To:
`
`Subject:
`
`Sent:
`
`Sent As:
`
`Attachments:
`
`BandGrip, Inc. (docketing@watson-ip.com)
`
`U.S. Trademark Application Serial No. 88265665 - SMART SUTURE - BND191506
`
`February 09, 2021 06:21:38 PM
`
`ecom114@uspto.gov
`
`Attachment - 1
`Attachment - 2
`Attachment - 3
`Attachment - 4
`Attachment - 5
`Attachment - 6
`Attachment - 7
`Attachment - 8
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`Attachment - 25
`Attachment - 26
`Attachment - 27
`Attachment - 28
`
`United States Patent and Trademark Office (USPTO)
`Office Action (Official Letter) About Applicant’s Trademark Application
`
`U.S. Application
`Serial No.
`88265665
`
`     
`
`Mark:   SMART
`SUTURE
`
` 
` 
` 
`

`

`Correspondence
`Address: 
`Jovan N.
`Jovanovic
`THE WATSON IP
`GROUP PLC
`SUITE 200
`3133 HIGHLAND
`DRIVE
`HUDSONVILLE
`MI 49426
`Applicant:  
`BandGrip, Inc.
`
`    
`
`Reference/Docket
`No. BND191506
`
`   
`
`Correspondence
`
`Email Address:  
`
`docketing@watson-
`ip.com
`
`FINAL OFFICE ACTION
`
`The USPTO must receive applicant’s response to this letter within six months of the issue date below or the application will be abandoned. 
`Respond using the Trademark Electronic Application System (TEAS) and/or Electronic System for Trademark Trials and Appeals (ESTTA).   A
`
`link to the appropriate TEAS response form and/or to ESTTA for an appeal appears at the end of this Office action.   
`
`Issue date:  February 09, 2021
`
`This FINAL Office action is being issued in response to applicant’s communication filed January 6, 2021. For the reasons outlined below, the
`deceptiveness refusal and, in the alternative, the descriptiveness refusal are maintained and made FINAL. All arguments and evidence from prior
`Office actions are incorporated herein by reference.
`
`TRADEMARK ACT SECTION 2(a) REFUSAL - DECEPTIVENESS
`
`Registration is refused because the applied-for mark consists of or includes deceptive matter in relation to the identified goods.  Trademark Act
`
`Section 2(a), 15 U.S.C. §1052(a).   
`
`A term is deceptive when all three of the following criteria are met:
`
`(1)       
`
`Is the term misdescriptive of the character, quality, function, composition or use of the goods [and/or services]?
`
`(2)       
`
`If so, are prospective purchasers likely to believe that the misdescription actually describes the goods [and/or services]?
`
`(3)       
`
`If so, is the misdescription likely to affect the purchasing decision of a significant portion of relevant consumers?
`
`In re Tapco Int’l Corp. , 122 USPQ2d 1369, 1371 (TTAB 2017) (citing In re Budge Mfg. Co., 857 F.2d 773, 775, 8 USPQ2d 1259, 1260 (Fed.
`Cir. 1988)); TMEP §1203.02(b); see also In re Spirits Int’l, N.V. , 563 F.3d 1347, 1353, 1356, 90 USPQ2d 1489, 1492-93, 1495 (Fed. Cir. 2009)
`(holding that the test for materiality incorporates a requirement that a “significant portion of the relevant consumers be deceived”).
`
`Applicant seeks to register the wording “SMART SUTURE” for use on “bandages for surgical use for skin wounds having mechanical hooks
`that penetrate the skin on either side of the wound for attachment to the skin”.
`
`The word “SMART” in the mark refers to “equipped with intelligent behavior,” according to the attached dictionary evidence. The word
`“SUTURE” refers to “any material, as gut, thread, wire, etc., so used” to join “together the two edges of a wound or incision by stitching or
`similar means,” according to the dictionary evidence of record. The combined wording immediately conveys, based on the basic definition of
`
`  
` 
` 
` 
`  
` 
` 
` 
` 
` 
` 
` 
`

`

`each word in the mark, that applicant’s bandages for surgical use for skin wounds are equipped with intelligent behavior, either because of their
`materials or their features, and because they serve the function of joining together the two edges of a wound or incision.
`
`However, in this case, the applied-for mark “SMART SUTURE” is mis-descriptive of the character, quality, function, or use of the goods
`because applicant indicates in its response that the goods do not use smart technology and are not sutures.
`
`Consumers would be likely to believe this misdescription in the mark, because the attached evidence from E-Textiles Series, HospiMedica,
`Science, Google Patents, and Illinois Chemistry Department shows that the wording “SMART SUTURE” is a term-of-art in the medical field
`that refers to sutures that are equipped with intelligent behavior because they are made of special materials such as dissolvable threads or because
`they form a knot to enhance the healing process. The evidence demonstrates that consumers have come to expect the wording “smart sutures” to
`refer to goods with these features because the wording is widely used by retailers and consumers to refer to sutures with intelligent behavior or
`materials.
`
`  A
`
` misdescriptive feature or characteristic would be material to the purchasing decision of a significant portion of the relevant consumers when
`the evidence demonstrates that the misdescription would make the product or service more appealing or desirable to prospective purchasers.  In
`re White Jasmine LLC, 106 USPQ2d 1385, 1392 (TTAB 2013) (citing In re Juleigh Jeans Sportswear Inc., 24 USPQ2d 1694, 1698-99 (TTAB
`
`1992)); TMEP §1203.02(d).  
`
`“Smart sutures” are more desirable or appealing because they improve the wound healing process, as the attached evidence indicates. Thus, the
`misdescription is likely to affect a significant portion of the relevant consumers’ decision to purchase applicant’s goods.
`
`Applicant argues that several third party marks use the word “SMART” without using computer technology. However, the wording “SMART
`SUTURE” is a term-of-art in the medical field, according to the attached evidence. Therefore, the applied-for mark differs from the third party
`marks.
`
`For these reasons, registration is refused under Trademark Act Section 2(a).
`
`Applicant should note the additional ground for refusal.
`
`TRADEMARK ACT SECTION 2(e)(1) REFUSAL - DESCRIPTIVENESS
`
`In the alternative, registration is refused because the applied-for mark merely describes a feature, characteristic, purpose, function or use of
`applicant’s goods.   Trademark Act Section 2(e)(1), 15 U.S.C. §1052(e)(1); see TMEP §§1209.01(b), 1209.03 et seq.
`
`  A
`
` mark is merely descriptive if it describes an ingredient, quality, characteristic, function, feature, purpose, or use of an applicant’s goods and/or
`services.  TMEP §1209.01(b); see, e.g., In re TriVita, Inc., 783 F.3d 872, 874, 114 USPQ2d 1574, 1575 (Fed. Cir. 2015) (quoting In re Oppedahl
`& Larson LLP, 373 F.3d 1171, 1173, 71 USPQ2d 1370, 1371 (Fed. Cir. 2004)); In re Steelbuilding.com, 415 F.3d 1293, 1297, 75 USPQ2d 1420,
`
`1421 (Fed. Cir. 2005) (citing Estate of P.D. Beckwith, Inc. v. Comm’r of Patents , 252 U.S. 538, 543 (1920)).  
`
`Applicant seeks to register the wording “SMART SUTURE” for use on “bandages for surgical use for skin wounds having mechanical hooks
`that penetrate the skin on either side of the wound for attachment to the skin”.
`
`The word “SMART” in the mark means “equipped with intelligent behavior,” according to the attached dictionary evidence. The word
`“SUTURE” means “any material, as gut, thread, wire, etc., so used” to join “together the two edges of a wound or incision by stitching or
`similar means,” according to the dictionary evidence of record. The combined wording immediately conveys, based on the basic definition of
`each word in the mark, that applicant’s bandages for surgical use for skin wounds are equipped with intelligent behavior because they contain
`materials or use features that join together the two edges of a wound or incision using technology. Thus, the words in the mark immediately
`convey the nature and purpose of the goods.
`
`Applicant argues that the applied-for mark is not descriptive because the goods are not “smart” since they do not use computer technology.
`Instead, applicant argues that the applied-for mark is suggestive because the word “SMART” indicates that the bandages are sturdy and can be
`applied in the same manner as a suture and are a smart choice.
`
`However, as applicant’s website indicates, the bandage uses a “patented micro-anchor technology” designed to “prevent common problems
`associated with conventional closure materials.” This statement indicates that applicant’s “bandages” are a type of “closure material” and are
`equipped with intelligent behavior that has been patented and results in less closure problems as a result of the patented technology. Thus, the
`goods are “SMART” despite not using computer technology.
`
` 
` 
` 
` 
`  
`  
` 
` 
` 
` 
`

`

`Applicant also argues that the goods are not sutures. However, applicant’s website refers to the goods as “closure materials,” which
`encompasses bandages and sutures. The site also states that the bandages “are used to join together two edges of a wound or incision using hooks
`that penetrate the skin.” A suture, based on the basic dictionary definition of record, is “any material” used “to join “together the two edges of a
`wound or incision.” Therefore, applicant may have used the term “bandage” in the identification but the nature and function of the goods are or
`encompass sutures. Therefore, the word “SUTURES” is descriptive, if not generic.
`
`Because each word in the mark is descriptive or generic, registration is refused under Trademark Act Section 2(e)(1).
`
`How to respond.   Click to file a request for reconsideration of this final Office action that fully resolves all outstanding requirements and
`refusals and/or click to file a timely appeal to the Trademark Trial and Appeal Board (TTAB) with the required filing fee(s).
`
`/Shaila E. Lewis/
`Trademark Examining Attorney
`Law Office 114
`(571) 270-1527 (phone)
`(571) 270-2527 (fax)
`Shaila.Lewis@uspto.gov
`
`RESPONSE GUIDANCE
`Missing the response deadline to this letter will cause the application to abandon.   A response or notice of appeal must be received by
`the USPTO before midnight Eastern Time of the last day of the response period.   TEAS and ESTTA maintenance or unforeseen
`
`circumstances could affect an applicant’s ability to timely respond.   
`
`Responses signed by an unauthorized party are not accepted and can cause the application to abandon.  If applicant does not have an
`attorney, the response must be signed by the individual applicant, all joint applicants, or someone with legal authority to bind a juristic
`applicant.  If applicant has an attorney, the response must be signed by the attorney.
`
`If needed, find contact information for the supervisor of the office or unit listed in the signature block.
`
` 
` 
`  
`  
`  
` 
` 
`

`

`Benabald
`
`aes76
`=.Textiles”series
`
`By Nicola Davies
`DRCAree
`
`Windows 10 Enterprise N 2016 LTSB 64-bit Build 14393 11:15:34 PM 2/3/2021
`
`SS urgical sutureshavebeenusedforcenturiestojoin twoedgesofa
`woundtogetherto allow the body to heal faster. Originally, sutures
`were made from plant or animal materials such assilk, cotton, or catgut.
`OeaeMSUNC Tem gyTelib acyuataterMeLMien MeOburma
`MitomeMe CelerymTORTMUmeCeCROmee WTMca leoaeie
`into the tissue, or permanent, in which case they need to be removed
`after the wound has healed sufficiently to remain closed.
`Bloateraeeeecw IACRCCreeCaeCautacesirelloat Briteec
`wearable, With a reduction in size comes an abundance of new appli-
`cations. Thread-based technology has miniaturized electronic systems
`to such a degreethat theycan be integrated into surgical sutures. This
`allows modern sutures to be replaced with smartsutures that are capa-
`ble ofso much more than just holding tissue together.
`The developmentof thread-based technology hasbeenstudied by many
`PCa a(aclmiaeee saraeosathe anceaa)
`commerciallyfeasible due to the high cost of the materials and equip-
`mentrequired for mass production. The thread hasalso been largely
`inflexible, making practical applications scarce. In contrast, the flexibil-
`eumamleeelRend Aeemeretemeio
`than thetraditional two dimensional diagnostic devices. Recent devel-
`PaneMnlaey momCremaCe TORTCaleanaprety
`conceivable reality within a year or two.
`
`Google Chrome
`
`86.0.4240.198
`
`Wi
`
`11:15:32 PM 2/3/2021
`https://trustedwriter.com/wp-content/uploads/2019/09/Smart-Sutures-Davies-1-2.pdf
`
`

`

`https:/Avww. hospimedica.com/surgical-techniques/articles/54250000/smart-suture-aids-minimally-invasive-surgers
`html
`0203/2021 11:31:13 PM
`
`
`
`
`
`
`DAILY CLINICAL NEWS
`
`«COIN?
`
`
`
`BefClaael eA ey
`
`
`Geta Quote Today!
`
`INTL: +1(949) 273-8000
`US/CAN: (800) 400-7972
`info@ampronix.com www.ampronix.com
`
`Smart” Suture Aids Minimally Invasive Surgery
`
`Posted on 06 May 2002
`QO © @ ® Oo
`By HospiMedicastaffwriters
`Based on new biodegradableplastics, a suture has been designed thatcantieitself into a perfect knot or be taught
`to have one shape at one temperature and another shape at a different temperature. This advance could be
`particularly useful in minimally invasive surgery.
`
`The biocompatible plastics were developed by two scientists, Robert Langer, professor of chemical and biomedical
`engineering at the MassachusettsInstitute of Technology (Cambridge, MA, USA) and AndreasLendlein, a researcher
`at the University of Technology (Aachen, Germany). To create the new material,
`they designed a biodegradable
`multiblockcopolymer in which block-building segments are linked togetherin linear chains. The polymer contains a
`hard segment and a “switching” segment, both with different thermal properties, so that the material forms a temporary
`shapeat one temperature and a permanentshapeata higher temperature
`
`This "shape memory" makesthe material ideal for use in sutures for minimally invasive surgery, whereit is extremely
`
`PERRY HEALTH“
`
`GLOBAL LEADER IN PERSONAL PROTECTIVE
`
`WEAR AND EQUIPMENT
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`
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`
`

`

`https:/Avww. hospimedica.com/surgical-techniques/articles/54250000/smart-suture-aids-minimally-invasive-surgers
`html
`0203/2021 11:31:13 PM
`
`HIS SHAPE HIEHIVIY HeaReS WIE Meta Ue! WE USE ITT SULUEED IUE HITIITIely HivaSive SUIYeTY, WHIETE IL IS CAUETIELY
`difficult to knot a suture in a confined space. "We created a temporary shape in the form of an elongatedfiber, which
`was then used to loosely tie a suture to close a wound onarat,” explained Dr. Langer. After increasing the
`temperature,the suture material shrunk, creating a knot with just the right amount oftension onthe surroundingtissue.
`
`The polymer could also befirst shaped as a string that, when heated, could change into a sheet to prevent adhesion
`between two internal tissues after an operation, or change into a screw for holding bonestogether, or a stent. "I think
`there could be manydifferent applications,” said Dr. Langer.
`
`Related Links:
`MIT
`University ofTechnology
`
`000090
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`Current approachesforimplanting medical devices, many of which are polymeric in nature, often
`require complex surgery followed by device implantation. With the advent of minimally invasive
`surgery (1), itis possible to place small devices with laprascopes. Such advances create new
`Opportunities but also new challenges. How does one implanta bulky device or knot a suture in a
`confined space?It occurred to usthat the creation of biocompatible (and ideally in many cases
`degradable) shape-memory polymers with the appropriate mechanical properties might enable the
`developmentof novel types of medical devices.
`Shape-memory polymers possessthe ability to memorize a permanent shape that can
`substantially differ from theirinitial temporary shape. Large bulky devices could thus potentially be
`introduced into the body in a compressed temporary shape by means of minimally invasive
`surgery and then be expanded on demandto their permanent shapeto fit as required.In the same
`
`way, a complex mechanical deformation could be performed automatically instead of manually by
`
`r
`:
`Biodegradable, Elastic Shape-Memory Polymers for
`Potential Biomedical Applications
`Andreas Lendlein'.”, Robert Langer”
`+ See all authors andaffiliations
`Science
`21 May
`2002:
`Vo!
`73,
`pp.1
`DOI:
`1126/science.1066
`
`
`Article
`
`Figures & Data
`
`Info & Metrics
`
`eLetters
`
`PpF
`
`Abstract
`Theintroduction of biodegradable implant materials as well as minimally invasive surgical
`procedures in medicine has substantially improved health care within the past few decades.
`This report describes a group of degradable thermoplastic polymers that are able to change
`their shapeafter an increase in temperature. Their shape-memory capability enables bulky
`implants to be placedin the body through small incisions or to perform complex mechanical
`deformations automatically. A smart degradable suture wascreatedtoillustrate the potential
`of these shape-memory thermoplastics in biomedical applications.
`
`Science
`
`Vol
`Tableot Contents
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`& Print
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`

`the surgeon. Thetransition from the temporary to the permanent shape couldbeinitiated by an
`external stimulus such as a temperature increase above the switchingtransition temperatureTtrans
`of the polymer [movie $1 (19)].
`The thermally induced shape-memoryeffect has been described fordifferent material classes:
`polymers(2, 3), such as polyurethanes (4-7), poly(styrene-block-butadiene) (8) and
`polynorbernene(9, 10); hydrogels (11,12); metallic alloys (13); and ceramics(14). All of these
`materials are nondegradable in physiological environments and manylack either biocompatibility
`or compliance in mechanicalproperties.
`In
`In metallic alloys, the shape-memory effect is due to a martensitic phasetransition (13).
`contrast, the polymers designed to exhibit a thermally induced shape-memory effect require two.
`components on the molecularlevel: cross-links to determine the permanent shape and switching
`segments withT4sn5 to fix the temporary shape. AboveTj,ans, the permanent shape can be
`deformed by application of an external stress. After cooling belowTtrans and subsequentrelease of
`the external stress, the temporary shapeis obtained. The sample recoversits permanent shape
`upon heating to T >Ttrans.
`Cross-links can beeither covalent bondsor physicalinteractions. Recently, we have reported on
`shape-memory polymers(15), which are covalently cross-linked polymer networks containing
`hydrolyzable switching segments. Emphasisin the present work wasput on the developmentof a
`group of polymers that contain physical cross-links. These thermoplastics are easily processed
`from solution or melt and are substantially tougher than polymer networks.In particular, they are
`degradable, showinglinear mass loss during hydrolytic degradation.
`We selectedlinear, phase-segregated multiblockcopolymers as the structural concept for our
`polymer system, because this polymer architecture allowstailoring of macroscopic properties by
`variation of molecular parameters.
`In thefirst step of the polymer synthesis, macrodiols with different thermal characteristics are
`synthesized through ring-opening polymerization of cyclic diesters or lactones, with a low-
`molecular-weightdiolasinitiator, and purified (16).
`In the current study, oligo(s-caprolactone)diol
`(OCL) was chosen asthe precursorfor the switching segments having a melting transition
`temperature (T ;). Crystallizable oligo(p-dioxanone)diol (ODX), with a higherT ,, than OCL was
`chosen as a hard segmentto provide the physical cross-links (17). The melting transition of the
`latter macrodiols is determined by the average chain length, which can betailored by the
`monomer/initiatorratio (16, 17).
`In the second step, the two macrodiols are coupled with 2,2(4),4-trimethylhexanediisocyanate (18)
`Hard segmentcontents of the synthesized polymers range from 0 to 83 weight % (wt %); and
`number-average molecular weights (M ,), which were determined by meansof gel permeation
`chromatographyrelative to polystyrene standards, are between 35,000 and 77,000, with
`polydispersities around2. Figure 1 shows melting properties of multiblockcopolymersdiffering in
`their hard segment contents. Glasstransition temperatures are between —51° and 0°C [table S2
`(19)].
`
`Figure 1
`Tm and enthalpies AH,, of multiblockcopolymers(36).T;, (OCL), solid
`squares; AH,, (OCL), Solid circles;T,, (ODX), open squares; AH,, (ODX),
`
`opencircles ow 20 30a 506070
`
`Hardsegmentcontent (wt%)
`£ Download high-res image
`( Openin new tab
`& Download Powerpoint
`
`foreverspin”
`BSB maven cannon
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`The multiblockcopolymers can be elongated up to 1000%[table $1 (19)] before they break. This
`allows deformations between permanent and temporary shape up to 400%, whereas the maximum.
`deformation for Ni-Ti alloys is 8% (20). The mechanical properties strongly dependonthe hard
`segment content. Increasing the amountof ODXin the reaction mixture leadstoastiffer polymer
`and a decreaseof the corresponding elongationsat break. This can be observedatall three
`investigated temperatures and is due to increased crystallinity [table $1 (19)].
`To quantify shape-memory properties, programming and recovery were investigated by cyclic
`thermomechanicaltests (21, 22). This simple test describes shape memoryin one dimension;
`however, the effect takesplacein all three dimensions. Theeffect is commonly described with two
`important parameters.The strain fixity rate R ; describesthe ability of the switching segmentto fix
`the mechanical deformation, which is applied during the programming process. Forour polymers,R
`ylies between 98 and 99.5%. The strain recovery rate R , quantifies the ability of the material to
`recoverits permanent shape. R depends on the cycle numberand gradually approaches 100%
`becauseof reorientation of the polymer chainsin the unoriented pressedfilms during the early
`cycles, becauseofinelastic behavior.In thefirst cycle, R , has values between 76 and 80% for our
`multiblockcopolymers and reaches 98 to 99% in thethird cycle. Ni-Ti alloys show stressesin the
`range of 200 to 400 MPa during shape-memorytransition, whereas the shape-memory
`thermoplastics producestresses in the range between 1 and 3 MPa, depending on the hard
`segment content (23). The lower value for shape-memory polymers resembles the mechanical
`stressesin soft tissue (24).
`To record the changein elengation during the shape-memoryeffect, another cyclic
`thermomechanical experiment was performed (Fig. 2). Step 1 is the deformation of the permanent
`shape and correspondsto a standardstress-strain test. After maintaining this strain for 5 min to
`allow relaxation for chains,the stressis then held constant while the sampleis cooled (step 2),
`whereby the temporary shapeis fixed. Then stress is completely removed after waiting for 10 min
`(step 3), and the sampleis now in its temporary shape. Heating in step 4 (2 K min“") actuates the
`shape-memoryeffect. The contraction of the sample can be observed on the strain axis, and the
`fastest shape changeis recordedatTtrans = 40°C.
`
`Figure 2
`Cyclic thermomechanicalexperiment of PDC35 (37)with Trans = 40°C.
`Results ofthe first cycle are shown. Step 1 ofthe experiment was
`strain-controlled; steps 2 through4to the beginningof next cycle were
`
`stress-controlled & Download high-res image
`
`( Openin new tab
`+ Download Powerpoint
`
`Weintroduced hydrolyzable ester bondsin our polymers sothat they would cleave under
`physiological conditions. The degradation kinetics can be controlled through the composition and
`relative masscontentof the precursor macrodiols. An increasein the ODX contentleads to a
`fasterloss in mass(Fig. 3), because the concentration ofrapidly hydrolyzable ODX-ester bondsin
`the amorphousphaseis increased.
`
`Figure 3
`
`0a
`
`l erste 2 esse]
`
`

`

` a)
`
`Hydrolytic degradation ofthermoplastic shape-memory elastomersin
`aqueous buffer solution (pH 7) at 37°C. The relative mass loss for
`multiblockcopolymers differing in their hard segment contentis shown
`Denaatitpend) =(PDC10,circles; PDC17, squares; PDC31, upward-pointingtriangles;
`PDC42, downward-pointingtriangles). m(t), Sample massafter a
`£ Download high-res image
`degradation periodt; m(t q), original sample mass.
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`& Download Powerpoint
`
`Established synthetic degradable suture materials are mainly aliphatic polyhydroxy acids showing
`bulk degradation. This degradation process canbe split into several stages (25), the first three of
`which are swelling, loss of molecular weight, and loss of sample mass.
`The degradation of Llactide-based polyesters showsa nonlinear masslossleading to a sudden
`releaseof potentially acidic degradation products from the bulk material, which may cause a
`strong inflammatory response(26). The high crystallinity of oligomerparticles slows down
`degradationat the end of the processand leadsto the formation offibrous capsulesin vivo (27).
`In contrast, the multiblockcopelymers presented here show linear masslossin vitro (Fig. 3),
`resulting in a continuousrelease of degradation products.
`The tissue compatibility of our polymer wasinvestigated with chorioallantoic membrane (CAM)
`tests, which are a sensitive methodof evaluating toxicity (28). Nine separate experiments were
`carried out.All tests showed good tissue compatibility when graded according to Folkman(29).
`There wasno detectable changein the numberor shape of blood vessels or damageunderorin
`thevicinity of the polymerfilm (Fig. 4).
`
`~0.5 cm). For a positive control sample, see (25). & Download high-res image
`
`Figure 4
`Results of CAM tests of PDC38 (sample length:
`
`left, ~0.3 cm; right,
`
`(@ Open in new tab
`& Download Powerpoint
`
`Achallengein endoscopic surgery is the tying of a knot with instruments and sutures to close an
`incision or open lumen.It is especially difficult to manipulate the suture so that the woundlips are
`pressed together underthe right stress. When the knotis fixed with a forcethat is too strong,
`necrosis of the surrounding tissue can occur(30).
`If the force is too weak,scartissue, which has
`poorer mechanical properties, forms and may lead to the formation of hernias (31). A possible
`solution is the design of a smart surgical suture, whose temporary shape would be obtained by
`elongating the fiber with controlled stress. This suture could be applied loosely in its temporary
`shape; whenthe temperature wasraised aboveTtrans, the suture would shrink andtighten the knot,
`applying the optimumforce (32)(Fig. 5).
`
`also available as movie $2 (19).
`
`Figure 5
`A fiber of a thermoplastic shape-memorypolymer was programmed by
`stretching about 200%.After forminga looseknot, both ends of the
`‘suture werefixed. The photo series shows, from top to bottom, how
`‘the knot tightened in 20 s when heated to 40°C. This experimentis
`
`

`

`& Download high-res image
`Open in new tab
`£ Download Powerpoint
`
`An additional set of experiments to test the feasibility of this concept was performed. Thehighly
`elastic shape-memory thermoplastics were extruded into monofilaments (33). A sterilized suture
`(34) was programmedundersterile conditions by exerting a controlled stress on the extrudedfiber
`and subsequentthermal quenching. This smart suture wastestedin the following animal model: A.
`rat (WAG;weight, 250 g; albino) waskilled and shaved. An incision was madethrough the belly
`tissue and the abdominal muscle. The wound wasloosely sutured with a standard surgical needle
`3
`(HermannButsch,size 15, circle). Whenthe temperature wasincreased to 41°C, the shape-
`memory effect was actuated (Fig. 6). This test was carried out fourtimes using twodifferent
`animals. For thesetests,the fibers were elongated by 200% during programming and were able to
`generate a force of 1.6 N upon actuation of the shape-memory effectin vitro. During the animal
`experiment, 0.1 N could be detectedin the surroundingtissue (35).
`
`ac
`
`at
`20%
`& Download high-res image
`Ctperilsoh
`& Download Powerpoint
`
`Figure 6
`Degradable shape-memory suture for woundclosure. The photoseries
`from the animal experiment shows (leftto right) the shrinkage of the
`fiber while temperature increases.
`
`Thisfeasibility study suggests that this type of material has the potential to influence how
`implants are designed and could enable new surgical devicesin the future.
`* To whom correspondence should be addressed. E-mail: a.lendlein@mnemoscience.de
`
`REFERENCES AND NOTES
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`17.4 H.G. Grablowitz, A. Lendlein,in preparation
`18.4 Both macrodiols were dissolved in 1,2-dichloroethane and heated to 80°C. An equimolar amountof
`2,2(4),4-trimethylhexanediisocyanate was added. The synthesis was carried out under exclusion of water,
`andsolvents and monomers were dried by standard techniques. Thecrude product wasprecipitatedin
`hexane.
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`2 |. 4 The material was pressedinto films having a thickness of 300 to 500 ym. Dog bone-shaped samples