally extending tail 192B having a
relatively smaller width dimension. The implant head 192A includes
a slot or other feature designed to accept the longitudinally
extending tail 192B. FIGS. 29B-29C show a method of using the
implant 192. The implant 192 can be passed behind the hyoid bone.
The implant head 192A is passed around the hyoid bone. The
longitudinally extending tail 192B can be passed through the slot
in the implant head 192A. The longitudinally extending tail 192B is
tensioned. The implant 192 wraps around the hyoid bone, as shown in
FIG. 29C. In some methods, the longitudinally extending tail 192B
is passed around the hyoid bone. The longitudinally extending tail
192B can be passed through the slot in the implant head 192A. The
longitudinally extending tail 192B can be tensioned. The implant
192 wraps around the hyoid bone, as shown in FIG. 29C.
[0160] The implant head 192A, including the slot, and/or the
longitudinal extending tail 192B can have additional features. The
implant can include a locking mechanism. The locking mechanism can
be a ratchet formed within or on the implant head 192A, the slot,
and/or the longitudinal extending tail 192B. The locking mechanism
can lock the implant 192 against the hyoid bone once the implant
192 has been tensioned. FIG. 30 shows an embodiment of the locking
mechanism, surrounding a cross-section of a body structure, such as
the hyoid bone. The longitudinally extending tail 192B includes
teeth and/or ratchets that engage the slot. The slot includes teeth
and/or ratchets that engage the longitudinally extending tail 192B.
The locking mechanism locks the implant 192 in place after the
implant 192 has been tensioned. The bone anchors 178 can also
include teeth and/or ratchets that engage the longitudinally
extending tail 192B. The longitudinally extending tail 192B can
include teeth and/or ratchets that engage the bone anchor 178. The
teeth and/or ratchet can provide a knotless method of locking the
implant to the bone anchor.
[0161] The implant 192 can be manufactured from a biocompatible
material (e.g., plastic). The implant 192 can be formed from any
process (e.g., braiding suture). The teeth and/or ratchet can be
formed into the implant (e.g., crimped into the suture). The teeth
and/or ratchet can take any shape (e.g., balls, triangular teeth,
and/or slits).
[0162] FIG. 31 illustrates a method of attaching an implant to a
hyoid bone. The method can include the step of drilling a small
hole in the hyoid bone (e.g., a through hole). The implant 194 can
be passed through the hole. The implant 194 can be reduced in
diameter in order to fit through the small hole. The implant 194
can have a collapsed configuration and an expanded configuration.
The implant 194 can be passed through the hole in the collapsed
configuration. The implant 194 can be expanded to the expanded
configuration after passing through the small hole. In the expanded
configuration, the implant 194 cannot pass through the hole. For
instance, the implant 194 can have a generally T-shaped
configuration as shown in FIG. 31. The T-shape prevents the implant
194 from passing through the hole in the hyoid bone. A suture 106
(e.g., suture, suture tape) can be attached to the implant 194. The
implant 194 can include a longitudinally extending tail 194B. The
suture 106 can be coupled to the longitudinally extending tail
194B. The longitudinally extending tail 194B can be disposed within
the hole. The suture 106 and/or longitudinally extending tail 194B
can be connected to the bone or tissue (e.g., mandible, thyroid
cartilage).
[0163] The implant 194 can be constructed from a material suitable
for expanding (e.g., super elastic metal or plastic). The implant
194 can be constrained in the collapsed configuration, having a
small diameter for delivery and/or insertion into the hole. The
implant 194 can be constrained by a sheath. The implant 194 is
allowed to expand once delivered and/or once the restraint is
removed. The expanded configuration has a larger diameter than the
collapsed configuration.
[0164] FIGS. 32A-32B illustrates a method of attaching an implant
to a hyoid bone. The method can include the step of drilling a
small hole in the hyoid bone (e.g., a through hole). The implant
195 can be passed through the hole. The implant 195 can have a
reduced diameter configuration in order to fit through the small
hole. The implant 195 can have a collapsed configuration and an
expanded configuration. The implant 195 can be passed through the
hole in the collapsed configuration. The implant 195 can be
expanded to the expanded configuration after passing through the
small hole. In the expanded configuration, the implant 195 cannot
pass through the hole. FIGS. 32A-32B illustrate an embodiment of
the implant 195. The implant 195 can include barbs 196. For
instance, the barbs 196 can have a generally J-shaped configuration
as shown in FIG. 32B. The J-shape prevents the implant 195 from
passing through the hole in the hyoid bone. The barbs 196 can be
formed from a material suitable for expanding (e.g., super elastic
metal or plastic). FIG. 32A shows the barbs 196 in the collapsed
configuration. The barbs 196 can be constrained by a sheath. The
barbs 196 can be constrained by the small hole. The implant 195 can
be coupled to a suture 106. FIG. 32B shows the barbs 196 in the
expanded configuration. The sheath has been removed. The barbs 196
can have a larger diameter preventing the barbs 196 from passing
back through the small hole.
[0165] FIG. 33A-33B illustrates a method of attaching an implant to
a hyoid bone. The method can include the step of drilling a small
hole in the hyoid bone (e.g., a through hole). The implant 197 can
be passed through the hole. The implant 197 can be reduced in
diameter in order to fit through the small hole. The implant 197
can have a collapsed configuration and an expanded configuration.
The implant 197 can be passed through the hole in the collapsed
configuration. The implant 197 can be expanded to the expanded
configuration after passing through the small hole. In the expanded
configuration, the implant 197 cannot pass through the hole. FIGS.
33A-33B illustrate an embodiment of the implant 197. The implant
197 can include a suture 198. The implant 197 can have a collapsed
configuration wherein the suture 198 extends along a longitudinal
axis. The implant 197 can have an expanded configuration wherein
the suture 198 forms a suture ball. FIG. 33A shows the implant 197
in the collapsed configuration. The suture 198 can be constrained
by a sheath. The suture 198 can be constrained by the small hole.
FIG. 33B shows the implant 197 in the expanded configuration. The
suture 198 can have a larger diameter preventing the implant 197
from passing back through the small hole. The implant 197 can be
coupled to suture 106. The implant 197 and/or the suture 106 may be
coupled to a bone or tissue (e.g., mandible).
[0166] FIGS. 34A-34F illustrate an embodiment of a suture passer
200. The suture passer 200 can include a first section 202. The
first section 202 can include a first handle 204. The first section
can include a first tip 206. The first section 202 can be coupled
to a second section 208. The first section 202 can be joined with,
for example, a pivot pin to the second section 208 akin to a
scissors tool. The second section 208 can include a second handle
210. The second section 208 can include a second tip 212.
[0167] The first tip 206 can form a jaw. The second tip 212 can
form a jaw. The jaw can be curved. The jaw can include serrations
or other features to improve grip to the bone or other tissue. The
curvature of the jaw can allow the first tip 206 to surround a
portion of a body structure, such as the hyoid bone. In some
embodiments, the first tip 206 surrounds approximately 180 degrees
of the hyoid bone. In some embodiments, the first tip 206 surrounds
greater than 180 degree of the hyoid bone, approximately 270
degrees of the hyoid bone, greater than 270 degrees of the hyoid
bone, etc. The curvature of the jaw can allow the second tip 212 to
surround a portion of the hyoid bone. In some embodiments, the
second tip 212 surrounds approximately 180 degrees of the hyoid
bone. In some embodiments, the second tip 212 surrounds greater
than 180 degree of the hyoid bone, approximately 270 degrees of the
hyoid bone, greater than 270 degrees of the hyoid bone, etc. The
first tip 206 and the second tip 212 can surround the entire hyoid
bone or a substantial portion thereof.
[0168] The assembly can include a plunger 216. The plunger 216 can
include a head 214. The head 214 can have an enlarged
cross-sectional area. The head 214 can guide the plunger 216. The
plunger 216 can be flexible and/or elastic. As shown in FIG. 34B,
the first section 202 can include a slot 218, either distal or
proximal to the pivot. The slot 218 can be sized to accept the
plunger 216. The slot 218 can be smaller than the diameter of the
head 214 to limit the head 214 from passing through the slot 218.
The slot 218 can be located on the opposite side of the pivot as
the first handle 204. The slot 218 can be tapered. The slot 218 can
extend from a surface 220 of the first section 202 to an interior
lumen 222 of the first section 202 as described herein.
[0169] The plunger 216 can include a suture engagement mechanism.
The suture engagement mechanism can be similar to the suture
engagement mechanisms described herein for example with references
to FIGS. 4A-4D. The suture engagement mechanism can include slots,
holes, notches or lumens to engage the suture 106. The plunger 216
can engage the suture 106 to pass the suture 106.
[0170] As shown in FIG. 34C, the second tip 212 can include an
interior lumen 224. The interior lumen 224 can be sized to accept
the plunger 216. In some embodiments, the second section 208 can
include a slot (not shown). The slot on the second section 208 can
be substantially similar to slot 218. The slot can be located on
the opposite side of the pivot as the second handle 210. The slot
on the second section 208 can be tapered. The slot on the second
section 208 can extend from a surface of the second section 208 to
the interior lumen 224 of the second section 202.
[0171] The interior lumen 222 of the first section 202 and the
interior lumen 224 of the second section 202 can be aligned when
the first tip 206 and the second tip 212 are brought together as
shown in FIG. 34B. The interior lumens 222, 224 can form a
continuous channel for the plunger 216 between the proximal slot
opening on a sidewall and the distal-facing tip opening. The
interior lumen 222 of the first section 202 is open at the first
tip 206. The interior lumen 224 of the second section 208 is open
at the second tip 212. This allows the plunger 216 to pass between
the first section 202 and the second section 208.
[0172] As shown in FIG. 34D, the suture passer 200 is advanced
toward the hyoid bone. The suture passer 200 can be passed through
a submental incision. The first tip 206 can be pivoted to surround
the hyoid bone. The second tip 212 can be pivoted to surround the
hyoid bone. The first tip 206 and the second tip 212 can be pivoted
separately or simultaneously. The first tip 206 can be pivoted by
actuating the handle 204. The second tip 212 can be actuated by
pivoting the handle 210. The tips 206, 212 are brought toward each
other. In some embodiments, the tips 206, 212 touch. In some
embodiments, the tips 206, 212 are in close proximity. In some
embodiments, a small gap is formed between the first tip 206 and
the second tip 212. The interior lumen 222 of the first section 202
and the interior lumen 224 of the second section 208 are aligned
when the tips 206, 212 are brought together. In some methods, the
action of closing the tips 206, 212 stabilizes the suture passer
200 against the hyoid bone.
[0173] FIG. 34E shows that the plunger 216 can enter the slot 218
of the first section 202. The plunger 216 can be guided by the head
214. The plunger 216 can enter the interior lumen 222 of the first
section 202. The plunger 216 can be advanced toward the interior
lumen 224 of the second section 208. The plunger 216 can enter the
interior lumen 224 of the second section 208. In some methods, the
plunger 216 can exit the slot in the second section 208 (not
shown). The head 214 can abut the surface 220 when the plunger 216
reaches the slot in the second section 208. The enlarged
cross-section of the head 214 can prevent the head 214 from
entering the slot 218. In other techniques, the plunger 216 enters
the slot in the second section 208 and exits the slot 218 of the
first section 202.
[0174] FIG. 34F show a cross-sectional view of the first section
202. The slot 218 can be tapered in some embodiments. The interior
lumen 222 can align with the interior lumen 224. The interior
lumens 222, 224 can be sized to accept the plunger 216. The plunger
216 can be advanced until it protrudes from the interior lumen 222.
The plunger 216 can span the gap between the first tip 206 and the
second tip 212. In other embodiments, the plunger 216 extends from
the interior lumen 222 directly into the interior lumen 224. The
plunger 216 can include a sharpened tip 228 to penetrate any tissue
within the gap. The plunger 216 can bridge any potential gap
between the first tip 206 and the second tip 212.
[0175] In some techniques, the second tip 212 can engage the suture
106 carried by the plunger 216. The second tip 212 can include a
snare or other feature to engage the suture 106. The second tip 212
can unload the suture 106 from the plunger 216 as the plunger 216
is retracted. In some techniques, the plunger 216 is retracted with
the first tip 206.
[0176] In some techniques, the second tip 212 engages the suture
106. The plunger 216 could include a snare or other feature to
engage the suture 106. The plunger 216 can be advanced through the
first tip 202 toward the suture 106. The plunger 216 would engage
the suture 106 from the second tip 212. The plunger 216 can engage
the suture 106 as the plunger 216 enters the interior lumen 224 of
the second tip 212. The plunger 216 can be retracted to pull the
suture 106 through the first tip 206.
[0177] It is contemplated that various combinations or
subcombinations of the specific features and aspects of the
embodiments disclosed above may be made and still fall within one
or more of the inventions. Further, the disclosure herein of any
particular feature, aspect, method, property, characteristic,
quality, attribute, element, or the like in connection with an
embodiment can be used in all other embodiments set forth herein.
Accordingly, it should be understood that various features and
aspects of the disclosed embodiments can be combined with or
substituted for one another in order to form varying modes of the
disclosed inventions. Thus, it is intended that the scope of the
present inventions herein disclosed should not be limited by the
particular disclosed embodiments described above. Moreover, while
the invention is susceptible to various modifications, and
alternative forms, specific examples thereof have been shown in the
drawings and are herein described in detail. It should be
understood, however, that the invention is not to be limited to the
particular forms or methods disclosed, but to the contrary, the
invention is to cover all modifications, equivalents, and
alternatives falling within the spirit and scope of the various
embodiments described and the appended claims. Any methods
disclosed herein need not be performed in the order recited. The
methods disclosed herein include certain actions taken by a
practitioner; however, they can also include any third-party
instruction of those actions, either expressly or by implication.
For example, actions such as "passing a suture to suspend the hyoid
bone" include "instructing the passing of a suture to suspend the
hyoid bone." The ranges disclosed herein also encompass any and all
overlap, sub-ranges, and combinations thereof. Language such as "up
to," "at least," "greater than," "less than," "between," and the
like includes the number recited. Numbers preceded by a term such
as "approximately", "about", and "substantially" as used herein
include the recited numbers (e.g., about 10%=10%), and also
represent an amount close to the stated amount that still performs
a desired function or achieves a desired result. For example, the
terms "approximately", "about", and "substantially" may refer to an
amount that is within less than 10% of, within less than 5% of,
within less than 1% of, within less than 0.1% of, and within less
than 0.01% of the stated amount.
* * * * *