Europiisches Patentamt
`
`9 European Patent Office
`
`Office européen des brevets
`
`® Publicationnumber:
`
`0 1 29 634
`
`A1
`
`®
`
`EUROPEAN PATENT APPLICATION
`
`@ Application number: 838501803
`
`® lnt.Cl.‘: A 61 M 25/00
`
`@ Date offiling: 27.06.83
`
`
`
`
`(9 Date of publication of application:
`02.01.85 Bulletin 85/1
`
`Designated Contracting States:
`DE FR GB rr NL SE
`
`® Applicant: Drettner, Bérje
`Skrovensborgs gird
`S-11 1 29 Tringsund(SEl
`
`® Inventor: Drettner.Bfirie
`Skrovensborgs gird
`S-111 29 TréngsundiSE)
`
`
`
`Representative: Grennberg, Erik Bertil et al,
`H ALBIHNS PATENTBYRA AB Box 7664
`S-103 94 StockholmiSEi
`
`
`@ An instrument for the treatment of sinusitis.
`
`@ An instrument fortreating sinusitis enabling the introduc-
`tion of one end of a plastic tube into a maxillary sinus and
`anchoring it there for successive irrigations distributed over a
`period oftime. Said end ofthe plastic tube (4) is provided with
`an arcuate bend for securing after introduction. Introduction
`is made by entering the tube into the lumen of a cannula (1),
`whereby the arcuate bend is elastically straightened. The
`sharp end (3) of the cannula (1) is introduced into the sinus,
`and the tube is then slid out with its said end into the sinus and
`regains its arcuate bend for securing, and the cannula is
`removed, the plastic tube securely remaining until purposely
`removed.
`
`
`
`EP0129634A1
`
`
`Croydon Printing Company Ltd.
`
`Lombard Exhibit 1023, p. 1
`
`Lombard Exhibit 1023, p. 1
`
`
`
`9 European Patent Office
`
`Office européen des brevets
`
`® Publicationnumber:
`
`0 1 29 634
`
`A1
`
`®
`
`EUROPEAN PATENT APPLICATION
`
`@ Application number: 838501803
`
`® lnt.Cl.‘: A 61 M 25/00
`
`@ Date offiling: 27.06.83
`
`
`
`
`(9 Date of publication of application:
`02.01.85 Bulletin 85/1
`
`Designated Contracting States:
`DE FR GB rr NL SE
`
`® Applicant: Drettner, Bérje
`Skrovensborgs gird
`S-11 1 29 Tringsund(SEl
`
`® Inventor: Drettner.Bfirie
`Skrovensborgs gird
`S-111 29 TréngsundiSE)
`
`
`
`Representative: Grennberg, Erik Bertil et al,
`H ALBIHNS PATENTBYRA AB Box 7664
`S-103 94 StockholmiSEi
`
`
`@ An instrument for the treatment of sinusitis.
`
`@ An instrument fortreating sinusitis enabling the introduc-
`tion of one end of a plastic tube into a maxillary sinus and
`anchoring it there for successive irrigations distributed over a
`period oftime. Said end ofthe plastic tube (4) is provided with
`an arcuate bend for securing after introduction. Introduction
`is made by entering the tube into the lumen of a cannula (1),
`whereby the arcuate bend is elastically straightened. The
`sharp end (3) of the cannula (1) is introduced into the sinus,
`and the tube is then slid out with its said end into the sinus and
`regains its arcuate bend for securing, and the cannula is
`removed, the plastic tube securely remaining until purposely
`removed.
`
`
`
`EP0129634A1
`
`
`Croydon Printing Company Ltd.
`
`Lombard Exhibit 1023, p. 1
`
`Lombard Exhibit 1023, p. 1
`
`
`
`An instrument for the treatment of sinusitis
`
`0129634
`
`The present
`
`invention regards an instrument useful for the
`
`treatment of sinusitis, and particularly useful for repeat—
`
`ed irrigations for treating maxillary sinusitis. More
`
`particularly, it regards an instrument for the treatment
`
`of sinusitis comprising tUbe means provided with a sharp
`
`end for piercing and making a hole in tissue for entering
`
`a cavity, and a plastic tube provided for entering one end
`
`thereof into said cavity through said tube means, said one
`
`end being provided with anchoring means for removably
`securing said one end within said cavity, said securing
`
`means comprising means for forming said one end into a
`
`shape incompatible with said hole.
`
`One of the most
`
`important and efficient known methods for
`
`treating maxillary sinusitis is the drainage of purulent
`
`secretion, by means of introducing a liquid through a
`
`catheter or the like, which is introduced into the sinus,
`
`whereby the liquid and pus may exit through the existing
`
`natural
`
`lument (ostium).
`
`It is often necessary to renew this operation, which is
`
`unpleasant and painful particularly due to the introduction
`
`of a cannula through bone, albeit made under local ane-
`
`stesia. Therefore,
`
`instruments have been constructed where
`
`an introduced tube may be left for renewed irrigation
`
`through the same hole made in the tissue. Another reason
`
`why this is desirable is that it is advantageous to provide
`
`ventilation of the sinus when its ostium is obstructed by
`
`inflammation of the mucus.
`
`One instrument used for this purpose is the Foley catheter
`
`(see Abdel-Salam & Gibb, J. Laryngology and Otology 95(1981)
`
`221—223). A trocar is used for introducing a catheter which
`
`at its end is provided with an inflatable balloon for
`
`retention.
`
`In order to inflate the balloon,
`
`the catheter
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`Lombard Exhibit 1023, p. 2
`
`Lombard Exhibit 1023, p. 2
`
`
`
`0129634
`
`must be provided with a special lumen used only for this
`purpose, beside the lumen used for irrigation. Therefore,
`the catheter and the trocar must have a rather large dia—
`
`meter, making a correspondingly large hole.
`
`Another known instrument comprises a catheter tube provided
`
`at its end with wings which at introduction are folded
`together but which will fold out, roughly into a T—form
`after introduction by means of a trocar (see Illum & Jeppe-
`
`10
`
`sen, Acta Otolaryngol. 73 (1972) 506-512). Also this
`instrument needs a trocar of relatively large diameter,
`
`due mainly to the fact that the wings are obtained by
`cutting the tube, and therefore,
`the tube cannot be of
`
`very small diameter.
`
`15
`
`20
`
`Although the known instruments can be kept in place for
`subsequent irrigations,
`(they both have anchoring means
`which tend to disturb venting mainly due to their size and
`
`form) it would be desirable to keep the mucous membrane
`as mechanically undisturbed as possible during the time
`when the catheter is left in place, which may be for
`
`several days. Further, it would be desirable to have a
`round, soft form likely not
`to disturb even used in ca—
`vities of different size and form, and which is not likely
`
`25
`
`to blow out when a patient sneezes.
`
`It is therefore a first object of the invention to obtain
`
`an instrument permitting the insertion of a securable
`catheter by means of a piercing instrument having a dia-
`meter as small as possible. It is a second object to be
`able to obtain an anchorable catheter having anchoring
`
`30
`
`means that are less voluminous and less prone to disturb
`
`mucous tissue than what has been the case in the prior
`
`art. A third object is to obtain an inexpensive but versa-
`
`35
`
`tile instrument.
`
`Lombard Exhibit 1023, p. 3
`
`Lombard Exhibit 1023, p. 3
`
`
`
`3
`
`0129634
`
`Those objects and other objects and advantages are ob-
`
`tained, according to the invention, by providing an
`
`instrument of the kind mentioned in the introduction,
`wherein the anchoring means comprise an arcuate bend at
`
`5
`
`one end of the plastic tube when free, which bend is
`
`elastically stretched out when kept
`
`in the tube used
`
`for its introduction. This end, when let free inside
`
`the cavity, will reform its arcuate bend, which serves
`
`as an anchoring means. When positively drawn out of
`
`10
`
`its hole, it will straighten out and can be pulled out
`
`after the end of treatment of the patient.
`
`For easy manufacture, it is suitable to form the arcuate
`
`bend as a helix. The plastic tube end may then be wound
`
`15
`
`a couple of turns on to a mandrel and be given a perma-
`
`nent
`ment.
`
`tendency to keep its form by suitable heat treat—
`'
`
`-It is also suitable to form the end of the plastic tube
`
`20
`
`as a spiral bend, e.g.
`
`in a plane perpendicular to the
`
`general direction of the tube. This will give a parti—
`
`cularly gentle distributed anchoring likely to give
`
`minimum strain to the mucus
`
`inside the cavity.
`
`25
`
`It is preferred to utilize a plastic tube of the kind pro—
`
`vided with X—ray absorbent matter, as this gives consider-
`
`able ease in X—ray explorations.
`
`For maximum irrigation efficiency, it is preferred to pro-
`
`30
`
`vide the arcuate portion of the plastic tube with several
`openings,
`from which irrigation liquid may exit. This '
`
`also tends to improve ventilation between irrigations, as
`
`probably not all the openings will be obstructed by pus.
`
`35
`
`The invention will now be further described in relation
`
`to non-limiting embodiments thereof. Fig 1 shows a par—
`
`Lombard Exhibit 1023, p. 4
`
`Lombard Exhibit 1023, p. 4
`
`
`
`4
`
`0129634
`
`tially sectioned cannula provided with a straightened
`
`plastic tube. Fig 2 shows a plastic tube set free,
`
`show—
`
`ing an example of an anchoring configuration. Fig.
`
`3 shows
`
`another example of an anchoring configuration.
`
`The partially sectioned View of Pi
`1 shows a cannula 1,
`provided with a standard Luer-Lok B/fitting 2 at one
`
`end and a.sharp cutting edge 3 at the other end. Inside
`
`the cannula is a plastic tube 4 having, beside its end
`
`hole 5, several side openings 6. Although naturally not
`
`visible in Fig l, where the plastic tube 4 is everywhere
`
`straight,
`
`its material is internally tensioned so that
`
`when brought out of the lumen of the cannula,
`
`the form
`
`of its end will bend into a form susceptible to its
`
`anchoring in a cavity when entered by means of the cannula.
`
`Thus, when used,
`
`the cannula is pierced through a tissue
`
`wall of a cavity, and then,
`
`the tube 4
`
`is moved out
`
`through
`
`the lumen and exits at 3. The cannula may be drawn back
`
`and removed,
`
`leaving the plastic tube in place. The end
`
`of this tube then takes an arcuate bend, exemplified in
`
`Figs.2 and 3. Many forms are possible for the arcuate
`
`bend.
`
`The bend as of Fig Z'is obtained by rolling the plastic
`
`tube over a suitable mandrel and held there during succes—
`
`sive heating and cooling cycles, whereby the tensions
`
`created by rolling are evened out, such that the arcuate
`
`form becomes permanented.
`
`When mounting the tube 4 within the cannula 1,
`
`this is best
`
`performed by entering the tube 4
`
`from the pointed end 3.
`
`In order to facilitate this,
`
`the end of the lumen should be
`
`deburred at its inner edge, as otherwise, its edge may
`
`damage the plastic tube 4, particularly when the arcuate
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`form is drawn in.
`
`Lombard Exhibit 1023, p. 5
`
`Lombard Exhibit 1023, p. 5
`
`
`
`0129634
`
`In order to make the holes 6 in the tube 4, it has been
`
`found suitable to burn them by means of a laser ray. This
`
`may be done before bending. 1f made before bending,
`
`the
`
`holes may be placed at will and also easily on concave sides
`
`of the arcuate portion.
`
`According to a tested example,
`
`the cannula was of stainless
`
`steel with an outer diameter of 2,5 mm and an inner dia-
`
`meter of 2,1 mm,
`
`together with a plastic catheter having
`
`10
`
`an outer diameter of 1,8 mm and an inner diameter of 1,5
`
`mm. The overall
`
`length of the cannula was 11 cm.
`
`The plastic catheter was made by taking a length of poly—
`
`ethylene ("Tygon"),
`
`the middle of which was wound about
`
`15
`
`six turns around a mandrel having a circular form and
`
`a diameter of about 6 mm. The mandrel was dipped alter—
`natively in near—boiling water (980C) and in ice water
`
`three times in succession, whereby the deformation was
`
`made permanent. The helix portion was then cut off at
`
`20
`
`the middle, creating two catheters. The holes had been
`
`made in the tube beforehand.
`
`It is preferred for hygienic reasons to condition the
`
`instrument of the invention as a disposable unit.
`
`In
`
`order to facilitate its practical use, it may be packed
`
`together with plastic sacks filled with a suitable irri-
`gation liquid and provided with suitable means for
`
`fitting to the protruding end of the anchored plastic
`
`tube.
`
`30
`
`After insertion,
`
`the anchored plastic tube may, after
`
`a first irrigation, be cut off a short length outside
`
`the nostril, such that it may be pushed into the nostril
`
`and out of view until next irrigation. The patient may
`
`35
`
`thus be under policlinical treatment, often making
`
`hospitalization unnecessary.
`
`Lombard Exhibit 1023, p. 6
`
`Lombard Exhibit 1023, p. 6
`
`
`
`LAIMS
`
`0129634
`
`1. An instrument for the treatment of sinusitis comprising
`
`tube means provided with a sharp end for piercing and
`
`making a hole in tissue for entering a cavity, andzaplastic
`tube provided for entering one end thereof into said cavfiy
`through said tube means, said one end being provided with
`
`anchoring means for removably securing said one end within
`
`said cavity, said securing means comprising means for
`
`10
`
`forming said one end into a shape incompatible with said
`
`hole, characterized in that said anchoring means comprise
`
`an arcuate bend at said one end of the plastic tube when
`
`free, said one end of the plastic.tube being elastically
`
`straightened out when residing in said tube means.
`
`15
`
`2. The instrument of claim 1, further characterized in that
`
`said arcuate bend is a helical bend.
`
`3. The instrument of claim 1, further characterized in that
`
`20
`
`said arcuate bend is a spiral bend.
`
`4. The instrument of claim 1, further characterized in that
`
`the plastic tube is made of a material comprising X—ray
`
`absorbent matter.
`
`5. The instrument of claim 1, further characterized in that
`
`said one end of the plastic tube is provided with several.
`
`side openings.
`
`25
`
`30
`
`35
`
`Lombard Exhibit 1023, p. 7
`
`Lombard Exhibit 1023, p. 7
`
`
`
`0129634
`
`
`
`
`
`E.._..__.._._......_...._._...
`
`FIG. 3
`
`Lombard Exhibit 1023, p. 8
`
`Lombard Exhibit 1023, p. 8
`
`
`
`9)) 2:22:88" “em
`
`F
`
`EUROPEAN SEARCH REPORT
`
`0129634
`I
`Innum r
`
`A”"'°‘"°
`
`be
`
`DOCUMENTS CONSIDERED TO BE RELEVANT
`Citation oI document with indication. where appropriate.
`of relevant passages
`
`Category
`
`Relevant
`to claim
`
`CLASSIFICATION OF THE
`APPLICATION (lnt CI. 3)
`
`EP
`
`83 85 0180
`
`A 61 M 25/00
`
`(WILDEMEERSCH)
`BE-A— 893 679
`* Page 6,
`line 27 — page 7,
`line
`12;
`page 8,
`lines 11-22; page 9,
`lines 22-26; page 12,
`lines 7—17;
`figures 1-4 *
`
`(MOOREHEAD)
`US-A-4 068 659
`* Column 4,
`lines 4—63; column 5,
`lines 10-15; figure 2 *
`
`(PATEL)
`US-A—3 860 006
`* Column 3,
`lines 33—58; figure 1
`*
`.
`
`(COOK)
`US-A—3 924 633
`* Abstract; figure 3 *
`
`.. .. _.
`
`GB-A—Z 018 600
`
`(FINNEY)
`
`SEARCHED (Int. Cl. 3)
`
`A 61 M
`
` EPOForm15030382
`
`The present search report has been drawn up for all claims
`
`Place at search
`THE HAGUE
`
`Date of completion of the search
`29-12-1983
`
`Examiner
`GERMANO A.G.
`
`CATEGORY OF ClTED DOCUMENTS
`
`: particularly relevant it taken alone
`particularly relevant it combined with another
`document of the same category
`: technological background
`: non-written disclosure
`: intermediate document
`
`: theory or principle underlying the invention
`: earlier patent document. but published on. or
`after the filing date
`: document cited in the application
`: document cited for other reasons
`,.
`;
` isles;‘ea‘i‘lysaréegasnai.59 "
`document
`
`Lombard Exhibit 1023, p. 9
`
`Lombard Exhibit 1023, p. 9
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
