CA2185564C - Dimensionally adjustable soft tissue expander and method - Google Patents
Dimensionally adjustable soft tissue expander and methodInfo
- Publication number
- CA2185564C CA2185564C CA002185564A CA2185564A CA2185564C CA 2185564 C CA2185564 C CA 2185564C CA 002185564 A CA002185564 A CA 002185564A CA 2185564 A CA2185564 A CA 2185564A CA 2185564 C CA2185564 C CA 2185564C
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- Prior art keywords
- expander
- base
- folds
- fold
- central portion
- Prior art date
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- Expired - Fee Related
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- 210000004872 soft tissue Anatomy 0.000 title claims abstract description 26
- 238000000034 method Methods 0.000 title description 11
- 210000001519 tissue Anatomy 0.000 claims description 36
- 230000002093 peripheral effect Effects 0.000 claims description 17
- 239000000463 material Substances 0.000 claims description 13
- 229920001971 elastomer Polymers 0.000 claims description 11
- 239000000806 elastomer Substances 0.000 claims description 11
- 239000012530 fluid Substances 0.000 claims description 11
- 238000002513 implantation Methods 0.000 claims description 5
- 239000010410 layer Substances 0.000 description 38
- 230000007547 defect Effects 0.000 description 8
- 230000035876 healing Effects 0.000 description 7
- 238000003780 insertion Methods 0.000 description 6
- 230000037431 insertion Effects 0.000 description 6
- 239000007788 liquid Substances 0.000 description 5
- 229920002379 silicone rubber Polymers 0.000 description 4
- 239000002356 single layer Substances 0.000 description 3
- 210000000988 bone and bone Anatomy 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 208000002847 Surgical Wound Diseases 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 150000001768 cations Chemical class 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000000284 resting effect Effects 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/02—Devices for expanding tissue, e.g. skin tissue
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medical Informatics (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Dermatology (AREA)
- Molecular Biology (AREA)
- Pathology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
- Materials For Medical Uses (AREA)
- Professional, Industrial, Or Sporting Protective Garments (AREA)
Abstract
A soft tissue expander (10) includes a dimensionally adjustable base (14) having folds (34). The shape of the base (14) is optimally adjusted by extending or foreshortening the folds (34) prior to inserting the expander (10) into an incision formed below a layer of skin to be expanded.
Description
Wo 95/Z6696 -1- T_"~ 7 DIM~ IONALLY ADJUSTAB~E SOFT TISSUE EXPANDER AND METHOD
Field of the Invention The invention relates to soft tissue ~Yr~nri~rs and methods for ~Yr~ln~;nr skin using soft tissue expanders.
I~escri~tion of the Prior Art Conv~nt;nn~l soft ti3sue expanders include a cover and base ~l~.f;ninr an interior chamber and an inlet port through which liquid may be inj ected into the chamber to expand the cover above the base. The base i8 generally flat and has a shape ~ tpr~ n~ during m~nllf~rture of the ~ a..der. The inlet port may be mounted in the 10 cover or may be external to the e~cLlldt:L and connected to the ~ i~r by a tube so that injected liquid flows through the tube and into the ~nrlPr Conv~-ntinn~l ~Yr~n~l~r8 are rnll~rcGrl and inserted in surgic-ally formed incisions beneath the layer of skin to be ,oYn~n~
15 The pocket may be considerably larger than the expander base to fAr; 1 ;tate accurate location of the ~Yr~n~l~or relative to the overlying and adjacent tissue and to assure that the expander base is inserted flat.
After insertion, the ;nr1Rion is closed and the collapsed 20 P~ P- is left in place for a period of time sufficient to allow healing to occur. During healing the ; nr; cinn outside of the ~ n~r base closes and holds the base of the C~ rCP~ ~Yr~n~l~r in place beneath the layer of skin.
After healing has completed and the F~Yr~n~ r is stabilized in 25 place, fluid is injected into the expal-~der through the inlet port using a hypodermic needle to force the compliant cover above the base and expand the area of the layer of live skin overlying the cover. The cover is preferably formed from a highly ~ l; ;Int silicone elastomer material which expands during the expansion W0 95/26696 2 1 8 5 5 ~ 4 A .~ 7 process. When the expander i5 collapsed for insertion, the cover may have a greater area than the base and the cover may be folded over itself on top of the base as illustrated and described in Ernest ~. Manders United States Patent No. 4,574,780 entitled "Soft 5 Tissue ~ rr~nr~r and Method".
Following insertion of s~ffi~ nt liquid into the cavity of the ; ,1 ~nterl expander and Prr~nqinn of the overlying skin to a desired extent, the liquid is withdrawn and the ~An~l~r is rnll:~rq~ and surgically removed. The ~ .1 tissue flap may be 10 ~rtF~n~ d to cover an adjacent defect, or may be surgically removed and applied to a remote area of the patient ~ s body .
The shape of the ~r~n~ tissue flap is in large part deter-mined by the shape of the expander base. The shapes of bases used in convPn~inn~l tissue expanders are fixed during manufacture and 15 cannot be varied.
Conv~nt;nn~l croissant-shaped expanders have fixed crescent shaped bases . These e..,uc~.-de ~. are used to expand skin adj acent a skin defect 80 that the P~r~n~ l skin may be F.~t~nA~ to cover the defect. An inventory of different size crescent-shaped ~
20 with different size crescent-shaped bases, must be ~~=;nt~;n~-d in order to assure that a surgeon has available a proper shaped ~rr~nrl~r for use in ~r~n~l;n~ tissue to cover a given size defect.
Conventional expanders do not have adjustable bases. It is conv~nt;nn~l for hospitals performing soft tissue ~ nqinn to 25 stock inventories of different size expanders having a similar shape but different size bases in order to assure that a surgeon has available an appropriate size expander to meet the requirements of a particular desired soft t$ssue expansion ~Lu~e~uLe. Mainten-ance of the large inventories of expanders is an expensive and WO95126696 21 85564 I-J/I~-9~ 7 undesirable necessity arising frQm the inability to adjust the shape of bases of convF~ntinn~1 expanders S of the InventiDn The invention is a soft tissue expander formed from an 5 elastome; material and having a highly ~ nt cover and a dimen-sionally adjustable base joined to the cover at the peripheral edge of the expander. An i~let port is cnnn~rt~ to the cavity formed between the cover and the base. The inlet port may be an PYt~rnll port r~nn~Ct~d to the expander by a tube or may be an 1nt~rn~1 port 10 mounted directly in the cover.
The base of the ~.de, ;nrl~ q one or more folds at an edge of the base. The folds may extend completely around the expander or, alternatively, may extend from the base a short distance into the cover. The folds permit a surgeon to adjust the shape of the 15 base of the c~ de ~ prior to inserting the expander into a surgically-formed ;nr;qjnn located below a layer of skin to be r~n~l~d. After the ; nr; qinn is closed and heals around the ~-rr~n~l~r, the bage ig cnnf;nPd in place by surrounding tis3ue and r-;nt ,;nc the shape in which it was inserted throughout the expan-20 sion process.
Fluid i~serted into the ~Yr~n~l~.r through the port f orces thecos~pliant cover away from the base to expand the overlying skin tissue in a convPnt;nn~l manner. The area of the =Yr~n~l~d tissue i8 determined in large part by the shape given to the base by the 25 surgeon when the ~ is inserted into the tissue ;nr;q;nn In this way, the surgeon may ~djust the shape of the base of an ~an~1~r to a desired configuration so that a gingle eYpander may be used for a variety of types of expansion procedures without the necessity of m~;nt~;n;nrJ an inventory of sDecialized ~xr~n~lPrs for 3 o each procedure .
-Wo 95126696 2 1 8 5 5 6 4 ~ 7 The adjustable expander affords a surgeon the ability torespond to unexpected surgical conditions discovered during surgery. This condition may indicate the procedure re~uires an expander have a shape different than the shape of the expander 5 initially selected for; ,1iqnt~t jnn, In such a case, a surgeon using an adjustable e~LlldeL can easily adjust the shape of the base of the selected ~L~ del. There is no need to use a different expander or to wait unit a different expander is obtained from inventory .
The ~ rl ~s~d adjustable soft tissue expanders include one or more folds ~YtQn~;ns across the base. In an expander including a pair of opposed tapered arms, the folds permit extension and retraction of the arms and rotation of the arms 80 that the base of the Q~n~lQr may be moved to assume a crescent shape with the ends 15 of the arms close to each other or the ends of the arms spaced apart from each other. Alternatively, the base may also be shaped to form an Ql on~te base or a relatively short base. Each arm is movable ; n~ "t of the position of the other arm. This flexibility in shaping the expander base permits the surgeon great 20 fl~-r;h;l ;ty in performing soft tissue expangion procedures and improves the ability to shape an Q~n~ skin layer to meet the needs of a particular patient.
other objects and features of the invention will become appa-rent as the description proceeds, especially when taken in conjunc-25 tion with the ~ ~ ying drawings illustrating the invention, ofwhich there are 12 3heets and eight Qmh~; q Descril:1tion of the Drawin~s Figure 1 is a top view of a first ~ ;r1Qnt adjustable soft tissue expander;
W095/26696 _5~ J~S. 't7 Figure 2 is a horizontal sectional view taken through the expander of Figure l;
Figure 3 is a sectional view taken along curved line 3--3 of Figure 2;
Figures 4, 5 and 6 are sP~ n~l views showing the expander of Figures 1-3;, 1 :~nted beneath a layer of skin, partially P~n~
and completely P~:~n~1pd;
Figures 7-9 are views illustrating different positions of the '"L.,."AP. of Figure l;
Figure 10 i9 a top view of a second; ' '; - ~ adjustable expander;
Figure 11 i8 a view showing the P~An~1Pr of Figure 10 in a second Pl oT~tP~ position;
Figures 12 and 13 are horizontal sectinn~ll views through the P~:~n~Prs of Figures 10 and 11, respectively;
Figures I4 and 15, 16 and 17, and 18 and 19 are h~r;7r1nt~1 sectional views taken through third, fourth and fifth embodiment adjustable tissue expanders;
Figures 20-23 are top views of a sixth: ' -'; adjustable 20soft tissue P~n~Pr in different positions;
Figure 24 is a top view of a seventh Pmhorl; ~ adjustable P~n~P~; and Figure 25 is a view similar to Figure 3 showing an eighth : ' _'; adjustable expander.
25 De3cril~tion of the Preferred Emhodiments First Embodiment Exl~ander The first P~nh.~; t adjustable soft tissue expander lo shown in Figures 1-9 is generally crescent-shaped and ;n~ Pq an expand-able cover 12 oYerlying base 14 with the ~over and base j oined 30 together at peripheral edge 16 to define a fluid tight chamber 18 WO 95/26696 -- 6 ~ Sr7 between the cover and base. A conventional ~rt ~rn:~l inlet port 20 is rnnnPrt~1 to the ~Yp;ln~f~r by tube 22 to permit fluid, conventionally a saline solution, to be injected into the chamber 18 or withdrawn from the chamber 18. Fluid is injected or 5 withdraw. by inserting a hypodermic needle into the inlet port 20.
The expander ;nrlt~ q a tubular central portion 24 and a pair of tubular ~leSC~llL arms 26 and 23 which are joined to the ends of the tubular central portion. The arms are bent to one side of the tubular portion and are tapered away from the tubular portion to 10 closed ends 30 and 32 located to one side of the central portion.
The base and coYer of the 1; srl 95~.1 r~;~nrlPrs are preferably formed of a silicone elastomer material. In practice, the covers and bases of the disclosed expanders are considerably thinner than illustrated in the drawings. Preferably, the expander cover is 15 formed of a silicon polymer elastomer having an ~ nq;c~n ratio of several hundred percent to permit proper f~lrp:lnc;nn of an overlying skin layer. The base i8 adjustable in shape. During r~ nR;rTI the base is supported by muscle and bone and does not change shape.
Figure 25 illustrates an ~ ..de~ with a reinforced base. Bases 20 w~tich are not reinforced bow ~' - dly a short distance into the underlying ti8sue during PYr~nqinn.
The cover and base of ~ ..de~ 10 at central portion 24 are folded into a plurality of overlapping folds 34, each of which extends circumferentially around the cover and base. Folds 34 25 extend across the width of the bage 14 and acro88 the ~ntl~r cover 12. Each fold 34 includes a double thickness layer of elastomer material with adj acent f olds j oined to each other and folds at the ends of the central portion joining the large ~i _; on ends of arms 26 and 2a . Tube 22 opens into the interior WosS/26696 - 2 1 8 5 5 6 4 1P~_I/L~ _ . ~7 chamber 18 through a wall of arm 26 away from the folds 34. If desired, port 20 may be mounted on an arm 26 or 28.
The shape of the base of ~lpfl;ltprl expander 10 is easily - adjusted by moving the two arms 26 and 28 to a desired location and 5 allowing the folds in the central portion 24 to c~-rPRpnn~l;nsly foreshorten or lengthen as required. For example, Figure 7 illustrates ~Yr~n~Pr 10 in an Plnn~tPfl position in which the arms 26 and 28 are spaced laterally apart from each other and the folds 34 on the middle portion have been foreshortened to permit 10 sPr~r~t;nn of the arms. The e~dllder base has been lengthened.
Figure 8 illustrates a different position of PY~n~n~lPr base 14 in which the arms 26 and 28 have been rotated toward each other and the folds 34 on the side of the middle portion adjacent arm ends 30 and 32 have been lengthened and the folds on the side of the middle 15 portion away from the arm ends have been foreshortened in order to permit the rotation of the arms. The shape of base 14 has been corrPR~nnrl;n~ly changed, as illustrated.
Figure 9 illustrates the position of e~ de 10 where the arms 26 and 28 have been rotated in a direction opposite to the 20 direction of rotation illustrated in Figure 8 to space the arm ends 30 and 32 away from each other and lengthen the folds on the side of the middle portion away from arm ends 30 and 32 and foreshorten the folds on the side of the middle portion adjacent the arm ends.
The folds permit a surgeon to adjust the shape of the ~ P-25 base 80 that, when implanted beneath the layer of skin, the basehas an optimum shape for the de-:ired tissue expansion. For instance, when it i9 npr~pRR;~ry to form a small PYr~n~lPd skin flat to cover a _mall defect, the base of PYr~n~Pr 10 may be positioned as in Figure 8 with the arms 30 and 32 located close together to 30 either side of the defect. When expansion is re~auired to form a Wo 95/26696 8 5 5 6 4 ~ ~ " ' 5~7 large flap to cover a -larger defect, the expander base may be positioned as in Figure 2. Expansion of a yet larger flap to cover a yet larger defect may require positioning the ~ a~ldeL as shown in Figure 7. Positioning the expander base as shown in Figure g may also be desirable for othe; procedures.
Figure 4 illustrates collapsed expander 10 as shown in Figures 1 and 2 ;--lr]~nt~ in an ;n~;Rinn or pocket beneath a soft layer of skin 36. The cover conforms to the shape of the base. The expander base 14 is supported by a layer of muscle or by bone. The folds 34 in the central portion of the expander overlap each other and lie nearly f lat on each other at a shallow angle relative to the expander during healing. The folds present a smooth surface to the overlying and underlying tissue. Cover 12 rests flush on base 14. The incision formed prior to insertion of expander 10 below lS layer 36 is closed or healed around the peripheral edge 16, 80 that tissue layer 3 6 is j oined to underlying tissue outwardly of the expander edge 16 and the base is held in po8ition in the; nr; qinn and cannot change shape during expansio~ Base 14 is illustrated as being f lat . In practice, the base may be curved somewhat to conform to the shape of underlying support tissue.
Figure 5 illustrates partial expansion of expander 10. In this position, sufficient liquid has been injected into the chamber 18 to force~the cover 12 upwardly away from the supported base 14 and expand the overlying tissue 36 as shown. During expansion, the folds 38 ~.~t~n~;n~ across the base 14 at central portion 24 remain folde2 in the position assumed when the expander 10 was implanted beneath layer 36 as shown in Figure 4. During P~n~;nn of the cover, the folds 40 extending across the width of the cover at the middle portion between opposite sides of edge 16 are foreshortened as illustrated in Figure 5.
WO 95l26696 2 ~1 8 5 5 64 1 ~u . 7 _g_ When expander 10 is fully ;nfl~tP~i and expansion of the overlying tissue layer 36 is complete, the length of the cover has been increased sufficiently to efface the folds 40, as shown in - Figure 6. Folds 38 ~t.on~in~ across the base 14 remain in the 5 inserted ~43ition.
After expansion has been completed as shown in Figure 6, the fluid in chamber 18 i9 withdrawn through port 20, the ~
port and tube are surgically removed and the ~ n~orl tissue layer 36 is advanced or applied over a remote site in accordance with 10 conv~ntinnAl surgical ,uLucedu~:s.
Second r ~ _ ~im~ L Exoander Figures 10-13 illustrate a second ' '1 ~ ~li cinnF~lly adjustable crescent-shaped sot tissue expander 50. ~Yp~n~lPr 50 is formed from the same m~t~r;~l forming ~ n~lf.r 10 and includes ,,~"n~Ahle cover 52, base 54 and peripheral edge 56 joining the cover and base to define an interior chamber 58. Tube 60 ,nnnf~ctR
inlet port 62 to the chamber 58.
~ Yp:: nrlPr 50 ; nr~ R a tubular central portion 64 and a pair of tubular tapered crescent arms 66 and 68 which join the ends of 20 the central portion as illustrated. The arms include closed narrow ends 70 and 72.
~ nri~r 50 inr'l~ R a gingle large circumferential fold 74 ~1tt~n-;;n~ around central portion 64. As ghown in Figure 12, fold 74 is double th; rkn~R~ to form three-th; nknPRR layers surrounding 25 the central portion. The fold extends across the width of the base and the cover between oppo~ite sides of edge 56. The old permits adjustment of the shape of the expander base prior to impli~nt~tinn to ~n~ ' te the requirements of a particular surgical procedure.
For instance, the arms 66 and 68 of the P~n~lPr may be moved 30 apart, without rotation, as shown in Figure 13 to elongate the , W09s/266~6 2 f 8 5 5 6 4 ~ ; (7 expander and foreshorten or entirely efface the fold 74 80 that the arms are spaced apart . Additionally, fold 74 may be ~l rnrJ~tp~l or foreshortened at one side of edge 56 and foreshortened or elongated at the opposite side of edge 58 to permit rotation of the arms 66 5 and 68 relative to the central portion for adjustment of the shape of base 54 similar to adjustment of base 14 of expander 10.
The adjustability of the shape of base 54 permits a surgeon to implant the expander with the base having an optimum shape f or nc;rn of a particular overlying tigsue layer. The cover 52 0 overlying base 54 conforms to the; l~ntpd shape of base 54 and is n~ by the injection of fluid through port 62 and tube 60 into the chamber 58 as described in connection with ~ ncirn of expander 10. The arms 66 and 68 may be rotated as rer~uired. The arms need not be rotated together or be in symmetrical pr,c;t,rnc 15 when;, l~nt~-~l. Expander 50 assumes a shape similar to the shape of a valise handle when fully ~l rnrJ~terl as shown in Figure 13 .
'rh;rd Embodiment Adiustable Soft Tissue ExT~ander Figures 14 and 15 are similar to Figures 12 and 13 and illus-trate a third: ~'; soft tissue expander 80. ~n~ r 80 is 20 ;rl~ntlr;~l to ~ de~ 50 with the exception that the thickness of the ~ nfl~hle cover and base at middle portion 82 is less than the th;rknPRc of the cover and base at arms 84 and 86. A wide, thin tubular fold 88 is formed in middle portion 82 and extends across the e~nrl~r base 90 and overlying cover (not illustrated). The 25 thin central portion has greater flexibility than the thicker arms and permits ready forming of fold 88. Additionally, the thin fold permits greater expansion of the ce~tral portion of the cover, which is desirable because the central part of the soft tissue flap must be exT~n~ further than the tissue overlying the arms.
Wo 9sl26696 2 I J 5 6 4 ~ t7 Figure 15 shows expander 8 o in an elongated position in which the arms 84 and 86 are spaced a greater distance apart from each other than in Figure 14 and the fold 88 has been fully fore-shortened or effaced. In this position, the expander assumes a valise handle shape .
The shape of the base 90 of expander 80 may be adjusted similar to the shape5 of the bases of expanders 10 and 50 consis-tent with the requirements of particular surgical ~LUI_e:dUL~S. The cover of the t~ al~de~ conforms to the shape of the base.
After insertion of the PYr~nriPr and healing of the inr;~ir,n, fluid is injected into the interior chamber of the expander and the cover and overlying tissue are PYr~n~Pd as described previously.
Fourth Embodiment Adlustable Soft Tis6ue Ex~ander Figures 16 and 17 illustrate a fourth ' _ '; t soft tissue I.YrWn~P~ 100 having a generally crescent shape. ~Yr~n~1Pr 100 is like P~n.1Pr 50 with the Pl~r~.rt ~ rn that the tubular central portion 102 is tapered and the base 104 has a width 106 adjacent arm 108 less than the width of the base 110 adjacent the other arm 112. See Figure 17. Widths 106 and 110 extend across the base to opposite sides of edge 114. A single deep fold 116 is formed in the middle portion by inverting the narrow end of the middle portion into the wide end of the middle portion as shown in Figure 16. The tapered central portion 102 facilitates folding the narrow width end into the wider width end to form the fold and is useful when difficulty is Pnrr~llntpred in making the fold. ~Yr~nt1Pr 100, when fully Pl rnr,~tP-i a~ shown in Figure 17, assumes the shape of a valise handle.
The area of base 104 of expander 10 is adjusted as previously described by varying the length or angle of fold 116 or, if 30 required, by completely PFf~ri nrJ the fold. Once the area of the Wo 9~/26696 2 1 8 5 5 6 4 ~ 7 base has been lPt~'rminP~l, the surgeon implants the expander and, after healing has ~een completed, the overlying cover (not illus-trated) is P~n~ l as previously described.
Fifth Embodiment Adlustable Soft Tissue Ex~ander Figure~ 18 and 19 disclose a fi~th P ' ';rrl~nt adjustable soft tissue expander 120 similar to second ~rnhQrl1 t expander 50.
~n-lPr 120 includes a single layer tubular central portion 122 and crescent arms 124 and 126 joined to the ends of the central portion. The expander includes a single layer of elastomer 12a 0 ~ton~;nr completely around the base 130 and the cover (not illus-trated) which joins the base at edge 132. Second elastomer layers 134 are formed on the outside of the first layer 128 on both arms 124 and 126. The central portion 122 of ~ ;le~ 120 ls thinner than the arms 124 and 126 in order to facilitate inverting one end of the central portion into the other end to form fold 136 shown in Figure 18. The fold extends around the central portion and across both the cover and base.
The inner layer 128 of expander 120 may be relatively thin and possesses improved f~ ih;l;ty over the flexibility of the thicker two-layers arms 124 and 126. The flexibility of the inner portion f~r; l; t~tes forming the fold 136, adjugtment of the shape of the base by varying the depth and angle of the fold, and p~r~ncirn Prior to; ,lAnt~tirn of expander 120, a surgeon adjusts the shape of the .~l~r~n~Pr base 130 by lengthening or foreshortening the fold, and rotating the arms relative to the middle portion or completely ef facing the fold as reriuired in order that the base assumes a proper shape for performing the desired soft tissue expansion. The expander with the base in the proper shape is then implanted and P~r~n~P(l as previously ~Pcrr; hP~ . The cover over-lying base 130 conforms to the shape of the base when implanted so WO95~Z6696 _13_ F~ ~J~ 7 that the expansion of overlying tissue is in part governed by the shape of the base.
Figure 19 illustrates expander 120 in the fully elongated or P~tPn~iPd position in which fold 136 is effaced and the expander assumes the shape of a valise handle.
Si~th ~ li t Adiustable Soft Ti99ue ~ rn;ln~r Figures 20-23 disclose a sixth pmhofli~-~t adjustable soft tissue expander 140 including a tubular central portion 142, a pair of folded arms 144 and 146 each joining one end of the central portion, a base and an P~n~l~hle cover The arms include rounded closed ends 148 and 150 located away from the central portion. As illustrated in Figure 21, the arms are tapered in width from a maximum width at central portion 142 to a minimum width at ends 148 and 150.
The expander 140 includes an inlet port and tube communicating the port to the interior chamber of the ~l... ",1.-, . The port and tube are similar to the ports and tubes previously described.
A plurality of circumferential folds 152 are formed along the length of each arm 144 and 146 from the central portion 142 to ends 148 and 150. The folds extend across the width oi the P~,.n~Pr base (not illustrated) and across the width of the expander cover 154 and cross opposite sides of the circumferential edge 156 joining the base and cover. The folds are similar to the previously described folds and are formed by folding or inverting circumferential portions of the arms into portions located more closely adjacent the central portion 142 Th~ outer edges 156 of the folds face away from the ce~tral portion.
The folded arms 144 and 146 of P~rn~n~Pr 140 are highly flexible and may be moved to change the shape of the base. This 30 flP~ihil ity assures that a surgeon can vary the shape of the
Field of the Invention The invention relates to soft tissue ~Yr~nri~rs and methods for ~Yr~ln~;nr skin using soft tissue expanders.
I~escri~tion of the Prior Art Conv~nt;nn~l soft ti3sue expanders include a cover and base ~l~.f;ninr an interior chamber and an inlet port through which liquid may be inj ected into the chamber to expand the cover above the base. The base i8 generally flat and has a shape ~ tpr~ n~ during m~nllf~rture of the ~ a..der. The inlet port may be mounted in the 10 cover or may be external to the e~cLlldt:L and connected to the ~ i~r by a tube so that injected liquid flows through the tube and into the ~nrlPr Conv~-ntinn~l ~Yr~n~l~r8 are rnll~rcGrl and inserted in surgic-ally formed incisions beneath the layer of skin to be ,oYn~n~
15 The pocket may be considerably larger than the expander base to fAr; 1 ;tate accurate location of the ~Yr~n~l~or relative to the overlying and adjacent tissue and to assure that the expander base is inserted flat.
After insertion, the ;nr1Rion is closed and the collapsed 20 P~ P- is left in place for a period of time sufficient to allow healing to occur. During healing the ; nr; cinn outside of the ~ n~r base closes and holds the base of the C~ rCP~ ~Yr~n~l~r in place beneath the layer of skin.
After healing has completed and the F~Yr~n~ r is stabilized in 25 place, fluid is injected into the expal-~der through the inlet port using a hypodermic needle to force the compliant cover above the base and expand the area of the layer of live skin overlying the cover. The cover is preferably formed from a highly ~ l; ;Int silicone elastomer material which expands during the expansion W0 95/26696 2 1 8 5 5 ~ 4 A .~ 7 process. When the expander i5 collapsed for insertion, the cover may have a greater area than the base and the cover may be folded over itself on top of the base as illustrated and described in Ernest ~. Manders United States Patent No. 4,574,780 entitled "Soft 5 Tissue ~ rr~nr~r and Method".
Following insertion of s~ffi~ nt liquid into the cavity of the ; ,1 ~nterl expander and Prr~nqinn of the overlying skin to a desired extent, the liquid is withdrawn and the ~An~l~r is rnll:~rq~ and surgically removed. The ~ .1 tissue flap may be 10 ~rtF~n~ d to cover an adjacent defect, or may be surgically removed and applied to a remote area of the patient ~ s body .
The shape of the ~r~n~ tissue flap is in large part deter-mined by the shape of the expander base. The shapes of bases used in convPn~inn~l tissue expanders are fixed during manufacture and 15 cannot be varied.
Conv~nt;nn~l croissant-shaped expanders have fixed crescent shaped bases . These e..,uc~.-de ~. are used to expand skin adj acent a skin defect 80 that the P~r~n~ l skin may be F.~t~nA~ to cover the defect. An inventory of different size crescent-shaped ~
20 with different size crescent-shaped bases, must be ~~=;nt~;n~-d in order to assure that a surgeon has available a proper shaped ~rr~nrl~r for use in ~r~n~l;n~ tissue to cover a given size defect.
Conventional expanders do not have adjustable bases. It is conv~nt;nn~l for hospitals performing soft tissue ~ nqinn to 25 stock inventories of different size expanders having a similar shape but different size bases in order to assure that a surgeon has available an appropriate size expander to meet the requirements of a particular desired soft t$ssue expansion ~Lu~e~uLe. Mainten-ance of the large inventories of expanders is an expensive and WO95126696 21 85564 I-J/I~-9~ 7 undesirable necessity arising frQm the inability to adjust the shape of bases of convF~ntinn~1 expanders S of the InventiDn The invention is a soft tissue expander formed from an 5 elastome; material and having a highly ~ nt cover and a dimen-sionally adjustable base joined to the cover at the peripheral edge of the expander. An i~let port is cnnn~rt~ to the cavity formed between the cover and the base. The inlet port may be an PYt~rnll port r~nn~Ct~d to the expander by a tube or may be an 1nt~rn~1 port 10 mounted directly in the cover.
The base of the ~.de, ;nrl~ q one or more folds at an edge of the base. The folds may extend completely around the expander or, alternatively, may extend from the base a short distance into the cover. The folds permit a surgeon to adjust the shape of the 15 base of the c~ de ~ prior to inserting the expander into a surgically-formed ;nr;qjnn located below a layer of skin to be r~n~l~d. After the ; nr; qinn is closed and heals around the ~-rr~n~l~r, the bage ig cnnf;nPd in place by surrounding tis3ue and r-;nt ,;nc the shape in which it was inserted throughout the expan-20 sion process.
Fluid i~serted into the ~Yr~n~l~.r through the port f orces thecos~pliant cover away from the base to expand the overlying skin tissue in a convPnt;nn~l manner. The area of the =Yr~n~l~d tissue i8 determined in large part by the shape given to the base by the 25 surgeon when the ~ is inserted into the tissue ;nr;q;nn In this way, the surgeon may ~djust the shape of the base of an ~an~1~r to a desired configuration so that a gingle eYpander may be used for a variety of types of expansion procedures without the necessity of m~;nt~;n;nrJ an inventory of sDecialized ~xr~n~lPrs for 3 o each procedure .
-Wo 95126696 2 1 8 5 5 6 4 ~ 7 The adjustable expander affords a surgeon the ability torespond to unexpected surgical conditions discovered during surgery. This condition may indicate the procedure re~uires an expander have a shape different than the shape of the expander 5 initially selected for; ,1iqnt~t jnn, In such a case, a surgeon using an adjustable e~LlldeL can easily adjust the shape of the base of the selected ~L~ del. There is no need to use a different expander or to wait unit a different expander is obtained from inventory .
The ~ rl ~s~d adjustable soft tissue expanders include one or more folds ~YtQn~;ns across the base. In an expander including a pair of opposed tapered arms, the folds permit extension and retraction of the arms and rotation of the arms 80 that the base of the Q~n~lQr may be moved to assume a crescent shape with the ends 15 of the arms close to each other or the ends of the arms spaced apart from each other. Alternatively, the base may also be shaped to form an Ql on~te base or a relatively short base. Each arm is movable ; n~ "t of the position of the other arm. This flexibility in shaping the expander base permits the surgeon great 20 fl~-r;h;l ;ty in performing soft tissue expangion procedures and improves the ability to shape an Q~n~ skin layer to meet the needs of a particular patient.
other objects and features of the invention will become appa-rent as the description proceeds, especially when taken in conjunc-25 tion with the ~ ~ ying drawings illustrating the invention, ofwhich there are 12 3heets and eight Qmh~; q Descril:1tion of the Drawin~s Figure 1 is a top view of a first ~ ;r1Qnt adjustable soft tissue expander;
W095/26696 _5~ J~S. 't7 Figure 2 is a horizontal sectional view taken through the expander of Figure l;
Figure 3 is a sectional view taken along curved line 3--3 of Figure 2;
Figures 4, 5 and 6 are sP~ n~l views showing the expander of Figures 1-3;, 1 :~nted beneath a layer of skin, partially P~n~
and completely P~:~n~1pd;
Figures 7-9 are views illustrating different positions of the '"L.,."AP. of Figure l;
Figure 10 i9 a top view of a second; ' '; - ~ adjustable expander;
Figure 11 i8 a view showing the P~An~1Pr of Figure 10 in a second Pl oT~tP~ position;
Figures 12 and 13 are horizontal sectinn~ll views through the P~:~n~Prs of Figures 10 and 11, respectively;
Figures I4 and 15, 16 and 17, and 18 and 19 are h~r;7r1nt~1 sectional views taken through third, fourth and fifth embodiment adjustable tissue expanders;
Figures 20-23 are top views of a sixth: ' -'; adjustable 20soft tissue P~n~Pr in different positions;
Figure 24 is a top view of a seventh Pmhorl; ~ adjustable P~n~P~; and Figure 25 is a view similar to Figure 3 showing an eighth : ' _'; adjustable expander.
25 De3cril~tion of the Preferred Emhodiments First Embodiment Exl~ander The first P~nh.~; t adjustable soft tissue expander lo shown in Figures 1-9 is generally crescent-shaped and ;n~ Pq an expand-able cover 12 oYerlying base 14 with the ~over and base j oined 30 together at peripheral edge 16 to define a fluid tight chamber 18 WO 95/26696 -- 6 ~ Sr7 between the cover and base. A conventional ~rt ~rn:~l inlet port 20 is rnnnPrt~1 to the ~Yp;ln~f~r by tube 22 to permit fluid, conventionally a saline solution, to be injected into the chamber 18 or withdrawn from the chamber 18. Fluid is injected or 5 withdraw. by inserting a hypodermic needle into the inlet port 20.
The expander ;nrlt~ q a tubular central portion 24 and a pair of tubular ~leSC~llL arms 26 and 23 which are joined to the ends of the tubular central portion. The arms are bent to one side of the tubular portion and are tapered away from the tubular portion to 10 closed ends 30 and 32 located to one side of the central portion.
The base and coYer of the 1; srl 95~.1 r~;~nrlPrs are preferably formed of a silicone elastomer material. In practice, the covers and bases of the disclosed expanders are considerably thinner than illustrated in the drawings. Preferably, the expander cover is 15 formed of a silicon polymer elastomer having an ~ nq;c~n ratio of several hundred percent to permit proper f~lrp:lnc;nn of an overlying skin layer. The base i8 adjustable in shape. During r~ nR;rTI the base is supported by muscle and bone and does not change shape.
Figure 25 illustrates an ~ ..de~ with a reinforced base. Bases 20 w~tich are not reinforced bow ~' - dly a short distance into the underlying ti8sue during PYr~nqinn.
The cover and base of ~ ..de~ 10 at central portion 24 are folded into a plurality of overlapping folds 34, each of which extends circumferentially around the cover and base. Folds 34 25 extend across the width of the bage 14 and acro88 the ~ntl~r cover 12. Each fold 34 includes a double thickness layer of elastomer material with adj acent f olds j oined to each other and folds at the ends of the central portion joining the large ~i _; on ends of arms 26 and 2a . Tube 22 opens into the interior WosS/26696 - 2 1 8 5 5 6 4 1P~_I/L~ _ . ~7 chamber 18 through a wall of arm 26 away from the folds 34. If desired, port 20 may be mounted on an arm 26 or 28.
The shape of the base of ~lpfl;ltprl expander 10 is easily - adjusted by moving the two arms 26 and 28 to a desired location and 5 allowing the folds in the central portion 24 to c~-rPRpnn~l;nsly foreshorten or lengthen as required. For example, Figure 7 illustrates ~Yr~n~Pr 10 in an Plnn~tPfl position in which the arms 26 and 28 are spaced laterally apart from each other and the folds 34 on the middle portion have been foreshortened to permit 10 sPr~r~t;nn of the arms. The e~dllder base has been lengthened.
Figure 8 illustrates a different position of PY~n~n~lPr base 14 in which the arms 26 and 28 have been rotated toward each other and the folds 34 on the side of the middle portion adjacent arm ends 30 and 32 have been lengthened and the folds on the side of the middle 15 portion away from the arm ends have been foreshortened in order to permit the rotation of the arms. The shape of base 14 has been corrPR~nnrl;n~ly changed, as illustrated.
Figure 9 illustrates the position of e~ de 10 where the arms 26 and 28 have been rotated in a direction opposite to the 20 direction of rotation illustrated in Figure 8 to space the arm ends 30 and 32 away from each other and lengthen the folds on the side of the middle portion away from arm ends 30 and 32 and foreshorten the folds on the side of the middle portion adjacent the arm ends.
The folds permit a surgeon to adjust the shape of the ~ P-25 base 80 that, when implanted beneath the layer of skin, the basehas an optimum shape for the de-:ired tissue expansion. For instance, when it i9 npr~pRR;~ry to form a small PYr~n~lPd skin flat to cover a _mall defect, the base of PYr~n~Pr 10 may be positioned as in Figure 8 with the arms 30 and 32 located close together to 30 either side of the defect. When expansion is re~auired to form a Wo 95/26696 8 5 5 6 4 ~ ~ " ' 5~7 large flap to cover a -larger defect, the expander base may be positioned as in Figure 2. Expansion of a yet larger flap to cover a yet larger defect may require positioning the ~ a~ldeL as shown in Figure 7. Positioning the expander base as shown in Figure g may also be desirable for othe; procedures.
Figure 4 illustrates collapsed expander 10 as shown in Figures 1 and 2 ;--lr]~nt~ in an ;n~;Rinn or pocket beneath a soft layer of skin 36. The cover conforms to the shape of the base. The expander base 14 is supported by a layer of muscle or by bone. The folds 34 in the central portion of the expander overlap each other and lie nearly f lat on each other at a shallow angle relative to the expander during healing. The folds present a smooth surface to the overlying and underlying tissue. Cover 12 rests flush on base 14. The incision formed prior to insertion of expander 10 below lS layer 36 is closed or healed around the peripheral edge 16, 80 that tissue layer 3 6 is j oined to underlying tissue outwardly of the expander edge 16 and the base is held in po8ition in the; nr; qinn and cannot change shape during expansio~ Base 14 is illustrated as being f lat . In practice, the base may be curved somewhat to conform to the shape of underlying support tissue.
Figure 5 illustrates partial expansion of expander 10. In this position, sufficient liquid has been injected into the chamber 18 to force~the cover 12 upwardly away from the supported base 14 and expand the overlying tissue 36 as shown. During expansion, the folds 38 ~.~t~n~;n~ across the base 14 at central portion 24 remain folde2 in the position assumed when the expander 10 was implanted beneath layer 36 as shown in Figure 4. During P~n~;nn of the cover, the folds 40 extending across the width of the cover at the middle portion between opposite sides of edge 16 are foreshortened as illustrated in Figure 5.
WO 95l26696 2 ~1 8 5 5 64 1 ~u . 7 _g_ When expander 10 is fully ;nfl~tP~i and expansion of the overlying tissue layer 36 is complete, the length of the cover has been increased sufficiently to efface the folds 40, as shown in - Figure 6. Folds 38 ~t.on~in~ across the base 14 remain in the 5 inserted ~43ition.
After expansion has been completed as shown in Figure 6, the fluid in chamber 18 i9 withdrawn through port 20, the ~
port and tube are surgically removed and the ~ n~orl tissue layer 36 is advanced or applied over a remote site in accordance with 10 conv~ntinnAl surgical ,uLucedu~:s.
Second r ~ _ ~im~ L Exoander Figures 10-13 illustrate a second ' '1 ~ ~li cinnF~lly adjustable crescent-shaped sot tissue expander 50. ~Yp~n~lPr 50 is formed from the same m~t~r;~l forming ~ n~lf.r 10 and includes ,,~"n~Ahle cover 52, base 54 and peripheral edge 56 joining the cover and base to define an interior chamber 58. Tube 60 ,nnnf~ctR
inlet port 62 to the chamber 58.
~ Yp:: nrlPr 50 ; nr~ R a tubular central portion 64 and a pair of tubular tapered crescent arms 66 and 68 which join the ends of 20 the central portion as illustrated. The arms include closed narrow ends 70 and 72.
~ nri~r 50 inr'l~ R a gingle large circumferential fold 74 ~1tt~n-;;n~ around central portion 64. As ghown in Figure 12, fold 74 is double th; rkn~R~ to form three-th; nknPRR layers surrounding 25 the central portion. The fold extends across the width of the base and the cover between oppo~ite sides of edge 56. The old permits adjustment of the shape of the expander base prior to impli~nt~tinn to ~n~ ' te the requirements of a particular surgical procedure.
For instance, the arms 66 and 68 of the P~n~lPr may be moved 30 apart, without rotation, as shown in Figure 13 to elongate the , W09s/266~6 2 f 8 5 5 6 4 ~ ; (7 expander and foreshorten or entirely efface the fold 74 80 that the arms are spaced apart . Additionally, fold 74 may be ~l rnrJ~tp~l or foreshortened at one side of edge 56 and foreshortened or elongated at the opposite side of edge 58 to permit rotation of the arms 66 5 and 68 relative to the central portion for adjustment of the shape of base 54 similar to adjustment of base 14 of expander 10.
The adjustability of the shape of base 54 permits a surgeon to implant the expander with the base having an optimum shape f or nc;rn of a particular overlying tigsue layer. The cover 52 0 overlying base 54 conforms to the; l~ntpd shape of base 54 and is n~ by the injection of fluid through port 62 and tube 60 into the chamber 58 as described in connection with ~ ncirn of expander 10. The arms 66 and 68 may be rotated as rer~uired. The arms need not be rotated together or be in symmetrical pr,c;t,rnc 15 when;, l~nt~-~l. Expander 50 assumes a shape similar to the shape of a valise handle when fully ~l rnrJ~terl as shown in Figure 13 .
'rh;rd Embodiment Adiustable Soft Tissue ExT~ander Figures 14 and 15 are similar to Figures 12 and 13 and illus-trate a third: ~'; soft tissue expander 80. ~n~ r 80 is 20 ;rl~ntlr;~l to ~ de~ 50 with the exception that the thickness of the ~ nfl~hle cover and base at middle portion 82 is less than the th;rknPRc of the cover and base at arms 84 and 86. A wide, thin tubular fold 88 is formed in middle portion 82 and extends across the e~nrl~r base 90 and overlying cover (not illustrated). The 25 thin central portion has greater flexibility than the thicker arms and permits ready forming of fold 88. Additionally, the thin fold permits greater expansion of the ce~tral portion of the cover, which is desirable because the central part of the soft tissue flap must be exT~n~ further than the tissue overlying the arms.
Wo 9sl26696 2 I J 5 6 4 ~ t7 Figure 15 shows expander 8 o in an elongated position in which the arms 84 and 86 are spaced a greater distance apart from each other than in Figure 14 and the fold 88 has been fully fore-shortened or effaced. In this position, the expander assumes a valise handle shape .
The shape of the base 90 of expander 80 may be adjusted similar to the shape5 of the bases of expanders 10 and 50 consis-tent with the requirements of particular surgical ~LUI_e:dUL~S. The cover of the t~ al~de~ conforms to the shape of the base.
After insertion of the PYr~nriPr and healing of the inr;~ir,n, fluid is injected into the interior chamber of the expander and the cover and overlying tissue are PYr~n~Pd as described previously.
Fourth Embodiment Adlustable Soft Tis6ue Ex~ander Figures 16 and 17 illustrate a fourth ' _ '; t soft tissue I.YrWn~P~ 100 having a generally crescent shape. ~Yr~n~1Pr 100 is like P~n.1Pr 50 with the Pl~r~.rt ~ rn that the tubular central portion 102 is tapered and the base 104 has a width 106 adjacent arm 108 less than the width of the base 110 adjacent the other arm 112. See Figure 17. Widths 106 and 110 extend across the base to opposite sides of edge 114. A single deep fold 116 is formed in the middle portion by inverting the narrow end of the middle portion into the wide end of the middle portion as shown in Figure 16. The tapered central portion 102 facilitates folding the narrow width end into the wider width end to form the fold and is useful when difficulty is Pnrr~llntpred in making the fold. ~Yr~nt1Pr 100, when fully Pl rnr,~tP-i a~ shown in Figure 17, assumes the shape of a valise handle.
The area of base 104 of expander 10 is adjusted as previously described by varying the length or angle of fold 116 or, if 30 required, by completely PFf~ri nrJ the fold. Once the area of the Wo 9~/26696 2 1 8 5 5 6 4 ~ 7 base has been lPt~'rminP~l, the surgeon implants the expander and, after healing has ~een completed, the overlying cover (not illus-trated) is P~n~ l as previously described.
Fifth Embodiment Adlustable Soft Tissue Ex~ander Figure~ 18 and 19 disclose a fi~th P ' ';rrl~nt adjustable soft tissue expander 120 similar to second ~rnhQrl1 t expander 50.
~n-lPr 120 includes a single layer tubular central portion 122 and crescent arms 124 and 126 joined to the ends of the central portion. The expander includes a single layer of elastomer 12a 0 ~ton~;nr completely around the base 130 and the cover (not illus-trated) which joins the base at edge 132. Second elastomer layers 134 are formed on the outside of the first layer 128 on both arms 124 and 126. The central portion 122 of ~ ;le~ 120 ls thinner than the arms 124 and 126 in order to facilitate inverting one end of the central portion into the other end to form fold 136 shown in Figure 18. The fold extends around the central portion and across both the cover and base.
The inner layer 128 of expander 120 may be relatively thin and possesses improved f~ ih;l;ty over the flexibility of the thicker two-layers arms 124 and 126. The flexibility of the inner portion f~r; l; t~tes forming the fold 136, adjugtment of the shape of the base by varying the depth and angle of the fold, and p~r~ncirn Prior to; ,lAnt~tirn of expander 120, a surgeon adjusts the shape of the .~l~r~n~Pr base 130 by lengthening or foreshortening the fold, and rotating the arms relative to the middle portion or completely ef facing the fold as reriuired in order that the base assumes a proper shape for performing the desired soft tissue expansion. The expander with the base in the proper shape is then implanted and P~r~n~P(l as previously ~Pcrr; hP~ . The cover over-lying base 130 conforms to the shape of the base when implanted so WO95~Z6696 _13_ F~ ~J~ 7 that the expansion of overlying tissue is in part governed by the shape of the base.
Figure 19 illustrates expander 120 in the fully elongated or P~tPn~iPd position in which fold 136 is effaced and the expander assumes the shape of a valise handle.
Si~th ~ li t Adiustable Soft Ti99ue ~ rn;ln~r Figures 20-23 disclose a sixth pmhofli~-~t adjustable soft tissue expander 140 including a tubular central portion 142, a pair of folded arms 144 and 146 each joining one end of the central portion, a base and an P~n~l~hle cover The arms include rounded closed ends 148 and 150 located away from the central portion. As illustrated in Figure 21, the arms are tapered in width from a maximum width at central portion 142 to a minimum width at ends 148 and 150.
The expander 140 includes an inlet port and tube communicating the port to the interior chamber of the ~l... ",1.-, . The port and tube are similar to the ports and tubes previously described.
A plurality of circumferential folds 152 are formed along the length of each arm 144 and 146 from the central portion 142 to ends 148 and 150. The folds extend across the width oi the P~,.n~Pr base (not illustrated) and across the width of the expander cover 154 and cross opposite sides of the circumferential edge 156 joining the base and cover. The folds are similar to the previously described folds and are formed by folding or inverting circumferential portions of the arms into portions located more closely adjacent the central portion 142 Th~ outer edges 156 of the folds face away from the ce~tral portion.
The folded arms 144 and 146 of P~rn~n~Pr 140 are highly flexible and may be moved to change the shape of the base. This 30 flP~ihil ity assures that a surgeon can vary the shape of the
2 1 8 5 5 6 4 r .,Ll~ ~7 expander base by - v~ t of the arms elongating or foreshortening the individual folds and rotating the folds or even by effacing one or more folds completely.
Figure 20 illustrates both arms 144 and 146 bent downwardly so that the P~r~n~lor base assumes a crescent shape If desired, the arms may be bent downwardly further to position ends 148 and 150 closer together than shown in Pigure 20. The arms may be f~l~n~te~
to position the ends further below the central portion. The arms may be shortened.
Figure 21 illustrates both arms ~ t~nr~ directly away from the central portion with ends 148 and 150 spaced a distance away from the ends of the central portion without rotating folds 152. If desired, the ends may be pulled further away from the central portion to elongate the arms and foreshorten the folds. The folds may be completely effaced to position the ends 148 and 150 a maximum distance away f rom the central portion .
Figure 22 illustrates the position of expander 140 in which the folds have been lengthened and the arms have been partially r~nl 1 ~rS~l within the central portion.
Figure 23 illustrates the position of expander 140 in which the arms have been completely rql 1 ~rsed within the central portion with the tips of ends 148 and 150 ~l~t~nrl; n~ short distances outwardly of the ends of the central portion.
The surgeon may adjust the shape of the base of expander 140 by varying the position of the arms 144 and 146 as required. The arils of expander 140, and the arms of the other disclose~
expanders, need not be moved to symmetrical positions with regard to the central portion of the expander. For instance, one arm of expander 140 may be bent down and the other arm may be bent up so that the base of the expander assumes a sinuous or S-shape.
Wo95/26696 2 ~ 8 ~56q ~ 7 Prior to impl~nt~t; ~n of expander 140, the surgeon adjustR the base of the expander by moving arms 144 and 146 as required. The plural folds in the two arms permit the 5urgeon great flP~;h;l;ty in adjusting the shape of the base. If the arms are fully P~rtPn-lPt1 outwardly f~ m the cer1tral portion, the base has a long and relatively narrow shape. If both arms are bent down from the central portion, the expander base assumes a narrow crescent shape.
Other shapes are readily available, as previously described, Once the expander base has bee~ adjusted as required, the ~ nrlPr is implanted below a skin layer and the ; nn; cion is allowed to heal 90 that the base is held in the desired inserted shape. Fluid is injected into the interior cavity of the ~7~An~lPr to expand the cover and overlying tissue as previously described.
Seventh Embodiment DimeTlsion~l lv Adiustable Tissue ~rrl~n~Pr Figure 24 illustrates a seventh embodiment sof t tissue p~n~Pr 160 similar to expander 140 with the exception that a plurality of like folds 162 exte~d along the entire length of the P~?;'ns''r between opposed closed ends 164 and 166. The ~ 160 includes two folded arms 168 and 170. ~ach arm extends from a closed end 164, 166 to the wide central portion of the ~cntlPr.
The folds 162 exte~d circumfere~tially around the P~n~Pr which ; n~ 1PR a base (not illustrated) and an P~n~ hle cover 172 overlying the base and joined to the base at circumferential edge 174. An inlet port (not illustrated~ is cnnnPcted to one end of inlet tube 176 which opens through a wall of the ''~E ~n~r to communicate the port \-~ith the i~terior chamber of the ~ n~iPr between the cover and base . The tube is pref erably mounted on a fold adjacent an outer fold edge 178 to permit maximum foreshortening and lengthening of the fold during manipulation of W095/26696 -16- r~ 7 the expander by the surgeon to adjust the shape of the expander base prior to implantation.
Expander 160 includes folds spaced along the entire length of the expander from end to end. The folds may be foreshortened or lengthened to adjust the shape of the expander base before implantation .
The folds in expander 160 all have outer edges 178 facing expander end 166 with double thickness fold layers. In this way, the double thirknPcc fold layers in the ~ de~ all extend in the same direction and do not overlap each other. The adjustability of the base of expander 160 is Pnh~nrPd by providing folds of the same nriPnt~tinn along the entire length of the expander. ~lri;tinn~lly, the expander does not include a fixed .1~ ~ir,n central portion so that the base is provided with an additional degree of adjust-ability over the bases of the previously described expanders. The shape of the entire length of the base may be adjusted.
After adjustment of the shape of the base of expander 160 by the surgeon, the expander is positioned within a surgical incision.
The inri R jr,n iS closed, healing occurs and the overlying skin tissue is P~An~Pd by injecting fluid into the cavity of the expander through tube 176 as previously described. The ~n~:lh] e cover 172 conforms in shape to the shape of the base, assuring that the overlying tissue layer is P~:~n~Pd above the base and assumes a desired shape.
Eirhth Embodiment Dimensionallv Adjustable Tissue ~ n~lPr Figure 25 lllustrates an eighth embodiment adjustable soft tissue expander 180 which is identical to the previously described soft tissue expander 1 0 shown in Figures 1 through 9 except that the parts of the expander base underlying the arms are reinforced.
30 Expander 180 ~ncludes a cover 182, base 184 and edge 186 The cover W0 9~/~6696 T ~ A?~j~7 211855~;4 and base define a~ inflAt~hle interior chamber 188. The expander has a general crescert shape with a pair of tubular arms 190, 192 P~rtPntl;n~ away from tubular ce~Ltral portion 194. A plurality of overlying folds 196 extend around the central portion 194. The 5 expander 180 includes a ~ ~nt;n~ ; layer of elastomer material defining the ;ntPr;or surface of chamber 188, like expander 10.
Elements 182-194 correspond to like elements of expander 10.
Base 184 of expander 180 includes layers 198 of reinforced silicone elastomer material under arms 190 and 192. The reinforced 10 layers 198 prevent the limited expansion of the portions of the base underlying the arms during PYr~An~ion of the overlying cover and tissue layer. The reinforced layers 198 may be identical to the reinforced layers in the base of the ~An~prs disclosed in Manders U.S. patent number 4,574,780. The layers 198 asaure that the portions of the base underlying the arms 190 and 192 are ~l;r- s;onAlly stable during tis8ue P~An~;on.
If desired, the bases of any of the rl;~rloged adjustable soft tissue PYrAn-lPrS may be provided with a layer of reinforced silicone elastomer to assure dimensional stability of the base 20 during expansion. The layer may underlie the complete area of the base, ;nf~ rlin~ the fold or folds, or may lln~l~rl;l~ areas away from the folds. In P~ Pr 180, a single layer of reinforced ~;l;c~nP
elastomer may be provided P~tPnA;n~ under both the arms and under the elastomer material forming the folds 196 in the central portion 25 194. In such case, the reinforced layer would be folded together with the overlying non-reinforced elastomer layer in the base.
All of the disclosed P~n~Pr.s include bases with folds extending across the widths of the bases. The folds permit adjust-ment of the shape of the base by the surgeon prior to implantation.
30 The adjustment is achieved by lengthening, foreshortening or W0 9~26696 2 1 8 5 5 6 4 r~ 'A'''7 rotating the folds. The folds also extend up into the covers from the bases and across the overlying covers to permit the covers to conform to the shape of the bases.
It is contemplated that the invention includes an expander 5 having a base ~.~th a fold ~Rt~n~11n~ inwardly from an edge of the base to permit adjusting the shape of the base and with a cover joining the edge of the base with sufficient rn~rl;~nnP at the fold in the base so that the cover conforms to the adjusted shape of the base. The cover may be formed from very thin, highly ,_ , l;~nt 10 ~ qt~ -r material and need not include a fold or folds which extend up from the ba5e and entirely across the cover to an opposite edge of the base. The invention includes an .o~r~nflf~r in which the fold or folds in the base end in a fold or folds ~ tF.n~l;n~ a short distance from the edge into the cover. These 15 folds facilitate dimensional flexibility at the cover to permit the surgeon to adjust the shape of the base as required.
As illustrated in the drawings, the folds may overlap each other and lie flat with adjacent sides resting flat on each other nearly parallel to the wall of the expander. Alternatively, the 20 folds may extend generally perpendicular to the wall of the expander to form vertical corr~at;nnq of the type shown in Figures 8 and 9 The bases of the expanders disclosed herein are all disclosed as being flat. Expanders are commonly m~n~ ntured with flat 25 bases. In practice, expanders are inserted in incisions or pockets made below curved s~in layers where the bases of the inserted expanders are curved and not flat. ~n~rS may be made with curved, non-flat base9 for insertion into curved pockets.
While we have illustrated and described preferred embodiments 30 of our invention, it is understood that this is capable of modifi-W095/26C96 2 ~ 855~4 ~ (7 cation, and we therefore do not wish to be limited to the precise details set ~orth, but desire to a~rail ourselves of such changes and alterations as fall within the purview of the following claims.
Figure 20 illustrates both arms 144 and 146 bent downwardly so that the P~r~n~lor base assumes a crescent shape If desired, the arms may be bent downwardly further to position ends 148 and 150 closer together than shown in Pigure 20. The arms may be f~l~n~te~
to position the ends further below the central portion. The arms may be shortened.
Figure 21 illustrates both arms ~ t~nr~ directly away from the central portion with ends 148 and 150 spaced a distance away from the ends of the central portion without rotating folds 152. If desired, the ends may be pulled further away from the central portion to elongate the arms and foreshorten the folds. The folds may be completely effaced to position the ends 148 and 150 a maximum distance away f rom the central portion .
Figure 22 illustrates the position of expander 140 in which the folds have been lengthened and the arms have been partially r~nl 1 ~rS~l within the central portion.
Figure 23 illustrates the position of expander 140 in which the arms have been completely rql 1 ~rsed within the central portion with the tips of ends 148 and 150 ~l~t~nrl; n~ short distances outwardly of the ends of the central portion.
The surgeon may adjust the shape of the base of expander 140 by varying the position of the arms 144 and 146 as required. The arils of expander 140, and the arms of the other disclose~
expanders, need not be moved to symmetrical positions with regard to the central portion of the expander. For instance, one arm of expander 140 may be bent down and the other arm may be bent up so that the base of the expander assumes a sinuous or S-shape.
Wo95/26696 2 ~ 8 ~56q ~ 7 Prior to impl~nt~t; ~n of expander 140, the surgeon adjustR the base of the expander by moving arms 144 and 146 as required. The plural folds in the two arms permit the 5urgeon great flP~;h;l;ty in adjusting the shape of the base. If the arms are fully P~rtPn-lPt1 outwardly f~ m the cer1tral portion, the base has a long and relatively narrow shape. If both arms are bent down from the central portion, the expander base assumes a narrow crescent shape.
Other shapes are readily available, as previously described, Once the expander base has bee~ adjusted as required, the ~ nrlPr is implanted below a skin layer and the ; nn; cion is allowed to heal 90 that the base is held in the desired inserted shape. Fluid is injected into the interior cavity of the ~7~An~lPr to expand the cover and overlying tissue as previously described.
Seventh Embodiment DimeTlsion~l lv Adiustable Tissue ~rrl~n~Pr Figure 24 illustrates a seventh embodiment sof t tissue p~n~Pr 160 similar to expander 140 with the exception that a plurality of like folds 162 exte~d along the entire length of the P~?;'ns''r between opposed closed ends 164 and 166. The ~ 160 includes two folded arms 168 and 170. ~ach arm extends from a closed end 164, 166 to the wide central portion of the ~cntlPr.
The folds 162 exte~d circumfere~tially around the P~n~Pr which ; n~ 1PR a base (not illustrated) and an P~n~ hle cover 172 overlying the base and joined to the base at circumferential edge 174. An inlet port (not illustrated~ is cnnnPcted to one end of inlet tube 176 which opens through a wall of the ''~E ~n~r to communicate the port \-~ith the i~terior chamber of the ~ n~iPr between the cover and base . The tube is pref erably mounted on a fold adjacent an outer fold edge 178 to permit maximum foreshortening and lengthening of the fold during manipulation of W095/26696 -16- r~ 7 the expander by the surgeon to adjust the shape of the expander base prior to implantation.
Expander 160 includes folds spaced along the entire length of the expander from end to end. The folds may be foreshortened or lengthened to adjust the shape of the expander base before implantation .
The folds in expander 160 all have outer edges 178 facing expander end 166 with double thickness fold layers. In this way, the double thirknPcc fold layers in the ~ de~ all extend in the same direction and do not overlap each other. The adjustability of the base of expander 160 is Pnh~nrPd by providing folds of the same nriPnt~tinn along the entire length of the expander. ~lri;tinn~lly, the expander does not include a fixed .1~ ~ir,n central portion so that the base is provided with an additional degree of adjust-ability over the bases of the previously described expanders. The shape of the entire length of the base may be adjusted.
After adjustment of the shape of the base of expander 160 by the surgeon, the expander is positioned within a surgical incision.
The inri R jr,n iS closed, healing occurs and the overlying skin tissue is P~An~Pd by injecting fluid into the cavity of the expander through tube 176 as previously described. The ~n~:lh] e cover 172 conforms in shape to the shape of the base, assuring that the overlying tissue layer is P~:~n~Pd above the base and assumes a desired shape.
Eirhth Embodiment Dimensionallv Adjustable Tissue ~ n~lPr Figure 25 lllustrates an eighth embodiment adjustable soft tissue expander 180 which is identical to the previously described soft tissue expander 1 0 shown in Figures 1 through 9 except that the parts of the expander base underlying the arms are reinforced.
30 Expander 180 ~ncludes a cover 182, base 184 and edge 186 The cover W0 9~/~6696 T ~ A?~j~7 211855~;4 and base define a~ inflAt~hle interior chamber 188. The expander has a general crescert shape with a pair of tubular arms 190, 192 P~rtPntl;n~ away from tubular ce~Ltral portion 194. A plurality of overlying folds 196 extend around the central portion 194. The 5 expander 180 includes a ~ ~nt;n~ ; layer of elastomer material defining the ;ntPr;or surface of chamber 188, like expander 10.
Elements 182-194 correspond to like elements of expander 10.
Base 184 of expander 180 includes layers 198 of reinforced silicone elastomer material under arms 190 and 192. The reinforced 10 layers 198 prevent the limited expansion of the portions of the base underlying the arms during PYr~An~ion of the overlying cover and tissue layer. The reinforced layers 198 may be identical to the reinforced layers in the base of the ~An~prs disclosed in Manders U.S. patent number 4,574,780. The layers 198 asaure that the portions of the base underlying the arms 190 and 192 are ~l;r- s;onAlly stable during tis8ue P~An~;on.
If desired, the bases of any of the rl;~rloged adjustable soft tissue PYrAn-lPrS may be provided with a layer of reinforced silicone elastomer to assure dimensional stability of the base 20 during expansion. The layer may underlie the complete area of the base, ;nf~ rlin~ the fold or folds, or may lln~l~rl;l~ areas away from the folds. In P~ Pr 180, a single layer of reinforced ~;l;c~nP
elastomer may be provided P~tPnA;n~ under both the arms and under the elastomer material forming the folds 196 in the central portion 25 194. In such case, the reinforced layer would be folded together with the overlying non-reinforced elastomer layer in the base.
All of the disclosed P~n~Pr.s include bases with folds extending across the widths of the bases. The folds permit adjust-ment of the shape of the base by the surgeon prior to implantation.
30 The adjustment is achieved by lengthening, foreshortening or W0 9~26696 2 1 8 5 5 6 4 r~ 'A'''7 rotating the folds. The folds also extend up into the covers from the bases and across the overlying covers to permit the covers to conform to the shape of the bases.
It is contemplated that the invention includes an expander 5 having a base ~.~th a fold ~Rt~n~11n~ inwardly from an edge of the base to permit adjusting the shape of the base and with a cover joining the edge of the base with sufficient rn~rl;~nnP at the fold in the base so that the cover conforms to the adjusted shape of the base. The cover may be formed from very thin, highly ,_ , l;~nt 10 ~ qt~ -r material and need not include a fold or folds which extend up from the ba5e and entirely across the cover to an opposite edge of the base. The invention includes an .o~r~nflf~r in which the fold or folds in the base end in a fold or folds ~ tF.n~l;n~ a short distance from the edge into the cover. These 15 folds facilitate dimensional flexibility at the cover to permit the surgeon to adjust the shape of the base as required.
As illustrated in the drawings, the folds may overlap each other and lie flat with adjacent sides resting flat on each other nearly parallel to the wall of the expander. Alternatively, the 20 folds may extend generally perpendicular to the wall of the expander to form vertical corr~at;nnq of the type shown in Figures 8 and 9 The bases of the expanders disclosed herein are all disclosed as being flat. Expanders are commonly m~n~ ntured with flat 25 bases. In practice, expanders are inserted in incisions or pockets made below curved s~in layers where the bases of the inserted expanders are curved and not flat. ~n~rS may be made with curved, non-flat base9 for insertion into curved pockets.
While we have illustrated and described preferred embodiments 30 of our invention, it is understood that this is capable of modifi-W095/26C96 2 ~ 855~4 ~ (7 cation, and we therefore do not wish to be limited to the precise details set ~orth, but desire to a~rail ourselves of such changes and alterations as fall within the purview of the following claims.
Claims (39)
PROPERTY OR PRIVILEGE IS CLAIMED AS DEFINED AS FOLLOWS:
1. A dimensionally adjustable tissue expander adapted to be inserted under soft tissue to be expanded, the expander comprising a substantially flat base having a shape and defining a peripheral edge; a cover formed from an expandable elastomer, the cover overlying the base and joined to the base at the peripheral edge to define a closed interior chamber; a movable S-shaped fold in the base having a number of adjustable shapes;
and a port for inflating and deflating the chamber, said fold being freely movable to vary the shape of the base.
and a port for inflating and deflating the chamber, said fold being freely movable to vary the shape of the base.
2. An expander as in claim 1 wherein said fold is located adjacent the peripheral edge.
3. An expander as in claim 1 including a first plurality of overlapping S-shaped folds in the base, all of said folds extending in the same direction.
4. An expander as in claim 3 including a second plurality of overlapping S-shaped folds, all of said second folds extending in a direction opposite the direction of said first folds.
5. An expander as in claim 1 wherein the base is elongate and defines opposed ends, and including a plurality of overlapping folds extending from one end of the base to the other end of the base, all of said folds extending in the same direction.
6. A dimensionally adjustable tissue expander comprising a substantially flat base defining a peripheral edge; a cover formed from an expandable elastomer, the cover overlying the base and joined to the base at the peripheral edge to define a closed interior chamber; a fold extending from the peripheral edge a distance into the base and a distance into the cover; and a port for inflating and deflating the chamber, said fold being freely movable to adjust the shape of the base to a selected shape for expansion of a soft tissue layer overlying the cover the base having sufficient compliance to insure that the base retains the selected shape from implantation of the expander into a surgically-formed incision until tissue surrounding the expander base heals.
7. An expander as in claim 6 wherein said fold extends from the peripheral edge on one side of the base across the base to the peripheral edge on the opposite side of the base.
8. An expander as in claim 6 including a plurality of overlapping folds in the base.
9. An expander as in claim 8 wherein said base is elongate, the expander including opposed ends and said folds are spaced along the length of the expander.
10. A dimensionally adjustable tissue expander comprising a substantially flat base defining a peripheral edge; a cover formed from an expandable elastomer, the cover overlying the base and joined to the peripheral edge of the base to define a closed interior chamber; the base including a freely movable dimensionally adjustable fold having a number of adjustable shapes; the expander including a central portion, and opposed arms to either side of the central portion and a port for inflating and deflating the chamber, said fold being freely movable to adjust the shape of the base to a selected shape for expansion of a soft tissue layer overlying the cover, the base having sufficient compliance to insure that the base retains the selected shape from implantation of the expander into a surgically-formed incision until tissue surrounding the expander base heals.
11. An expander as in claim 10 wherein the fold extends circumferentially around the expander.
12. An expander as in claim 10 including folds extending around each of said arms and all folds on each arm are oriented in the same direction.
13. An expander as in claim 12 wherein said central portion is generally rectangular.
14. An expander as in claim 10 wherein the fold extends around the central portion.
15. An expander as in claim 14 wherein said central portion is tapered.
16. An expander as in claim 14 wherein the material forming the central portion is thinner than the material forming the arms.
17. An expander as in claim 14 wherein the expander has the shape of a valise handle when fully elongated.
18. A dimensionally adjustable tissue expander adapted to be implanted under soft tissue to be expanded, the expander comprising a substantially flat imperforate base, the base defining a peripheral edge; an expandable imperforate cover formed of compliant material overlying the base and joined to the base at the peripheral edge to form a closed interior chamber between the cover and base; a port opening into the chamber to permit fluid to be injected into the chamber and to be withdrawn from the chamber; and a first adjustable fold in the base.
19. An expander as in claim 18 wherein said fold extends to the edge.
20. An expander as in claim 19 wherein said fold extends past the edge and into the cover.
21. An expander as in claim 19 wherein said fold extends across the base between opposed sides of the peripheral edge.
22. An expander as in claim 21 wherein said fold extends circumferentially around the expander.
23. An expander as in claim 18 including a plurality of adjustable folds in the base.
24. An expander as in claim 23 wherein said folds overlie each other.
25. An expander as in claim 23 wherein said folds are spaced from each other.
26. An expander as in claim 18 including a second fold in the base spaced from said first fold and the base includes a non-adjustable portion between the folds.
27. An expander as in claim 26 wherein the expander includes a pair of arms and a plurality of overlapping folds on each arm.
28. An expander as in claim 18 wherein the base is elongate and includes opposed ends and including a plurality of folds spaced along the base from one end of the base to the other end of the base.
29. An expander as in claim 18 including a tubular central portion, a pair of tubular arms each located to one side of the central portion, said arms being tapered from a maximum width at the central portion to a minimum width at the ends of the arms, said fold being located in the central portion of the base.
30. An expander as in claim 29 wherein the fold extends circumferentially around the expander.
31. An expander as in claim 30 wherein the material forming the fold is thinner than the material forming the arms.
32. An expander as in claim 29 including a plurality of folds in the central portion of the base.
33. An expander as in claim 32 wherein the folds extend around the central portion.
34. An expander as in claim 29 wherein the arms are curved and both ends are located to one side of the central portion so that the expander has a crescent shape and a valise handle shape when fully elongated.
35. An expander as in claim 34 wherein said central portion is thinner than said arms.
36. An expander as in claim 29 wherein said central portion is tapered.
37. An expander as in claim 20 including a tapered tubular arm and an adjustable fold extending around the arm.
38. An expander as in claim 37 including a plurality of overlapping folds on the arm.
39. An expander as in claim 18 wherein said fold is S-shaped.
Applications Claiming Priority (3)
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| US22110494A | 1994-03-31 | 1994-03-31 | |
| US221,104 | 1994-03-31 | ||
| PCT/US1995/003667 WO1995026696A1 (en) | 1994-03-31 | 1995-03-22 | Dimensionally adjustable soft tissue expander and method |
Publications (2)
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|---|---|
| CA2185564A1 CA2185564A1 (en) | 1995-10-12 |
| CA2185564C true CA2185564C (en) | 1999-10-05 |
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|---|---|---|---|
| CA002185564A Expired - Fee Related CA2185564C (en) | 1994-03-31 | 1995-03-22 | Dimensionally adjustable soft tissue expander and method |
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| US (1) | US5571179A (en) |
| EP (1) | EP0752836B1 (en) |
| AU (1) | AU2193295A (en) |
| CA (1) | CA2185564C (en) |
| DE (1) | DE69521793T2 (en) |
| ES (1) | ES2159316T3 (en) |
| WO (1) | WO1995026696A1 (en) |
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| US5141508A (en) * | 1991-01-14 | 1992-08-25 | Medical Engineering Corporation | Tissue expander |
| US5146933A (en) * | 1991-09-20 | 1992-09-15 | Dow Corning Wright Corporation | Implantable prosthetic device and tethered inflation valve for volume |
| US5236454A (en) * | 1991-11-04 | 1993-08-17 | Miller Archibald S | Stacked breast implant |
-
1995
- 1995-03-22 ES ES95914845T patent/ES2159316T3/en not_active Expired - Lifetime
- 1995-03-22 WO PCT/US1995/003667 patent/WO1995026696A1/en active IP Right Grant
- 1995-03-22 EP EP95914845A patent/EP0752836B1/en not_active Expired - Lifetime
- 1995-03-22 CA CA002185564A patent/CA2185564C/en not_active Expired - Fee Related
- 1995-03-22 AU AU21932/95A patent/AU2193295A/en not_active Abandoned
- 1995-03-22 DE DE69521793T patent/DE69521793T2/en not_active Expired - Fee Related
- 1995-07-18 US US08/503,621 patent/US5571179A/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| ES2159316T3 (en) | 2001-10-01 |
| EP0752836B1 (en) | 2001-07-18 |
| CA2185564A1 (en) | 1995-10-12 |
| EP0752836A1 (en) | 1997-01-15 |
| US5571179A (en) | 1996-11-05 |
| AU2193295A (en) | 1995-10-23 |
| DE69521793T2 (en) | 2002-08-08 |
| WO1995026696A1 (en) | 1995-10-12 |
| DE69521793D1 (en) | 2001-08-23 |
| EP0752836A4 (en) | 1997-09-03 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |