U.S. patent application number 12/833504 was filed with the patent office on 2010-11-04 for nasal implant introduced through an injection technique.
Invention is credited to Iyad SAIDI.
Application Number | 20100280611 12/833504 |
Document ID | / |
Family ID | 39226073 |
Filed Date | 2010-11-04 |
United States Patent
Application |
20100280611 |
Kind Code |
A1 |
SAIDI; Iyad |
November 4, 2010 |
NASAL IMPLANT INTRODUCED THROUGH AN INJECTION TECHNIQUE
Abstract
A method for non-surgically treating an internal nasal valve of
a patient comprising, injecting a working device into the internal
nasal valve of the patient, wherein the injected working device in
the nasal tissue causes an alteration of an internal or external
nasal valve. A device introduced by injection into the nose,
allowing for structural support or tilling of defects in the nose,
and causing a change in external shape of the nose. The device and
inserts and implants described also have use in cosmetic
applications relating to the facial tissue.
Inventors: |
SAIDI; Iyad; (Arlington,
VA) |
Correspondence
Address: |
OBLON, SPIVAK, MCCLELLAND MAIER & NEUSTADT, L.L.P.
1940 DUKE STREET
ALEXANDRIA
VA
22314
US
|
Family ID: |
39226073 |
Appl. No.: |
12/833504 |
Filed: |
July 9, 2010 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
12507697 |
Jul 22, 2009 |
|
|
|
12833504 |
|
|
|
|
11898768 |
Sep 14, 2007 |
7780730 |
|
|
12507697 |
|
|
|
|
60846736 |
Sep 25, 2006 |
|
|
|
Current U.S.
Class: |
623/10 |
Current CPC
Class: |
A61F 2/18 20130101; A61F
2/186 20130101; A61F 5/08 20130101 |
Class at
Publication: |
623/10 |
International
Class: |
A61F 2/18 20060101
A61F002/18 |
Claims
1. A delivery system, the delivery system comprising: an
introducing needle; an implant having a length, width and thickness
sized for said implant to reside within soft tissue of a nose and
which will fit within a core of the introducing needle, wherein
said implant has a stiffness to resist bending in the nasal tissue
of the patient, and wherein the implant is structurally preformed
to a desired shape or shapeable after insertion to alter the shape
of tissue within the nose, wherein the implant further includes one
or more sutures to assist in guiding the placement of the
implant.
2. An apparatus for use in the treatment of a nasal valve condition
of a patient's nose where said treatment includes placing an
implant in soft tissue of the nose surrounding the internal nasal
value, said apparatus comprising: an introduction needle configured
to contain the implant, the introduction needle comprising an
advancement shaft, handle portion, and stop mechanism, the stop
mechanism configured to control movement of the advancement shaft;
an implant having a length, width and thickness sized for said
implant to reside within the soft tissue of the nose and which will
fit within a core of the introduction needle, wherein said implant
further has a stiffness to resist bending in the nasal tissue of
the patient, wherein the implant is structurally preformed to a
desired shape or shapeable after insertion to alter the shape of
tissue within the nose, and wherein the implant further comprises
one or more sutures to assist in guiding the placement of the
implant.
3. An apparatus for use in a treatment of a nasal valve collapse
where said treatment includes placing of an implant in a nose, said
apparatus comprising: an introduction needle configured to contain
the implant, the introduction needle comprising an advancement
shaft that controls movement of the implant out of the introduction
needle; an implant having a length, width and thickness sized for
said implant to fit within a core of the introduction needle and to
reside within the nose, wherein said implant is structurally
preformed to a desired shape or shapeable after insertion to alter
the shape of tissue within the nose, wherein the structure is
further selected to have a stiffness that will resist bending of
the nasal tissue of the patient, and wherein the implant further
comprises a suture attached to and extending from each of a first
and second end of the implant to assist in guiding the placement of
the implant.
4. The apparatus according to claim 2, wherein the material for the
implant is a bioabsorbable polymer selected from the group
consisting of Poly-L-lactic acid, Poly-dl-lactic acid,
Poly-e-caprolactone, and Poly-glycolic acid.
5. The apparatus according to claim 2, wherein the material for the
implant is a metal or metal alloy selected from the group
consisting of titanium-containing alloys, platinum-tungsten alloys,
nickel-containing alloys, nickel-titanium alloys, nitinol, and
malleable metals.
6. The apparatus according to claim 2, wherein the material for the
implant is a polymer selected from the group consisting of
polystyrene, polyethylene, and polypropylene.
7. The apparatus according to claim 2, wherein the implant is made
of two or more materials.
8. The apparatus according to claim 2, wherein the implant further
comprises magnetic resonance imaging visible material.
9. The apparatus according to claim 8, wherein the magnetic
resonance imaging visible material comprises bands of material
disposed on either end of the implant.
10. The apparatus according to claim 2, wherein the implant is made
of braided or woven material from a single material, and wherein
the braided or woven material comprises pores configured to allow
ingrowth of tissue after implantation.
11. The system according to claim 1, wherein the implant includes a
suture extending from a trailing end of the implant.
12. The system according to claim 11, wherein the suture is made of
absorbable material.
13. The apparatus according to claim 3, wherein the introduction
needle further comprises a stop mechanism that controls movement of
the advancement shaft after the introduction needle arrives at a
desired location in the nose.
14. The apparatus according to claim 1, wherein the sutures have a
diameter substantially similar to a diameter of the implant.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of and is based upon and
claims the benefit of priority under 35 U.S.C. .sctn.120 for U.S.
Ser. No. 12/507,697, filed Jul. 22, 2009, which is a divisional
application of U.S. Ser. No. 11/898,768, filed Sep. 14, 2007. This
application also claims the benefit of priority under 35 U.S.C.
.sctn.119(e) for U.S. Provisional Application No. 60/846,736, filed
on Sep. 25, 2006. The entire contents of each of these prior
applications are incorporated herein by reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] This invention has been created without the sponsorship or
funding of any federally sponsored research or development
program.
SEQUENCE LISTING OR PROGRAMS
[0003] Not Applicable.
FIELD OF THE INVENTION
[0004] The invention relates to methods, implants, and devices for
non-surgically supporting the nasal valve, and achieving cosmetic
changes to the shape of the nose (e.g., rhinoplasty). The device is
introduced through an injectable method into the nasal tissue, and
by specially designed suture.
BACKGROUND OF THE INVENTION
[0005] The information provided below is not admitted to be prior
art to the present invention, but is provided solely to assist the
understanding of the reader.
[0006] The internal nasal valve is the narrowest point in the nasal
airway and is the point that often limits inspiration flow. A large
percentage of inspiratory resistance is attributable to internal
nasal valve function or malfunction. Collapse of one or both
internal nasal valves is a common cause of nasal airway
obstruction. Narrowness of the nasal valve may lead to difficulty
in respiration and snoring as well as other breathing related
disorders such as sleep apnea. Internal nasal valve collapse can be
a consequence of previous surgery, trauma, aging, or primary
weakness of the upper or lower lateral cartilage and is often
symptomatic and debilitating.
[0007] A description of the nasal valve and its functions are more
fully described in Cole, "The Four Components of the Nasal Valve",
American Journal of Rhinology, Vol. 17, No. 2, pp. 107-110 (2003).
See also, Cole, "Biophysics of Nasal Air Flow: A Review", American
Journal of Rhinology, Vol. 14, No. 4, pp. 245-249 (2000).
[0008] Surgery to strengthen the nasal valve has been shown to
significantly improve quality of life for treated patients. Rhee,
et al., "Nasal Valve Surgery Improves Disease--Specific Quality of
Life", Laryngoscope, Vol. 115, pp. 437-440 (2005). The most common
procedure for treating nasal valve collapse is the so-called alar
batten grafting. In batten grafting, a patient's cartilage is
harvested from any one of a number of locations such as the nasal
septum or the ear. The cartilage is sculpted to an appropriate size
and shaped and beveled on the edges for improved cosmetics. The
batten graft is placed in the desired location of the nasal passage
through either an external or endonasal approach. A pocket is
formed overlying the cartilages of the nose with the pocket sized
to receive the batten graft. Placement of the batten graft is shown
in FIG. 4 (page 577) of Millman, et al., "Alar Batten Grafting for
Management of the Collapsed Nasal Valve", Laryngoscope, Vol. 112,
pp. 574-579 (2002). Other nasal valve surgeries are described in
Kalan, et al., "Treatment of External Nasal Valve (Alar Rim)
Collapse with an Alar Strut", Journal of Laryngology and Otology,
Vol. 115, pages 788-791 (2001); Karen, et al., "The Use of
Percutaneous Sutures for Graft Fixation in Rhinoplasty", Archives
Facial Plastic Surgery, Vol. 5, pp. 193-196 (2003) and Fanous,
"Collapsed Nasal-Valve Widening by Composite Grafting to the Nasal
Floor", Journal of Otolaryngology, Vol. 25, No. 5, pp. 313-316
(1996).
[0009] The harvesting of a portion of the patient's natural
cartilage is an additional procedure and requires sculpting or
other modification of the graft prior to use. Accordingly,
surgically implanted synthetic nasal dilators, and non-surgical
external dilators and cones have been suggested. An example of a
surgically implanted dilator is found in U.S. Pat. No. 6,106,541 to
Hurbis dated Aug. 22, 2000. In the '541 patent, the nasal dilator
has a V-shape with an apex placed over the bridge of the nose to
support the nasal tissue at the area of the internal valve. Other
examples include U.S. Pat. No. 6,322,590 to Sillers et al., dated
Nov. 27, 2001. However, use of such devices require an open
surgical technique for insertion.
[0010] External (non-implanted) nasal dilators which are placed
temporarily, and are removed by the patient are also available.
Such external devices are possibly placed on the outside surface of
the nose such as the "Breathe Right strips, U.S. Pat. No.
5,533,440, or U.S. Pat. No. 7,114,495 by Lockwood. Other devices
may be placed in the nasal cavity (but not implanted in the nose),
such as U.S. Pat. No. 7,055,523 given to Brown, and U.S. Pat. No.
6,978,781 given to Jordan. However, such devices can be
uncomfortable, unsightly, and require the patient to remove and
replace the device on a periodic basis.
[0011] Therefore, there is an urgent need for identifying methods
and systems for repairing nasal valves and related nasal
structures, including the repairing of the internal nasal valve
collapse, which would eliminate the need for invasive surgical
techniques. And thus eliminating risks and costs of general
anesthesia and operating room expenses, and shorten recovery
periods. It is also desirable to identify methods and systems that
are implanted within the nose, eliminating the need for disposable
external devices.
[0012] Unlike previous implant methods known and described, the
implant of this invention is inserted by means of an injection
technique, and does not require surgical incisions. It is inserted
percutaneously or transmucosally, usually under local anesthetic
only. The implant may have different shapes and/or physical
properties than previous implants described. This allows for it to
be inserted by means of a non surgical technique, and the position
may be adjusted initially after placement. One aspect of the
invention would permit the implant to be adjusted after
implantation.
[0013] Unlike previous nasal strips and dilators, the current
invention provides a device and means whereby the device(s) is
embedded within the tissue of the nose. It is designed to be
permanent or long lasting. It is not visible externally, and does
not require the replacement or the adjustment by the patient and/or
the physician.
BRIEF SUMMARY OF THE INVENTION
[0014] Objects of the present invention include providing a method
and system for treating internal nasal valve collapse. According to
the present invention, this is achieved by non-surgical or
minimally invasive treatment. Treatment of the internal nasal valve
includes injecting a working implant into the tissue of the
patient, affecting the internal nasal valve of the patient. The
injection of the implant of this invention into the tissue
surrounding internal nasal valve, according to the invention,
causes an alteration or a change in the internal nasal valve
angle.
[0015] In certain embodiments, the increase in internal nasal valve
angle is affected by the working device which causes an increase in
the structural strength of the tissue surrounding the nasal valve,
thus preventing the tissue from collapsing during inspiration.
[0016] In another embodiment, the working device is injected into
more lateral structures of the nose which causes adjustment of the
position of the lateral aspect of the lateral nasal cartilage
whereby affecting the external nasal valve.
[0017] In another embodiment, the working device is injected into
more lateral structures of the nose, strengthening the lateral
nasal cartilage, supporting the external nasal valve, and
preventing collapse during inspiration.
[0018] In another embodiment, the working device is injected into
more lateral structures of the nose, strengthening the attachments
of lateral nasal cartilage to the bone adjacent to the piriform
aperture, and supporting the external nasal valve, and preventing
collapse during inspiration.
[0019] In another embodiment, the treatment method includes
inserting an implant adjacent to lower lateral cartilage, the nasal
dorsum, the paramedian tissue of the nasal dorsum, or the
collumella to change the external shape of the nose.
[0020] In another embodiment, the implant is cylindrical in shape,
though other shapes have also been described and fall within the
scope of the present invention. The size is selected such that the
implant can fit in the core of a needle (similar to a hypodermic
needle). It is introduced into the nasal tissue by inserting the
needle into the desired location. The implant is then maintained in
that position by application of gentle pressure on the implant by
an advancement shaft as the needle is withdrawn.
[0021] In another embodiment the implant has variable physical
properties, depending on the particular application. Implants may
have a rigid or flexible shape or configuration. The insert may be
moldable such that the shape is changed and maintained just before
or after implantation, or later modified as desired by the patient
or as needed to obtain the results desired. Furthermore, implants
can have shape-memory, with a tendency to return to its preset
shape when deflected.
[0022] In another embodiment of the invention, the invention
relates to an injection device for introducing the implant, which
comprises of an introduction needle containing the implant.
[0023] In another embodiment the implant may have sutures attached
at either or both ends, and a separate guiding needle attached to
at least one end of one of the sutures. This needle may be passed
along the desired path of the implant. The attached sutures can
then be used to guide the implantation of the implant, and to
adjust position in the tissue immediately after implantation. These
sutures may then be trimmed as needed.
[0024] The treatment method, according to embodiments of the
invention, may be used to treat, nasal snoring, sleep apnea, and/or
internal nasal valve collapse.
[0025] In another embodiment, a system for non-surgically treating
the nasal valves of a patient or changing the shape of the nose
includes an introducing needle, an implant present within the
needle, an advancement shaft, and a handle portion. In certain
embodiments of the invention, there may be a stop element to
possibly control the movement of the advancement shaft after the
introduction needle containing the implant is placed in the desired
location.
[0026] In another embodiment, the system includes a pre-loaded
syringe with a working device. In one embodiment, the working
device is comprising a solid or a semi-solid material, or a hollow
or a non-hollow cylinder of material. In another embodiment, the
working device is comprising a woven mesh of material,
biodegradable material, or a combination thereof.
[0027] In certain embodiments, the nasal implant proposed is an
implant introduced into the nose through an injection technique,
either transmucosally from inside the nose, or transcutaneously,
from outside the nose.
[0028] The implant of the present invention is intended for
insertion into the nose tissue and serves to augment or modify the
structure of the nose and the nasal or flow passages. The implant
provides support of nasal valves in the nose and may serve to fill
defects and/or supplement or modify the contour of the nose in the
manner desired for the purpose. The implant is introduced into a
desired location within the nose or nasal passageway using an
injection method. The implant is first incorporated into an
injection device. The injection device may include a stop mechanism
which serves to indicate when the implant is fully implanted.
[0029] The implant may be of any appropriate shape, including a
cylindrical, an oval, or a rectangular and may include one or more
tapered ends
[0030] The implant of the present invention may be malleable, which
would permit the shape of the implant to be adjusted before or
after implantation. While not required, it may be preferred to use
an implant made of a material which has shape memory properties.
This property would permit the shape memory properties to be
activated, or adjusted after implantation with the application of
an external condition, such as temperature, magnetic field, or
light.
[0031] In another embodiments of the invention, the implant may
have spring like properties.
[0032] In another embodiments of the invention, the implant may be
manufactured from a solid material, a composite of materials and
may be a single material or may be a composite of one or more
materials. The implant may be in the form of a rod or rod-like
structure or may have a woven or braided structure. The implant may
be woven or braided with several materials. In addition, the
implant may be manufactured with biodegradable materials, including
those with shape memory.
[0033] The implant may be introduced or injected through a
transmucosal or transcutaneous route. The implant may be implanted
within soft tissue of the nose in a location appropriate to provide
the desired effect or result. When implanted into the soft tissue
of the nose, the implant may serve to support the soft tissue
relative to the underlying bone structure. Further, the implant may
be used to augment the lower lateral cartilages of the nose. In
another aspect of the invention the implant may be placed in the
nose superior or inferior to the nasal cartilage. Further it may be
placed in a manner which will serve to augment the dorsum of the
nose, or the collumella and may additionally be placed in a
paramedian location in the nose.
[0034] In another embodiment, the implant along with the inserting
device and may be altered to be used in other areas of the body
such as, but not limited to, naso-labial folds, lips, and
marrienette lines.
[0035] One embodiment of the invention is to provide a non-surgical
approach for treating and eliminating these cosmetic conditions
whether related to nasal valve problems or any other cosmetic
related conditions.
[0036] The implant may be introduced into the desired location
using a pull through technique, a guiding needle, or a combination
of such techniques. The implant may he provided separately or with
an injection device Where desired the implant may incorporate a
special pull through suture. The implant may additionally include a
trailing suture. Where a pull through needle or trailing suture is
used, both may be made or manufactured using materials which are
dissolvable after the implant process is completed.
DESCRIPTION OF THE FIGURES
[0037] A more complete appreciation of the invention and many of
the attendant advantages thereof will be readily obtained as the
same becomes better understood by reference to the following
detailed description when considered in connection with the
accompanying drawings, wherein:
[0038] FIG. 1 is a perspective view of the front, top and left side
of a patient's nose showing skeletal components and cartilages.
Labeled are the Nose (N), Nasal bone (NB), Left upper cartilage
(LUC), Right upper lateral cartilage (RUC), septal cartilage (SC),
Right lower lateral cartilage (RLC), and Left lower lateral
cartilage (LLC), and Left accessory nasal cartilage (LANC).
[0039] FIG. 2 is a bottom plan view of the components of FIG. 1; In
addition to the labels above, the Medial Crus (MC) and Lateral Crus
(LC) are labeled, which together comprise the lateral cartilage.
The Right Nose (RN) and Left nose (LN) are also labeled.
[0040] FIG. 3 is a right side elevation view of the components of
FIG. 1; In this illustration, in addition to the labels above, the
Right accessory nasal cartilage (RANC) is shown.
[0041] FIG. 4 is an oblique lateral view of the nasal structures.
The nasal dorsum has both a bony and a cartilaginous component to
give the nose the lateral profile. The upper lateral cartilage
(ULC), and lower lateral cartilages (LLC) are labeled, and give the
nose its structure. The Maxillary bone (MB) is the bone of the
maxilla adjacent to the nose. The nasal shape and valve is also
affected by the strength of the attachment of the lower lateral
cartilage to the maxillary bone.
[0042] FIG. 5 is a bottom plan view of the nose showing the
relation of the lower lateral cartilage (LLC) to the Medial
cartilage (MC) and both their relationship to the nasal airway
(NA). The Right nasal airway (RNA), and left nasal airway (LNA) are
illustrated.
[0043] FIG. 6 is a cross sectional view of the nose. The Lateral
cartilage (LC) refers to either the upper or lower lateral
cartilage, depending on the area of collapse. The Nasal valve angle
(NVA) is the angle created by the lateral cartilage and the septum
(S). The lateral cartilage in this case is thinner, and weaker, and
there is corresponding narrowing of the nasal airway (NA) due to
collapse and narrowing of the nasal valve.
[0044] FIG. 7 is a cross sectional view of the nose after
implantation of an implant (I). The Lateral cartilage (LC) is
supported by the implant, (I). The Nasal valve angle (NVA) is thus
supported from collapsing during inspiration, widening the nasal
airway (NA). In this case the implant is implanted on the outer
surface of the lateral cartilage and septum (S).
[0045] FIG. 8 is an oblique lateral view of the nasal structures
after implantation of an two implants acting as a batten grafts.
The lower lateral cartilages (LLC) and Maxillary bones (MB) are
labeled. The implants (I1) and (I2) give support to the lateral
edge of the lower lateral cartilage, and strengthen its attachments
to the maxillary bone. In this illustration, the implant I1 is
situated medial to the lower lateral cartilage, but overlying the
maxillary bone, while implant I2 is placed lateral to the lower
lateral cartilage, and also lateral to the maxillary bone.
[0046] FIG. 9 is an oblique lateral view of the nasal structures
after implantation of the proposed implants into other areas of the
nose to achieve structural and cosmetic changes in the nose, not
necessarily related to the nasal valve. Some of the implant
locations proposed here and included for illustration purposes are:
dorsal implants (DI), used to modify the dorsal profile of the
nose; Inferior Lower lateral cartilage Implant (ILLCI), which
strengthens the lower lateral cartilage shape and form, thus also
affecting the shape of the nose, and of the nasal tip; and Superior
Lower Lateral Cartilage implant (SLLCI) also used to modify the
shape of the lower lateral cartilage, and the nasal form; and a
Collumella Implant (CI) used to give support to the collumella.
[0047] FIG. 10 is an oblique lateral view of the nasal structures
after implantation of the proposed implants into further areas of
the nose to achieve structural and cosmetic changes in the nose.
Shown here is an implant that is can be used as a Total Dorsal
Profile Implant (TDPI), Paramedian Implants (PI), and Tip Implants
(TI).
[0048] FIG. 11. The proposed modification to the nasal implant,
where the implant, (c), has attached to it a guiding needle, (a), a
"pull through" suture, (b), and a trailing suture, (d).
[0049] FIG. 12. The introducing device composed of the implant (d)
placed in an introducing needle (e). There is the advancement shaft
(c) which is used to advance the implant (d), into the desired
location. The stop (b) prevents the thumb control (a) and
advancement shaft (c) from advancing after the implant is expressed
from the introducing needle, and placed in the desired location in
the tissue. In the attachments FIGS. 12A and B show an alternate
arrangement in which the injector device (A) and the introduction
needle and implant (B) are packaged separately, but can be attached
through a locking attachment (f).
[0050] FIG. 13 Representative shapes of the nasal implants. The
implants in general is elongated in shape having a length and side
profile as shown in [FIG. 13a]. The side profile may be oval in
shape (FIG. 13b), rectangular or oblong (FIG. 13c), or have tapered
at the ends (FIG. 13d). Furthermore, it may be a hollow cylinder,
or made of two or more materials (FIG. 13e).
[0051] FIG. 14. The standard introduction method of the implant, in
this case implanted into the lateral nose, to support the external
nasal valve. In FIG. 14-1 the introduction needle containing the
implant is first introduced through the nasal mucosa, and deep to
the lower lateral cartilage. The introduction needle is then
advanced into the desired location for the implant (FIG. 14-2). The
introduction needle is then withdrawn, as the implant is maintained
in position by advancing the advancement shaft (FIG. 14-3). After
removal of the introduction needle, the implant is now present in
the desired location (FIG. 14-4). In certain situations, the
implants shape may then be adjusted after implantation to assume
the desired shape (FIG. 14-5).
[0052] FIGS. 15(a)-(b). The introduction method using the
additional introduction modification shown in FIG. 11. In FIG.
15(a)-1 through 15(a)-3, the guiding needle is first introduced and
passed to along the path through which the implant will be placed.
The "pull through" suture is then advanced. The implant is then
advanced, usually with the guide of an introduction needle system
as shown in FIG. 15(b)-4. The introduction needle is removed while
the advancement shaft is advanced to maintain the implant in the
desired location (FIG. 15(b)-5). The pull through and trailing
sutures may then used to finely adjust the position of the implant
after implantation (FIG. 15(b)-6). The sutures are then cut of at
the skin or mucosal surface FIG. 15(b)-7).
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0053] Referring now to the drawings, wherein like reference
numerals designate identical or corresponding parts throughout the
several views.
[0054] Before the subject invention is described further, it is to
be understood that the invention is not limited to the particular
embodiments of the invention described below, as variations of the
particular embodiments may be made and still fall within the scope
of the appended claims. It is also to be understood that the
terminology employed is for the purpose of describing particular
embodiments, and is not intended to be limiting. Instead, the scope
of the present invention will be established by the appended
claims.
[0055] In this specification and the appended claims, the singular
forms "a," "an" and "the" include plural reference unless the
context clearly dictates otherwise. Unless defined otherwise, all
technical and scientific terms used herein have the same meaning as
commonly understood to one of ordinary skill in the art to which
this invention belongs.
[0056] Where a range of values is provided, it is understood that
each intervening value, to the tenth of the unit of the lower limit
unless the context clearly dictates otherwise, between the upper
and lower limit of that range, and any other stated or intervening
value in that stated range, is encompassed within the invention.
The upper and lower limits of these smaller ranges may
independently be included in the smaller ranges, and are also
encompassed within the invention, subject to any specifically
excluded limit in the stated range. Where the stated range includes
one or both of the limits, ranges excluding either or both of those
included limits are also included in the invention.
[0057] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood to one of
ordinary skill in the art to which this invention belongs. Although
any methods, devices and materials similar or equivalent to those
described herein can be used in the practice or testing of the
invention, the preferred methods, devices and materials are now
described.
[0058] All publications mentioned herein are incorporated herein by
reference for the purpose of describing and disclosing the subject
components of the invention that are described in the publications,
which components might be used in connection with the presently
described invention.
[0059] The information provided below is not admitted to be prior
art to the present invention, but is provided solely to assist the
understanding of the reader.
[0060] The details of one or more embodiments of the invention are
set forth in the accompanying drawings and the description below.
Other features, objects, and advantages of the invention will be
apparent from the description and drawings, and from the
claims.
[0061] The structure of the lower two thirds of the nose is
determined primarily by the nasal septal cartilage, and paired
upper and lower lateral cartilages, covered by a soft tissue
envelope [FIGS. 1-4]. Structural weakness of these cartilages, or
their attachments may result in deleterious functional and cosmetic
changes to the nose. The nasal valves may collapse contributing to
a dynamic nasal obstruction. Internal and external nasal valves
exist.
[0062] The internal nasal valves are formed by the angle of the
septum and the lower edge of the upper lateral cartilage [FIG. 5].
During inspiration, air flow creates a negative pressure on the
cartilage, resulting in a collapse of the nasal walls, as seen in
FIG. 6. This leads to nasal obstruction. In some cases there may
also be collapse of the nasal valve at rest, resulting in a
constricted airway even at rest which is further exacerbated with
inspiration.
[0063] The external valve is formed by the shape of the lower
lateral cartilage, and the strength of the attachments of these
lower lateral cartilages to the lateral anterior maxillary bone.
Weakening of this lateral cartilage also leads to airway
obstruction which is exacerbated with inspiration.
[0064] Nasal patency is critical to the airway, and nasal
obstruction can contribute to snoring, sleep apnea, and disrupted
sleep. The patency of a good nasal airway is also critical for the
growing number of people using continuous positive airway pressure
(CPAP) for sleep apnea.
[0065] Collapse and weakening of the nasal cartilage can also lead
to external deformities and cosmetic changes to the nose. Loss of
support and volume of the lower lateral cartilages, mid-nasal
portion or the dorsum can lead to undesirable cosmetic changes.
Relative tissue defects on the dorsum of the nose may lead to an
irregular nasal profile. These cosmetic differences have
traditionally been addressed by surgical rhinoplasty.
[0066] Common causes of nasal cartilage and nasal valve collapse
today are prior surgery or trauma that weakens the cartilage, age,
or congenital weakness of the nasal cartilage.
[0067] Current therapies to correct nasal valve collapse include
several non-surgical and surgical devices and techniques.
Non-surgical devices include external splints placed on the nasal
surface which splay the lateral nasal walls outwardly, thus
widening the nasal airway. External strips are such an external
device (U.S. Pat. Nos. 5,533,440, 6,238,411, 6,982,359, 7,114,495).
Other devices previously proposed include cone shaped applicators
placed into the nostril, or dilators having a variety of proposed
shapes (U.S. Pat. Nos. 7,055,523, 6,978,781).
[0068] Surgical therapies for repair of the valve collapse include
insertion of spreader grafts (for internal valve collapse), batton
grafts (for external valve collapse), or suspension sutures. These
are placed through surgical incision techniques, or external
rhinoplasty approach. The grafts are most commonly harvested from
septal or auricular cartilage.
[0069] Implants (e.g., stents) made from alloplastic materials
inserted surgically through an external approach have also been
described (U.S. Pat. Nos. 6,106,541, 6,454,803, 6,322,590,
2,173,848). These prevent the morbidity or limitations of
homografts, but still require an incision surgical technique for
placement.
[0070] Implants introduced through injection technique have been
introduced into the palate and used for the treatment of snoring
and sleep apnea (U.S. Pat. No. 7,077,144).
[0071] With reference to the figures provided herewith, in which
identical elements are numbered identically throughout, a
description of the preferred embodiment of the present invention
will now be provided.
A. Anatomy
[0072] Before proceeding with a description of the apparatus and
method of the present invention, a review of relevant anatomy will
facilitate an understanding of the present invention. FIGS. 1-3
show in perspective, bottom plan and right side elevation,
respectively, components of the nose with skeletal muscle, soft
tissue (such as external skin or nasal mucosa) and blood vessels
removed.
[0073] The nose N includes nasal bone NB at an upper end of the
nose. The bottom of the nose N includes the lower cartilage also
referred to as the major alar cartilage. There is both a right
lower cartilage RLC and a left lower cartilage LLC, which are
generally symmetrical in structure.
[0074] The lower cartilages RLC, LLC include an external component
referred to as the lateral crus LC and an internal component
referred to as the medial crus MC. The medial crus and septal nasal
cartilage create a nasal septum NS divide the nose N into a left
nostril LN and a right nostril RN.
[0075] Upper cartilages reside between the lower cartilages and the
nasal bones NB. The upper cartilages include both a right upper
cartilage RUC and a left upper cartilage LUC separated by a septal
cartilage SC extending down the bridge of the nose N. The opposing
edges of the lower cartilage LLC, RLC and upper cartilage LUC, RUC
may move relative to one another. Disposed between the opposing
edges is an accessory nasal cartilage (left and right) LANC,
RANC.
[0076] When congested, during inhalation, airflow through the
nostrils creates an inward pressure at the junction between the
upper and lower cartilages. This pressure is expressed as a
function of nasal resistance which is estimated as 10 centimeters
of water per one liter per second. Cole, "The Four Components of
the Nasal Valve", American Journal of Rhinology, pages 107-110
(2003).
[0077] In response to these forces, a weakened nasal valve may
collapse inwardly as illustrated in FIG. 6. In FIG. 6, it will be
appreciated that the inward deflection is exaggerated for ease of
illustration. It will be noted with reference FIG. 5 that the
narrow angle between the LLC and the MC illustrated in FIG. 6, and
the relative weakness of the LLC contribute to the inward
deflection and collapse of the airway.
B. Implant
[0078] 1. The Implant:
[0079] The implant to be used in the present invention should be
adapted for deployment in a nose. Thereto, the implant should be
adapted for introduction into the nose of a patient, to be reliably
positioned or installed within said nose and/or to be retained in
said nose. The adaptation may be such that the form (or shape) of
the implant is adapted or preformed to the anatomy of the nose for
which it is intended. For example, the location in the nose and the
required effect (e.g. bulking only or stiffening) may dictate that
different shaped implants, or implants with different materials be
used. The implant is self-holding when imbedded in the tissue.
[0080] Implants that can be used in the present invention include
metallic implants, polymeric implants, biodegradable implants and
covered or coated implants. They may be composed of a variety of
metal compounds and/or polymeric materials, fabricated in
innumerable designs, composed of degradable and/or nondegradable
components, fully or partially covered with graft materials (such
as the so called "covered stents") or "sleeves", and can be bare
metal or drug-eluting.
[0081] The implants may be comprised of a metal or metal alloy such
as stainless steel, spring tempered stainless steel, stainless
steel alloys, gold, platinum, super elastic alloys, cobalt-chromium
alloys and other cobalt-containing alloys (including ELGILOY
(Combined Metals of Chicago, Grove Village, Ill.), PHYNOX (Alloy
Wire International, United Kingdom) and CONICHROME (Carpenter
Technology Corporation, Wyomissing, Pa.)), titanium-containing
alloys, platinum-tungsten alloys, nickel-containing alloys,
nickel-titanium alloys (including nitinol), malleable metals
(including tantalum); a composite material or a clad composite
material and/or other functionally equivalent materials; and/or a
polymeric (non-biodegradable or biodegradable) material.
Representative examples of polymers that may be included in the
implant construction include polyethylene, polypropylene,
polyurethanes, polyesters, such as polyethylene terephthalate
(e.g., DACRON or MYLAR (E. I. DuPont De Nemours and Company.
Wilmington, Del.)), polyamides, polyaramids (e.g., KEVLAR from E.I.
DuPont De Nemours and Company), polyfluorocarbons such as
poly(tetrafluoroethylene with and without copolymerized
hexafluoropropylene) (available, e.g., under the trade name TEFLON
(E. I. DuPont De Nemours and Company), silk, as well as the
mixtures, blends and copolymers of these polymers. Stents also may
be made with engineering plastics, such as thermotropic liquid
crystal polymers (LCP), such as those formed from
p,p'-dihydroxy-polynuclear-aromatics or
dicarboxy-polynuclear-aromatics.
[0082] Further types of implants (e.g., stents) that can be used
with the described therapeutic agents are described, e.g., in PCT
Publication No. WO 01/01957 and U.S. Pat. Nos. 6,165,210;
6,099,561; 6,071,305; 6,063,101; 5,997,468; 5,980,551; 5,980,566;
5,972,027; 5,968,092; 5,951,586; 5,893,840; 5,891,108; 5,851,231;
5,843,172; 5,837,008; 5,766,237; 5,769,883; 5,735,811; 5,700,286;
5,683,448; 5,679,400; 5,665,115; 5,649,977; 5,637,113; 5,591,227;
5,551,954; 5,545,208; 5,500,013; 5,464,450; 5,419,760; 5,411,550;
5,342,348; 5,286,254; and 5,163,952. Removable drug-eluting stents
are described, e.g., in Lambert, T. (1993) J. Am. Coll. Cardiol.:
21: 483A. Moreover, the stent may be adapted to release the desired
agent at only the distal ends, or along the entire body of the
stent.
[0083] In addition to using the more traditional stents, stents
that are specifically designed for drug delivery can be used.
Examples of these specialized drug delivery stents as well as
traditional stents include those from Conor Medsystems (Palo Alto,
Calif.) (e.g., U.S. Pat. Nos. 6,527,799; 6,293,967; 6,290,673;
6,241,762; U.S. Patent Application Publication. Nos. 2003/0199970
and 2003/0167085; and PCT Publication No. WO 03/015664).
[0084] Other examples of stents that can be used in accordance with
the invention include those from Boston Scientific Corporation,
(e.g., the drug-eluting TAXUS EXPRESS.sup.2Paclitaxel-Eluting
Coronary Stent System; over the wire stent stents such as the
Express' Coronary Stent System and NIR Elite OTW Stent System;
rapid exchange stents such as the EXPRESS.sup.2 Coronary Stent
System and the NIR ELITE MONORAIL Stent System; and self-expanding
stents such as the MAGIC WALLSTENT Stent System and RADIUS Self
Expanding Stent); Medtronic, Inc. (Minneapolis, Minn.) (e.g.,
DRIVER ABT578-eluting stent, DRIVER ZIPPER MX Multi-Exchange
Coronary Stent System and the DRIVER Over-the-Wire Coronary Stent
System; the S7 ZIPPER MX Multi-Exchange Coronary Stent System; S7,
S670, S660, and BESTENT2 with Discrete Technology Over-the-Wire
Coronary Stent System); Guidant Corporation (e.g., cobalt chromium
stents such as the MULTI-LINK VISION Coronary Stent System;
MULTI-LINK ZETA Coronary Stent System; MULTI-LINK PIXEL Coronary
Stent System; MULTI-LINK ULTRA Coronary Stent System; and the
MULTI-LINK FRONTIER); Johnson & Johnson/Cordis Corporation
(e.g., CYPHER sirolimus-eluting Stent; PALMAZ-SCHATZ Balloon
Expandable Stent; and S.M.A.R.T. Stents); Abbott Vascular (Redwood
City, Calif.) (e.g., MATRIX LO Stent; TRIMAXX Stent; and DEXAMET
stent); Conor Medsystems (Menlo Park, Calif.) (e.g., MEDSTENT and
COSTAR stent); AMG GmbH (Germany) (e.g., PICO Elite stent);
Biosensors International (Singapore) (e.g., MATRIX stent, CHAMPION
Stent (formerly the S--STENT), and CHALLENGE Stent); Biotronik
(Switzerland) (e.g., MAGIC AMS stent); Clearstream Technologies
(Ireland) (e.g., CLEARFLEX stent); Cook Inc. (Bloomington, Ind.)
(e.g., V-FLEX PLUS stent, ZILVER PTX self-expanding vascular stent
coating, LOGIX PTX stent (in development); Devax (e.g., AXXESS
stent) (Irvine, Calif.); DISA Vascular (Pty) Ltd (South Africa)
(e.g., CHROMOFLEX Stent, S-FLEX Stent, S-FLEX Micro Stent, and
TAXOCHROME DES); Intek Technology (Baar, Switzerland) (e.g., APOLLO
stent); Orbus Medical Technologies (Hoevelaken, The Netherlands)
(e.g., GENOUS); Sorin Biomedica (Saluggia, Italy) (e.g., JANUS and
CARBOSTENT); and stents from Bard/Angiomed GmbH Medizintechnik KG
(Murray Hill, N.J.), and Blue Medical Supply & Equipment
(Marietta, Ga.), Aachen Resonance GmbH (Germany); Eucatech AG
(Germany), Eurocor GmbH (Bonn, Gemany), Prot, Goodman, Terumo
(Japan), Translumina GmbH (Germany), MIV Therapeutics (Canada),
Occam International B.V. (Eindhoven, The Netherlands), Sahajanand
Medical Technologies PVT LTD. (India); AVI
Biopharma/Medtronic/Interventional Technologies (Portland, Oreg.)
(e.g., RESTEN NG-coated stent); and Jomed (e.g., FLEXMASTER
drug-eluting stent) (Sweden). Other types of stents can be in
US20060147492A1: Medical implants and anti-scarring agents. The
entire content of US20060147492A1 is incoportated herein by
reference.
[0085] Generally, the implants are inserted in a similar fashion
regardless of the site or the disease being treated. Briefly, a
preinsertion examination is conducted by direct visualization,
possible endoscopy, and rarely diagnostic imaging. The areas of
structural defects, volume defects, of dynamic collapse of the nose
are noted. The implant size and material is selected to suit the
particular application, where more than one implant material and
size may be available.
[0086] Topical local anesthetic may be applied by a combination of
topical anesthetic cream applied to the skin (e.g. 4% lidocaine
cream available commercially) and/or topical anesthetic solution
(e.g 4% lidocaine solution) applied on a cotton pledget in the
nasal cavity. Local anesthetic may be infiltrated directly in the
area where the implant will be placed, or also injected to perform
regional blocks, such as an infraorbital nerve block.
[0087] The implant is then introduced through an injection
technique as illustrated in this patent (for example, see FIG. 14).
The implant is introduced through the injection method into the
desired location in the nasal tissues. The introducing needle is
gradually withdrawn, while the implant is maintained in its desired
position by means of the advancement shaft of the introduction
device. Generally, the puncture site performed by the introduction
needle is small, and does not require repair.
[0088] After insertion, the implant shape may be adjusted manually.
In some situations a special condition is applied to allow for
adjustment of the shape of the implant. For example, in the case of
an implant with certain physical properties, heat may be applied by
external application of a heating pad to the nose. This is
transmitted through the tissue to the implant which raises its
temperature. The shape of the implant is then adjusted to the
desired shape, and the external heat source is removed. The implant
then maintains this new shape as it is cools.
[0089] A post insertion examination, is performed to visually
confirm that the desired structural and shape change to the nose
has been achieved. Rarely, diagnostic imaging or endoscopy may also
be used at this stage.
[0090] Implants are typically maneuvered into place directed by
visual and tactile control. In certain aspects, the implant (e.g.,
stent) can further include a radio-opaque, echogenic material, or
MRI responsive material (e.g., MRI contrast agent) to aid in
visualization of the device under ultrasound, fluoroscopy and/or
magnetic resonance imaging. The radio-opaque or MRI visible
material may be in the form of one or more markers (e.g., bands of
material that are disposed on either end of the implant).
[0091] As suitable implant materials, both organic and inorganic
materials, as well as combinations thereof may be used. The
material of the implant may be solid, (e.g. titanium, nitinol, or
Gore-tex), braided or woven from a single material (such as
titanium, or Polyethylene Terephthalate, or a combination of
materials). The woven materials may have pores which allow ingrowth
of tissue after implantation. It may be manufactured from
biodegradable materials (e.g poly-L lactic, Poly-D lactic, and
poly-L glycolic acid) which will gradually absorb after
implantation. It may be malleable, allowing adjustment of the shape
before, or after implantation.
[0092] Synthetic polymers provide for very suitable organic implant
(e.g., stent) materials. Advantages of such polymers include the
ability to tailor mechanical properties and degradation kinetics to
suit various applications. Synthetic polymers are also attractive
because they can be fabricated into various shapes. Numerous
synthetic polymers can be used to prepare synthetic
polymer-comprising stents useful in aspects of the invention. They
may be obtained from sources such as Sigma Chemical Co., St. Louis,
Mo., Polysciences, Warrenton, Pa., Aldrich, Milwaukee, Wis., Fluka,
Ronkonkoma, N.Y., and BioRad, Richmond, Calif.
[0093] Representative synthetic polymers include alkyl cellulose,
cellulose esters, cellulose ethers, hydroxyalkyl celluloses,
nitrocelluloses, polyalkylene glycols, polyalkylene oxides,
polyalkylene terephthalates, polyalkylenes, polyamides,
polyanhydrides, polycarbonates, polyesters, polyglycolides,
polymers of acrylic and methacrylic esters, polyacrylamides,
polyorthoesters, polyphe azenes, polysiloxanes, polyurethanes,
polyvinyl ohols, polyvinyl esters, polyvinyl ethers, polyvinyl
halides, polyvinylpyrrolidone, poly(ether ether ketones,
silicone-based polymers and blends and copolymers of the above. The
stent may comprise both oligomers and polymers of the above.
[0094] Specific examples of these broad classes of polymers include
poly(methyl methacrylate), poly(ethyl methacrylate), poly(butyl
methacrylate), poly(isobutyl methacrylate), poly(hexyl
methacrylate), poly(isodecyl methacrylate), poly(lauryl
methacrylate), poly(phenyl methacrylate), poly(methyl acrylate),
poly(isopropyl acrylate), poly(isobutyl acrylate), poly(octadecyl
acrylate), polyethylene, polypropylene, poly(ethylene glycol),
poly(ethylene oxide), poly(ethylene terephthalate), poly(vinyl
alcohols), poly(vinyl acetate), poly(vinyl chloride), polystyrene,
polyurethane, poly(lactic acid), poly(butyric acid), poly(valeric
acid), poly[lactide-co-glycolide], poly(fumaric acid), poly(maleic
acid), copolymers of poly (caprolactone) or poly (lactic acid) with
polyethylene glycol and blends thereof.
[0095] The polymers used in implants (e.g., stents) may be
non-biodegradable. Examples of preferred non-biodegradable polymers
include ethylene vinyl acetate (EVA), poly(meth)acrylic acid,
polyamides, silicone-based polymers and copolymers and mixtures
thereof.
[0096] Polymers used in implants (e.g., stents) may also be
biodegradable. The rate of degradation of the biodegradable stent
is determined by factors such as configurational structure,
copolymer ratio, crystallinity, molecular weight, morphology,
stresses, amount of residual monomer, porosity and site of
implantation. The skilled person will be able to choose the
combination of factors and characteristics such that the rate of
degradation is optimized.
[0097] Examples of preferred biodegradable polymers include
synthetic polymers such as polyesters, polyanhydrides,
poly(ortho)esters, polyurethanes, siloxane-based polyurethanes,
poly(butyric acid), tyrosine-based polycarbonates, and natural
polymers and polymers derived therefrom such as albumin, alginate,
casein, chitin, ch[embedded image not shown]osan, collagen,
dextran, elastin, proteoglycans, gelati[embedded image not shown]
and other hydrophilic proteins, glutin, zein and other prolamines
and hydrophobic proteins, starch and other polysaccharides
including cellulose and derivatives thereof (e.g. methyl cellulose,
ethyl cellulose, hydroxypropyl cellulose, hydroxy-propyl methyl
cellulose, hydroxybutyl methyl cellulose, carboxymethyl cellulose,
cellulose acetate, cellulose propionate, cellulose acetate
butyrate, cellulose acetate phthalate, cellulose acetate succinate,
hydroxypropylmethylcellulose phthalate, cellulose triacetate,
cellulose sulphate), poly-1-lysine, polyethylenimine, poly(allyl
amine), polyhyaluronic acids, and combinations, copolymers,
mixtures and chemical derivatives thereof (substitutions, additions
of chemical groups, for example, alkyl, alkylene, hydroxylations,
oxidations, and other modifications routinely made by those skilled
in the art). In general, these materials degrade either by
enzymatic hydrolysis or exposure to water in vivo, by surface or
bulk erosion. The foregoing materials may be used alone, as
physical mixtures (blends), or as a co-polymer.
[0098] Other polymers are polyesters, polyanhydrides, polystyrenes
and blends thereof. The polyesters and polyanhydrides are
advantageous due to their ease of degradation by hydrolysis of
ester linkage, degradation products being resorbed through the
metabolic pathways of the body in some cases and because of their
potential to tailor the structure to alter degradation rates. The
mechanical properties of the biodegradable material are preferably
selected such that early degradation and concomitant loss of
mechanical strength required for it's functioning as a structure
supporting implant is prevented.
[0099] Biodegradable polyesters are for instance poly(glycolic
acid) (PGA), poly(lactic acid) (PLA), poly(glycolic-co-lactic acid)
(PGLA), poly(dioxanone), poly(caprolactone) (PCL),
poly(3-hydroxybutyrate) (PHB), poly(3-hydroxyvalerate) (PHV),
poly(lactide-co-caprolactone) (PLCL), poly(valerolactone) (PVL),
poly(tartronic acid), poly(B-malonic acid), poly(propylene
fumarate) (PPF) (preferably photo cross-linkable), poly(ethylene
glycol)/poly(lactic acid) (PELA) block copolymer, poly(L-lactic
acid-.epsilon.-caprolactone) copolymer, and
poly(lactide)-poly(ethylene glycol) copolymers.
[0100] Biodegradable polyanhydrides are for instance
poly[1,6-bis(carboxyphenoxy)hexane], poly(fumaric-co-sebacic)acid
or P(FA:SA), and such polyanhydrides may be used in the form of
copolymers with polyimides or poly(anhydrides-co-imides) such as
poly4trimellitylimidoglycine-co-bis(carboxyphenoxy)hexanell,
poly[pyromellitylimidoalanine-co-1,6-bis(carboph-enoxy)-hexane],
poly[sebacic acid-co-1,6-bis(p-carboxyphenoxy)hexane] or P(SA:CPH)
and poly[sebacic acid-co-1,3-bis(p-carboxyphenoxy)propane] or
P(SA:CPP).
[0101] Other suitable stent materials are biocompatible materials
that are accepted by the tissue surface. The broad term
biocompatible includes also nontoxicity, noncarcinogenity, chemical
inertness, and stability of the material in the living body.
Exemplary biocompatible materials are titanium, alumina, zirconia,
stainless steel, cobalt and alloys thereof and ceramic materials
derived therefrom such as ZrO2 and/or Al203.
[0102] As examples of inorganic implants (e.g., stents) materials
calcium phosphate matrices (CaP) and hydroxyapatite (HA) matrices
may be used, wherein HA may optionally be combined with tricalcium
phosphate to form such compounds as biphasic calcium phosphate
(BCP). CaP, sintered hydroxyapatite and bioactive glasses or
ceramics, such as 45S5 Bioglass.RTM. (US Biomaterials Corp, USA),
and apatite- and wollastonite-containing glass-ceramic
(glass-ceramic A-W) may also be used. Very suitable matrix
materials are the combined materials such as osteoinductive
hydroxyapatite/(HA/TCP) matrices, preferably BCP.
[0103] One form of the nasal implant described here is introduced
through an injection device. The implant (A) is elongated in shape
having a length L and side profile P [FIG. 13 a]. The side profile
may be oval in shape, rectangular, or tapered at the ends [FIG. 13
(b, c, and d)]. Furthermore, it may be a hollow cylinder (FIG.
13e), or made of a composite of materials, or a braid of wires.
They are introduced into the nose non-surgically through an
injection device. The injection route may include transcutaneous
route, i.e. through the nasal skin, or transmucossally, through the
internal mucosa of the nose. The intention of this device is that
it be introduced under local anesthetic.
[0104] The nasal implant may also incorporate an introduction
needle and suture, and/or a trailing suture (FIG. 11). This
provides an alternative method for introduction of the implant. The
guiding needle is introduced through the skin, or mucosa, and
tracked along the desired path to the location chosen for the
implant and then to a location where it exits the body, such as
through the skin. This guiding needle is introduced and guided by
the physicians fingers, or using standard medical instruments. This
method for introduction of the implant which includes a "pull
through" and trailing sutures is illustrated in FIGS. 15(a)-(b).
After introduction of the "pull through" suture shown in FIGS.
15(a)-(b), the guiding needle may be cut off. The implant is then
introduced with the injection device in FIG. 12, with the guidance
of the "pull through" suture, as illustrated in FIGS. 15(a)-(b).
Alternatively, it may be introduced without an injection device,
but simply by guiding it to the desired location by gently pulling
on the "pull through" suture. The trailing suture can also be used
to make adjustments to the position of the implant in situ. When
the desired position is accomplished, the "pull through" suture,
and the trailing sutures are cut. The suture can be made of
absorbable material. The suture may have a diameter similar to the
diameter of the implant, or be smaller or larger.
[0105] The injector device allows the introduction of the implant
into the body through an injection technique. Shown in FIG. 12, it
incorporates the nasal implant (FIG. 14-d), an introducing needle
(FIG. 14-e). The implants are introduced through an injection
device either through the transcutaneous route or through the nasal
mucosa. The implant is placed through a straight introducer device,
or a specially curved introducer device, or may be malleable to
allow for special shaping of the needle prior to injection.
[0106] These implants may be placed adjacent to the upper lateral
cartilage, below the nasal surface, as illustrated in FIG. 7. This
will apply lateral force to the medial portion of the lateral nasal
cartilage, stenting the internal nasal valves open. This is an
alternative to the spreader grafts currently placed surgically.
[0107] The implants may be placed adjacent to the lateral edge of
the lower lateral cartilages. The implants may extend to the bony
process of the anterior maxillary bone as illustrated in FIG. 8.
This will secure the lateral cartilage more securely to the
maxillary bone, preventing lateral nasal collapse. These implants
may be placed to secure the external valve in place of alar batten
grafts that are now employed and are applied surgically. They may
be inserted overlying or underlying the lateral surface of the
lower lateral cartilage.
[0108] The implants may have a straight or curved shape.
Alternately, they may have a malleable property, and can have the
shape adjusted after implantation. They may also have shape memory
properties (such as composed of Nitinol) which allows for their
shape to assume a predetermined shape after implantation. Use of
inserts made of materials which have shape memory properties permit
the implant to assume a preset shape after insertion. Alternately,
certain conditions may be applied, such as application of heat,
cold, light, or a magnetic field, that will allow the material to
assume a desired fixed or modified shape after implantation. The
necessary condition will depend on the intrinsic properties of the
shape memory material chosen to produce the implant. The fixed
shape of the implant may also be adjusted before or after
insertion. The implant may be composed of biodegradable materials,
with or without shape memory.
[0109] Another aspect of this invention provides for the use of the
described injectable implants for cosmetic changes to the nose. The
implants may be introduced transcutaneously or transmucosally to
improve the structural strength of the nasal cartilages, or to fill
defects in the nasal contours. Examples of proposed areas where the
implants can be placed include locations adjacent to the lower
lateral cartilage as lateral alar implants, in the mid nasal
region, and the nasal dorsum, or the collumella, as illustrated in
FIG. 9, and FIG. 10.
EXAMPLES
[0110] Three working examples of useful implants have been produced
for insertion into the nose.
[0111] The first is a 1.4 cm long, 0.8 mm thick titanium rod that
is incorporated in a 16 gauge injection needle. This is designed
for use into the lateral nasal wall which supports the external
valve. The implant is injected in a fashion similar to the
technique illustrated in FIG. 14. The currently preferred method of
introduction is transmucosaly (from inside the vestibule of the
nose). The implant is placed between the lower lateral cartilage
and the nasal mucosa, and extends over the maxillary bone. When
placed, it appears similar to the implant 11 shown in FIG. 8. One
implant is placed for each side of the nose, if bilateral valve
collapse is present. After implantation, the shape of the implant
can be adjusted by molding the shape of the titanium implant.
[0112] In another example, a 1.8 cm long and 1 mm thick rod
manufactured from a 85:15 poly (L-lactide-co-glycolide) polymer has
been produced. It is introduced using a 14 gauge needle. This
polymer is bio-absorbable. It is inserted transcutaneously over the
medial portion of the nose, similar to the one shown in FIG. 7.
After implantation, the material has some structural strength, and
by providing an upward force on the medial portion of the upper
lateral cartilage, it supports the internal nasal valve, preventing
its collapse. The shape of the implant can be adjusted after
implantation by temporarily placing a heating pad at 64 degrees
Celsius on the surface of the nose. This temperature is tolerated
by the human nose for a brief period of time. The temperature is
transmitted to the implant, and at such a temperature the polymer
softens, and the implant shape can manually adjusted. The implant
retains the new shape as it cools.
[0113] The third example used is a tapered rod with an oval shaped
cross section similar to the implant shown in FIG. 13b. The implant
dimensions may be trimmed prior to implantation depending on the
particular size desired for the particular patient to be implanted.
This implant is manufactured from a porous polyethylene. It is
inert, non-absorbable, and has a porous structural surface which
allows for fibrovascular tissue ingrowth. It is introduced through
a 14 gauge needle, into the dorsum of the nose, filling in volume
defects in the nose. This is similar to the DI implant shown FIG.
9.
[0114] Unless otherwise defined, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art of molecular biology. Although methods
and materials similar or equivalent to those described herein can
be used in the practice or testing of the present invention,
suitable methods and materials are described herein. All
publications, patent applications, patents, and other references
mentioned herein are incorporated by reference in their entirety.
In case of conflict, the present specification, including
definitions, will control. In addition, the materials, methods, and
examples are illustrative only and are not intended to be
limiting.
EQUIVALENTS
[0115] Those skilled in the art will recognize, or be able to
ascertain using no more than routine experimentation, many
equivalents to the specific embodiments of the invention described
herein. Such equivalents are intended to be encompassed by the
following claims.
[0116] Obviously, numerous modifications and variations of the
present invention are possible in light of the above teachings. It
is therefore to be understood that within the scope of the appended
claims, the invention may be practiced otherwise than as
specifically described herein.
* * * * *