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Q: collagen injections to treat snoring ( Answered,   0 Comments )
Question  
Subject: collagen injections to treat snoring
Category: Health
Asked by: cpsnake-ga
List Price: $200.00
Posted: 13 Dec 2003 09:31 PST
Expires: 12 Jan 2004 09:31 PST
Question ID: 286698
What information,to include patents, is available on the use and
success of collagen injections into the soft palate to reduce or
eliminate snoring?

Request for Question Clarification by umiat-ga on 13 Dec 2003 17:37 PST
Hello, cpsnake-ga,

 There is a relatively new therapy which involves the injection of a
sclerosing agent into the soft palate which results in collagen
formation and  hardening  of the palate. Vibration is reduced which
then inhibits or reduces snoring. Is this the procedure to which you
are referring?
 I have found no procedure which actually involves the injection of
pure collagen into the palate.

umiat
Answer  
Subject: Re: collagen injections to treat snoring
Answered By: pafalafa-ga on 22 Dec 2003 07:58 PST
 
Hello cpsnake-ga,

Thanks for asking such an interesting question. I'm told I have a
wicked snore, but of course, I don't really believe it.  However, it's
good to be up-to-date on the latest treatment options, just in
case...!

The brief answer to your question is:

Injection of a substance into the soft palate to reduce snoring is a
relatively new medical procedure that just came into use around 2001,
and is known as snoreplasty.  While it appears to be effective and
safe based on short term results, there are not yet any long-term
studies of this procedure.

Currently, collagen does not appear to be directly injected into the
soft palate; rather it is formed there as a result of injections. 
However, there are patent applications on file that envision direct
injection of collagen and related materials, and these are discussed
in more detail below.

Please bear in mind that I am not a doctor.  Although I believe I have
provided you reliable information in this answer, nothing here should
be taken as medicial advice.

If anything presented here is unclear -- or if you need additional
information -- please let me know by posting a Request for
Clarification, and I?ll be happy to assist you further.

All the best,

pafalafa-ga

==========

In a careful search of medical information sources on the internet, I
did not come across any reference to direct injection of collagen into
the soft palate as a means of treating snoring.  However, there are a
number of patent applications that envision precisely this treatment,
and these are detailed, below.

First, however, it seems best to offer an overview of the technique
known as snoreplasty.  This is a non-surgical technique involving
injection of an agent into the soft palate, in order to induce
inflammation and subsequent formation of collagen in the palate, which
in turn, stiffens the tissue and reduces palate-related snoring.

An Australian site on snoring treatments offers a nice ?plain English?
write-up on snoreplasty (with pictures!), which can be seen here:

http://www.snoring.com.au/snoreplasty/index.shtml

The most salient section regarding your question is this excerpt from the site:

-----

How Does Injection Snoreplasty Work?

The injection agents currently used for snoreplasty are known as
sclerosants. These agents are traditionally used for closing
superficial varicose veins. Investigators of the Injection Snoreplasty
procedure have used a variety of agents including sodium tetradecyl
sulphate (Sotrodecol) and more recently alcohol. Other sclerosant
agents are being investigated for their relative benefits to the
reduction of snoring in the Snoreplasty patient.

Following injection, an inflammatory reaction is created in the
tissues of the patient?s soft palate. During the healing process,
fibrosis of the injected region occurs in which stiffening fibres of
collagen are laid down within the palate. It is this fibrosis process
which stiffens the soft palate and in turn reduces snoring. The
healing changes may take up to two months to finalise.

The very long-term results of the fibrosis are not known at this
stage, as Injection Snoreplasty has been under investigation for only
the last two years. Repeat injections may be helpful if a useful
result has not occurred within the first couple of months of the
Snoreplasty procedure or possibly one to two years after the initial
Snoreplasty procedure should the initial benefits wear off and snoring
symptoms recur.

As Injection Snoreplasty is a newly introduced technique, the best
combination of injection agent, pattern of injection of the soft
palate or the need for repeat injections have yet to be fully
established.

----------

It?s important to point out the statement made above about long-term
impacts:  ?very long-term results of the fibrosis are not known at
this stage...?.  These types of injections are a relatively recent
innovation.  Although they appear to be effective in reducing
palate-related snoring, there have been very few follow-up studies on
snoreplasty, and there simply has not been enough time since its
introduction in 2001 to conduct any long-term follow-up studies.

==========

A search on ?snoreplasty? at the U.S. National Institutes of Health PubMed site:


http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=PubMed

returned only 4 results (related searches -- e.g. snoring and
injections -- did not uncover additional articles of note):

Lafrentz JR, Brietzke SE, Mair EA.
Evaluation of palatal snoring surgery in an animal model.
Otolaryngol Head Neck Surg. 2003 Oct;129(4):343-52. 


Brietzke SE, Mair EA.
Injection snoreplasty: extended follow-up and new objective data.
Otolaryngol Head Neck Surg. 2003 May;128(5):605-15. 


Levinson SR. 
Injection snoreplasty.
Otolaryngol Head Neck Surg. 2001 Nov;125(5):579-80. 

Brietzke SE, Mair EA. 
Injection snoreplasty: how to treat snoring without all the pain and expense.
Otolaryngol Head Neck Surg. 2001 May;124(5):503-10. 

The summary of the Brietzke article, which introduced this new
technique in 2001, can be found here:

----------

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11337652&dopt=Abstract&itool=iconabstr

OBJECTIVE: We introduce Injection Snoreplasty: an innovative, safe,
and effective palatal snoring procedure with minimal cost and
discomfort to the patient. A well-described sclerotherapy agent,
Sotradecol, is injected into the soft palate to reduce/eliminate
palatal flutter snoring.

STUDY DESIGN AND SETTING: Twenty-seven patients with a diagnosis of
palatal flutter snoring (respiratory disturbance index less than 10)
by sleep study were enrolled in the protocol. Office treatment
sessions were performed 6 to 8 weeks apart. Success was judged by
subjective improvement in snoring and objective evidence of palatal
stiffening/scarring.

RESULTS: Twenty-five (92%) of 27 patients reported significant
decrease in snoring. There were no significant postinjection
complications. Visual analog pain scale confirmed minimal discomfort.
Most patients received more than 1 treatment (average, 1.8) in order
to receive optimal palatal stiffening.

CONCLUSION/SIGNIFICANCE: Injection Snoreplasty is a simple, safe, and
effective office treatment for primary snoring. Advantages over
current snoring procedures include simplicity, low cost, decreased
posttreatment pain levels, and minimal/no convalescence

----------

Dr. Brietzke?s 2003 follow-up study is also on the brief list, and the
summary can be found here:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12748553&dopt=Abstract

His main conclusion is that the treatment is effective, although 18%
of those treated experienced snoring relapse.


==========

The apparent success of snoreplasty seems to have generated a good
deal of interest in the technique, for there are a number of patents
and patent applications in the U.S. the envision variations on this
technique.

A Lexis-Nexis patent search on the terms: [ snoring and collagen and
injection ] produced a list of 82 items, almost all of them filed in
just the past few years, although some of them predate the 2001
introduction of snoreplasty.

For example, there is patent application 20020157675, filed October
31, 2002 by the Closure Medical Corp. in North Carolina, and titled:
?Compositions and medical procedure to treat snoring?.  Here are some
key excerpts from this application:

----------

A method of treating snoring, includes injecting least one of a
monomer composition, a polymer solution and a microparticle solution
into a patient's soft palate, optionally with a least one of an
additional medicament, bioactive agent, sclerotic agent or stiffening
agent. The injected composition, if not already polymerized prior to
injection, is allowed to polymerize to form a polymer within the soft
palate, thereby stiffening the soft palate, rendering it resistant to
palatal flutter....

...The present invention is directed to an improved palatal stiffening
composition or solution and a procedure using such a composition or
solution for reduction and/or elimination, and preferably long-term
reduction and/or elimination, of snoring. The procedure of the present
invention comprises injecting at least one of a polymerizable monomer
composition, a polymer composition, and a microparticle solution into
a patient's soft palate to stiffen the soft palate, thereby reducing
or substantially eliminating palatal flutter. The procedure of the
present invention is not only minimally invasive and economical, but
also provides long-term relief from snoring.

...This invention is directed to compositions and methods for treating
snoring by injecting at least one of a polymerizable monomer
composition, a polymer solution or a microparticle solution into a
patient's soft palate to reduce palatal flutter by stiffing the
patient's soft palate...
			
...According to embodiments of the present invention, the composition
or solution can be injected alone, or it can be injected together with
at least one of a medicament, a bioactive agent, a sclerotic agent,
and a stiffening agent. Furthermore, in embodiments, the composition
or solution can itself include one or more medicaments, bioactive
agents, sclerotic agents, and stiffening agents. Moreover, in
embodiments, a single medicament or agent can provide a
medicinal/bioactive effect as a primary effect and a sclerotic and/or
stiffening effect as a secondary effect. In addition, in other
embodiments comprising microparticles, the primary effect of the
microparticles can be sclerotic and/or stiffening while the secondary
effect can be a medicinal or bioactive effect. In other words, while
the microparticles may primarily cause scar tissue formation and/or
stiffening, thus serving a sclerotic and/or stiffening purpose, the
microparticles may also provide a secondary medicinal or bioactive
purpose. Thus, in various embodiments, a single composition can
provide both a medicinal/bioactive effect and a sclerotic/stiffening
effect...

...The compositions or solutions of this invention may further contain
fibrous reinforcement and colorants such as dyes, pigments, and
pigment dyes. Examples of suitable fibrous reinforcement include PGA
microfibrils, collagen microfibrils, and others as described in U.S.
patent application Ser. No. 09/471,392 filed on Dec. 23, 1999...

----------

Two things worth pointing out here: (1) collagen is one of materials
under consideration here, and (2) this technique envisions injecting
materials that can, themselves, stiffen the palate, in addition to
inducing natural healing processes that cause stiffening.

==========

Another related patent is:

Patent number 6390096, granted May 21, 2002, to Restore Medical Inc.
in St. Paul, Minnesota.  The patent title is:

?Needle with pre-loaded implant for snoring treatment?

Here are some relevant excerpts:

----------

An apparatus for use in treating snoring of a patient suffering from
snoring includes an implant of bio-compatible material sized to be
embedded within the soft palate. The implant is disposed within a bore
of a distal tip of a needle for penetration into the soft palate. The
bore is sized to receive a rod from a proximal end of the needle with
the rod opposing the implant to eject the implant from the distal tip
upon relative sliding movement of said needle and said rod. The needle
at the distal tip is perforated for fluid to flow through a wall of
the needle into engagement with the implant. The implant is selected
to altering a dynamic response of the soft palate to airflow past the
soft palate....


FIGS. 40-41 illustrate an implant formed of twisted or braided
fibers... While a single type fiber could be used, the embodiment is
preferably formed of two different fibers...braided or twisted
together. One fiber...may be provided for encouraging fibrotic
response. Such a fiber...may be polyester or silk suture material (in
which individual fibers...may be formed of braided or twisted
elements). The other fiber ...may be a bio-resorbable fiber as in FIG.
33 (e.g., bio- resorbable suture material which may include natural
materials such as collagen or synthetic materials such as the PDS
suture material previously described). Alternatively, the second
fiber...may be a non-resorbable material such as polypropylene suture
material to provide added stiffness to the implant. The fibers... may
be bonded together along the axial length of the implant...to provide
added stiffness.

==========

The other patent materials available on this topic all seem to be
variations on related themes.  The main point for your interests, I
suppose, is that direct injection of collagen into the soft palate as
a means of controlling snoring is not currently being practiced, as
far as I know, but it is envisioned as a possible treatment (usually
in addition with other agents) in a number of patent materials.



I hope this provides you the information you need.  As I said above,
if you need additional information on anything, just let me know.

And of course...Happy Holidays.

pafalafa-ga


search strategy: In addition to the searches described above, I also
conducted a Google search on: snoring collagen palate injection
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