U.S. patent application number 14/174709 was filed with the patent office on 2014-06-05 for devices and methods for treating pain associated with tonsillectomies.
This patent application is currently assigned to INTERSECT ENT, INC.. The applicant listed for this patent is INTERSECT ENT, INC.. Invention is credited to Anthony J. ABBATE, Lisa EARNHARDT, David C. GALE, Jerome E. HESTER, Bin HUANG, Richard E. KAUFMAN, Vijaykumar RAJASEKHAR, Gail M. ZALER.
Application Number | 20140154236 14/174709 |
Document ID | / |
Family ID | 43032522 |
Filed Date | 2014-06-05 |
United States Patent
Application |
20140154236 |
Kind Code |
A1 |
HESTER; Jerome E. ; et
al. |
June 5, 2014 |
DEVICES AND METHODS FOR TREATING PAIN ASSOCIATED WITH
TONSILLECTOMIES
Abstract
Described here are devices and methods for treating one or more
conditions or symptoms associated with a tonsil procedure. In some
variations, a drug-releasing device may be at least partially
delivered to one or more tonsillar tissues before, during, or after
a tonsil procedure. In some variations, the drug-releasing device
may be configured to be biodegradable. In other variations, the
drug-releasing device may comprise one or more hemostatic materials
or one or more adhesives. The drug-releasing device may be
configured to release one or more drugs or agents, such as, for
example, one or more analgesics, local anesthetics,
vasoconstrictors, antibiotics, combinations thereof and the
like.
Inventors: |
HESTER; Jerome E.; (Menlo
Park, CA) ; ABBATE; Anthony J.; (Santa Clara, CA)
; KAUFMAN; Richard E.; (Los Gatos, CA) ; GALE;
David C.; (Kennesaw, GA) ; ZALER; Gail M.;
(Milpitas, CA) ; HUANG; Bin; (Pleasanton, CA)
; EARNHARDT; Lisa; (Menlo Park, CA) ; RAJASEKHAR;
Vijaykumar; (Apple Valley, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
INTERSECT ENT, INC. |
Menlo Park |
CA |
US |
|
|
Assignee: |
INTERSECT ENT, INC.
Menlo Park
CA
|
Family ID: |
43032522 |
Appl. No.: |
14/174709 |
Filed: |
February 6, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12768628 |
Apr 27, 2010 |
8663192 |
|
|
14174709 |
|
|
|
|
61173093 |
Apr 27, 2009 |
|
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Current U.S.
Class: |
424/94.64 ;
514/165; 514/3.1; 514/304; 604/93.01; 606/228 |
Current CPC
Class: |
A61B 2017/00893
20130101; A61B 2017/0647 20130101; A61B 17/04 20130101; A61L 31/16
20130101; A61B 17/3468 20130101; A61B 17/06166 20130101; A61B
2017/0073 20130101; A61B 17/08 20130101; A61B 2090/3991 20160201;
A61L 17/10 20130101; A61B 2017/06176 20130101; A61B 17/083
20130101; A61M 37/0069 20130101; A61B 17/0644 20130101; A61B
2017/0641 20130101; A61M 31/002 20130101; A61B 17/064 20130101;
A61B 17/26 20130101; A61B 17/068 20130101; A61B 2017/0649 20130101;
A61M 31/00 20130101; A61B 2090/3987 20160201 |
Class at
Publication: |
424/94.64 ;
604/93.01; 606/228; 514/304; 514/165; 514/3.1 |
International
Class: |
A61L 31/16 20060101
A61L031/16; A61L 17/10 20060101 A61L017/10; A61B 17/08 20060101
A61B017/08; A61M 31/00 20060101 A61M031/00; A61B 17/04 20060101
A61B017/04 |
Claims
1. A method for treating a patient comprising: performing a tonsil
procedure; and at least partially delivering at least one
drug-releasing implant to tonsillar tissue of the patient.
2. The method of claim 1 wherein the at least one drug-releasing
implant comprises at least one polymer filament.
3. The method of claim 2 wherein the at least one polymer filament
comprises one or more anchoring features that impair removal of the
at least one polymer filament from the tonsillar tissue.
4. The method of claim 3 wherein the anchoring features comprises
one or more notches in a surface of the at least one polymer
filament.
5. The method of claim 3 wherein the anchoring feature comprises
one or more barbs or prongs.
6. The method of claim 1 wherein the at least one drug-releasing
implant comprises a suture.
7. The method of claim 1 wherein the at least one drug-releasing
implant comprises a plurality of space-filling implants.
8. The method of claim 7 wherein the plurality of space-filling
implants comprise one or more fibrin glue components.
9. The method of claim 1 further comprising covering at least a
portion of the tonsillar tissue with one or more films, sheets,
meshes, or patches.
10. The method claim 1 wherein the one or more drug-releasing
implant comprises a clip, and wherein the clip comprises a surface
member and at least one anchoring member.
11. The method of claim 1 further comprising affixing a
tissue-restraining device to the tonsillar tissue.
12. The method of claim 1 wherein the at least one drug-releasing
implant is configured to release an anti-inflammatory.
13. The method of claim 1 wherein the at least one drug-releasing
implant is configured to release an antibiotic.
14. The method of claim 1 wherein the at least one drug-releasing
implant is configured to release a painkiller or local
anesthetic.
15. The method of claim 1 wherein the at least one drug-releasing
implant is biodegradable.
16. The method of claim 1 wherein the at least one drug-releasing
implant comprises a polymer.
17. The method of claim 1 wherein the tonsil procedure is a
tonsillectomy or an adenoidectomy.
18. The method of claim 17 wherein the tonsillar tissue comprises a
tonsillar bed.
19. The method of claim 1 wherein the at least one drug-releasing
implant comprises an adhesive.
20. The method of claim 19 wherein the adhesive is a fibrin glue.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 12/768,628, filed on Apr. 27, 2010 and titled
"DEVICES AND METHODS FOR TREATING PAIN ASSOCIATED WITH
TONSILLECTOMIES", which claims priority to U.S. Provisional Patent
Application Ser. No. 61/173,093, filed on Apr. 27, 2009 and titled
"DEVICES AND METHODS FOR TREATING PAIN ASSOCIATED WITH
TONSILLECTOMIES," the contents of each of which are incorporated by
reference herein in their entirety.
FIELD
[0002] The present invention relates generally to devices and
methods for the treatment of one or more tonsils, adenoids, and/or
surrounding tissue.
BACKGROUND
[0003] One of the oldest known surgical procedures, a tonsillectomy
is an operation during which one or more portions of the palatine
tonsils ("tonsils") are removed. An adenoidectomy is a procedure
during which one or more portions of the pharyngeal tonsils
("adenoids") are removed. Tonsillectomies and adenoidectomies are
usually performed to alleviate one or more symptoms that may be
associated with infected or enlarged tonsils or adenoids, such as
chronic sore throats, recurring strep throat, abscesses, upper
airway obstructions, ear infections, bad breath, and sleep apnea.
Tissue may be removed in one of many ways, such as cold dissection,
electrocautery removal, laser removal, coblation, microdebriding,
radiofrequency ablation, and harmonic scalpel dissection.
[0004] Tonsillectomies and adenoidectomies are very common, with
over 800,000 procedures being performed each year in the United
States. Despite the frequency of these procedures, as well as the
varied means by which they are performed, tonsillectomies and
adenoidectomies are still associated with a great deal of
post-operative pain and discomfort. More specifically, there is
usually a seven- to ten-day recovery period during which a patient
may experience pain, discomfort, dehydration and weight loss.
Additionally, there is an approximately 1-7% rate of post-operative
hemorrhaging, as well as a risk of infection.
[0005] Little has been done to successfully reduce the pain or
discomfort following a tonsillectomy or adenoidectomy. Generally, a
physician will prescribe antibiotics and narcotics (e.g.,
acetaminophen, codeine) for post-operative pain. Oral
administration of such antibiotics and narcotics may be
undesirable, as swallowing may be extremely painful for a patient.
Additionally, the amount of narcotic ingested may yield other
undesirable side effects, such as drowsiness, dizziness,
light-headedness, or other complications that result from the
exposure of the entire body to the effects of the narcotic. Other
post-operative treatment methods, including topical, intravenous,
intralesional and oral administration of narcotics, non-steroidal
ant-inflammatory drugs (NSAIDS), steroids, and/or local anesthetics
have been minimally effective at reducing pain or discomfort. As
such, it would be desirable to provide a more effective way of
reducing pain or discomfort following a tonsil procedure (e.g., a
tonsillectomy, adenoidectomy, or the like).
BRIEF SUMMARY
[0006] Described here are devices and methods for treating the
tonsils, adenoids, and/or surrounding tissue. Generally, one or
more devices are attached to or implanted in or around tissue, and
may be configured to release one or more drugs to the tonsil or
adenoids. In some variations, the devices are used to treat an
inflamed or enlarged tonsil or adenoids. In other variations, the
devices are used to aid in post-operative recovery following a
tonsillectomy or adenoidectomy (e.g., by locally delivering one or
more drugs, by covering or manipulating exposed tissue, etc.).
[0007] In some variations, one or more sutures or suture-like
materials may be at least partially implanted in tonsillar tissue.
In some of these variations, the one or more sutures are configured
to release one or more drugs to the tonsils. In other variations,
the suture is configured to self-anchor within tissue (e.g., the
suture may comprise one or more unidirectional elements that allow
suture to be pulled through tissue in a first direction, but resist
movement in an opposite direction). In still other variations, the
suture is biodegradable.
[0008] In other variations, one or more tissue-piercing devices may
implanted into, around, or adjacent to tonsillar tissue. Generally
the tissue-piercing devices are designed to pierce, puncture, or
otherwise penetrate tissue. In some of these variations, the
tissue-piercing devices comprise one or more filaments, spikes, or
staples. In some variations, the tissue-piercing devices are
configured to resist removal from tissue. In some of these
variations, the tissue-piercing devices comprise one or more barbs,
prongs, notches, threading, or a combination thereof.
[0009] In still other variations, one or more clips may be attached
to tonsillar tissue. Generally the clips may comprise a surface
member and one or more anchoring members. In some of these
variations, the surface member and anchoring members may be formed
from a single piece of material. In other variations, one or more
sutures or tissue-piercing devices may be used to attach the
surface member to tissue.
[0010] In other variations, one or more tissue-restraining devices
may be applied to tonsillar tissue. In some of these variations,
the tissue-restraining device may be configured to stretch an area
of tissue. In other variations, the tissue-restraining device may
be configured to help prevent movement of one or more tissues. The
tissue-restraining device may comprise a body member, and may
additionally comprise one or more anchors. Anchors may be used to
attach the tissue-restraining device to tissue, and may have any
suitable configuration of elements, as described in more detail
below.
[0011] In some variations, a plurality of space-filling implants
may be used to fill one or more spaces within tonsillar tissue. The
space-filling implants may comprise one or more beads, pellets,
seeds, capsules, or a combination thereof. The space-filling
implants may self-assemble to conform to the shape of one or more
spaces within tonsillar tissue. In some variations, one or more
space-filling implants may be configured to burst upon application
of one or more forces or stimuli thereto.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIGS. 1A-1C are illustrations of the tonsils, adenoids, and
their surrounding anatomy.
[0013] FIGS. 2A-2K depict illustrative variations of
tissue-piercing devices.
[0014] FIG. 3 depicts a variation of a filament comprising
notches.
[0015] FIGS. 4A-4D show illustrative variations of tissue-piercing
devices that are configured to anchor in tissue.
[0016] FIG. 5 depicts a variation of a tissue-piercing device
comprising a staple.
[0017] FIGS. 6A, 6B, 7A, 7B and 8 illustrate different variations
of the devices described here, where the device comprises a
staple.
[0018] FIGS. 9A and 9B illustrate a perspective view and a side
view, respectively, of one variation of a device comprising a
clip.
[0019] FIGS. 10A, 10B, 11A, 11B and 12 are illustrative depictions
of variations of devices comprising a clip.
[0020] FIGS. 13A-13D, 14, 15, 16A, 16B, 17, 18A and 18B are
illustrative depictions of variations of devices that are
configured to stretch or restrain tissue.
[0021] FIGS. 19A, 19B and 20 are illustrative depictions of
variations of devices described here, where the device comprises a
plurality of space-filling implants.
[0022] FIGS. 21A and 21B are illustrative depictions of suitable
holders for use with the devices described here.
[0023] FIGS. 22A and 22B are illustrative depictions of suitable
variations of delivery devices for use with the devices described
here.
[0024] FIGS. 23A-23C and 24A-24C depict illustrative methods of
delivering tissue-piercing devices to tissue.
[0025] FIGS. 25A-25D illustrate depictions of a variation of a
device that is configured to hold or restrain tissue.
[0026] FIGS. 26A and 26B illustrate a variation of a device
comprising a patch.
DETAILED DESCRIPTION
[0027] The palatine tonsils ("tonsils") and pharyngeal tonsils
("adenoids") are masses of lymphoid tissues that help protect the
body against infection. FIGS. 1A-1C illustrate the tonsils and
adenoids, as well as their surrounding anatomy. The tonsils are
located in the throat, and can be seen through the mouth, as
illustrated in FIG. 1A. Shown there are palatine tonsils (100), the
palatopharyngeal arch (102), and the palatoglossal arch (104). The
palatopharyngeal arch (102) comprises mucosa overlaying the
palatopharyngeus muscle, while the palatoglossal arch (104)
comprises mucosa overlaying the palatoglossus muscle. The
palatoglossus and palatopharyngeus muscles, together with the
superior constrictor muscle, make up the tonsillar fossa. FIG. 1B
shows a perspective view of the tonsillar fossa. Shown there is
superior constrictor muscle (106), palatoglossus muscle (108), and
palatopharyngeus muscle (110). Also shown there is glossopharyngeal
nerve (112), which sits in the outer wall of the pharynx (not
shown) beneath the superior constrictor muscle (106). Generally,
the glossopharyngeal nerve (112) is a cranial nerve that innervates
the tonsils and a portion of the tongue.
[0028] The tonsillar fossa forms a "tonsillar bed" for the tonsils,
and the tonsils are connected thereto. Specifically, the tonsils
lay on the superior constrictor muscle (106), and are bounded
posteriorly by the palatopharyngeus muscle (110) and anteriorly by
the palatoglossus muscle (108). During a tonsillectomy, a surgeon
separates at least a portion of the tonsils from the muscles of the
tonsillar fossa while attempting to minimize damage done to the
tonsillar fossa. If the tonsillar bed is punctured during a
tonsillectomy, the glossopharyngeal nerve may be injured. Once the
tonsils are removed, one or more portions of the mucosa of the
palatopharyngeal or palatoglossal arch ("mucosal flaps") may be
pulled over the exposed tissue and sutured into place, thereby
sealing off the operation site.
[0029] The adenoids, on the other hand, are located behind the
nasal passages in the nasopharynx. FIG. 1C shows a sagittal
cross-section of a portion of the head and throat. Shown there is
nasopharynx (114) housing adenoid (116). Also shown there are the
palatopharyngeal (118) and palatoglossal (120) arches descending
from soft palate (122) and surrounding tonsil (124).
Adenoidectomies are similar to tonsillectomies in that the adenoids
are separated from surrounding tissue and removed through the
mouth.
[0030] Generally described here are devices and methods for
treating one or more areas of tonsillar tissue. When reference is
made to the term "tonsillar tissue" herein, it should be understood
that such tonsillar tissue can include, without limitation, any
portions of the palatine tonsils, adenoids, lingual tonsils, tubal
tonsils, tonsillar fossa (e.g., palatopharyngeal arch,
palatoglossal arch, superior constrictor muscle), or other
surrounding tissue (e.g., muscles, fascia, connective tissue). In
some instances, the devices described here may be used to treat one
or more inflamed or infected tonsils. In other instances, the
devices and methods may aid in recovery following a tonsil
procedure. When reference is made to the term "tonsil procedure"
herein, it should be understood that such tonsil procedures can
include, without limitation, any procedure such as tonsillectomies,
adenoidectomies, lingual tonsillectomies, other treatments for
sleep apnea, tonsillitis, or other tonsil conditions, and the like.
The devices and methods may help to minimize post-operative pain or
discomfort, may help prevent post-operative infection or
hemorrhaging, may shorten healing or recovery time, may do
combinations thereof, or the like.
[0031] Devices
[0032] Described here are devices for treating one or more portions
of tonsillar tissue. In some variations, the devices may be used to
treat tonsillar tissue during or following a tonsil procedure. The
devices may be configured to release one or more drugs or agents to
tonsillar tissue, but need not. The terms "drugs" or "agents" are
used interchangeably throughout, and it should be understood that
such drugs or agents may include, without limitation, any suitable
chemical substance or compound, whether active or inert.
Additionally, the devices may or may not be configured to
biodegrade, bioerode, or otherwise break down. In some variations,
one or more portions of the device may be configured to be
implanted into tissue. In some of these variations, one or more
portions of the device may be configured to puncture, pierce, or
otherwise penetrate tissue. In other variations, one or more
portions of the device may be configured to shield or cover one or
more areas of tonsillar tissue. In still other variations, the
devices may be configured to immobilize, stretch, compress,
tension, approximate or otherwise manipulate tissue or tissues.
[0033] The devices may have any suitable size, shape, or
configuration of elements. In some variations, one or more portions
of the device may be solid. In other variations, one or more
portions of the device may be semi-solid. The devices, or one or
more elements thereof, may include, but are not limited to, one or
more sutures, strands, threads, ribbons, filaments, fibers, rods,
tubes, spikes, staples, clips, gels, foams, emulsions, beads,
pellets, meshes, patches, sheets, films, combinations thereof, and
the like. These various devices and components will be described in
more detail below.
[0034] Any of the devices described here may be delivered to
tonsillar tissue in any suitable way. In some variations, at least
a portion of the device is implanted into tissue. In some of these
variations, the entire device may be implanted into tonsillar
tissue. In other variations, one or more portions of the device may
be implanted into tonsillar tissue. In some of these variations,
different portions of the device may be implanted in different
areas of tonsillar tissue. For example, in some variations one or
more portions of a device may be implanted in tissue of the
palatoglossal arch while another portion of the device may be
implanted in tissue of the palatopharyngeal arch. When a portion of
a device is implanted into tissue, that portion may be placed
inside of an opening or space inside of a tissue, beneath a tissue,
between tissues, or combinations thereof. When a device is placed
in an opening or space inside of tissue, this opening or space may
be naturally occurring or artificially formed. In other variations,
at least a portion of the device may be placed on, against, near or
adjacent tissue. In these variations, the portion of the device may
be held in place in any suitable manner. In some variations, one or
more portions of the device or separate components may be used to
anchor the device to tissue. In other variations, one or more
portions of the device adhere to tissue. In still other variations,
the surrounding tissue may be manipulated to surround or otherwise
engage the one or more portions of the device. For example, if a
mucosal flap is pulled and sealed to cover exposed tonsillar tissue
during a tonsillectomy, the mucosal flap may be used to cover at
least a portion of a device. In other instances, the palatoglossal
and palatopharyngeal arches may be brought and held closer
together, which may help to hold a portion of a device between the
arches.
[0035] Sutures
[0036] In some variations, one or more sutures or suture-like
materials (e.g., yarns, threads, cords, ribbons and the like,
collectively referred to as "sutures" herein) may be delivered to
tonsillar tissue. The sutures may or may not be configured to
deliver one or more drugs to the tonsillar tissue. When the suture
is configured to deliver one or more drugs, the suture may deliver
drug in any suitable manner, as will be described in more detail
below. Additionally, the suture may or may not be configured to
biodegrade, bioerode, or otherwise break down. The suture may
additionally include one or more features to aid in placement or
retention in tissue. For example, in some variations the suture may
be configured to self-anchor inside of tissue. More specifically,
the suture may comprise one or more unidirectional anchors, flaps,
barbs, or other elements that allow the suture to be pulled through
tissue in one direction, but resist movement in an opposite
direction. In this way, a suture may be threaded at least partially
through one or more areas of tonsillar tissue, but may resist being
pulled out of the tissue.
[0037] One or more sutures may be applied to tonsillar tissues in
any suitable manner. In some instances, one or more sutures may be
used to anchor or otherwise attach at least a portion of one or
more devices to tissue. In other instances, one or more sutures may
be used to join or attach two or more areas of tissue. For example,
in instances where the mucosal flaps are pulled over exposed
tonsillar tissue, one or more of the sutures described above may be
used to suture the mucosal flaps in place. In other instances, one
or more sutures may be used to approximate or otherwise reduce the
distance between the palatoglossal and palatopharyngeal arches.
This may help open the airway into the throat, and may further
assist in treating breathing disorders such as obstructive sleep
apnea. In still other instances, one or more sutures may be
stitched, advanced, or otherwise placed throughout one or more
regions of tonsillar tissue. In variations where the one or more
sutures are configured to release one or more drugs, placement in
or throughout one or more tissues allows the suture to provide
drugs to those regions of tonsillar tissue. To place a suture in a
region of tissue, the suture may be attached to a needle or other
structure, and the needle or other structure may be pulled through
a volume of tissue to introduce the suture thereto. In other
instances, the distal end of a cannula or tube (e.g., a hypotube)
may be advanced into a volume of tissue, and a length of suture can
be ejected from the cannula or tube into the tissue.
[0038] Tissue Piercing Devices
[0039] In some variations of the devices described here, the device
may be configured to pierce, puncture, or otherwise penetrate
tonsillar tissue. It should be noted, however, that although these
tissue-piercing devices may be configured to penetrate tissue, they
need not be used in practice to penetrate tissue. In some
instances, one or more tissue-piercing devices may be held against
an area of tissue by one or more patches, meshes, films or sheets,
such as those described below. When used to penetrate tissue, the
tissue-piercing device may penetrate tissue in order to facilitate
implantation in tonsillar tissue.
[0040] Each tissue-piercing device may have any suitable size,
shape, and configuration of elements. The tissue-piercing devices
may or may not be configured to release one or more drugs. When
configured to release one or more drugs, the tissue-piercing device
may release any suitable drug or drugs in any suitable manner, as
will be described in more detail below. Additionally, the
tissue-piercing device may or may not be configured to biodegrade,
bioerode, or otherwise break down, and may be made from any
suitable material or combination of materials, such as those
described below. The tissue-piercing device may be substantially
rigid, but need not be. Indeed, one or more portions of the
tissue-piercing device may be flexible. In some variations, the
tissue-piercing device may comprise one or more flexible portions
and one or more rigid portions.
[0041] FIGS. 2A-2K illustrate several suitable variations of
tissue-piercing devices. FIG. 2A illustrates one such variation of
tissue-piercing device (200) comprising filament (202). While shown
in FIG. 2A as being a filament (202), any suitable bar, fiber,
tube, or rod-like structure may be used. Tissue-piercing device
(200) may be inserted into tissue by pushing one end of
tissue-piercing device (200) against tissue. While shown in FIG. 2A
as having a circular cross-section, filament (202) may have any
suitable cross-sectional shape, such as, for example, an oval, a
triangle, a rectangle, a polygon, or a shape with irregular
geometry. Additionally, while shown in FIG. 2A as being straight,
filament (202) need not. Indeed, a filament (202) may have one or
more curves, bends, twists, or kinks. For example, FIG. 2B
illustrates a variation of tissue-piercing device (204) comprising
a curved filament (206). In these variations, the curved filament
(206) may have any suitable radius of curvature. Additionally, such
a curved configuration may reduce the depth to which
tissue-piercing device (204) may pierce. For example, when a
tissue-piercing device (204) is placed in the tonsillar bed, it may
be desirable to limit the penetration depth to reduce the
likelihood that a tissue-piercing device (204) puncture or
otherwise damage one or more nerves (e.g. the glossopharyngeal
nerve) or blood vessels (e.g. the carotid artery).
[0042] FIG. 2C illustrates another variation of a tissue-piercing
device (208) comprising a filament (210) that is wound into a coil
having loops (212). In these variations, the coiled filament (210)
may comprise any number of loops (212), and each loop (212) may
have any suitable diameter. The coiled filament (210) may take on
any suitable overall shape. In some variations, the coiled filament
(210) may be wound into a generally cylindrical shape, such as
tissue-piercing device (208) shown in FIG. 2C. In other variations,
the coiled filament (210) may be wound into a generally conical or
frustoconical shape, or may be wound into an hourglass shape.
[0043] While the tissue-piercing devices shown in FIGS. 2A-2C have
constant cross-sectional areas, they need not. Indeed, the
cross-sectional area of a tissue-piercing device may vary through
one or more portions of the device. FIG. 2D shows one such
variation of tissue-piercing device (214) comprising a filament
(216) with a tapered end (218). Tapered end (218) may aid the
tissue-piercing device (214) in piercing, puncturing, or otherwise
penetrating tissue. In other variations, the cross-sectional area
of the tissue-piercing device may vary along its entire length.
FIGS. 2E and 2F show a side view and a perspective view,
respectively, of one such variation of tissue-piercing device
(220). Shown there is spike (222), in which the cross-sectional
area decreases from a proximal end (224) to its distal end (226).
The reduced cross-sectional area of the distal end (226) may aid
tissue-piercing device (220) in piercing, puncturing, or otherwise
penetrating tissue.
[0044] A tissue-piercing device may be solid, or may be at least
partially hollow. Indeed, a tissue-piercing device may comprise one
or more pores, cavities, channels, or other spaces within the
device's body. FIG. 2G shows a cross-sectional side view of one
such variation of tissue-piercing device (228) comprising a spike
(230) with cavity (232) therein. Tissue-piercing device (228) may
comprise any number of cavities (232), and each cavity (232) may
have any suitable size, shape, and positioning within the
tissue-piercing device (228). In variations where tissue-piercing
devices (228) comprise one or more cavities (232), one or more of
the cavities (232) may act as a reservoir for one or more
solutions, powders, solids, foams, gels, or a combination thereof,
which may or may not comprise one or more drugs.
[0045] In variations where the cavity (232) holds one or more drugs
or drug-containing materials, one or more drugs may diffuse or
otherwise migrate from cavity (232) through the body of the
tissue-piercing device (228). In variations where the
tissue-piercing device (228) is configured to biodegrade, bioerode,
or break down, degradation of the device (228) may expose one or
more portions of the cavity (232). Once exposed, one or more drugs
or materials may be released from the cavity (232). FIG. 2H
illustrates another variation of tissue-piercing device (234)
comprising spike (236) with cavity (238) and channels (240)
therein. In these variations, one or more channels (240) may pass
from cavity (238) through the body of spike (236). In some
instances, one or more drugs or materials held in cavity (238) may
exit tissue-piercing device (234) through one or more of the
channels (240). Tissue-piercing device (234) may comprise any
number of channels (240), and each channel (240) may have any
suitable size or cross-sectional shape. The number of channels
(240), the size and shape of each channel (240), and the nature of
the drug or material held within cavity (238) may determine the
rate at which the drug or material exits the tissue-piercing
device. For example, increasing the cross-sectional area of a
channel (240) may increase the rate at which a material can pass
therethrough.
[0046] The tissue-piercing device may additionally include one or
more elements that are configured to engage one or more surfaces.
For example, FIGS. 2I and 2J show a side view and a perspective
view, respectively, of tissue-piercing device (242) having spike
(244) and base member (246). When spike of (244) of tissue-piercing
device (242) is implanted in tonsillar tissue, base member (246)
may press against or engage one or more tissue surfaces (not
shown). Indeed, the base member (246) may act as a stop, thereby
serving to limit the depth that spike (244) is able to penetrate.
Limiting the depth of penetration may reduce the likelihood that
spike (244) may penetrate deep enough to damage one or more nerves
(e.g., the glossopharyngeal nerve) or blood vessels (e.g., the
carotid artery) when penetrating the tonsillar bed or surrounding
tissue. For example, in some variations the penetration may be less
than about 5 mm, less than about 4 mm, less than about 3 mm, less
than about 2 mm, or the like. In instances where tissue-piercing
device (242) is used to anchor one or more devices to tonsillar
tissue, as will be described in more detail below, the base member
(242) may engage one or more portions of the one or more devices to
hold the one or more devices against tissue.
[0047] A base member may be any structure suitable to engage a
tissue surface, and may have any suitable size or shape. While
shown in FIGS. 2I and 2J as being as a circular plate, the base
member may be a plate with any suitable shape. In some variations,
the base member may comprise a plate with an oval, triangular,
rectangular, polygonal, or irregular shape. In other variations,
the base member may not be a plate at all. Indeed, in some
variations the base member may comprise a sphere, hemisphere,
pyramid, box, cube, or a shape with irregular geometry.
Additionally, the base member may include one or more cavities or
spaces, such as those described above. FIG. 2K illustrates a
cross-sectional side view of one such variation of tissue-piercing
device (248). Shown there is spike (250) and spherical base member
(252), each comprising a cavity ((254) and (256) respectively).
Cavities (254) and (256) may be separate, or may be joined via one
or more pores or channels (not shown).
[0048] In some variations, the tissue piercing device may include
one or more features that may help keep the tissue-piercing device
implanted in tissue. In some variations, the overall shape of the
tissue-piercing device may help keep the tissue-piercing implanted
in tissue, such as the coiled filament (210) shown in FIG. 2C. FIG.
3 illustrates another variation of tissue-piercing device (300).
Shown there is filament (302) with notches (304). Notches (304) may
allow tissue-piercing device (300) to pass through tissue in one
direction, but may resist movement in an opposite direction.
Tissue-piercing device (300) may comprise any suitable number of
notches (e.g., zero, one, two, three, four, five, or six or more),
and each notch may have any suitable size and be at any suitable
location on tissue-piercing device (300). The amount that a
tissue-piercing device (300) will resist being pulled from tissue
may depend, in part, on the number of notches (304), as well as the
size of each notch (304). For example, increasing the number of
notches (304) may make it more difficult to remove a
tissue-piercing device from tissue after it is implanted. Notches
(304) may be formed in any suitable manner, such as, for example,
cutting or etching the surface of tissue-piercing device (300).
[0049] In other variations, a tissue-piercing device comprises one
or more barbs, prongs, or other protrusions that allow for
unidirectional movement of the tissue-piercing device through
tissue. FIG. 4A shows one such variation of tissue-piercing device
(400) comprising spike (402) which comprises a barb (404). While
shown in FIG. 4A as having only one barb (404), the tissue-piercing
device (400) may have any suitable number of barbs (e.g., zero,
one, two, three, or four or more). Indeed, FIG. 4B shows one such
variation of tissue-piercing device (406) comprising a filament
(408) having two barbs (410). FIG. 4C shows another variation of
tissue-piercing device (412) comprising angled prongs (414). In
still other variations, such as that shown in FIG. 4D,
tissue-piercing device (416) comprises threading (418). Threading
(418) may allow the tissue-piercing device (416) to be "screwed"
into tissue such that the threading (418) engages tissue. This
engagement between the threading (418) and tissue may help to
prevent the tissue-piercing device (416) from being pulled out of
the tissue.
[0050] In some variations, the tissue-piercing device may comprise
one or more staples. A staple may be any size or shape, depending
on its intended use. FIG. 5 illustrates a suitable variation of
tissue-piercing device (500). Shown there is staple (502)
comprising base (504) and legs (506). Base (504) and legs (506) may
be formed from a single piece of material, or may be joined from
multiple separate pieces. Additionally, one or more portions of the
staple (502) (e.g., the base or portions thereof, the legs or
portions thereof, etc.) may be rigid, while one or more other
portions of the staple (502) may be flexible.
[0051] Generally, legs (506) may be configured to puncture
tonsillar tissue. In some variations, one or more legs (506) may
comprise one or more barbs, prongs, notches, or other structures
that help to hold legs (506) in place once implanted in tissue.
Additionally, while shown in FIG. 5 as being straight, legs (506)
need not be. Indeed, one or more legs (506) may be curved. In some
of these variations, one or more legs (506) may be curved inwardly.
FIGS. 6A and 6B illustrate one such variation of tissue-piercing
device (600) comprising staple (602) having base (604) and
inwardly-curved legs (606). To implant staple (602) in tissue, base
(604) may be flexed and the ends of legs (606) may be placed
adjacent tonsillar tissue (608), as shown in FIG. 6A. The base
(604) may then be unflexed, which may in turn drive legs (606) into
tonsillar tissue (608), as shown in FIG. 6B. Once implanted into
tissue (608), the curved legs (606) may help to prevent staple
(602) from being pulled out of tissue (608). Additionally, curved
legs (606) may reduce the overall depth of penetration of staple
(602), which may reduce the chance of staple (602) damaging one or
more sensitive structures, such as the glossopharyngeal nerve.
Similarly, FIGS. 7A and 7B illustrate another variation of
tissue-piercing device (700) comprising a staple (702) with base
(704) and outwardly-curved legs (706). To implant staple (702) into
tissue (708), base may be flexed and the ends of legs (706) may be
placed adjacent tissue (708), as shown in FIG. 7A. The base (704)
may then be unflexed, which may in turn drive legs (706) into
tissue (708), as shown in FIG. 7B.
[0052] While shown in FIGS. 5, 6A, 6B, 7A and 7B as having two
legs, a staple may have any suitable number of legs (e.g., two,
three, four, or five or more). For example, FIG. 8 shows one
variation of tissue-piercing device (800) comprising staple (802)
having three legs (804). While all three legs (804) are shown in
FIG. 8 as being inwardly curved, each leg (804) may be straight,
outwardly curved, or have some alternate configuration. Each leg
(804) may have the same configuration, or may have different
configurations.
[0053] Clips
[0054] Some variations of the devices described here may comprise
one or more clips. Generally, each clip comprises a surface member
and one or more anchoring members, and is configured to attach to
tonsillar tissue by at least partially implanting one or more
anchoring members into tissue. This may be achieved by pushing a
clip against tonsillar tissue such that the anchoring members are
driven into tissue. In some variations, one or more portions of the
clip may be configured to release one or more drugs. When the clip
is configured to release one or more drugs, it may do so in any
suitable manner, such as those described in more detail below.
Additionally, the clip may or may not be configured to biodegrade,
bioerode, or otherwise break down.
[0055] FIGS. 9A and 9B show a perspective view and a side view,
respectively, of one such variation of clip (900). Shown there is
surface member (902) and anchoring members (904). Surface member
(902) is generally configured to remain at or above a tonsillar
tissue surface while anchoring members (904) may pierce, puncture
or otherwise penetrate tonsillar tissue to attach clip (900)
thereto. Surface member (902) may shield otherwise exposed
tonsillar tissue against stimuli, forces, or materials that may
otherwise come into contact with the tonsillar tissue. While shown
in FIGS. 9A and 9B as being a circular plate, surface member (902)
may be any suitable size or shape. In some variations, surface
member (902) may be oval, squared, rectangular, triangular,
polygonal, or may have an irregular shape. Additionally, while
shown in FIGS. 9A and 9B as being flat, surface member (902) need
not be. Indeed, surface member (902) may comprise one or more
ridges, waves, bumps, uneven surfaces, or the like. Surface member
(902) may be rigid, or may be flexible. In some variations, surface
member (902) may have one or more rigid portions and one or more
flexible portions.
[0056] Anchoring members (904) may have any suitable size, shape,
and configuration of elements. As shown in FIGS. 9A and 9B,
anchoring elements (904) may comprise struts (906) with barbs
(908). Similarly, anchoring member (904) may comprise any suitable
structure, including, but not limited to, struts, barbs, spikes,
hooks, curved legs, combinations thereof and the like. FIGS. 10A
and 10B show a top perspective view and bottom perspective view,
respectively, of one such variation of clip (1000). Shown there is
surface member (1002) and anchoring members (1004) comprising
v-shaped barbs (1006). Also shown there is reinforcement member
(1008), which may be any suitable structure (e.g., a bar, rod,
plate, etc.) capable of providing structural reinforcement to at
least a portion of surface member (1002). FIG. 11A illustrates
another such variation of clip (1100). Shown there is surface
member (1102) and anchoring members (1104) comprising curved legs
(1106). Curved legs may help anchor clip (1100) to tissue while
reducing the depth at which the anchoring member (1104) penetrate.
While shown in FIG. 11A as being curved outward, curved legs (1106)
may also be curved inward. Additionally, a clip may have a
combination of the anchoring devices described here. FIG. 11B
illustrates one such variation of clip (1108) comprising surface
member (1110), curved legs (1112) and barbed strut (1114).
[0057] The surface member and anchor members may be made of a
single piece of material, but need not be. Indeed, in some
variations one or more sutures or tissue-piercing devices described
above may be used to anchor a surface member to tissue. In some of
these variations, the suture (or a needle attached thereto) or
tissue-piercing device may be used to puncture one or more portions
of the surface member. In other variations, the surface member may
comprise one or more apertures through which a suture or
tissue-piercing device may pass to anchor the surface member to
tonsillar tissue. FIG. 12 shows one such variation of clip (1200).
Shown there is surface member (1202) comprising apertures (1204).
Also shown there is staple (1206) with legs (1208) passing through
two of the apertures (1204).
[0058] Tissue-Restricting Devices
[0059] In some variations of the devices described here, the
devices may be configured to stretch, immobilize, tension,
reposition, or otherwise resist changes in tonsillar tissue. FIGS.
13A-13D illustrate one such device (1300). Shown in FIG. 13A is a
perspective view of device (1300) comprising body member (1302) and
anchors (1304). FIG. 13C shows a side view of device (1300)
implanted in tonsillar tissue (1306), such that anchors (1304) at
least partially penetrate the tonsillar tissue (1306) at
penetration sites (1308). FIG. 13D shows a perspective view of
device (1300) implanted between the palatoglossal (1314) and
palatopharyngeal (1316) arches.
[0060] Once implanted into an area of tonsillar tissue (1306),
device (1300) may act to restrict movement of that tissue.
Generally, body member (1302) is made of a material that is capable
of flexing or bending from an original shape when subjected to one
or more forces or stimuli, but has a tendency to return to its
original shape when the force or stimuli is removed. The original
shape of the body member (1302) may be flat, or may comprise one or
more curves or bends. Certain actions (i.e. swallowing) may cause
tonsillar tissue to move, shift, or otherwise reconfigure, which
under certain circumstances (e.g., following a tonsillectomy) may
cause pain or discomfort. This movement may cause tonsillar tissue
(1306) between penetration sites (1308) move toward each other, as
indicated by arrows (1310) in FIG. 13C, which may in turn cause
body member (1302) to bend or flex. The body member's (1302)
tendency to return to its original shape may resist this bending or
flexing. This resistance may in turn cause the device (1300) to
provide one or more forces (1312) to the tonsillar tissue (1306) at
penetration sites (1308). These forces (1312) may help to keep the
tonsillar tissue (1306) stretched, and may prevent the tonsillar
tissue (1306) from otherwise moving. This, in turn, may help to
minimize pain or discomfort experienced by a patient.
[0061] Additionally, the tendency of body member (1302) to return
to its original shape may help to keep device (1300) implanted in
tonsillar tissue (1306). Before the anchors (1304) of device (1300)
are inserted into tonsillar tissue (1306), the body member (1302)
may be slightly flexed or bent, as shown in FIG. 13B. The anchors
(1304) may then be inserted into tissue (1306), and the tendency of
body member (1302) to return to its original shape may bias anchors
(1304) into the tonsillar tissue (1306). This may cause the device
to continually apply one or more forces to tissue, which may
thereby hold the tonsillar tissue (1306) in a stretched
configuration.
[0062] While shown in FIGS. 13A-13D as being rectangular in shape,
body member (1302) may have any suitable dimensions or shape. For
example, FIG. 14 shows one such variation of device (1400)
comprising a square-shaped body member (1402) and anchors (1404).
Other suitable body member shapes include, but are not limited to,
circles, ovals, triangles, polygons, shapes with irregular
geometry, and the like. While shown in both FIGS. 13A-13C as having
anchors (1304), device (1300) need not. In variations that do
include anchors (1304), device (1300) may comprise any number of
anchors (e.g., one, two, three, four, five, six, or seven or more).
Each anchor (1304) may have any suitable size, shape, or
dimensions. In some variations, such as that shown in FIGS.
13A-13C, an anchor may comprise a single spear. In other
variations, such as that shown in FIG. 14, an anchor may comprise
two or more spears. In still other variations, an anchor may
comprise one or more barbs, spears, thorns, hooks, or other
structures capable of affixing a body member to tissue.
[0063] In variations that do not include an anchor, the body member
may be connected to tonsillar tissue in any suitable way. FIG. 15
shows one such variation of device (1500), comprising body member
(1502) and strips (1504). Generally, strips (1504) are attached to
tissue to anchor device (1500) against tonsillar tissue (not
shown). This can be done in any suitable manner. In some
variations, one or more strips (1504) may be sutured into or
against tissue. In other variations, one or more strips (1504) may
comprise one or more adhesives that connect the strips (1504) to
tissue. In still other variations, one or more of the
tissue-piercing devices described above may be inserted at least
partially through one or more strips (1504) to anchor the strips to
tissue. Each strip (1504) may be made from any suitable material,
such as, for example, a woven or non-woven mesh.
[0064] FIGS. 16A and 16B illustrate another suitable variation of
device (1600) comprising body member (1602). FIG. 16A shows a
perspective view of body member (1602), including one or more
apertures (1604). Apertures (1604) may be configured such that at
least a portion of one or more anchoring devices (1606) may pass
therethrough to hold the ends (1608) of body member (1602) against
tonsillar tissue (1610), as shown in a side view in FIG. 16B. The
anchoring devices (1606) may be any suitable structure, such as,
for example, one or more of the tissue-piercing devices described
above. Body member (1602) may comprise any number of apertures
(1604) (e.g., one, two, three, four, five, or six or more), but the
number of anchoring devices (1606) used need not match the number
of apertures (1604). In some instances, one or more apertures
(1604) may go unfilled, or an individual anchoring device (1606)
(e.g., a two-pronged staple) may pass through multiple apertures
(1604).
[0065] While the variations shown in FIGS. 13A-16B are configured
to apply force to tonsillar tissue in two directions, the body
members may be configured to apply force in any number of
directions. FIG. 17 illustrates one such variation of device (1700)
in which body member (1702) is configured to apply force to
tonsillar tissue (not shown) in three directions. As shown there,
body member (1702) comprises three arms (1704), each having an
anchor (1706). When implanted in tissue (not shown), each arm may
be capable of exerting one or more forces to tonsillar tissue.
While shown in FIG. 17 as all having anchors (1706), each arm may
be attached to tissue in any suitable manner described above.
Additionally, body member (1702) may have any suitable number of
arms (e.g., one, two, three, four, or five or more).
[0066] FIGS. 18A and 18B show another suitable variation of device
(1800). Shown there is body member (1802) comprising arms (1804),
anchors (1806), and flaps (1808). While shown there as having four
arms (1804), body member (1802) may have any suitable number of
arms, and each arm may be attached to tissue in any suitable
manner, as described in more detail above. Additionally, flaps
(1808) may span between adjacent arms (1804), and may act to cover
tissue. In this way, device (1800) may help to protect exposed
tonsillar tissue from contact with one or more materials that may
irritate the tissue or otherwise cause pain to a patient. Flaps
(1808) may be made from any suitable material, including, but not
limited to one or more meshes, films, or sheets.
[0067] In still other variations, one or more devices may be
configured to compress tissue or pull two or more areas of tissue
toward each other. For example, FIGS. 25A-25D illustrate one
variation of device (2500). FIGS. 25A and 25B illustrate top and
bottom perspective views respectively of device (2500) comprising
base portion (2502) and wings (2504). Device (2500) may be
configured such that it may hold tissue between wings (2504). For
example, device (2500) may be placed in the throat such that device
(2500) holds the palatoglossal (2506) and palatopharyngeal (2508)
arches between wings (2504), as shown in FIG. 25C. In these
variations device (2500) may act to bring or hold one or more
portions of the palatoglossal (2506) and palatopharyngeal (2508)
arches in closer approximation. In some variations, device (2500)
may further serve to hold one or more additional device (not shown)
between the arches.
[0068] Additionally, in some variations, device (2500) may comprise
one or more additional structures to help hold device (2500) in
place relative to tissue. For example, some variations wings (2504)
of device (2500) may comprise one or more barbs (2510), as
illustrated in FIG. 25D. These barbs may anchor into or otherwise
engage surrounding tissue to help hold device (2500) in place.
Although shown in FIG. 25D as comprising barbs (2510), device may
comprise any structure suitable for improving engagement between
device (2500) and tissue, such as, for example, hooks, spikes,
prongs, or the like.
[0069] Space-Filling Implants
[0070] In some variations, the devices comprise one or more
space-filling implants. These space-filling implants may be any
suitable structure, such as, for example, pellets, seeds, beads,
capsules, microspheres, microcapsules, combinations thereof or the
like. Generally, a plurality of these space-filling implants may be
used to at least partially fill one or more cavities, chambers, or
spaces inside of a tissue. For example, FIGS. 19A and 19B show a
plurality of beads (1900) placed into space (1902). When placed in
space (1902), as shown in FIG. 19A, the plurality of beads (1900)
may self-assemble to conform to the contours of space (1902). This
self-assembly allows the space-filling implants to fit within
spaces (1902) of varying sizes and shapes. Additionally, one or
more gels or foams, such as those described in more detail below,
may be used to fill in any gaps between space-filling implants.
[0071] Additionally, when one or more forces (1904) or other
stimuli cause the dimensions of space (1902) to change, the
plurality of beads (1900) may adjust to conform to this change, as
shown in FIG. 19B. In some variations, however, the space-filling
implants may resist changes to the space (1902) in which they are
placed. In some variations, the space-filling implants may adhere
to each other once implanted, such that the space-filling implants
are joined or otherwise attached together after their initial
self-assembly. This adherence may be achieved in any suitable
manner, such as, for example, covering the space-filling implants
with one or more adhesive coatings (e.g., coatings of fibrin glue,
cyanoacrylate glue, or the like), or providing one or more stimuli
(e.g., heat, light, etc.) that cause adjoining space-filling
implants to fuse together. Once two space-filling implants become
joined or attached, they may resist movement relative to each
other. Thus, when a force or stimulus would otherwise cause the
shape or size of space change, the attached space-filling implants
may resist this change.
[0072] While shown in FIGS. 19A and 19B as being an oval-shaped
bead (1900), each space-filling implant may have any suitable
shape. For example, an individual space-filling implant may be
spherical, box-shaped, conical, frustoconical, rod-like, pyramidal,
irregularly shaped, combinations thereof, or the like.
Additionally, one space-filling implant may or may not have the
same shape and dimensions as another space-filling implant. The
space-filling implants may or may not be configured to release one
or more drugs, as described in more detail below, and may or may
not be configured to biodegrade, bioerode, or otherwise break
down.
[0073] The space-filling implants described here may be placed in
any suitable space in or around tonsillar tissue, and may be
delivered via any suitable structure (e.g., a funnel, needle,
hypotube, cannula, or other tube-like structure). In some
instances, this space may be naturally occurring (e.g., a gap
between two tissues). In other instances, this space may be
artificially formed. For example, one or more channels or gaps may
be formed during a tonsil procedure. Alternatively, one or more
spaces may be created (e.g., by inserting a needle, trocar, or
other suitable device into tissue) for the purpose of receiving a
plurality of space-filling implants. In other variations, a
plurality of space-filling implants may at least partially fill one
or more cavities, chambers, or other spaces disposed inside of one
the other devices described above. In still other variations,
space-filling implants adhere to tissue, and are placed adjacent a
tissue surface. In yet other variations, one or more patches,
meshes, films, sheets, or the like may used to hold a plurality of
space-filling implants in place against tissue. FIG. 20 illustrates
one such variation in which space-filling beads (2000) are held in
place against tonsillar tissue (2002) by a patch (2004). Patch
(2004) may be attached or joined to tissue in any suitable manner,
such as those described below.
[0074] In some variations, one or more of space-filling implants
comprise a capsule or other structure that has one or more cavities
or spaces formed therein. In these variations, the space-filling
implant may burst or otherwise break when subjected to a certain
force or stimulus (e.g., heat, light, pH change, chemicals, etc.).
One or more solutions or substances (e.g., drug-containing
solutions, adhesives, etc.) may be placed in these structures, such
that the solution or substance is released when the space-filling
implant breaks. For example, one or more of the space-filling beads
(2000) shown in FIG. 20 may comprise a cavity (not shown) which
holds an anesthetic or painkiller therein. When one or more forces
or stimuli are applied to patch (2004), such as, for example,
compressive forces that may occur when swallowing food, these
forces or stimuli may cause one or more space-filling beads (2000)
to rupture. This may release an amount of anesthetic or painkiller,
which may reduce the sensation of pain in the tonsillar tissue.
[0075] In variations where one or more space-filling implants
comprise a capsule or other cavity-containing structure, these
space-filling implants may be configured to break or rupture at
different times. In some variations, devices with different
dimensions may rupture under different forces. For example, a
device with a thicker wall surrounding a cavity may require a
greater force to rupture than a device with a thinner wall
surrounding the cavity. In variations where the space-filling
implants are configured to biodegrade, bioerode, or otherwise break
down, the space-filling implants may become more susceptible to
rupturing over time. As such, by providing space-filling implants
with different degradation times, some space-filling implants may
rupture at earlier times than others. Overall, the space-filling
implants may be configured to break or rupture at different times
over the span of a treatment regimen.
[0076] In other variations, the space-filing implants may comprise
a capsule that is configured to break or dissolve to release a
material that solidifies after release. For example, in some
variations different space-filling implants may comprise different
components of a fibrin glue. When the capsules break, the
components of the fibrin glue may mix to form a solid fibrin
matrix, which in turn may adhere to surrounding tissue. Generally,
a fibrin clot may be formed by mixing fibrinogen and thrombin in an
aqueous environment, as the thrombin polymerizes the fibrinogen
into a polymer matrix. Thus, in these variations, some capsules may
contain a thrombin solution, while other capsules contain a
fibrinogen solution. When the capsules break or dissolve, these
components may join to form a polymerized fibrin matrix. It should
be appreciated that the fibrinogen and thrombin solutions may
comprise one or more clotting factors or other elements (calcium
chloride) that may aid in the fibrin polymerization process, and
may also comprise one or more drugs or agents that may be released
from the resulting fibrin matrix.
[0077] In still other variations, one or more space-filling
implants may be expandable. These space-filling implants may be any
suitable expandable structure, such as, for example, an inflatable
structure (e.g., a balloon) or a swellable implant. The expandable
space-filling implants may be delivered to one or more spaces, such
as those described above, in either an expanded or an unexpanded
form. When delivered in an unexpanded from, the expandable
space-filling implants may expand in response to one or more forces
or stimuli. These forces or stimuli may or may not be naturally
provided by the body. For example, when a space-filling implant
comprises one or more swellable materials, the space-filling
implant may expand as it comes into contact with saliva or other
fluids introduced to tonsillar tissue. When the space-filling
implant comprises a balloon or other inflatable structure, the
balloon may be inflated after delivery to the tonsillar tissues. In
some variations, the balloon may be filled with a drug-containing
solution, and may be configured to elute one or more drugs over a
period of time. In other variations, the balloon may comprise one
or more elements (e.g., hooks, barbs, or the like) that may anchor
the balloon to one or more areas of tonsillar tissue. Additionally,
when one or more expandable space-filling implants expand in or
around a space in the tonsillar tissues, the space-filling implants
may exert one or more forces on the surrounding tissue, and in some
instances may dilate or otherwise reconfigure surrounding tonsillar
tissue.
[0078] Foams and Gels
[0079] In some variations, one or more gels or foams may be
administered to one or more portions of the tonsillar tissue. Gels
or foams may be administered to tonsillar tissue during or
following a tonsil procedure. Gels or foams may provide one or more
beneficial functions. In some variations, the gels or foams may
deliver one or more drugs to surrounding tissues, as will be
described in more detail below. In other variations, the gels or
foams may help to seal off or otherwise shield exposed tonsillar
tissue or exposed tissue of the tonsillar fossa from external
stimuli, such as acidic compounds or other aggravating chemicals
that may be ingested while eating or drinking, or abrasive forces
or temperature changes caused by ingesting food or liquids.
[0080] Any suitable gel or foam may be used. In some variations,
the gels or foams may be biodegradable, bioabsorbable, bioerodible,
dissolvable, or otherwise configured to break down. Gels may be
made from any colloidal system in which a porous network of small
particles, which may or may not be connected, spans the volume of a
liquid medium. Foams may be formed by trapping one or more gas
bubbles in a liquid or solid. In some variations, one or more gels
or foams may naturally adhere to tissue. For example, when a gel or
foam is made from chitosan, chitin, polyvinylpyrrolidone (PVP),
polyvinyl alcohol (PVA), fibrin glue, or similar materials, that
gel or foam may adhere to tissue.
[0081] In instances where one or more gels or foams are
administered to tissue, they may be administered in any suitable
way. In some variations, one or more gels or foams may be placed in
one or more holes, channels, gaps, or other spaces inside of
tonsillar tissue. These spaces may be naturally occurring or
artificially formed. In other instances, one or more gels or foams
may be used to cover or coat one or more tissue surfaces. In some
of these variations, the gel or foam may naturally adhere to a
tissue surface, as noted above. In other variations, one or more
structures may be used to hold the gels or foams in place against
the tissue. Indeed, in some of these variations, one or more
patches, films, sheets, or meshes, as described in more detail
below, may be used to hold one or more gels or foams against
tissue. In these variations, the patch, film, sheet, or mesh may be
anchored or otherwise attached to tissue, and the one or more gels
or foams may be placed beneath the patch, film, sheet, or mesh. Any
suitable patch, film, sheet, or mesh may be used, such as those
described herein. In instances where the mucosal flap is sutured
over the exposed tonsillar bed, one or more gels or foams may be
placed beneath the mucosal flap.
[0082] In other variations, one or more gels or foams may be
capable of solidifying upon delivery. The gels or foams may
solidify in response to one or more stimuli (e.g., heat, energy,
light, changes in pH, moisture, chemicals or biological materials,
etc.), or may solidify naturally upon delivery to tonsillar tissue.
In some of these variations, the gel or foams may delivered to one
or more spaces in or around the tonsillar tissue, at which point
the gel or foam may solidify. When the gel or foam contains one or
more drugs, the gel or foam may be used to create one or more solid
drug-releasing boluses.
[0083] Additionally, one or more gels or foams may be used in
conjunction with one or more of the devices described here (e.g.,
tissue-piercing devices, tissue-restriction devices, clips,
space-filling implants, or a combination thereof). In some
variations, one or more gels or foams may be used to at least
partially coat one of the devices. In other variations, one or more
gels or foams may be used to fill one or more spaces, cavities or
reservoirs within one of the devices.
[0084] Patches, Sheets, Films, and Meshes
[0085] In some variations one or more patches, sheets, films,
meshes, or a combination thereof may be placed in, on, or around
the tonsillar tissue. Any of these devices may or may not be
configured to deliver one or more drugs to the tonsillar tissue.
When configured to deliver one or more drugs, the patches, sheets,
films, or meshes may release drug in any suitable manner as
described below. Additionally, one or more portions of these
devices may be configured to biodegrade, bioerode, or otherwise
break down.
[0086] Generally, one or more patches, sheets, films, meshes, or a
combination thereof may be applied to tonsillar tissue. In some
instances, one or more of these devices may be at least partially
implanted in tissue. In other instances, one or more of these
devices may be used to cover one or more tissue surfaces. When
these devices are used to cover one or more tissue surfaces, the
patches, sheets, films or meshes may help to shield the tonsillar
tissue from one or more stimuli or chemicals that may irritate
tonsillar tissue. In some instances, the patches, sheets, films, or
meshes may entirely or partially seal some or all of a portion of
tonsillar tissue from outside stimuli or chemicals. In other
instances, the patches, sheets, films or meshes may act as a
temporary haemostatic barrier. Additionally, these patches, sheets,
films or meshes may be used to hold one or more additional devices
against tonsillar tissue. In other variations, the patches, sheets,
films, or meshes may be configured such that blood, or one or more
components of blood, may pass through at least a portion of the
device.
[0087] These devices may be attached to tonsillar tissue in any
suitable manner. In some variations, one or more portions of the
device may naturally adhere to tissue. For example, when a film or
sheet is made from a polymer such as chitosan, chitin, PVP, PVA, or
the like, the film or sheet may adhere to tissue. For example,
sucralfate may be used to help connect one or more portions of the
device to tissue. In other instances, one or more biocompatible
adhesives (e.g., a fibrin glue or a cyanoacrylate glue) may be used
to connect one or more portions of the device to tissue. In still
other instances, one or more sutures or the tissue-piercing devices
may be used to anchor one or more portions of the device to tissue.
In yet other instances, one or more additional patches, films,
sheets, or meshes may overlay the device to hold it in place. In
still other instances, one or more of the clips or
tissue-restricting devices described above may be used to anchor
one or more portions of the device to tissue.
[0088] Any suitable patch, film, sheet, or mesh may be administered
to the tonsillar tissue. When a mesh is used, the mesh may be woven
or non-woven, and may have any suitable pore size. In some
variations, the mesh comprises a pore size sufficient to allow for
tissue ingrowth. Indeed, any of the patches, sheets, or meshes may
be configured for tissue ingrowth. For example, a patch, film,
sheet, or mesh may comprise one or more roughened or porous
surfaces that may help to initiate tissue ingrowth.
[0089] When a film is applied to tissue, the film may be pre-formed
or may be formed after administration to tissue. In variations when
the film is formed upon administration, a gel or foam, such as
those described above, or some other solidifying material may be
administered to the tonsillar tissue. In some variations, the gel
or foam naturally cures into a film when placed against tonsillar
tissue. In other variations, the gel or foam cures upon application
of one or more stimuli thereto. Examples of suitable stimuli
include, but are not limited to heat, light, electricity, moisture,
chemicals, biological materials (e.g., proteins, enzymes, and the
like), and changes in pH. In some variations, a layer of fibrin
glue may be applied to a tissue surface to form a polymerized
fibrin sheet thereon. When a sheet is applied to tonsillar tissue,
the sheet may be made from any suitable material, such as those
described below.
[0090] When tonsils are removed during a tonsillectomy, one or more
clots may form on or in the tonsillar beds. In some instances, a
large scab may dislodge from tonsillar tissue during recovery from
a tonsil procedure, which may result in a potentially problematic
bleeding episode. To help prevent such a bleeding episode, it may
be desirable to minimize the size of clots that may form on
tonsillar tissue. As such, it may be desirable for a patch or sheet
to comprise one or more apertures or cells passing therethrough to
help regulate the size of clots formed. For example, FIGS. 26A and
26B illustrate one variation of patch (2600). Shown in FIG. 26A is
patch (2600), which comprises a frame (2602) and a plurality of
cells (2604) defined thereby. The patch (2600) may be placed over
and attached to the tonsillar bed (2606) or other tonsillar tissue
during or following a tonsil procedure, as shown in FIG. 26B. When
placed against tissue, blood may pool in cells (2604), and may form
a plurality of smaller scabs (not shown). These smaller scabs may
reduce the likelihood that a bleeding episode will occur. It should
be appreciated that cells (2604) may be any suitable size or shape,
and that patch (2600) may have a thickness sufficient to allow for
pooling of blood in cells (2604).
[0091] Drug Delivery
[0092] Any of the devices described here may be used to deliver one
or more drugs. Each device described here may be configured to
release any suitable number of drugs over any suitable period or
periods of time. The number of drug-releasing devices, the
selection of drugs, the timing of delivery, and the overall amount
of drug or drugs released may be determined by the intended
treatment plan, and may be further fine-tuned to the meet the
specific needs of an individual patient. Each drug delivered should
be released at a rate that provides a patient with a healthy, safe,
and effective dosage and should be administered at an overall
dosage that is also healthy, safe, and effective.
[0093] The devices described here may deliver one or more drugs in
any number of ways. In some variations, at least a portion of the
device itself incorporates one or more drugs. In some instances,
the drug may diffuse out of or may otherwise be released from the
device over time. In other instances, the device may comprise one
or more cavities, channels, pockets or other space from which a
drug or drug-containing material may be released. In still other
variations, the device may comprise one or more drug-eluting
layers, boluses or reservoirs disposed on one or more surfaces of
the device.
[0094] Any suitable device or portions thereof may be configured to
release one or more drugs to tonsillar tissue. In some variations,
one or more drugs may be incorporated into one or more portions of
the device's body. Each drug may be incorporated into the entire
body, or may only be incorporated into one or more portions of the
body. For example, in variations where the device comprises a
staple with two legs, as described above, a first drug may be
incorporated into the first leg, while a second drug may be
incorporated into the second leg. In some instances, the one or
more drugs may diffuse out of the device body. In variations where
one or more portions of the device is biodegradable, bioerodible,
or otherwise configured to break down, the one or more drugs may be
released as these portions degrade or erode.
[0095] In other variations, the body of the device may comprise one
or more cavities, channels, pores, pockets or other spaces that may
hold one or more drugs or drug-containing materials. The spaces may
hold one or more drugs, one or more drug-containing solutions,
foams, powders, solids, gels, or a combination thereof. In some
variations, one or more drugs may diffuse out of the spaces through
the device body. In other variations, the drugs or drug-containing
materials may exit the device via one or more pores or passageways
in the body of the device. In variations where one or more portions
of the device is biodegradable, bioerodible, or otherwise
configured to break down, one or more of the spaces may become
exposed to tissue as these portions degrade or erode. In these
instances, one or more drugs or drug-containing materials may be
released from the device when the space becomes exposed to
tissue.
[0096] In still other variations, one or more surfaces of a device
may comprise one or more drug-releasing layers or boluses disposed
thereon. The drug-releasing layers or boluses may be made of any
suitable biocompatible material that is capable of releasing a drug
over a period of time, and may be configured in any suitable way.
Each device may comprise any number of drug-releasing layers or
boluses (e.g., zero, one, two, three, four or more). Each
drug-releasing layer may coat or cover the entire surface of the
device, or may only cover one or more selected portions of the
device. Additionally, one drug-releasing layer may be at least
partially disposed over one or more additional drug-releasing
layers.
[0097] Overall, the device may be configured to release one or more
drugs over a predetermined period of time. This period of time may
be on the order of hours, on the order of days, or on the order of
weeks. This period of drug delivery will likely be determined with
consideration of the nature and amount of the drug or drugs to be
released as well as the intended treatment regimen. For example,
when the device is used to treat one or more symptoms of a tonsil
procedure, the period may be between less than about a day, between
about 1 day to about 21 days, between about 1 day to about 18 days,
between about 1 day to about 15 days, between about 1 day to about
12 days, between about 1 to about 9 days, between about 1 to about
7 days, between about 1 to about 5 days, between about 1 to about 3
days, between about 3 days to about 21 days, between about 3 days
to about 18 days, between about 3 days to about 15 days, between
about 3 days to about 12 days, between about 3 to about 9 days,
between about 3 to about 7 days, between about 3 to about 5 days,
between about 5 days to about 21 days, between about 5 days to
about 18 days, between about 5 days to about 15 days, between about
5 days to about 12 days, between about 5 to about 9 days, between
about 5 to about 7 days, between about 7 days to about 21 days,
between about 7 days to about 18 days, between about 7 days to
about 15 days, between about 7 days to about 12 days, between about
7 to about 9 days, between about 9 days to about 21 days, between
about 9 days to about 18 days, between about 9 days to about 15
days, between about 9 days to about 12 days, between about 12 days
to about 21 days, between about 12 days to about 18 days, between
about 12 days to about 15 days, between about 15 days to about 21
days, between about 15 days to about 18 days, or between about 18
days to about 21 days. As will be described in more detail below,
this period may not begin immediately upon implantation or
administration of the device.
[0098] Drugs may be released at a constant rate from the device,
but need not be. Indeed, the devices may be configured with any
suitable release rate profile. In some variations, the daily amount
of drug released may decrease over time. For example, a device may
release a certain amount of drug for a first period of time (e.g.,
one day), then may release a second amount of drug for a second
period of time. Similarly, the amount of drug delivered may change
any number of times during a span of time. The amount of drug
released may decrease over time, or may increase over time, or may
increase over one span of time and decrease over a different span
of time. Furthermore, in some variations a device may comprise
multiple drug eluting layers, and each layer may be configured to
have a different and specific release profile. Of course, it should
be understood that each layer may comprise, contain, include, or be
configured to release one or more drug or agent therefrom. Each
layer may comprise, contain, include, or be configured to release
the same or a different drug or agent therefrom. Similarly, the
device body may additionally comprise a drug, and the device body
may provide a different release profile from those of one or more
drug eluting layers.
[0099] In still further variations, the device may comprise one or
more barrier layers. These layers may or may not release one or
more drugs, and may delay the release of one or more drugs from one
or more drug releasing layers or from the device itself. The
barrier layer may or may not be a bulk-eroding polymer, or may or
may not be a surface-eroding polymer. In some variations, the
barrier layer may prevent the passage of drug therethrough. In
these variations, the barrier layer may provide a time during which
no drug is released from at least a portion of a drug releasing
layer or from at least a portion of the device. Once the barrier
layer has sufficiently degraded or otherwise eroded, drug release
may begin or resume. In other variations, the barrier layer may
allow some amount drug to pass therethrough. In some of these
variations, the amount of drug that passes through barrier layer
may be less than that which would be released from the drug
releasing layer in the absence of the barrier layer. The barrier
layer thus may provide a period during which a smaller amount of
drug is released from at least a portion of the drug releasing
layer. Once the barrier layer has sufficiently degraded or
otherwise eroded, the amount of drug released from the device may
increase.
[0100] These aforementioned drug-delivery variations, and
combinations thereof, may allow the device to provide a variable
drug release profile, or provide bursts, either initial or delayed,
in addition to the device's baseline release profile. Additionally,
these variations may allow the device to provide different drug
release profiles that are separated in time. For example, the
device may comprise two drug releasing layers separated by a
barrier layer. The outer drug releasing layer may release an
initial amount of drug over an initial period of time, and may
follow any suitable drug release profile. The barrier layer may
then degrade or erode over a certain period of time, during which
some or no drug is released from a second drug releasing layer.
Once this degradation has substantially finished, the second drug
releasing layer may then release a second amount of drug over a
second period of time, and this release may also follow any
suitable drug release profile. Each drug releasing layer may
release any suitable amount of any suitable drug over any suitable
amount of time, as described above.
[0101] Additionally, one or more release rate modifiers may also be
used. The release rate modifier may be any suitable biocompatible
material that serves to alter the rate at which a drug is released
from the device. In some variations, the release rate modifier may
include a hydrophilic agent. In some variations, the release rate
modifier is a polyethylene glycol, e.g., a polyethylene glycol with
a molecular weight of between about 3000 to about 13000, between
about 3000 to about 11000, between about 3000 to about 9000,
between about 3000 to about 7000, between about 3000 to about 5000,
between about 5000 to about 13000, between about 5000 to about
11000, between about 5000 to about 9000, between about 5000 to
about 7000, between about 7000 to about 13000, between about 7000
to about 11000, between about 7000 to about 9000, between about
9000 to about 13000, between about 9000 to about 11000, between
about 11000 to about 13000, and the like. In some variations, the
release rate modifier is a polyethylene glycol with a molecular
weight of about 6000.
[0102] As mentioned herein throughout, the device may be configured
to deliver multiple drugs. In some variations, multiple types of
drug particles are contained within a single drug eluting layer or
within the device body. In other variations, a device comprises a
drug eluting layer that is discontinuous, having different sections
containing different drugs. In these variations, the different
sections may have different compositions, and thus may also provide
differing release rates. In still other variations, multiple drug
eluting layers may be used, where each layer contains a different
drug or combination of drugs. Drug-releasing boluses, as described
above, may also hold different drugs therein or may collectively
release different drugs than those released by the drug eluting
layer. In still other variations, the device itself may release a
different drug or combination of drugs than those drugs released by
a drug eluting layer or layers. Any combination of these variations
may also be used to achieve the desired drug delivery profiles.
[0103] Illustrative Agents
[0104] The device may comprise any suitable drug or agent, or
combination of drugs or agents, and the agent selected will largely
be determined by the desired use of the device. The device may
comprise one or more diagnostic agents, and may also comprise one
or more therapeutic agents. Diagnostic agents may be used, for
example, in diagnosing the presence, nature, and/or extent of a
disease or medical condition in a subject. Conversely, a
therapeutic agent may be used to treat or affect one or more
diseases, conditions, sensations, or symptoms.
[0105] Diagnostic agents include, for example, contrast agents for
use in connection with ultrasound imaging, magnetic resonance
imaging (MRI), nuclear magnetic resonance (NMR), computed
tomography (CT), electron spin resonance (ESR), nuclear medical
imaging, optical imaging, elastography, fluorescence imaging,
positron emission tomography (PET), radiofrequency (RF) and
microwave laser. Diagnostic agents may also include any other agent
useful in facilitating diagnosis of a disease or other condition in
a patient, whether or not imaging methodology is employed.
[0106] Examples of specific diagnostic agents include radio-opaque
materials such as iodine or iodine-derivatives, for example,
iohexyl and iopamidol. Other diagnostic agents such as, for
example, radioisotopes, are detectable by tracing radioactive
emissions. Examples of agents detectable by MRI are generally
paramagnetic agents including, but not limited to, gadolinium
chelated compounds. An example of an agent detectable by ultrasound
includes, but is not limited to, perflexane. An example of a
fluorescence agent includes, but is not limited to, indocyanine
green. Examples of agents used in diagnostic PET include, but are
not limited to, fluorodeoxyglucose, sodium fluoride, methionine,
choline, deoxyglucose, butanol, raclopride, spiperone,
bromospiperone, carfentanil, and flumazenil.
[0107] The device may also comprise any suitable therapeutic agent.
Suitable classes of therapeutic agents include, for example, local
anesthetics, painkillers/analgesics (e.g., anti-inflammatory
agents, opiates, etc.), vasoconstrictors, anti-allergens,
anti-cholinergic agents, antihistamines, anti-infectives,
anti-platelet agents, anti-coagulants, anti-thrombic agents,
anti-scarring agents, anti-proliferative agents, chemotherapeutic
agents, anti-neoplastic agents, decongestants, hemostatic agents,
healing promoting agents and vitamins (for example, retinoic acid,
vitamin A, depaxapanthenol, vitamin B and their derivatives),
hypersomolar agents, immunomodulators, immunosuppressive agents,
and combinations and mixtures thereof. It should be appreciated
that the devices described here may comprise any combinations of
drugs or agents (e.g., a combination of two, three, or four or more
drugs or agents). For example, the devices may comprise
combinations of local anesthetics and analgesics, combinations of
local anesthetics and antibiotics, combinations of local
anesthetics and vasoconstrictors, combinations of analgesics and
antibiotics, combinations of analgesics and vasoconstrictors,
combinations of analgesics and antibiotics, combinations local
anesthetics, antibiotics and vasoconstrictors, and the like.
[0108] Examples of local anesthetics suitable for use with the
described methods and devices include, but are not limited to,
ropivicaine, mepivicaine, bupivicaine, cocaine, procaine,
etidocaine, lidocaine, prilocaine, articaine, amylocaine,
benzocaine, butacaine, chloroprocaine, dimethocaine, meprylcaine,
metabutoxycaine, orthocaine, propoxycaine, procaine,
proxymetacaine, risocaine, tetracaine, tropane, cyclomethycaine,
hexylcaine, piperocaine, articaine, carticaine, cinchocaine,
etidocaine, trimecaine, iontocaine, combinations thereof and the
like. Examples of suitable vasoconstrictors include, but are not
limited to, epinephrine, levonordefrin, adrenaline derivatives
thereof, combinations thereof, and the like.
[0109] Anti-infective agents generally include antibacterial
agents, antifungal agents, antiparasitic agents, antiviral agents,
and antiseptics. Anti-inflammatory agents generally include
steroidal and nonsteroidal anti-inflammatory agents.
[0110] Examples of antiallergic agents that may suitable for use
with the described methods and devices include, but are not limited
to, pemirolast potassium (ALAMAST.RTM., Santen, Inc.), and any
prodrugs, metabolites, analogs, homologues, congeners, derivatives,
salts and combinations thereof. Examples of antiproliferative
agents include, but are not limited to, actinomycin D, actinomycin
IV, actinomycin I.sub.1, actinomycin X.sub.1, actinomycin C.sub.1,
and dactinomycin (COSMEGEN.RTM., Merck & Co., Inc.). Examples
of antiplatelet, anticoagulant, antifibrin, and antithrombin agents
include, but are not limited to, sodium heparin, low molecular
weight heparins, heparinoids, hirudin, argatroban, forskolin,
vapiprost, prostacyclin and prostacyclin analogues, dextran,
D-phe-pro-arg-chloromethylketone (synthetic antithrombin),
dipyridamole, glycoprotein IIb/IIIa platelet membrane receptor
antagonist antibodies, recombinant hirudin, and thrombin inhibitors
(ANGIOMAX.RTM., Biogen, Inc.), and any prodrugs, metabolites,
analogs, homologues, congeners, derivatives, salts and combinations
thereof. Examples of pro-healing agents include, but are not
limited to, sirolimus, everolimus, temsiolimus, and vitamin A.
[0111] Examples of cytostatic or antiproliferative agents that may
be suitable for uses with the described methods and devices
include, but are not limited to, angiopeptin, angiotensin
converting enzyme inhibitors such as captopril (CAPOTEN.RTM. and
CAPOZIDE.RTM., Bristol-Myers Squibb Co.), cilazapril or lisinopril
(PRINIVIL.RTM. and PRINZIDE.RTM., Merck & Co., Inc.); calcium
channel blockers such as nifedipine; colchicines; fibroblast growth
factor (FGF) antagonists, fish oil (omega 3-fatty acid); histamine
antagonists; lovastatin (MEVACOR.RTM., Merck & Co., Inc.);
monoclonal antibodies including, but not limited to, antibodies
specific for Platelet-Derived Growth Factor (PDGF) receptors;
nitroprusside; phosphodiesterase inhibitors; prostaglandin
inhibitors; suramin; serotonin blockers; steroids; thioprotease
inhibitors; PDGF antagonists including, but not limited to,
triazolopyrimidine; and nitric oxide, and any prodrugs,
metabolites, analogs, homologues, congeners, derivatives, salts and
combinations thereof.
[0112] Examples of antibacterial agents that may be suitable for
use with the described methods and devices include, but are not
limited to, aminoglycosides, amphenicols, ansamycins,
.beta.-lactams such as penicillins, lincosamides, macrolides,
nitrofurans, quinolones, sulfonamides, sulfones, tetracyclines,
vancomycin, and any of their derivatives, or combinations thereof.
Examples of penicillins that may be suitable for use with the
described methods and devices include, but are not limited to,
amdinocillin, amdinocillin pivoxil, amoxicillin, ampicillin,
apalcillin, aspoxicillin, azidocillin, azlocillin, bacampicillin,
benzylpenicillinic acid, benzylpenicillin sodium, carbenicillin,
carindacillin, clometocillin, cloxacillin, cyclacillin,
dicloxacillin, epicillin, fenbenicillin, floxacillin, hetacillin,
lenampicillin, metampicillin, methicillin sodium, mezlocillin,
nafcillin sodium, oxacillin, penamecillin, penethamate hydriodide,
penicillin G benethamine, penicillin G benzathine, penicillin G
benzhydrylamine, penicillin G calcium, penicillin G hydrabamine,
penicillin G potassium, penicillin G procaine, penicillin N,
penicillin O, penicillin V, penicillin V benzathine, penicillin V
hydrabamine, penimepicycline, phenethicillin potassium,
piperacillin, pivampicillin, propicillin, quinacillin,
sulbenicillin, sultamicillin, talampicillin, temocillin, and
ticarcillin.
[0113] Examples of antifungal agents suitable for use with the
described methods and devices include, but are not limited to,
allylamines, imidazoles, polyenes, thiocarbamates, triazoles, and
any of their derivatives. Antiparasitic agents that may be employed
include, but are not limited to, atovaquone, clindamycin, dapsone,
iodoquinol, metronidazole, pentamidine, primaquine, pyrimethamine,
sulfadiazine, trimethoprim/sulfamethoxazole, trimetrexate, and
combinations thereof.
[0114] Examples of antiviral agents suitable for use with the
described methods and devices include, but are not limited to,
acyclovir, famciclovir, valacyclovir, edoxudine, ganciclovir,
foscamet, cidovir (vistide), vitrasert, formivirsen, HPMPA
(9-(3-hydroxy-2-phosphonomethoxypropyl)adenine), PMEA
(9-(2-phosphonomethoxyethyl)adenine), HPMPG
(9-(3-Hydroxy-2-(Phosphonomethoxy)propyl)guanine), PMEG
(9-[2-(phosphonomethoxy)ethyl]guanine), HPMPC
(1-(2-phosphonomethoxy-3-hydroxypropyl)-cytosine), ribavirin, EICAR
(5-ethynyl-1-beta-D-ribofuranosylimidazole-4-carboxamine),
pyrazofurin
(3-[beta-D-ribofuranosyl]-4-hydroxypyrazole-5-carboxamine),
3-Deazaguanine, GR-92938X
(1-beta-D-ribofuranosylpyrazole-3,4-dicarboxamide), LY253963
(1,3,4-thiadiazol-2-yl-cyanamide), RD3-0028
(1,4-dihydro-2,3-Benzodithiin), CL387626
(4,4'-bis[4,6-d][3-aminophenyl-N--,N-bis(2-carbamoylethyl)-sulfonilimino]-
-1,3,5-triazin-2-ylamino-biphenyl-2-,2'-disulfonic acid disodium
salt), BABIM (Bis[5-Amidino-2-benzimidazoly-1]-methane), NIH351,
and combinations thereof.
[0115] Examples of antiseptic agents suitable for use with the
described methods and devices include, but are not limited to,
alcohol, chlorhexidrine, iodine, triclosan, hexachlorophene, and
silver-based agents, for example, silver chloride, silver oxide,
and silver nanoparticles.
[0116] Analgesics may include opiates, anti-inflammatory agents,
and other painkillers. Examples of suitable opiates, include, but
are not limited to codeine, hydrocodone, dihydrocodeine, oxycodone,
fentanyl, propoxyphene, meperedine, hydromorphone, thebaine,
papaverine, morphine, acetyldihydrocodeine, buprenorphine,
oxymorphone, nalbuphine, buprenorphine, dihydroetorphine, tramadol,
derivates thereof, combinations thereof, and the like.
Anti-inflammatory agents may include steroidal and nonsteroidal
anti-inflammatory agents. Examples of suitable steroidal
anti-inflammatory agents include, but are not limited to,
21-acetoxypregnenolone, alclometasone, algestone, amcinonide,
beclomethasone, betamethasone, budesonide, chloroprednisone,
clobetasol, clobetasone, clocortolone, cloprednol, corticosterone,
cortisone, cortivazol, deflazacort, desonide, desoximetasone,
dexamethasone, diflorasone, diflucortolone, difluprednate,
enoxolone, fluazacort, flucloronide, flumethasone, flunisolide,
fluocinolone acetonide, fluocinonide, fluocortin butyl,
fluocortolone, fluorometholone, fluperolone acetate, fluprednidene
acetate, fluprednisolone, flurandrenolide, fluticasone propionate,
formocortal, halcinonide, halobetasol propionate, halometasone,
halopredone acetate, hydrocortamate, hydrocortisone, loteprednol
etabonate, mazipredone, medrysone, meprednisone,
methylprednisolone, mometasone furoate, paramethasone,
prednicarbate, prednisolone, prednisolone 25-diethylamino-acetate,
prednisolone sodium phosphate, prednisone, prednival, prednylidene,
rimexolone, tixocortol, triamcinolone, triamcinolone acetonide,
triamcinolone benetonide, triamcinolone hexacetonide, any of their
derivatives, and combinations thereof.
[0117] Examples of suitable nonsteroidal anti-inflammatory agents
include, but are not limited to, COX inhibitors. These COX
inhibitors may include COX-1 or COX nonspecific inhibitors such as,
for example, salicylic acid derivatives, aspirin, sodium
salicylate, choline magnesium trisalicylate, salsalate, diflunisal,
sulfasalazine and olsalazine; para-aminophenol derivatives such as
acetaminophen; indole and indene acetic acids such as indomethacin
and sulindac; heteroaryl acetic acids such as tolmetin, dicofenac
and ketorolac; arylpropionic acids such as ibuprofen, naproxen,
flurbiprofen, ketoprofen, fenoprofen and oxaprozin; anthranilic
acids (fenamates) such as mefenamic acid and meloxicam; enolic
acids such as the oxicams (piroxicam, meloxicam) and alkanones such
as nabumetone. The COX inhibitors may also include selective COX-2
inhibitors such as, for example, diaryl-substituted furanones such
as rofecoxib; diaryl-substituted pyrazoles such as celecoxib;
indole acetic acids such as etodolac and sulfonanilides such as
nimesulide).
[0118] Examples of chemotherapeutic/antineoplastic agents that may
be used in the devices described here include, but are not limited
to antitumor agents (e.g., cancer chemotherapeutic agents,
biological response modifiers, vascularization inhibitors, hormone
receptor blockers, cryotherapeutic agents or other agents that
destroy or inhibit neoplasia or tumorigenesis) such as alkylating
agents or other agents which directly kill cancer cells by
attacking their DNA (e.g., cyclophosphamide, isophosphamide),
nitrosoureas or other agents which kill cancer cells by inhibiting
changes necessary for cellular DNA repair (e.g., carmustine (BCNU)
and lomustine (CCNU)), antimetabolites or other agents that block
cancer cell growth by interfering with certain cell functions,
usually DNA synthesis (e.g., 6-mercaptopurine and 5-fluorouracil
(5FU), antitumor antibiotics and other compounds that act by
binding or intercalating DNA and preventing RNA synthesis (e.g.,
doxorubicin, daunorubicin, epirubicin, idarubicin, mitomycin-C and
bleomycin), plant (vinca) alkaloids and other anti-tumor agents
derived from plants (e.g., vincristine and vinblastine), steroid
hormones, hormone inhibitors, hormone receptor antagonists and
other agents which affect the growth of hormone-responsive cancers
(e.g., tamoxifen, herceptin, aromatase ingibitors such as
aminoglutethamide and formestane, trriazole inhibitors such as
letrozole and anastrazole, steroidal inhibitors such as
exemestane), antiangiogenic proteins, small molecules, gene
therapies and/or other agents that inhibit angiogenesis or
vascularization of tumors (e.g., meth-1, meth-2, thalidomide),
bevacizumab (Avastin), squalamine, endostatin, angiostatin,
Angiozyme, AE-941 (Neovastat), CC-5013 (Revimid), medi-522
(Vitaxin), 2-methoxyestradiol (2ME2, Panzem), carboxyamidotriazole
(CAI), combretastatin A4 prodrug (CA4P), SU6668, SU11248,
BMS-275295, COL-3, EMD 121974, IMC-1C11, IM862, TNP-470, celecoxib
(Celebrex), rofecoxib (Vioxx), interferon alpha, interleukin-12
(IL-12) or any of the compounds identified in Science Vol. 289,
Pages 1197-1201 (Aug. 17, 2000), which is expressly incorporated
herein by reference, biological response modifiers (e.g.,
interferon, bacillus calmette-guerin (BCG), monoclonal antibodies,
interleukin 2, granulocyte colony stimulating factor (GCSF), etc.),
PGDF receptor antagonists, herceptin, asparaginase, busulphan,
carboplatin, cisplatin, carmustine, cchlorambucil, cytarabine,
dacarbazine, etoposide, flucarbazine, fluorouracil, gemcitabine,
hydroxyurea, ifosphamide, irinotecan, lomustine, melphalan,
mercaptopurine, methotrexate, thioguanine, thiotepa, tomudex,
topotecan, treosulfan, vinblastine, vincristine, mitoazitrone,
oxaliplatin, procarbazine, streptocin, taxol or paclitaxel,
taxotere, azathioprine, docetaxel analogs/congeners, derivatives of
such compounds, and combinations thereof.
[0119] Examples of decongestants that may be used in the devices
and methods described here include, but are not limited to,
epinephrine, pseudoephedrine, oxymetazoline, phenylephrine,
tetrahydrozolidine, and xylometazoline. Examples of mucolytics that
may be used in the devices and methods described here include, but
are not limited to, acetylcysteine, dornase alpha, and guaifenesin.
Anti-histamines such as azelastine, diphenhydramine, and loratidine
may also be used in the methods and devices described here.
[0120] Suitable hyperosmolar agents that may be used in the devices
described here include, but are not limited to, furosemide, sodium
chloride gel, and other salt preparations that draw water from
tissue or substances that directly or indirectly change the
osmolarity of the mucous layer.
[0121] Other bioactive agents useful in the present invention
include, but are not limited to, free radical scavengers; nitric
oxide donors; rapamycin; methyl rapamycin; everolimus; tacrolimus;
40-O-(3-hydroxy)propyl-rapamycin;
40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin; tetrazole containing
rapamycin analogs such as those described in U.S. Pat. No.
6,329,386; estradiol; clobetasol; idoxifen; tazarotene;
alpha-interferon; host cells including, but not limited to
prokaryotes and eukaryotes such as, for example, epithelial cells
and genetically engineered epithelial cells; dexamethasone; and,
any prodrugs, metabolites, analogs, homologues, congeners,
derivatives, salts and combinations thereof.
[0122] Examples of free radical scavengers include, but are not
limited to, 2,2',6,6'-tetramethyl-1-piperinyloxy, free radical
(TEMPO); 4-amino-2,2',6,6'-tetramethyl-1-piperinyloxy, free radical
(4-amino-TEMPO); 4-hydroxy-2,2',6,6'-tetramethyl-piperidene-1-oxy,
free radical (TEMPOL),
2,2',3,4,5,5'-hexamethyl-3-imidazolinium-1-yloxy methyl sulfate,
free radical; 16-doxyl-stearic acid, free radical; superoxide
dismutase mimic (SODm) and any analogs, homologues, congeners,
derivatives, salts and combinations thereof. Nitric oxide donors
include, but are not limited to, S-nitrosothiols, nitrites,
N-oxo-N-nitrosamines, substrates of nitric oxide synthase,
diazenium diolates such as spermine diazenium diolate, and any
analogs, homologues, congeners, derivatives, salts and combinations
thereof.
[0123] Materials
[0124] The devices described here may be made of any suitable
material or combinations of material. In some variations, one or
more of the materials may biodegradable, bioerodible, or otherwise
erodible. In these variations, the rate of biodegradation of the
degradable portions of the device may be affected by a number of
factors including, but not limited to, the type of material from
which the portion is formed, the size and shape of the device, and
the deployment conditions. The devices described here may be made
from a single material, or may be made from a combination of
materials.
[0125] One or more portions of the device may comprise one or more
polymers. A polymer may be biodegradable, but need not be. Examples
of biodegradable polymers that may be suitable for use with the
methods and devices describe here include, but are not limited to,
aliginate, cellulose and ester, dextran, elastin, fibrin,
hyaluronic acid, polyacetals, polyarylates (L-tyrosine-derived or
free acid), poly(.alpha.-hydroxy-esters),
poly(.beta.-hydroxy-esters), polyamides, poly(amino acid),
polyalkanotes, polyalkylene alkylates, polyalkylene oxylates,
polyalkylene succinates, polyanhydrides, polyanhydride esters,
polyaspartimic acid, polybutylene diglycolate, poly(caprolactone),
poly(caprolactone)/poly(ethylene glycol) copolymers,
poly(carbonate), L-tyrosine-derived polycarbonates,
polycyanoacrylates, polydihidropyrans, poly(dioxanone),
poly-p-dioxanone, poly(epsilon-caprolactone),
poly(epsilon-caprolactone-dimethyltrimethylene carbonate),
poly(esteramide), poly(esters), aliphatic polyesters,
poly(etherester), poly(ethylene glycol)/poly(orthoester)
copolymers, poly(glutarunic acid), poly(glycolic acid),
poly(glycolide), poly(glycolide)/poly(ethylene glycol) copolymers,
poly(glycolide-trimethylene carbonate), poly(hydroxyalkanoates),
poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate),
poly(imino carbonates), polyketals, poly(lactic acid), poly(lactic
acid-co-glycolic acid), poly(lactic acid-co-glycolic
acid)/poly(ethylene glycol) copolymers, poly(lactide),
poly(lactide-co-caprolactone), poly(DL-lactide-co-glycolide),
poly(lactide-co-glycolide)/poly(ethylene glycol) copolymers,
poly(lactide)/poly(ethylene glycol) copolymers,
poly(lactide)/poly(glycolide) copolymers, polyorthoesters,
poly(oxyethylene)/poly(oxypropylene)copolymers, polypeptides,
polyphosphazenes, polyphosphoesters, polyphosphoester urethanes,
poly(propylene fumarate-co-ethylene glycol), poly(trimethylene
carbonate), polytyrosine carbonate, polyurethane, PorLastin or
silk-ealastin polymers, spider silk, tephaflex, terpolymer
(copolymers of glycolide,lactide or dimethyltrimethylene
carbonate), and combinations, mixtures or copolymers thereof.
Examples of nonbiodegradable polymers suitable for use with the
methods and devices described herein include, but are not limited
to poly(ethylene vinyl acetate), poly(vinyl acetate), silicone
polymers, polyurethanes, polysaccharides such as a cellulosic
polymers and cellulose derivatives, acyl substituted cellulose
acetates and derivatives thereof, copolymers of poly(ethylene
glycol) and poly(butylene terephthalate), polystyrenes, polyvinyl
chloride, polyvinyl fluoride, poly(vinyl imidazole),
chorosulphonated polyolefins, polyethylene oxide, and copolymers
and blends thereof.
[0126] In other variations, one or more portions of the device
comprise one or more metals, metallic materials, or metal alloys.
Examples of suitable metals include, but are not limited to zinc,
magnesium, cobalt, chromium, nickel, platinum, stainless steel,
titanium, tantalum, and iron, combinations thereof and the like.
Examples of suitable metal alloys include, but are not limited to,
magnesium, nickel-cobalt alloys, nickel-titanium alloys,
copper-aluminum-nickel alloys, copper-zinc-aluminum-nickel alloys,
combinations thereof and the like. In still other variations, one
or more portions of the device may comprise an elastomeric
material.
[0127] In some variations, one or more portions of the device may
comprise one or more hemostatic agents, which may help to stop or
prevent bleeding. For example, the devices described here may
comprise oxidated cellulose (e.g., OXYCEL.RTM., SURGICEL
NU-KNIT.RTM.), gelatin foams (e.g., GELFOAM.RTM., SURGIFLO.RTM.,
SURGIFOAM.RTM., THROMBIGEL.RTM., THROMBINAR.RTM.), microfibrillar
collagen (e.g., ACTIFOAM.RTM., AVITENE.RTM., COSTASIS.RTM.,
HELISTAT.RTM., INSTAT.RTM.), one or more sealants or adhesives (as
described in more detail below), combinations thereof, and the
like.
[0128] In some variations, one or more portions of the device
comprise a mucoadhesive material or other adhesive material. For
example, some devices comprise one or more mucoadhesive hydrogels,
e.g., PLG polymers, polyacrylic acids, carageenan, alginate,
xantham gum, carboxymethylcellulose, hydroxypropyl cellulose,
chitins, chitosan, hyaluronic acids, lectins, their derivatives,
combinations thereof, and the like. In other variations, the
devices may comprise a fibrin glue, a cyanoacrylate glue,
combinations thereof or the like. When the devices comprise a
fibrin glue, the glue may be formed by mixing fibrinogen and
thrombin. Fibrin glues may further comprise one or more clotting
factors or other components of the clotting cascade (e.g., vitamin
K, calcium, phospholipids, and the like), which may affect the
strength or durability of the resulting polymerized fibrin. The
fibrin glue may further comprise one or more anti-fibrinolytic
agents (e.g., apoprotien), that may affect the rate of
degradation/fibrolysis of the clot These adhesive materials may
additionally be configured to release one or more drugs
therefrom.
[0129] Methods
[0130] Also described here are methods for treating tonsillar
tissue. Generally, the methods described here comprise implanting
or delivering one or more of the devices described above to one or
more areas of tonsillar tissue. For example, in some methods one or
more tissue-piercing devices may be at least partially implanted
into tonsillar tissue. In other methods, one or more clips or
tissue-immobilizing devices may be anchored or otherwise connected
to tissue. In still other methods, a plurality of space filling
implants may be delivered in or around tonsillar tissue. In yet
other methods, one or more gels, foams, patches, meshes, films, or
sheets are implanted in, attached to, or otherwise delivered to
tonsillar tissue. In still other variations, a combination of the
aforementioned devices may be delivered to tonsillar tissue. Any of
these devices may be administered to or implanted in any suitable
area of tonsillar tissues. In some methods, one or more devices are
applied to the tonsils, adenoids, lingual tonsils, or tubal
tonsils. In other methods, one or more devices are applied to one
or more portions of the tonsillar fossa, such as the
palatopharyngeal arch, palatoglossal arch, and superior constrictor
muscle, or other connective or surrounding tissue.
[0131] When one or more of the devices applied here are delivered
to tonsillar tissues, these devices may be delivered to any
suitable tissue at any suitable time. In some methods, one or more
devices are delivered to one or more swollen or infected areas of
tonsillar tissue. In some of these methods, the devices may provide
one or more useful functions (e.g., reduce swelling) in
anticipation of a tonsillar procedure such as a tonsillectomy.
Indeed, in some variations the devices described here may be used
to treat one or more conditions or symptoms associated therewith,
such as, for example tonsillitis, obstructive sleep apnea, or the
like. In other methods, one or more devices are delivered to
tonsillar tissue during a tonsil procedure. For example, after at
least a portion of the palatine tonsils are removed during a
tonsillectomy, one or more devices may be delivered to the exposed
tonsillar bed. In some instances, one or more of the devices may
act to cover or seal the exposed tonsillar bed from external forces
or stimuli. In still other methods, one or more devices are
delivered to tonsillar tissue following a tonsil procedure. This
may provide utility in the continued treatment of post-operative
discomfort following a tonsil procedure. For example, if a patient
is still experiencing discomfort a week after a tonsil procedure,
one or more devices may be delivered to the tonsillar tissue to
provide one or more painkillers. It should be appreciated that the
devices may be delivered to tonsillar tissue at any combination of
the time points described above (e.g., one or more devices are
delivered prior to a tonsil procedure while one or more devices are
delivered during a tonsil procedure, one or more devices are
delivered during a tonsil procedure while one or more devices are
delivered following a tonsil procedure, etc.). It should also be
appreciated that one or more adhesives (e.g., a fibrin glue) may be
used to cover or coat a portion of one or more of the devices
described here, or may be used to help secure one or more of the
devices to tissue. These adhesives may be further configured to
release one or more drugs.
[0132] Generally, the devices described above may be configured to
release one or more drugs to tonsillar tissues. In some variations,
one or more drugs may treat inflammation or swelling of one or more
tonsillar tissues. In other variations, the one or more drugs may
help to aid in post-operative recovery following a tonsil
procedure. More specifically, these methods may comprise
administering one or more antibiotics, painkillers, hemostatic
agents, pro-healing drugs or a combination thereof. As noted above,
the devices may be administered before, during, or after a
tonsillectomy, adenoidectomy, lingual tonsillectomy or any other
tonsil procedure.
[0133] As mentioned above, some methods comprise at least partially
implanting one or more tissue-piercing devices into tonsillar
tissue. Any number of the tissue-piercing devices may be implanted
into tissue, and each tissue-piercing device may have any suitable
configuration of elements as described above. When multiple
tissue-piercing devices are implanted into tonsillar tissue, the
tissue-piercing devices may have the same configuration, or may
have different configurations. When the tissue-piercing devices are
configured to release one or more drugs over a period or periods of
time, the tissue-piercing devices may release the same drugs over
the same periods of time, or may deliver different drugs over
different periods of time. For example, some tissue-piercing device
may be configured to deliver an antibiotic over one period of time
(e.g., 3 days), while others may be configured to deliver one or
more painkillers or local anesthetics over a second period of time
(e.g., 10 days). This potential variability in configurations
between different tissue-piercing devices, as well as variability
in drug-delivery from other devices described here, may grant a
physician considerable leeway in tailoring a treatment regiment for
an individual patient.
[0134] The tissue-piercing devices may be implanted into tissue in
any suitable manner. The tissue-piercing devices may implanted
simultaneously, or sequentially. In some variations, a batch of
tissue-piercing devices are implanted simultaneously, but different
batches are implanted sequentially. In some methods, one or more
tissue-piercing devices may be introduced through a catheter via a
pusher. In other methods, tissue-piercing devices are released from
one or more guns or injector devices. In still other methods, a
plurality of tissue-piercing devices may be released from a holder.
The holder may be any suitable structure that is capable of
releasably housing one or more tissue-piercing devices. A holder
may have any suitable size or shape, and may be able to house any
number of tissue-piercing devices. For example, FIG. 21A shows a
block-shaped holder (2100) that is configured to hold three
filaments (2102), while FIG. 21B shows a cylindrical holder (2104)
configured to hold five filaments (2106).
[0135] A holder may be releasably house at least a portion of one
or more delivery devices. FIG. 22A illustrates a suitable variation
of delivery device (2200). Shown there is handle (2202) and rod
(2204), which is attached a holder (2206) housing a plurality of
tissue-piercing devices (2208). While shown as being straight, rod
(2204) may have one or more curves or angled portion. FIG. 22B
shows one such variation of delivery device (2210) comprising
handle (2212) and rod (2214). Also shown there is holder (2216) and
tissue-piercing devices (2218). While shown in FIG. 22B as having
one angled section (2220), rod (2214) may have any suitable number
of angled or curved sections.
[0136] FIGS. 23A-23C illustrate one method of applying a plurality
of tissue-piercing devices (2300) to tonsillar tissue (2302) from a
holder (2304). Holder (2304) may be attached to any suitable
delivery device, such as those described immediately above. First,
holder (2304) and tissue-piercing devices (2300) are advanced to
tonsillar tissue, as shown in FIG. 23A. The holder (2304) may then
be further advanced, such that one or more of the tissue-piercing
devices (2300) are pushed into the tonsillar tissue (2302), as
shown in FIG. 23B. The tissue-piercing devices (2300) may then be
disengaged from the holder (2304), such that the tissue-piercing
devices are left at least partially implanted in tonsillar tissue
(2302), as shown in FIG. 23C. The tissue-piercing devices (2300)
may be disengaged from holder (2304) in any suitable manner. In
some variations, the delivery device (not shown) may comprise one
or more pushers (not shown) that force the tissue-piercing devices
(2300) from holder (2304). In other variations, the tissue-piercing
devices may be configured to be held inside tissue, as described in
more detail above. Once the tissue-piercing devices (2300) are
inserted into the tonsillar tissue (2302), the tissue-piercing
devices (2300) may resist being pulled out of the tonsillar tissue
(2302). Thus, when holder (2304) is pulled away from tonsillar
tissue (2302), the tissue-piercing devices (2300) may be held in
place such that they disengage from holder (2304).
[0137] FIGS. 24A-24C illustrate another method by which a plurality
of tissue-piercing devices (2400) may be implanted into tonsillar
tissue (not shown). FIG. 24A shows a perspective view of hoop
(2402) comprising apertures (2404). Also shown there are
tissue-piercing devices (2400) at least partially disposed in
apertures (2404). Generally each tissue-piercing device (2400) may
be configured to slide or otherwise move through an aperture (2404)
of hoop (2402). To implant tissue-piercing devices (2400) into
tonsillar tissue, the tissue-piercing devices (2400) and hoop
(2402) may first be placed in an "open" configuration where the
majority of each tissue-piercing implant (2400) resides outside of
the hoop (2402), as shown in a top view in FIG. 24B. The hoop
(2402) may then be placed around a portion of tonsillar tissue, and
the tissue-piercing implants (2400) may be moved to a "closed"
configuration, in which a majority of each tissue-piercing device
(2400) has been advanced into the hoop (2402) via apertures (2404),
as shown in FIG. 24C. Moving tissue-piercing devices (2400) through
apertures (2404) may cause the tissue-piercing devices to penetrate
tonsillar tissue that is positioned inside of hoop (2402). In some
variations, the tissue-piercing devices (2400) may pass entirely
through apertures (2404) such that the hoop (2402) may be removed
while leaving the tissue-piercing devices (2400) implanted in
tissue. In other variations, one or more tissue-piercing devices
(2400) remain connected to hoop (2402) such that hoop (2402) is
held in place against tissue.
[0138] Although the foregoing invention has, for the purposes of
clarity and understanding been described in some detail by way of
illustration and example, it will be apparent that certain changes
and modifications may be practiced, and are intended to fall within
the scope of the appended claims.
* * * * *