CA2233702A1 - Modular liner for limb stump prosthesis - Google Patents
Modular liner for limb stump prosthesis Download PDFInfo
- Publication number
- CA2233702A1 CA2233702A1 CA002233702A CA2233702A CA2233702A1 CA 2233702 A1 CA2233702 A1 CA 2233702A1 CA 002233702 A CA002233702 A CA 002233702A CA 2233702 A CA2233702 A CA 2233702A CA 2233702 A1 CA2233702 A1 CA 2233702A1
- Authority
- CA
- Canada
- Prior art keywords
- liner
- stump
- amputee
- accordance
- vacuum
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
- A61F2/7812—Interface cushioning members placed between the limb stump and the socket, e.g. bandages or stockings for the limb stump
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/68—Operating or control means
- A61F2/74—Operating or control means fluid, i.e. hydraulic or pneumatic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/5044—Designing or manufacturing processes
- A61F2/5046—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, finite-element analysis or CAD-CAM techniques
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2002/5007—Prostheses not implantable in the body having elastic means different from springs, e.g. including an elastomeric insert
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/68—Operating or control means
- A61F2/70—Operating or control means electrical
- A61F2002/704—Operating or control means electrical computer-controlled, e.g. robotic control
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/76—Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means
- A61F2002/7615—Measuring means
- A61F2002/7655—Measuring means for measuring fluid pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
- A61F2/80—Sockets, e.g. of suction type
- A61F2002/802—Suction sockets, i.e. utilizing differential air pressure to retain the prosthesis on the stump
Abstract
Apparatus for effecting comfortable fitting of a prosthetic appliance over an amputee's limb stump which has an irregular surface. The apparatus includes a liner surrounding the stump. The liner is, in turn, at least indirectly, connected to the artificial limb. A vacuum pump is provided, the pump serving to draw vacuum at an interface of the stump and an inner wall of the liner, and a plurality of pressure-sensitive transducers are disposed about the stump at locations spaced from each other. The apparatus includes means, responsive to pressure reduction sensed by the transducers, to actuate the vacuum pump.
Description
V ~V~L ~ t ~ i¢ i LAr~ ~IK.~ ~002 , MO~ULAR Lr~ER FO~ LrM~ STU~P P~OSS~IS
Tcc~nical Field The present inve~tion is rel~ted broadly to the field of prosthetics. More ~pecifically, howeve~, the i~Ye~tion ~elates to a prost~etic liner for an arti~ici~l limb to ~ov~r - and be attached to the stump o~ ~n amputee. ~he specific focu6 of the inve~tion i6 a moduiar concept fo~ providing a cus~om-fitted li~er for a prosthesis for a~ amputee's li~b, such as a stump extendiDg downwardly fro~ an a~putee's ~nee vr fr~m above the '~nee.
~ack~round of the Ir.~entio~
~rarious prostbetic liners are known in the prior art.
~or exa~ple, U~ited Sta~es P~tent No. 5,4~6,443 (Wilsorl et al.~ i~s~ed on ~ovembe~ 7, 1995 for ~ device ch~racterized as P~OS~E~IC DE~ICE FOR AMoeUTEES. That refe~erce discusses the use of a prosthe~is ~hich h2s a relatively rigid, support shell di~nsiohed to recei~e a p~rtio~ of the resi~al lim~ of the a~putee. The apparatus alco includes a pad ~e~ber which ha6 a plurality of pouches at le~st partially filled with fluid. It is intended t~at the pad member of that referer.ce substantially encircle the residual portion of the a~putee' 5 leg with its fluid pouches ~ing position adjacent one ano.~.er about the e~d along the ieg. The pad ~ember having the pouches is, therefore, placed in ~edian enga~ement with the stu~p.
. V v ~ V ~ t l Klll 1~ 0 0 3 CA 02233702 1998-04-oi . ~ .
United St~tes Pate~t No. 5,405,405 (Love) i6sued o~ April 11, 1995 for an inve3tion entitled PROST~ETIC SOCKET
CO~T~I~IN~ INFLATABLE MEANS. That reference teaches a composite ~ocket member ~or use with ~ prosthetic applian~e An outer socket of the de~ice define6 an i~ne~ cavity generally co~forming to the cuter surface of t~e residual limb of the amputee. An inner ~ocket defines an i~ner cavity wh~ch is iAtended to receive t~e amputee's residual limb. The inner ~ocket confor~s to ~be s~.ape of the outer socket and~ when nested within the cav~ty of the ou~er.socket, defines an air space between the i~ner surface of t~e outer soc~et and the outer surface o~ the in~er socket. ~ inflatable bladder is disposed between the inrer 3~r~ace of the o~ter soeket and tke outer surface of the i~ner socket. Means are provided for inf~ation of the bladder. ~he movement and rotation s~ability of the prosthetic appliance is, thereby, controlled.
United States Pater~t No. 5,3~,245 (Fay et al.~ i~su~d on February 7, 1995 for a device characterized as an I~LATA~L~
PROSTHESIS LI~ER. The apparatus i~ludes a soc~et having 20 selectively inflata~le bladders which ena~le the p~osthesis to be customized to fit ~ individual patient. A liner hzv ng two liner parts is employed to ~ccomplish this gcal. One li~er part is placed o~to the amputee's stu.mp. A prosthetist then determines the region or regions where bladders are 2i needed to pro~ide a comfortable fit. ~hese areas a~e identified and overlain with an adhesive. The o~ter liner is v~ V.~t ~ L~ 3 LAt~ 300'I
. .
then brought into overlying relationship to t~e inner liner so that the two liner part5 adhere to one another along the outliAed regions. After in~l~tion of a ~l~dder or bla~ders, ~he inner li~er conforms ~o the stump, and the outer liner 5 conforms to the shape ~f ~e inner wall of the socket of the appliance. The dcviee can include an a~ular bladder at the proxi~al ri~ of the socket to create a seal in order to main~ain a suction within the socket.
United States Pate~t ~o. 5,314,497 (Fay et al.) is~ued on 10 May 24, 1954 for a de~ice cbaracte~ized a~ APPARATUS AND
N~OD FOR SEALING A LI~ER ~ A PR~STHESIS. The lincr of that reference is intended to cus~ion an ~mputee's stump when it is placed into a prosthesi~ soc~et. In order to acco~plish this, the liner i~cludes fielecti~e~y ~nflatable bladders or customizing the liner to fit individual pa~ients. The liner i6 made of two parts. T~e first is ~n inner liner and the ~eco~d i8 a~ outer li~er. A region or regions where inflation to expand the space betwee~ the two li~ers might be needed are defined and outli~e~ with ~a adhcsive. The inr.er and outer li~er portion~ a~here to one another alo~g the outlincd regions to define bladders. The bladders can the~ be 6electively i~f lated to confor~ the outer liner to the shape of the interior wall of the appliance socket.
United States Patent No. 5,246,464 ~Sabolich) issued on Septembe~ 21, 1993 for an apparatus characterized as M~IFICIAL LI~ WITH P.NATOMICALLY CON~IGUR~D SOCKET. The .v . v ~ ~ v ~ L ~ LA~ ~ L J<~ 00 5 device of that refere~ce includes a sy~tem of inf latAble compartments ~o enable t~e adjusting of the ~ize and fit of t~e prosthesis. Wi~h ~he provi6io~ of these compart~e~ts, the patient may adjust the dimensions of the socket by i~flatin~
S one or ~o~e of the compart~e~ts.
U~ited States Pate~t No. 5,139,523 (pato~ et al.) issued on Ausust 1~, 1992 for an ARTI~ L LI~ SOCKET ~PPARA~U5.
The device disclosed by t~.at reference ir.cludes A vent provided through a sleet~e support fo~ ~cnting the interior of the so~ket. T~.e ~efe~e~ce al~o tea.c~es the provision o~
pneumatic chambers to enhance comfort of the a~putee.
~ nited S.ates Patent ~o. 5,133,776 ~crowder) issued on July 2&, ~9g2. The apparatus of that reference i5 cha_acterized AS a PP~OS~HE;TIC VOLU~ CO~PENSATIC~N DEVICE. It i~cludes a~ air ceil or ce}l6 ~hieh m3y be placed iAto aD
exi~ting pros~hesis or incl~ded i~to a newly-~abricated prosthesis. Means are i~cluded to allo~ for manual adjustment of ~he degree of i~fla~ion of the air cell or cells 60 tha~
changes i~ volume of the residual li~b of the amputee may be co~pe~sated ~or as required. Infl~tion i~ acc~mplished by a fi~gertip operated pump. A valve is also ~roYided to Allow for exhausti~g air from ~e air cell.
U~itcd ~tates Patent No. 5,10~,45~ (coona~ I) issued on April 28, 1992 for a P~OST~ETI~ APPLI~NCE. That appliance in~ludes 6e~eral inflatable bladder~ which, when inflatnd, act again~t the rigid side walls of the prosthesis ~ember in order to force pvrtions o~ t~e socket mer:ber side. well~ inwardly to grip th-~ resid~al limb of the ~~put.ee. I~lati~n con~ol ~nea~6 a-e provided and ca~ 5 nclud~ ~ m~ually-~per~b~e air pump. O~e or r~ore loanual'y-~pera~le a r val-,-es are 2~
S provided. h valve is use~ in com~r.atiorl with ea~h of t~e bladders to a ~ lo~ ~or exh~st of a i ~ frcln the co~respon.dirlg bl ad~e- .
Unitecl Stetes P~te~t ~Jo. 4,~23,475 ~Gosthn_a~. et al. ) is~iued on May 8, 1990 . Tiie device of tha~ . eference is iQ ch~r~ter~ze~ as an ~FIJ~TA~L~ LIMB ~R~S~'nE IS hf~H PR~FC:RMED
I~E~ S~7RFACE. r'h~ re ere.~ce teache~ a stu~p-rece~vi~.g sceket a~d ~ plu~ali~ of ir,fl2table bladde~s. Mearls are emplsyed in ord~ t~ ena~;e o~e ~ ary the press~lres w~t!~in t~e blnd~ers.
The ~ladde~6 ar~ m~de o~ a re~ati~e ~ ,oft, ~l~xible membran2 15 material sl~ch ~s ~'yure~hane. ~'ae me~Dbr~.nes ~re loca~ed ad~acent the w~ig~ ec~ g ~or~lons of t.le stu~E~ to prcvide a relatively soft, ~-niform s~rrace t supp~t the stwnp. ~-~e various pressures i~. .he bldd~ers are ind~per.d~n~ of e~ch otker, a~d regulation by ~he usc- i~ er.vis'~ned.
~0 ~'nited States PGtent ~o. 4,555,7?9 ~Ja~.owi~k) issued o~;
~p~ , 1987 ~or Gn ~I~ SYS~M ~OS~ESI~ ,~OR AMPU~5S. T~.e s~te~ i~ven~io.~ incl~des a ;~oi'~w bc~y wi~ s~iff peri~hera walls and a~, cpen ~r,~ and a c~3-sh~pe~ ~art-t on definlng, with tke walls, a fir~t sock~ he sys;~. also incl~de5 a se~ond ~oc~et h~in~ stiff periphe.~al w~ , t~e sec~r.d socket beir.g s~usl,~- neste~ wi.thir the ri~ st so_~et. ~he socond V .J ' .~ L f ~) O 1~ 2c ~ 3 3 7 0 2 j~g g 8 &0 4 LoA~W F I RM ~ 0 ~ 7 50cket i~cludes ~paced apart inner a~d outer walls with cup-shaped closed end- i~tercoAnecte~ and hcrmetically sealed at their out~r ends. A continuou~ ai~ chamber bctween the in~er a~d outer ~alls is, t~ereby, def~ned. ~ ~anually-operated air 5 pu~p and ~ressure relief valve are ~ounted o~ the outer wall, Pressu~ized air can, thereby, be selectively introduced i~to .he c~amber ~nd sel~ctiYely txhausted t~erefrom.
Unite~ St~te6 Patent No. 4,432,101 ~Johnson) issued on ~ebru~ry 21, ~984 for a CUSHIO~I~IG ~ATEI.L~ SUPPOR~ DEVICE.
The device of that refere~ce includes an i~flatable/deflatable b~g which is insertable in a~ upper fro~t portion of a prostheEis. A q~ick disco~ect, han~-operable pump ena~les the u~er of the prost~esis to adjust the degree of bag infl~tion.
Unitcd States Pate~t No. 3,889,301 ~Bonner, Sr.) issued on June 17, 1975 for a THE~EU~IC STu~ ~EAI~I~G AIR SAC
~ROSTHESIS. A~ air sac is prov~ded to surround the amputee'~
leg ~tump. The sac, in turn, is surrounded by a casing which confines the pressure of the ~ir sac in~ardly against the stump. The distal end o~ t~e air s~c is supported around and b~neath the patient's stump. Means, between the air sac and the c~sing, are provided to distort the surf2ce o~ th~ air sac and give it vtrtical stabi~ity with respect to supporting mea~s.
A fo~t or partial leg prosthetic includes an artificial limb portion to si~ulste the n~tural li.~b of the amputee which l tS . 3 !1 a ff l ~ 3 J 1 2 2CA 0 2 2 3 3 7 0 2 i 9 9 8 - 0 4 - 0 l @10~ 8 has been remo~ed. T~e prosthe~ic doe~, ho~ever, al~o include mea~6 for ~ating the artificial li~b ~ortion to the re-idual limb of the amputee.
I~ accomplishing t~is f~nctior., it i6 Lmportant to consider comfort of t~e prosthetic user. In fact, in ma~y cases, the i6sue is not o~ly comfort, but also minimization of irritation ~o the stump. Where the amputee is a dia~etic, rubbing can crea~e a blister and infection which coul~ lead to the need fo~ further amputations or, in the extre~e case, even de~tb. Also, a liner ~ust provide a frien~ly, pressure-free e~vi_onment. Othe~wise, the stump fluid will be pressurized and cause 8~i~ and tissue inflammation.
As will be able to be se~n in ~iew of this discussion, a prosthesis liner which is custo~-fitted has sig~ificant ~dvnntages o~er one which may no~ be custom-fitted. A p~oblem with custom-fitted li~ers, however, is that it io costly and time consuming ~o measu~e, ~e~ble, and properly fi~ su~h an appli~3ce. It is co~on to ~ake one o~ more molds of the amputee's st~m~ i~ the p~oces6. Drying and curing of the mold can consu~e significa~t portion~ of time and re~ult in significant delays.
~ t is to the sho tcom~ngs o~ the prior art as roprese~ted by the references discussed hereinbefore and to ad~antageous dictates of the art tha~ the prese~t i~vention is directed.
2S It is an improved prosthetic liner which serves to solve many vv .~-~ 00 ~V . ~ L~ N R & S L.AW FIRl~l ~Dooa of t~e problems of the prior art a~d w~iCh considers the positiv~ dic~ates sug~csted by the prior art.
Sum~ary of the I~vention The present inve~tio~ is an appa~at~s for fitting a prosthetic appli~ce to a~ ~mputee's limb s~ump. Typieally, 6uch a limb ~tump has a~ irregular outer surface. ~he apparatus includes mea~s for con~ormi~g the irregular oute~
stump surface to a~ inner ~rface of a closed end li~sr which I0 is inte~ded to surround the stump. The inner liner is confor~d to the stump by applying a vacuu~ between the stump and t~e li~e~. There are one or more s~all t~bes whic~ enter the upper band portio~ af the inner liner. By applyin~ vacuu~
a~d holding it during fitting of the liner, the thin i~er liner will conform to the exact sha~e of the stump. This inner liner is made of a ~ery soft but tough elastic m~terial which sL~ulates the feeli~ of skin. It will move a~d absorb all 6u~faco pressures at t~e bony stu~p area. ~he inne- liner i8 reinforced i~ the axially central portion to restrict ~oveme~ and creeping. T~e outer wall surface of the lin~r is slightly textured And ~ade i~ suoh a ~ay to p~omote adhesion to all intermediate liner.
In a p~eferred e~bodi~er.t, probably at least two or more s~all, flat, thin, gelatinous shims ar- sel~-adhered to the 25 in~cr l~ner to build up the surface of the stump in suc~ a way as to eli~inate irregularities and provide a smoot~, unifor~
V~/ V~ LV J ! ~ ZJ~ N R & S L~W FIRM la 0lO
~urvature. Thc shim~ also provide more cushioning where needed. While the inAer surface sf the liner conforms to st~mp sh~pe, therefor-, the outer ~urfoc~ h~s a s~ooth ~adiused profilc.
An lntermediate liner i6 recei~ed over the in~er l~ner.
The intermediate liner i~ ~ade of ~ very soft, complia~t material which behaves like a liquid or a gel. This material, however, i~ quite to~g~, resilient and energy-absorbi~q and ha~ elongatio~ in a 1,000 to 3,000% ra~e. ~he i~termediate li~er has in~er and o~ater wall surfaces, both of which ~re textured and designed to promote self-adhesio~. This inter~ediate liner is placed over t~e inner, vacuum, co~formin~ liner. ~h~s, it ad~eres t~ t~e shim-radi~6ed outer surface of t~e inner liner and pr~vides a weight-~earing, ~5 enersy-absorbing ~o~for~ layer.
A~ outer liner, whic~ will haYe an inner wall surface desig~ed to promote self-adherence to ~he intermediate liner, is placed over the now composite liner assembly and becomes an integral part of it. The outer wall of the oute~ liner is ~0 smoo~, tough and abrasion-resist~nt. It will not degrade, tear, or b~ destroyed whe~ exposed ~o the socket rigid edge.
On~e su~h custom ~itting of an ambute with a liner is completed, the liner conforms to the stu~p with a soft, fatt~
tissue-like ~n~erior. The liner is, thereby, vcry friendly to the stump. Nevertbeless, the compo~itc liner has a tough, ab~a6ion-resistant, stron~, ela~to~eri~ outer surface. In .. , v~ vv ~v.~ V.)~ v N ~ & S LAW FIRX lalOll addition, the liDer can have a mechanism an~ means to change ~olume ~d yet maintain good co~tact to the 5tump.
I~ general, the amputee ctump will 1~6- body fluids and get smaller ~i.e. circ~ferentially 6maller). When thi6 h~ppen~, ~he omputee can lose contact ~ith the liner a~d ~eel a sensation of having lost the prosthetic li~ co~pletely as well as havi~g lost the neces6ary contact to ma~e for a smooth ~ai~. At a ~ini~,u~, comfo~t could be lost and dangerous psessure ~pots could be cr~ated. The i~er liner ca~, the~efore, he provided with a small tube connected to a miniat~re Yacuu~ pump. This p~p car. be ~ctiv~ted to suck in the i~ner wall of t~e composite liner to continue conformance to t~e s~ump. The ampute~ can control the amount of ~onformity by co~trolling ~ow muc~ vac~u~ is applied. Thls ~et~o~ will provide a p~essure-free enviro~me~t, and no inflatAble bladder~ whi~h ~ay cause pressure çpots are employed.
~ e present i~ventioD is thus a~ improved apparatu~ for fittin~ a p-~thetic appliance to a lim~ ~tu~p of an amputce.
More 6pecific feature~ and a~vantages obtained in Yie~ of those features ~ill become apparent with referer.ce to the D~T~ILED D~SCRIPTIO~ OF T~E INVE~TTON, ~ppended clai~s, ~nd the accompanyi~g drawing fisures.
--~0--v ~ V ~ L ~ 0 ~p ~ ;S ~ i N R ~ S LAW F I R~
CA 02233702 1998-04-01 1~3012 3rief Description of the Dra~ nc~
Figure 1 i~ a ~raSmentary side elev~tional vie~ of a typical limb ~tump;
Figure 2 is a sim?lified sectional view thereof with an S inner liner r~ccived over the ~mp;
Figure 3 ifi a view similar to Figure 2 illu6trating t~.e in~er li~er recei~ed over the stump with a plur~lity of gelatinous shims applied to the inner liner;
~ igure 4 is a 6implified sec~io~al Yiew thereof with an intermedia~e liner rccei~ed over the inner lin~r and an outer lincr received over the intermediate liner, and illustratin~
a ~acuu~ p~mp a~d controller;
Figure 5 i~ a si~plified sectional view thereof with the outer liner applied, a~d illustr~ting aut~matic initiated va~uum taki~g ~ea~s; a~d Figure 6 is a sLmp~ified sectional ~iew ~howing t~e composite liner asse~bly with th~ vacuum pump and a microproces60r as use~ i~ an alternati~e se~sor ~yStem.
~etailed Description of the In~ntio~
Re~erring ~ow to the drawings wherein like reference nu~erals de~ote like clements throughout t~e several vie~s, Figure 1 illustrates a typical stump lo of an amputee wherei~
a~putation ha6 occurred sliqhtly below the knee. It will bc seen that the stu~p 10 ~ an irresular surface 12 with so~.e J ~ ff l ~ 3 a l 2CZA 0 2 2 3 3 7 0 2 19 9 8 - 0 4 - 0 1 b~ 01~
~nde~taticns 14 ~nd protrusions 16. It is the provision of comfort to the amputee, i~ spite of the exifitence of these indent~ions 14 and protrusion~ 16, tbat the present invention is, in part, dlrecte~. Additionally, the inve~tion is also Yignificantly directed to the saving o~ time and expense incident to the fitting of a custom liner. ~ypically, the present invention ena~les the fitting of a custom liner to ~e acco~pli~hed within a s~.ort time. This is in contrast to prlor art methods and structure~ where, typically, a minimum iO of 4~7 hours, and often i~ excess of that amount of time, is in~ol~ed. Further, t~e pre~ent i~vention en~blcs the cus~o~.-~itted liner to be adjusted ~hen there is a loss o~ volume of the stump 10.
Figure 3 illustrates a plural ty of gelatinous s~.ims 18 having bee~ applied to an inner liner 20 rec~ived o~er t~.e ~t~mp 10 i~ order to ~ill in i~den~atio~s 14 in ~e 5tu~p 10 and provide a smoot~ly radi~ed surface 12. It ~ill be understood that t~e preferred em~odiment e~vision~ the app7icatio~ of a thir., elastic llner 20, typ~cally ~ade of polyurethane, silicon or other elasto~eric material, first being ~pplied to the stu~p 10. The lincr 20 i~ediately protects the skin surface of the amputec si~ce the thir., elastomeric li~er is quite soft ~nd fat-like tissue in text~e. Such a liner ~aD be pro~ided ~ith a stretcha~le me~h em~edded tberein as in ~pplican~s ~rior application Serial 0 ~ d 'O'ffl~ N R 8~ S LA~' F[R~ la 014 ~o, 0~/371,742, ~hich was filed on January 12, 19~5 and issued on Ja~uary 14, 1997 a~ ~.S. Patent No. 5,593,454.
Figure~ 2-3 illustrate at least o~e tube or conduit 22 extending axially into the i~ner liner 20 through an elastic b~ndJseAl 24 at an upper end the~eof. The tube 22 serves to convey vacuum to between thc amputee's stu~p 10 and the inner ~all 26 of the inner liner 20.
Figure 4 illustrates an i~ter~ediate liner 2a applied over t~e i~ner liner 20. This co~ponent 28 would have a gelatinous texture and would ~er~e as the weig~t-~esring, energy~a~sor~ing and conforming layer t~ provide a pre6~ure-f ree environment.
Fi5ur~ 4 ~lso llustr~tes a vacuu~ pump 30, w~ic~ is in ~luid communication with the tube or tubes 22 i~ the i~ner li~er 20, and a controller 32, which can be ~ed, i~ ~om~
~ho~iments, for effecting actuation of the ~acuum pump 30.
E~ch tube 22 can have a passage~ay which affo~ds ~luid com~unication between the insi~e of the tube 22 and the inner wall 26 of thc i~ner liner Z0. Such a passage~y enables a ~0 vacuu~ to ~e taken ~t the inte~face between _he stump 10 a~d the in~cr wall 26 o~ the i~Der liner 20. ~he inner liner 20 is, the~eby, drawn into clo6e con~ormity with t~e surface 12 of the stump 10. T~e controller 32 ~rvc~ to cnable volitional generation of the vacuu~ at the inte~face betwee~
the stu~p 10 and the inner wall 26 of the inner liner ~0.
v~ o lo.. )~ O~l~ J;~ N R & S L~W F~RM lal015 Figure 4-6 illustrate an outer liner 34 which ~ncases the f~ll ass-mbly. The outer liner 34 i~ highly ela~tic a~d tou~h and ha~ a hi~her modulus and bard~ess than either of thc other liner6, although it ~ould typically be made of a polyurethane material al~o. The outer lincr 34 ~erves to pro~i~e abrasion resista~ce, and it gi~es form eO the compositc assemb1y.
Figure 5 also illustrates a~ array of sensors 36 which ca~ be positioned at locations around the stu~p lO. The sensor~ 36 can serve to ascert~i~ that the~ a reduction in pressure around the stump lO as a res~lt of volume reduction which might occur because of perspiration or other factors.
The sensors 36 serYe to tran~mit to the co~troller or microproces~or 32, via ~ires 40, that a reduction in pressure condition has occurred. T~e microprocessor 32, in tu~, will function to actuate the vacuum pu~p 30, and the generatio~ of additio~al vacu~m wil~ result in the inner wall 26 of the i~er liner 20 being d~awn into tight enqage~ent with tke 6tump lO. Of course, th~ other li~ers will also be dra~rn in the same direc~ion, since, at this point, the three liners are ad~.ered ~o one another in a composite arrangement.
In vicw of the generation of additional vacuu~, various adverse effect~ can be avoi~ed. Particularly, a 100SR fit ~hich can result ~n rubbi~g a~d infection can ~e avoided, a~
can be a co~plete disen~ge~e~t of the composite liner from 2S the stump 10.
~ igure 6 illustrates an al,e natiYe mec~anism for ~utomatically controlli~g actuati.on of t~e ~a~uu~ pump 30.
The e~bo~ime~t of PiSure ~, as i~ true ~ the ca~e of the em~odi~ent o~ Fis~r~ 5, e~ploys, ~ypically, a plurality of S pressure-6ensiti-~e transdu_er5 38 p'aced a~ various locat~ons about the stump 10. ~he~e transdu~ers 38 sense a ~eduction in prefisure arou~d t~e s~ump 10 as a resu't o~ a loss of Yol~e ~-ithin t~e stunlp 10. ~ach ~ran~cer 38 in the e~bodi~ent of F_~ure 5, ~n t~n, h~s a lead wire ~o which run~ to the ~icrop~oce~or 3~. S~ch ~ lead ~ire ~r le~d wires 40 serve to coLvey ;nfo~mation with re~ard ~o pre-su-e sens~d by the various tra~ducer~ 3a to the ~icroprocesso. 32.
~ he ~icroproce~or 32, i~ respor.se to the pres~nre in~or~atio~ se~sed aGd conveye~ to ~he microp~ocess~r 32 from 75 the tra~du~e~s 39, wi:l; effect actuation o~ t~e vacuu~ pum?
30. O~ce a regai~_ng o~ a desired pressure ~s se3sed a~
result cf tbe generation v~ vac~u~, the ~.icroproces~or 32 will effect deactuati~n o. the vacuum pump 30.
~he em~c~dimen~c llu5t_-ated in Figure 6 functio;ls in a mar~ner similar ~o tllat embodiJqe~t ~hown in Fi~re ~. T~e tr2ns~ucers 38 are n~t, however, ~_clvi~e~ with lead wi-es ~0 i~ t_his e~bodime~t. Rat~er, e~c~l eran~ cer 38 is prov_Ge~
wi~h a tra~sm~tte- ~2. ~he micr~prooess.r 32 is, in ~urn, pr~vided with re~eivers 44 to acccp tbe transmitted 25 ir.fo..~natior. ~rom t~e transducers 38. Th~reafter, -_he v ~ V ~ L.~ IK~ IJ 17 microproces60r 32 functions in the Bame manACr ~s in the ea6e of the embodi~cnt of Figure 5.
It will be u~der~tood that this diEcl~sure, in ma~y re6pect~, is o~ly illustr~tive. Changes may be made in det~ils, particularly i~ matters of ~hape, size, material, and arrangeme~t of p~rts withou~ exceed~ng t~e scope of the invention. Accordingly, the scope of the i~vention is as defi~ed in t~e languase of tke appe~ded claims.
Tcc~nical Field The present inve~tion is rel~ted broadly to the field of prosthetics. More ~pecifically, howeve~, the i~Ye~tion ~elates to a prost~etic liner for an arti~ici~l limb to ~ov~r - and be attached to the stump o~ ~n amputee. ~he specific focu6 of the inve~tion i6 a moduiar concept fo~ providing a cus~om-fitted li~er for a prosthesis for a~ amputee's li~b, such as a stump extendiDg downwardly fro~ an a~putee's ~nee vr fr~m above the '~nee.
~ack~round of the Ir.~entio~
~rarious prostbetic liners are known in the prior art.
~or exa~ple, U~ited Sta~es P~tent No. 5,4~6,443 (Wilsorl et al.~ i~s~ed on ~ovembe~ 7, 1995 for ~ device ch~racterized as P~OS~E~IC DE~ICE FOR AMoeUTEES. That refe~erce discusses the use of a prosthe~is ~hich h2s a relatively rigid, support shell di~nsiohed to recei~e a p~rtio~ of the resi~al lim~ of the a~putee. The apparatus alco includes a pad ~e~ber which ha6 a plurality of pouches at le~st partially filled with fluid. It is intended t~at the pad member of that referer.ce substantially encircle the residual portion of the a~putee' 5 leg with its fluid pouches ~ing position adjacent one ano.~.er about the e~d along the ieg. The pad ~ember having the pouches is, therefore, placed in ~edian enga~ement with the stu~p.
. V v ~ V ~ t l Klll 1~ 0 0 3 CA 02233702 1998-04-oi . ~ .
United St~tes Pate~t No. 5,405,405 (Love) i6sued o~ April 11, 1995 for an inve3tion entitled PROST~ETIC SOCKET
CO~T~I~IN~ INFLATABLE MEANS. That reference teaches a composite ~ocket member ~or use with ~ prosthetic applian~e An outer socket of the de~ice define6 an i~ne~ cavity generally co~forming to the cuter surface of t~e residual limb of the amputee. An inner ~ocket defines an i~ner cavity wh~ch is iAtended to receive t~e amputee's residual limb. The inner ~ocket confor~s to ~be s~.ape of the outer socket and~ when nested within the cav~ty of the ou~er.socket, defines an air space between the i~ner surface of t~e outer soc~et and the outer surface o~ the in~er socket. ~ inflatable bladder is disposed between the inrer 3~r~ace of the o~ter soeket and tke outer surface of the i~ner socket. Means are provided for inf~ation of the bladder. ~he movement and rotation s~ability of the prosthetic appliance is, thereby, controlled.
United States Pater~t No. 5,3~,245 (Fay et al.~ i~su~d on February 7, 1995 for a device characterized as an I~LATA~L~
PROSTHESIS LI~ER. The apparatus i~ludes a soc~et having 20 selectively inflata~le bladders which ena~le the p~osthesis to be customized to fit ~ individual patient. A liner hzv ng two liner parts is employed to ~ccomplish this gcal. One li~er part is placed o~to the amputee's stu.mp. A prosthetist then determines the region or regions where bladders are 2i needed to pro~ide a comfortable fit. ~hese areas a~e identified and overlain with an adhesive. The o~ter liner is v~ V.~t ~ L~ 3 LAt~ 300'I
. .
then brought into overlying relationship to t~e inner liner so that the two liner part5 adhere to one another along the outliAed regions. After in~l~tion of a ~l~dder or bla~ders, ~he inner li~er conforms ~o the stump, and the outer liner 5 conforms to the shape ~f ~e inner wall of the socket of the appliance. The dcviee can include an a~ular bladder at the proxi~al ri~ of the socket to create a seal in order to main~ain a suction within the socket.
United States Pate~t ~o. 5,314,497 (Fay et al.) is~ued on 10 May 24, 1954 for a de~ice cbaracte~ized a~ APPARATUS AND
N~OD FOR SEALING A LI~ER ~ A PR~STHESIS. The lincr of that reference is intended to cus~ion an ~mputee's stump when it is placed into a prosthesi~ soc~et. In order to acco~plish this, the liner i~cludes fielecti~e~y ~nflatable bladders or customizing the liner to fit individual pa~ients. The liner i6 made of two parts. T~e first is ~n inner liner and the ~eco~d i8 a~ outer li~er. A region or regions where inflation to expand the space betwee~ the two li~ers might be needed are defined and outli~e~ with ~a adhcsive. The inr.er and outer li~er portion~ a~here to one another alo~g the outlincd regions to define bladders. The bladders can the~ be 6electively i~f lated to confor~ the outer liner to the shape of the interior wall of the appliance socket.
United States Patent No. 5,246,464 ~Sabolich) issued on Septembe~ 21, 1993 for an apparatus characterized as M~IFICIAL LI~ WITH P.NATOMICALLY CON~IGUR~D SOCKET. The .v . v ~ ~ v ~ L ~ LA~ ~ L J<~ 00 5 device of that refere~ce includes a sy~tem of inf latAble compartments ~o enable t~e adjusting of the ~ize and fit of t~e prosthesis. Wi~h ~he provi6io~ of these compart~e~ts, the patient may adjust the dimensions of the socket by i~flatin~
S one or ~o~e of the compart~e~ts.
U~ited States Pate~t No. 5,139,523 (pato~ et al.) issued on Ausust 1~, 1992 for an ARTI~ L LI~ SOCKET ~PPARA~U5.
The device disclosed by t~.at reference ir.cludes A vent provided through a sleet~e support fo~ ~cnting the interior of the so~ket. T~.e ~efe~e~ce al~o tea.c~es the provision o~
pneumatic chambers to enhance comfort of the a~putee.
~ nited S.ates Patent ~o. 5,133,776 ~crowder) issued on July 2&, ~9g2. The apparatus of that reference i5 cha_acterized AS a PP~OS~HE;TIC VOLU~ CO~PENSATIC~N DEVICE. It i~cludes a~ air ceil or ce}l6 ~hieh m3y be placed iAto aD
exi~ting pros~hesis or incl~ded i~to a newly-~abricated prosthesis. Means are i~cluded to allo~ for manual adjustment of ~he degree of i~fla~ion of the air cell or cells 60 tha~
changes i~ volume of the residual li~b of the amputee may be co~pe~sated ~or as required. Infl~tion i~ acc~mplished by a fi~gertip operated pump. A valve is also ~roYided to Allow for exhausti~g air from ~e air cell.
U~itcd ~tates Patent No. 5,10~,45~ (coona~ I) issued on April 28, 1992 for a P~OST~ETI~ APPLI~NCE. That appliance in~ludes 6e~eral inflatable bladder~ which, when inflatnd, act again~t the rigid side walls of the prosthesis ~ember in order to force pvrtions o~ t~e socket mer:ber side. well~ inwardly to grip th-~ resid~al limb of the ~~put.ee. I~lati~n con~ol ~nea~6 a-e provided and ca~ 5 nclud~ ~ m~ually-~per~b~e air pump. O~e or r~ore loanual'y-~pera~le a r val-,-es are 2~
S provided. h valve is use~ in com~r.atiorl with ea~h of t~e bladders to a ~ lo~ ~or exh~st of a i ~ frcln the co~respon.dirlg bl ad~e- .
Unitecl Stetes P~te~t ~Jo. 4,~23,475 ~Gosthn_a~. et al. ) is~iued on May 8, 1990 . Tiie device of tha~ . eference is iQ ch~r~ter~ze~ as an ~FIJ~TA~L~ LIMB ~R~S~'nE IS hf~H PR~FC:RMED
I~E~ S~7RFACE. r'h~ re ere.~ce teache~ a stu~p-rece~vi~.g sceket a~d ~ plu~ali~ of ir,fl2table bladde~s. Mearls are emplsyed in ord~ t~ ena~;e o~e ~ ary the press~lres w~t!~in t~e blnd~ers.
The ~ladde~6 ar~ m~de o~ a re~ati~e ~ ,oft, ~l~xible membran2 15 material sl~ch ~s ~'yure~hane. ~'ae me~Dbr~.nes ~re loca~ed ad~acent the w~ig~ ec~ g ~or~lons of t.le stu~E~ to prcvide a relatively soft, ~-niform s~rrace t supp~t the stwnp. ~-~e various pressures i~. .he bldd~ers are ind~per.d~n~ of e~ch otker, a~d regulation by ~he usc- i~ er.vis'~ned.
~0 ~'nited States PGtent ~o. 4,555,7?9 ~Ja~.owi~k) issued o~;
~p~ , 1987 ~or Gn ~I~ SYS~M ~OS~ESI~ ,~OR AMPU~5S. T~.e s~te~ i~ven~io.~ incl~des a ;~oi'~w bc~y wi~ s~iff peri~hera walls and a~, cpen ~r,~ and a c~3-sh~pe~ ~art-t on definlng, with tke walls, a fir~t sock~ he sys;~. also incl~de5 a se~ond ~oc~et h~in~ stiff periphe.~al w~ , t~e sec~r.d socket beir.g s~usl,~- neste~ wi.thir the ri~ st so_~et. ~he socond V .J ' .~ L f ~) O 1~ 2c ~ 3 3 7 0 2 j~g g 8 &0 4 LoA~W F I RM ~ 0 ~ 7 50cket i~cludes ~paced apart inner a~d outer walls with cup-shaped closed end- i~tercoAnecte~ and hcrmetically sealed at their out~r ends. A continuou~ ai~ chamber bctween the in~er a~d outer ~alls is, t~ereby, def~ned. ~ ~anually-operated air 5 pu~p and ~ressure relief valve are ~ounted o~ the outer wall, Pressu~ized air can, thereby, be selectively introduced i~to .he c~amber ~nd sel~ctiYely txhausted t~erefrom.
Unite~ St~te6 Patent No. 4,432,101 ~Johnson) issued on ~ebru~ry 21, ~984 for a CUSHIO~I~IG ~ATEI.L~ SUPPOR~ DEVICE.
The device of that refere~ce includes an i~flatable/deflatable b~g which is insertable in a~ upper fro~t portion of a prostheEis. A q~ick disco~ect, han~-operable pump ena~les the u~er of the prost~esis to adjust the degree of bag infl~tion.
Unitcd States Pate~t No. 3,889,301 ~Bonner, Sr.) issued on June 17, 1975 for a THE~EU~IC STu~ ~EAI~I~G AIR SAC
~ROSTHESIS. A~ air sac is prov~ded to surround the amputee'~
leg ~tump. The sac, in turn, is surrounded by a casing which confines the pressure of the ~ir sac in~ardly against the stump. The distal end o~ t~e air s~c is supported around and b~neath the patient's stump. Means, between the air sac and the c~sing, are provided to distort the surf2ce o~ th~ air sac and give it vtrtical stabi~ity with respect to supporting mea~s.
A fo~t or partial leg prosthetic includes an artificial limb portion to si~ulste the n~tural li.~b of the amputee which l tS . 3 !1 a ff l ~ 3 J 1 2 2CA 0 2 2 3 3 7 0 2 i 9 9 8 - 0 4 - 0 l @10~ 8 has been remo~ed. T~e prosthe~ic doe~, ho~ever, al~o include mea~6 for ~ating the artificial li~b ~ortion to the re-idual limb of the amputee.
I~ accomplishing t~is f~nctior., it i6 Lmportant to consider comfort of t~e prosthetic user. In fact, in ma~y cases, the i6sue is not o~ly comfort, but also minimization of irritation ~o the stump. Where the amputee is a dia~etic, rubbing can crea~e a blister and infection which coul~ lead to the need fo~ further amputations or, in the extre~e case, even de~tb. Also, a liner ~ust provide a frien~ly, pressure-free e~vi_onment. Othe~wise, the stump fluid will be pressurized and cause 8~i~ and tissue inflammation.
As will be able to be se~n in ~iew of this discussion, a prosthesis liner which is custo~-fitted has sig~ificant ~dvnntages o~er one which may no~ be custom-fitted. A p~oblem with custom-fitted li~ers, however, is that it io costly and time consuming ~o measu~e, ~e~ble, and properly fi~ su~h an appli~3ce. It is co~on to ~ake one o~ more molds of the amputee's st~m~ i~ the p~oces6. Drying and curing of the mold can consu~e significa~t portion~ of time and re~ult in significant delays.
~ t is to the sho tcom~ngs o~ the prior art as roprese~ted by the references discussed hereinbefore and to ad~antageous dictates of the art tha~ the prese~t i~vention is directed.
2S It is an improved prosthetic liner which serves to solve many vv .~-~ 00 ~V . ~ L~ N R & S L.AW FIRl~l ~Dooa of t~e problems of the prior art a~d w~iCh considers the positiv~ dic~ates sug~csted by the prior art.
Sum~ary of the I~vention The present inve~tio~ is an appa~at~s for fitting a prosthetic appli~ce to a~ ~mputee's limb s~ump. Typieally, 6uch a limb ~tump has a~ irregular outer surface. ~he apparatus includes mea~s for con~ormi~g the irregular oute~
stump surface to a~ inner ~rface of a closed end li~sr which I0 is inte~ded to surround the stump. The inner liner is confor~d to the stump by applying a vacuu~ between the stump and t~e li~e~. There are one or more s~all t~bes whic~ enter the upper band portio~ af the inner liner. By applyin~ vacuu~
a~d holding it during fitting of the liner, the thin i~er liner will conform to the exact sha~e of the stump. This inner liner is made of a ~ery soft but tough elastic m~terial which sL~ulates the feeli~ of skin. It will move a~d absorb all 6u~faco pressures at t~e bony stu~p area. ~he inne- liner i8 reinforced i~ the axially central portion to restrict ~oveme~ and creeping. T~e outer wall surface of the lin~r is slightly textured And ~ade i~ suoh a ~ay to p~omote adhesion to all intermediate liner.
In a p~eferred e~bodi~er.t, probably at least two or more s~all, flat, thin, gelatinous shims ar- sel~-adhered to the 25 in~cr l~ner to build up the surface of the stump in suc~ a way as to eli~inate irregularities and provide a smoot~, unifor~
V~/ V~ LV J ! ~ ZJ~ N R & S L~W FIRM la 0lO
~urvature. Thc shim~ also provide more cushioning where needed. While the inAer surface sf the liner conforms to st~mp sh~pe, therefor-, the outer ~urfoc~ h~s a s~ooth ~adiused profilc.
An lntermediate liner i6 recei~ed over the in~er l~ner.
The intermediate liner i~ ~ade of ~ very soft, complia~t material which behaves like a liquid or a gel. This material, however, i~ quite to~g~, resilient and energy-absorbi~q and ha~ elongatio~ in a 1,000 to 3,000% ra~e. ~he i~termediate li~er has in~er and o~ater wall surfaces, both of which ~re textured and designed to promote self-adhesio~. This inter~ediate liner is placed over t~e inner, vacuum, co~formin~ liner. ~h~s, it ad~eres t~ t~e shim-radi~6ed outer surface of t~e inner liner and pr~vides a weight-~earing, ~5 enersy-absorbing ~o~for~ layer.
A~ outer liner, whic~ will haYe an inner wall surface desig~ed to promote self-adherence to ~he intermediate liner, is placed over the now composite liner assembly and becomes an integral part of it. The outer wall of the oute~ liner is ~0 smoo~, tough and abrasion-resist~nt. It will not degrade, tear, or b~ destroyed whe~ exposed ~o the socket rigid edge.
On~e su~h custom ~itting of an ambute with a liner is completed, the liner conforms to the stu~p with a soft, fatt~
tissue-like ~n~erior. The liner is, thereby, vcry friendly to the stump. Nevertbeless, the compo~itc liner has a tough, ab~a6ion-resistant, stron~, ela~to~eri~ outer surface. In .. , v~ vv ~v.~ V.)~ v N ~ & S LAW FIRX lalOll addition, the liDer can have a mechanism an~ means to change ~olume ~d yet maintain good co~tact to the 5tump.
I~ general, the amputee ctump will 1~6- body fluids and get smaller ~i.e. circ~ferentially 6maller). When thi6 h~ppen~, ~he omputee can lose contact ~ith the liner a~d ~eel a sensation of having lost the prosthetic li~ co~pletely as well as havi~g lost the neces6ary contact to ma~e for a smooth ~ai~. At a ~ini~,u~, comfo~t could be lost and dangerous psessure ~pots could be cr~ated. The i~er liner ca~, the~efore, he provided with a small tube connected to a miniat~re Yacuu~ pump. This p~p car. be ~ctiv~ted to suck in the i~ner wall of t~e composite liner to continue conformance to t~e s~ump. The ampute~ can control the amount of ~onformity by co~trolling ~ow muc~ vac~u~ is applied. Thls ~et~o~ will provide a p~essure-free enviro~me~t, and no inflatAble bladder~ whi~h ~ay cause pressure çpots are employed.
~ e present i~ventioD is thus a~ improved apparatu~ for fittin~ a p-~thetic appliance to a lim~ ~tu~p of an amputce.
More 6pecific feature~ and a~vantages obtained in Yie~ of those features ~ill become apparent with referer.ce to the D~T~ILED D~SCRIPTIO~ OF T~E INVE~TTON, ~ppended clai~s, ~nd the accompanyi~g drawing fisures.
--~0--v ~ V ~ L ~ 0 ~p ~ ;S ~ i N R ~ S LAW F I R~
CA 02233702 1998-04-01 1~3012 3rief Description of the Dra~ nc~
Figure 1 i~ a ~raSmentary side elev~tional vie~ of a typical limb ~tump;
Figure 2 is a sim?lified sectional view thereof with an S inner liner r~ccived over the ~mp;
Figure 3 ifi a view similar to Figure 2 illu6trating t~.e in~er li~er recei~ed over the stump with a plur~lity of gelatinous shims applied to the inner liner;
~ igure 4 is a 6implified sec~io~al Yiew thereof with an intermedia~e liner rccei~ed over the inner lin~r and an outer lincr received over the intermediate liner, and illustratin~
a ~acuu~ p~mp a~d controller;
Figure 5 i~ a si~plified sectional view thereof with the outer liner applied, a~d illustr~ting aut~matic initiated va~uum taki~g ~ea~s; a~d Figure 6 is a sLmp~ified sectional ~iew ~howing t~e composite liner asse~bly with th~ vacuum pump and a microproces60r as use~ i~ an alternati~e se~sor ~yStem.
~etailed Description of the In~ntio~
Re~erring ~ow to the drawings wherein like reference nu~erals de~ote like clements throughout t~e several vie~s, Figure 1 illustrates a typical stump lo of an amputee wherei~
a~putation ha6 occurred sliqhtly below the knee. It will bc seen that the stu~p 10 ~ an irresular surface 12 with so~.e J ~ ff l ~ 3 a l 2CZA 0 2 2 3 3 7 0 2 19 9 8 - 0 4 - 0 1 b~ 01~
~nde~taticns 14 ~nd protrusions 16. It is the provision of comfort to the amputee, i~ spite of the exifitence of these indent~ions 14 and protrusion~ 16, tbat the present invention is, in part, dlrecte~. Additionally, the inve~tion is also Yignificantly directed to the saving o~ time and expense incident to the fitting of a custom liner. ~ypically, the present invention ena~les the fitting of a custom liner to ~e acco~pli~hed within a s~.ort time. This is in contrast to prlor art methods and structure~ where, typically, a minimum iO of 4~7 hours, and often i~ excess of that amount of time, is in~ol~ed. Further, t~e pre~ent i~vention en~blcs the cus~o~.-~itted liner to be adjusted ~hen there is a loss o~ volume of the stump 10.
Figure 3 illustrates a plural ty of gelatinous s~.ims 18 having bee~ applied to an inner liner 20 rec~ived o~er t~.e ~t~mp 10 i~ order to ~ill in i~den~atio~s 14 in ~e 5tu~p 10 and provide a smoot~ly radi~ed surface 12. It ~ill be understood that t~e preferred em~odiment e~vision~ the app7icatio~ of a thir., elastic llner 20, typ~cally ~ade of polyurethane, silicon or other elasto~eric material, first being ~pplied to the stu~p 10. The lincr 20 i~ediately protects the skin surface of the amputec si~ce the thir., elastomeric li~er is quite soft ~nd fat-like tissue in text~e. Such a liner ~aD be pro~ided ~ith a stretcha~le me~h em~edded tberein as in ~pplican~s ~rior application Serial 0 ~ d 'O'ffl~ N R 8~ S LA~' F[R~ la 014 ~o, 0~/371,742, ~hich was filed on January 12, 19~5 and issued on Ja~uary 14, 1997 a~ ~.S. Patent No. 5,593,454.
Figure~ 2-3 illustrate at least o~e tube or conduit 22 extending axially into the i~ner liner 20 through an elastic b~ndJseAl 24 at an upper end the~eof. The tube 22 serves to convey vacuum to between thc amputee's stu~p 10 and the inner ~all 26 of the inner liner 20.
Figure 4 illustrates an i~ter~ediate liner 2a applied over t~e i~ner liner 20. This co~ponent 28 would have a gelatinous texture and would ~er~e as the weig~t-~esring, energy~a~sor~ing and conforming layer t~ provide a pre6~ure-f ree environment.
Fi5ur~ 4 ~lso llustr~tes a vacuu~ pump 30, w~ic~ is in ~luid communication with the tube or tubes 22 i~ the i~ner li~er 20, and a controller 32, which can be ~ed, i~ ~om~
~ho~iments, for effecting actuation of the ~acuum pump 30.
E~ch tube 22 can have a passage~ay which affo~ds ~luid com~unication between the insi~e of the tube 22 and the inner wall 26 of thc i~ner liner Z0. Such a passage~y enables a ~0 vacuu~ to ~e taken ~t the inte~face between _he stump 10 a~d the in~cr wall 26 o~ the i~Der liner 20. ~he inner liner 20 is, the~eby, drawn into clo6e con~ormity with t~e surface 12 of the stump 10. T~e controller 32 ~rvc~ to cnable volitional generation of the vacuu~ at the inte~face betwee~
the stu~p 10 and the inner wall 26 of the inner liner ~0.
v~ o lo.. )~ O~l~ J;~ N R & S L~W F~RM lal015 Figure 4-6 illustrate an outer liner 34 which ~ncases the f~ll ass-mbly. The outer liner 34 i~ highly ela~tic a~d tou~h and ha~ a hi~her modulus and bard~ess than either of thc other liner6, although it ~ould typically be made of a polyurethane material al~o. The outer lincr 34 ~erves to pro~i~e abrasion resista~ce, and it gi~es form eO the compositc assemb1y.
Figure 5 also illustrates a~ array of sensors 36 which ca~ be positioned at locations around the stu~p lO. The sensor~ 36 can serve to ascert~i~ that the~ a reduction in pressure around the stump lO as a res~lt of volume reduction which might occur because of perspiration or other factors.
The sensors 36 serYe to tran~mit to the co~troller or microproces~or 32, via ~ires 40, that a reduction in pressure condition has occurred. T~e microprocessor 32, in tu~, will function to actuate the vacuum pu~p 30, and the generatio~ of additio~al vacu~m wil~ result in the inner wall 26 of the i~er liner 20 being d~awn into tight enqage~ent with tke 6tump lO. Of course, th~ other li~ers will also be dra~rn in the same direc~ion, since, at this point, the three liners are ad~.ered ~o one another in a composite arrangement.
In vicw of the generation of additional vacuu~, various adverse effect~ can be avoi~ed. Particularly, a 100SR fit ~hich can result ~n rubbi~g a~d infection can ~e avoided, a~
can be a co~plete disen~ge~e~t of the composite liner from 2S the stump 10.
~ igure 6 illustrates an al,e natiYe mec~anism for ~utomatically controlli~g actuati.on of t~e ~a~uu~ pump 30.
The e~bo~ime~t of PiSure ~, as i~ true ~ the ca~e of the em~odi~ent o~ Fis~r~ 5, e~ploys, ~ypically, a plurality of S pressure-6ensiti-~e transdu_er5 38 p'aced a~ various locat~ons about the stump 10. ~he~e transdu~ers 38 sense a ~eduction in prefisure arou~d t~e s~ump 10 as a resu't o~ a loss of Yol~e ~-ithin t~e stunlp 10. ~ach ~ran~cer 38 in the e~bodi~ent of F_~ure 5, ~n t~n, h~s a lead wire ~o which run~ to the ~icrop~oce~or 3~. S~ch ~ lead ~ire ~r le~d wires 40 serve to coLvey ;nfo~mation with re~ard ~o pre-su-e sens~d by the various tra~ducer~ 3a to the ~icroprocesso. 32.
~ he ~icroproce~or 32, i~ respor.se to the pres~nre in~or~atio~ se~sed aGd conveye~ to ~he microp~ocess~r 32 from 75 the tra~du~e~s 39, wi:l; effect actuation o~ t~e vacuu~ pum?
30. O~ce a regai~_ng o~ a desired pressure ~s se3sed a~
result cf tbe generation v~ vac~u~, the ~.icroproces~or 32 will effect deactuati~n o. the vacuum pump 30.
~he em~c~dimen~c llu5t_-ated in Figure 6 functio;ls in a mar~ner similar ~o tllat embodiJqe~t ~hown in Fi~re ~. T~e tr2ns~ucers 38 are n~t, however, ~_clvi~e~ with lead wi-es ~0 i~ t_his e~bodime~t. Rat~er, e~c~l eran~ cer 38 is prov_Ge~
wi~h a tra~sm~tte- ~2. ~he micr~prooess.r 32 is, in ~urn, pr~vided with re~eivers 44 to acccp tbe transmitted 25 ir.fo..~natior. ~rom t~e transducers 38. Th~reafter, -_he v ~ V ~ L.~ IK~ IJ 17 microproces60r 32 functions in the Bame manACr ~s in the ea6e of the embodi~cnt of Figure 5.
It will be u~der~tood that this diEcl~sure, in ma~y re6pect~, is o~ly illustr~tive. Changes may be made in det~ils, particularly i~ matters of ~hape, size, material, and arrangeme~t of p~rts withou~ exceed~ng t~e scope of the invention. Accordingly, the scope of the i~vention is as defi~ed in t~e languase of tke appe~ded claims.
Claims (11)
1. Apparatus for fitting a prosthetic appliance to an amputee's limb stump having an irregular surface, comprising:
(a) a thin, stretchable inner liner receivable over the amputee's stump and conforming thereto;
(b) a plurality of gelatinous shims adherable to said inner liner to eliminate irregularities in a contour of the stump surface;
c) an intermediate liner receivable over said inner liner having said shims adhered thereto; and d) a highly elastic, abrasion-resistant outer liner receivable over said intermediate liner.
(a) a thin, stretchable inner liner receivable over the amputee's stump and conforming thereto;
(b) a plurality of gelatinous shims adherable to said inner liner to eliminate irregularities in a contour of the stump surface;
c) an intermediate liner receivable over said inner liner having said shims adhered thereto; and d) a highly elastic, abrasion-resistant outer liner receivable over said intermediate liner.
2. Apparatus in accordance with Claim 1 further comprising means for taking vacuum at an interface between the amputee's limb stump and an inner wall of said inner liner, wherein said vacuum taking means comprises a vacuum pump in fluid communication with at least one port formed in said inner wall of said inner liner and controller means for actuating said pump.
3. Apparatus in accordance with Claim 2 wherein said controller means comprises a microprocessor.
4. Apparatus in accordance with Claim 3 further comprising means for ascertaining pressure reduction about said stump.
5. Apparatus in accordance with Claim 4 wherein said ascertaining means comprises a plurality of pressure-sensitive transducers spaced about the stump at different locations.
6. Apparatus in accordance with Claim 5 further comprising means for conveying information from said pressure-sensitive transducers to said microprocessor.
7. Apparatus in accordance with Claim 6 wherein said conveying means comprises cable means interconnecting said pressure transducers to said microprocessor.
8. Apparatus in accordance with Claim 6 wherein said conveying means comprises a transmitter associated with each transducer, and receiver means at said microprocessor.
9. A custom-fitted, composite liner for fitting a prosthetic appliance to an amputee's limb stump having an irregular surface, comprising:
(a) a liner surrounding the stump;
(b) a vacuum pump for taking vacuum at an interface of the limb stump and said liner;
c) a plurality of pressure-sensitive transducers placed about the stump at locations spaced from each other; and d) means, responsive to pressure reduction sensed by said transducers, for actuating said vacuum pump.
(a) a liner surrounding the stump;
(b) a vacuum pump for taking vacuum at an interface of the limb stump and said liner;
c) a plurality of pressure-sensitive transducers placed about the stump at locations spaced from each other; and d) means, responsive to pressure reduction sensed by said transducers, for actuating said vacuum pump.
10. Apparatus for fitting a prosthetic appliance to an amputee's limb stump, comprising:
(a) a thin, stretchable inner liner receivable over the amputee's stump and generally conforming thereto;
(b) an intermediate liner, having a gelatinous texture, receivable over said inner liner;
(c) an elastic, abrasion-resistant outer liner receivable over said intermediate liner; and (d) means for taking vacuum at an interface between the amputee's limb stump and an inner wall of said inner liner.
(a) a thin, stretchable inner liner receivable over the amputee's stump and generally conforming thereto;
(b) an intermediate liner, having a gelatinous texture, receivable over said inner liner;
(c) an elastic, abrasion-resistant outer liner receivable over said intermediate liner; and (d) means for taking vacuum at an interface between the amputee's limb stump and an inner wall of said inner liner.
11. Apparatus in accordance with Claim 10 wherein said vacuum taking means comprises a vacuum pump in fluid communication with at least one port formed in said inner wall of said inner liner.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/831,149 US5888230A (en) | 1997-04-01 | 1997-04-01 | Modular liner for limb stump prosthesis |
US08/831,149 | 1997-04-01 |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2233702A1 true CA2233702A1 (en) | 1998-10-01 |
Family
ID=25258396
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002233702A Abandoned CA2233702A1 (en) | 1997-04-01 | 1998-04-01 | Modular liner for limb stump prosthesis |
Country Status (4)
Country | Link |
---|---|
US (2) | US5888230A (en) |
EP (1) | EP0870485B1 (en) |
CA (1) | CA2233702A1 (en) |
DE (1) | DE69826917T2 (en) |
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- 1997-04-01 US US08/831,149 patent/US5888230A/en not_active Expired - Fee Related
-
1998
- 1998-04-01 DE DE69826917T patent/DE69826917T2/en not_active Expired - Fee Related
- 1998-04-01 CA CA002233702A patent/CA2233702A1/en not_active Abandoned
- 1998-04-01 EP EP98400770A patent/EP0870485B1/en not_active Expired - Lifetime
-
1999
- 1999-03-29 US US09/280,404 patent/US6231616B1/en not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
DE69826917T2 (en) | 2005-10-20 |
EP0870485B1 (en) | 2004-10-13 |
EP0870485A2 (en) | 1998-10-14 |
US5888230A (en) | 1999-03-30 |
EP0870485A3 (en) | 2000-08-30 |
US6231616B1 (en) | 2001-05-15 |
DE69826917D1 (en) | 2004-11-18 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
FZDE | Discontinued |