CA2078099A1 - Unitary inflatable penile prosthesis - Google Patents
Unitary inflatable penile prosthesisInfo
- Publication number
- CA2078099A1 CA2078099A1 CA002078099A CA2078099A CA2078099A1 CA 2078099 A1 CA2078099 A1 CA 2078099A1 CA 002078099 A CA002078099 A CA 002078099A CA 2078099 A CA2078099 A CA 2078099A CA 2078099 A1 CA2078099 A1 CA 2078099A1
- Authority
- CA
- Canada
- Prior art keywords
- reservoir
- pump
- fluid
- cylinders
- prosthesis
- 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
Links
- 239000012530 fluid Substances 0.000 claims abstract description 99
- 210000003899 penis Anatomy 0.000 claims abstract description 25
- 238000002513 implantation Methods 0.000 claims abstract description 19
- 210000004706 scrotum Anatomy 0.000 claims abstract description 16
- 238000000034 method Methods 0.000 claims description 21
- 239000007943 implant Substances 0.000 claims description 7
- 230000000717 retained effect Effects 0.000 claims description 3
- 238000010926 purge Methods 0.000 abstract description 6
- 210000005226 corpus cavernosum Anatomy 0.000 abstract description 3
- 230000008030 elimination Effects 0.000 abstract description 3
- 238000003379 elimination reaction Methods 0.000 abstract description 3
- 210000001015 abdomen Anatomy 0.000 abstract description 2
- 239000007787 solid Substances 0.000 abstract 1
- 238000002347 injection Methods 0.000 description 8
- 239000007924 injection Substances 0.000 description 8
- 229920002379 silicone rubber Polymers 0.000 description 6
- 210000000683 abdominal cavity Anatomy 0.000 description 4
- 230000006835 compression Effects 0.000 description 4
- 238000007906 compression Methods 0.000 description 4
- 210000000564 inguinal ring Anatomy 0.000 description 4
- 238000001356 surgical procedure Methods 0.000 description 4
- 239000000463 material Substances 0.000 description 3
- 101100192716 Mus musculus Purg gene Proteins 0.000 description 2
- NUHSROFQTUXZQQ-UHFFFAOYSA-N isopentenyl diphosphate Chemical compound CC(=C)CCO[P@](O)(=O)OP(O)(O)=O NUHSROFQTUXZQQ-UHFFFAOYSA-N 0.000 description 2
- 241000896693 Disa Species 0.000 description 1
- 241001163743 Perlodes Species 0.000 description 1
- 241000283984 Rodentia Species 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 230000001351 cycling effect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000001856 erectile effect Effects 0.000 description 1
- 201000001881 impotence Diseases 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 125000000446 sulfanediyl group Chemical group *S* 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
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
- A61F2/02—Prostheses implantable into the body
- A61F2/26—Penis implants
Abstract
ABSTRACT OF THE DISCLOSURE
A factory preassembled, preferably partially prefilled three piece penile prosthesis that can be implanted in a patient as one pre-assembled unit and filled without any required further connection or purging of air. The prosthesis has a pair of inflatable cylinders that can be implanted into the corpora cavernosa regions of the penis, the inflatable cylinders preferably being attached to a solid rear portion to which the various tubing is connected. The prosthesis also has a reservoir for implantation into the abdomen, a pump for implantation into the scrotum for transferring fluid from the reservoir into the cylinders, and a controllable valve associated with the pump for retaining the fluid within the cylinders and for controllably allowing it to escape from the cylinders back into the reservoir when desired. When fluid is pumped into the cylinders, the cylinders are inflated to to encourage the penis to an erect position. When the fluid is subsequently released from the cylinders, the cylinders deflate to allow the penis to return to a relaxed position. The volume of fluid within the preoperative prosthesis assembly is such that sufficient fluid may be readily displaced from the reservoir into the pump and cylinders to allow the reservoir to be inserted into the pelvic cavity of a patient without disconnecting the pump and cylinders. An alternate embodiment contemplates an unfilled prosthesis assembly, retaining the advantages of a preassembled unit in implantation time required and elimination of the potential for eventual connector failure.
A factory preassembled, preferably partially prefilled three piece penile prosthesis that can be implanted in a patient as one pre-assembled unit and filled without any required further connection or purging of air. The prosthesis has a pair of inflatable cylinders that can be implanted into the corpora cavernosa regions of the penis, the inflatable cylinders preferably being attached to a solid rear portion to which the various tubing is connected. The prosthesis also has a reservoir for implantation into the abdomen, a pump for implantation into the scrotum for transferring fluid from the reservoir into the cylinders, and a controllable valve associated with the pump for retaining the fluid within the cylinders and for controllably allowing it to escape from the cylinders back into the reservoir when desired. When fluid is pumped into the cylinders, the cylinders are inflated to to encourage the penis to an erect position. When the fluid is subsequently released from the cylinders, the cylinders deflate to allow the penis to return to a relaxed position. The volume of fluid within the preoperative prosthesis assembly is such that sufficient fluid may be readily displaced from the reservoir into the pump and cylinders to allow the reservoir to be inserted into the pelvic cavity of a patient without disconnecting the pump and cylinders. An alternate embodiment contemplates an unfilled prosthesis assembly, retaining the advantages of a preassembled unit in implantation time required and elimination of the potential for eventual connector failure.
Description
Z~ 9 RACK~I3Q~1D OF l`HE INVF.NTTON
1 . FIEL~ OF TI~E ~ NTT~)N
The present invention relates to a penile prosthesis for erecting a male penis, and methods of implanting the same.
1 . FIEL~ OF TI~E ~ NTT~)N
The present invention relates to a penile prosthesis for erecting a male penis, and methods of implanting the same.
2. DES~ TION OF lUi~UE~_aR~
A penile prosthesis is typically installed in a patient to remedy erectile impotence. One common type of penile prosthesis, termed an inflatable penile prosthesis or IPP, is provided with three separate functional elements, namely a sinqle cylinder or more commonly a pair of inflatable cylinders for insertion into the corpus cavernosa regions of the penis, a reservoir for disposition in the abdominal cavity and a pump for disposition in the scrotum, together with tubinq which is trimmed to length and used to interconnect all of the elements at the time of surgery. Specifically, there is typically one tube for connection from the pump to each cylinder and one tube for connection from the pump to the reservoir. In operation after implantation, the cylinders are filled with a fluid from the reservoir that inflates the cylinders, there~y causing the penis to erect When fluid is dra.ned from the cylinders back to the reservoir, the cylinders and penis return to a relaxed position (flacid state~. For inflation of the cylinders, the pump is manually activated to add f~uid from the reservoir to 2~ 9 the cylinders, with a valve being provided with the pump to permit and restrict the flow of fluid to and from the cylinders.
Such devices are described in various prior art references such as U.S. Patent No. 3,855,122, ~,954,102, 4,009,711, 4,201,202, S 4,235,227 and 4,318,39~. (The foregoing types of prostheses are commonly referred to as "three piece" penile prostheses, which terminology is preserved in the description of the present invention to distinguish over "two piece" penile prostheses wherein the pump also functions as the reservoir, though as shall be seen, the present invention does not have separate "pieces" but rather is one integrated assembly requiring no further interconnection at the time of implantation, in a preferred embodiment, a partially prefilled assembly substantially free of air and ready for implantation and final filling.) ~ he reservoir is usually a flexible bag for volume expansion and contraction primarily through shape chan~es as opposed to material stretching. For one method of implantation, the reservoir is typically inserted through the inguinal ring and implanted into the abdominal cavity behind the muscles of the lower abdomen of the patient. In that regard, the reservoir is senerally too large to be pushed throuqh the inguinal ring if it is filled with the intended working fluid, so the reservoir is usually substantially deflated before implantation.
Present surgical procedures include implanting the cylinders in the penis and filling them to test the resultant 2~
erection, and then emptying the cylinders, implanting an empty or substantially empty reservoir into the pelvic cavity, filling the reservoir with the filling fluid, implantinq the pump and then connecting all of the ele~ents together with the tubing.
In connecting the tubing from the reservoir to the pump, an extra long length of tubing is generally supplied. The tubing must be clamped off and trimmed to the proper length for the individual patient. The pump is then implanted into the scrotum and the cylinders are inserted into the penis pendulum.
As indicated above, the reservoir must be devoid of most fluid in order to be implanted through the inguinal ring, and the pump, cylinders and tubing do not have sufficient volume to retain all of the fluid needed in the system. Therefore, the prior art inflatable penile implant systems must remain unconnected, and are typically unfilled until after the reservoir is installed. This is because a filled reservoir, if first connected, cannot be sufficiently temporarily drained into the remaining components for implantation into a patient. ~hus, in order to properly install a prior art IPP of this type, it is necessary to first trim the tubing to length and fill the reservoir to purge most air therefrom, then to substantia~ly empty the reservoir and clamp the tubing without reintroducing air, then to pass the reservoir through the inguinal ring and into the abdominal cavity, and then to fill the reservoir through the unconnected tubing before the remainder of the device is installed and connected together. The air purging, -2^, ~9 etc. of the reservoir prior to its implantation and its refllling after implantation in the abdominal cavity is time consuming, thereby not only increasing implantation time, but also the cost and risk associated with implantation.
S Another problem with prior art penile implants of this type is that the attachment of the pump and cylinder to the reservoir often traps air within the system. Excessive air is undesirable because it is compressible, will leak throuqh a valve at a much higher rate than the intended fluid and has other undesirable effects such as possibly creating noise when beinq pumped with the fluid. Air also usually is present in lieu of an approximately equal amount of additional working fluid, thereby reducing the total amount of the working fluid present, potentially below the minimum required for proper operation of the system. Since the air will slowly disperse by osmosis through the implant wall over a period of time, an implant that works satisfactorily immediately after implantation on the comblnation of the intended working fluid and air functioninq for the time being as additional working fluid may not work properly after a period of time. Thus the presence of air should be minimized. To purge the assembled prosthesis of air, a small volume of fluid is added to the system. The surgeon must then wait while the trapped air separates from the fluid.
A needle is then inserted into the pocket of air and the air is withdrawn from the system. This procedure is repeated until all visible air is removed. The pump is then implanted into the JL~ ~! ' P . ~
2 " ~ ~ J . ~ ~ 9 ~crotum and t~e cyl~nder 18 inserted lnto the penl-~ pendulum.
~he a~sem~ly of the progthe~l~ and the sub~equent purg$ng of air are ~lqo tlme co~sum$ng step~ that extend the length o~ ~urgery.
~ddltionally, w~th ~he p~$or art methods, lt 1B diffi~ult to S ln~ure that all of the alr is removed from the prosthesiR
a~sem~ly as desi~ed.
The interconnection of the components of the prlor art pen$1e lmplant~ i8 al80 problçm~tlc. ~onnectors such a~ those descrl4ed in U.S. Patent No. 4,53~,183 have been used ~n the pa~t for thl3 purpo~e.) The tube~ must connect the ~omponent~
together a~ descr~bed above, but thi~ lnterconnect~on i8 time consumin~ and labor ~nten81ve, ~hereby ~l~o lncrea~lng the time requlred for the operation and the a~oclated r$sk3 of extendlng the tlme of the operat~on. Further, the ¢onnectoro pre~ent a step c~ge ~rom the ~lexi~l$ty o~ the tubeg, cre~lng ~tre~
concentration~ at the point of att~chment of the tu~e~ to ~he conneator~ and prov~dlng a posslblo sou~ce of fa$~ure over a perlod of tlme bec~u~e of repeated 1exing a~ those polnt~.
Elimination of the connec~or~ wo~ld el~minate thi~ potential 2~ source of failure, a4 a length o~ flexi~le tublng ~ntegral with th~ ~ame adjAcent tu~ing 1~ ltself extremely reliablo, In U.S. Patent No. 4,597,765, 8 method ~nd ~pp~r~tus for pac~ag$ng a fl~id filled pro8thes~s i3 dlsclo~ed uh~ch ~llows the p~efilltng of a prosthe3is at the fac~ory and ~h~ pment ~nd ~torage of the prosthesls in the f luid f ~ lled state, desplte the tenden~y fvr fluid mi~ra~lon through the wa~ 18 of the devlce, by __5__ 1 ~ !L ~ --_ ~ ~ - --Y P . -~ 1 1 establis~ing ma~s trangfer equ~l~br~um w~thin the pac~age. The method disclosed works well for two p~ece penile prostheses, particularly tho-~e adversely effected by sllght fluld 108~, but is not applicable to three plece pro~theses, a~ the re~ervo~r o~
a pref~lled ~hree piece prosthe~i~ generally cannot b~
~dequately coll~pse~ for lmpl~nt~tlon purpoSes.
It would thereforo be deQlr~ble to have a penile prosthe~l~
and 8 method of in~talling the same that would m~ke ~t easier and faste~ to implant, and which would eliminate the connector~
and thus a potential ~ourco of deteriora~ion and ~ailure ln the operatlng 3y~tem, thereby greatly reducing surgery tlme and fa~lure a~ter ~ome per$od o~ u~e, to the adv~nt~ge of the p~tlent and ~urgeon alike.
T~IL ~1, '9~ ~O~l P. 5~ 11 2f' ~ 9 The present ~nvention is a factory prea~sembled, prefer~bly part~ally pro~$11ed three plece penile pro~thesls that can ~e implanted ln a patlent a~ on- prs-a3æembled unit and fllled 5 wi~hout any requlred further Connection or purg$n~ of a~r. The p~osthes~s has a pa~r of ~n~latable cylinder~ that can be implanted l~to the corpora c~verno~a regions of the peni~, the lnflatable cyllnders preferably being attached to ~ ~ol~d rear portion to which the various tu~ing i5 connected. The 10 prosthe~l~ also ha~ a reservolr for lmpl~ntatlon ~nto the a~domen, a pump for implsntatlon ~nto th- ~crotum for transferrlng ~luld from the reservolr $nto th- cyl~nders, and a controlla~le v~lve a~soclated wlth the pump for reteln~ng the fluld within the cyllnder~ and ~or controllably ~llow~ng lt to 15 esc~pe from the cylinder~ ~ack into thc re3e~vo~r when desired.
When fluld 1~ pumped ~nto the cyl~nders, tho cyl~nder8 are infl~ted to encourag~ th~ penls to an erect po~it~on. When the ~luld ~8 subse~uently released from the cylinders, thC cylind-rs de~late to allow th~ penls to return to a relaxad poQitlon. The t 20 volume of flu~d wlthin the preoperativ~ p~osthesl~ a~em~ly i~
auch that sufficient fluld m~y be readlly dl~placed from the reser~olr into ~he pump and cylinders to allow the reservoir to ~e inser~ed lnto t~e pelvic cavity of a patlent without di~connectlng th~ pump and cyllnders.
T~IL ~ 1~ ' P. 6 1 1 2~ . ~f'~9 Accordlngly, a fllling port i~ provided on the prosthes~3, preferably $n the rear portlon, though on the pump or ln the a~soclated tu~ing lf de8ired, to ~ac~lltste fill~ng of the prosthesl8 to its operating volume after the re~ervoir is S lmplantod. A reseala~lo ~llling port 19 preferably prcvided ~or ea3y and ~ast filling wlth mlnimum opportunity for leakage.
~ he assemblcd prosthe4i~ 18 l~stalled by flr3t de~lating the reservolr by displaclng most of the fluid from the ~e8ervoir to tha pump and cyllnder~ and $n~ert~ng the oollap-~ed re~ervo~ r into the pelvle ~svl~y o~ the p8tient. The 8880mbly 19 then ln~ec~ed, typ~cally wlth ~ predetermlned amount of fluid, until tho prosthesis i~ fllled wlth ~n operatl~g volume of flu~d. The cyl~nde~s a~d pump ar- ~ub~equently lmplanted into the penls and scrotum, re3~ect~ely. Ther- 1~ no need for the surgoon to connect the var~ou~ component~, or pur~e air there~rom 28 wa~
re~ulred ln the prior art, as thi~ has already been done under closely controlled ~actory condltions.
Th~refore it 1~ sn ob~at o~ thio lnvention to provlde a three plece penlle pro~thesi~ that can be lnstalled lnto a pat~ent a~ a ~ingle unlt.
,. .
St ls also an ob~ect of thi~ invention to prov~de a thr~e plece penile prosthesls tha~ ~an ~e implanted and u~ed wlthout havlng to purge the ~ygtem of air ~t ~he ~lme o~ ~mplantatlon.
l ~IL ~ ' ' F ., 11 2~ 3~9 It 1~ also ~n ob~ect of the pre~ent ln~ention ~o prov~dc three p~ece penlle prosehesi~ that can be pack~ged and shlpped ln a pre-~ntexconnected ~t~te 90 t~Bt no connec~lon or as~embly i8 required upon lmplantation.
lt 1~ ~140 an o~ect of the present lnvention to provlde a three p~ece p~nlle pro~hesiJ that ca~ ~e fllled wLth~ut having to connect or d~connect any of the as~ociated ele~ents, lnclu~ing the tub~n~.
~t i~ another ob~-ct of the pre~ent invention to provlde three plece penlle pro~the8ig containing ~ volume of operatlng ~luld which can be all or mo~tly contfllned within ~he lnflatable cylln~ers, pump and asJoc~at-d tublnq ~uch that the oy~tem nee~
not be ~i~connected ln order to implant the reservo~r, It 1~ yet another ob~ect o~ the present $nventlon to p~ovlde a ~ully asse~led, part~ally fluid filled three pie~e penile prosthesi~ whlch 1~ blo wlthout Any disas~embly.
In another embodiment, lt 1~ yet another ob~ect o~ the pre~¢nt ln~entlon to prov~de ~ fully assembled, unfilled three plece penile pro3thesi~, the same being ~ree of ~he u~ual conne~torQ and thus fro- o~ a recognized and qubstantial ~ource of fallures of such lmpl~nt~, an~ ~urt~er be~ng more qu~ckly purged of mo~t a~r ~nd readlly l~planted without the ~ime con~uming a~sembly ~ ~h~ tlme o~ lmpl~ntat~on characteri8t~c of prlor art three piece penlle ~mplant5.
__9__ ~TLIL ~ `l P. 8~ 11 2~ S~ 9 Tho ob~ects and advantage~ of the pre~ent inventlon wlll become mo~e readlly ~pparent to those skilled ln t~e arS 8fter .reviewing the follo~lng detalled ~esorlptlon ~nd accompanylng S drawins3, whereln:
Flgure 1 1~ a ~lde vlew of A penlle pro3thesl3 a~sembly of the pre~ent ~nv~n~lon;
Figure ~ 1~ a slde view of the penlle pro~the~i~ asaembly o~ Flgure 1, where~n the reservo~r 18 implanted into the pelvlc cavlty of a patlent and t~e p~o~thosls a~embly ls ~elng ln~ected wlth a~d~tlonal worklng ~luld~
.~ Figure 3 is a ~ide vl~w o~ the penlle prosthe~s ~sembly of ~i~ure 2 with ~ho p~p of tho assembly $mp1anted lnto the 8crotum and the ~yllnder~ l~s~rted lnto the penl~ o~ the lS patient.
Flgure 4 i8 8n anatomlc draw~ng of the penlle pro~the~l~ ln a patient in a ~laccid ~ondltion.
Figure 5 ~9 an anatomlc draw~ng o~ the penile pro3tbe~i~ ln a patient ln an erect condi~io~.
Flgure 6 1~ a ~ross sectlon of the base portio~ 20 of a cyllnder illustratlng the deta~ls of injec~lon port 44 of F~gu~e~ l through 3.
JUL 1:1~ ' 9~ r~ P . 9 1 1 .`Q9 Figure 7 1s a c~os~ sect~on o~ the pump 14 ~llustratlng the details of ln~ectlor~ port 46 o~ Flgures 1 throuqh 3.
i ~ P . 1 ~ 1;
2 ~ 5 ~ . ! ~ 9 First referrlng to Figure ~, a penlle pro~the~i3 assembly 10 ~n 3ccordance with the present ~nvent~on may be seen. The a~embly 10 ha~ two ~nfl~table cylinders 12, each pars of ~
cyl~nde~ As~embly 18 ~nd connected to a pump 14 by a p~lr of fir~t tubes 16. Although two cyl~nder a38emblies 18 are ~hown, it ~s to ~e ~nderstood that only one cylinder 12 may be used i~
de81red.
The portion of ~he ~sse~bly ~mplanted in the penl~ ls the cylln~er asse~blleq 18, whlch comprise an lnflst~ble cyllnder 12 and a base portlon 20. In the preferred embodlment, betweon ach cyl~nder 12 and the respec~lve bas~ portion 20 is an exten~on member 23 hav~ng a bollow~ 24 there~n cons~r~cte~ ~o i. be extend~ble wleh the addltlon of a ~luid to ~he l.nterlor thereof. A d~tensi~le 81eeve 26 ls dlJpo~od over the bellow~
24 and attache~ ~h~ b~e portlon 20 to the cyll~der 12 ~o that when ~lu$d 1~ added to the bellows 24 to extond the ~am~, the 31eeve 26 ~s lt3elf ~tretched lnto ~n ex~ended po~l~lon, Sub8equent relea~e of a vAlve holdlng the fluld ln the bellow~
allow~ the game to retract, with the stretched sleeve 26 helping to expel fluid therefro~ and pull the cyllnder 12 b~ck to the relaxed posltion. ~hls 3heath and bellows lnflatable cyl~nder, ~;- wh$ch is one fo~m o~ ln~latable cylinder which may be used in t~e pre~ent invent~on, ~g described in deta~l ~n copending U.S.
P~tent Appl~catlon, Serlal No. 0~73~,426, T~IL ~ 5~1 P. 11- 11 2~ ~ 9 Fluid communScatlon bet~een the first tubes 16 and ~nfl~table cyl$nder 18 ~s establi~hed by sn openlng 28 loca~ed in the base portion 20, w$th stem 30 pro~dng a mean~ of ~ttachment for the tube 16. The pump 14 ls connected to the reservo~r ~2 by a ~econd tubo 3~, which l s contlnuou3 and without any ~onnectorY. ~he reservoir 32 1~ m~de from a flex~ble bag materlAl ~o that the vol~me of the reservoir 32 can lncrease and decrea~e aJ requlred. Whlle the re8exvolr 32 may have a port 36 which provlde3 polnt of entry for a needle tha~
can supply ~lu~ to the res~volr 32, the fllllng port for the ~y3tem 1~ el~ewhere, ~uch a~ fllllng port 44 ln the ~a~e portlon 20 of the ¢yllnder a~3embllo~, or ~ltornatively for ln~tance, rillin~ port 46 ln the pump hou~lng 38. (Typlcally both port8 wi11 not be u~ed on any one prosth¢31s, but could be lf deslred.) The fllling port ~s prefera~ly d~posed ln the ba~e portlon 20 ~ecau~e tha~ portlon i9 of sub~tantlal ssze and thlcknes~ already and not sub~ect to substantial flexlng tn use, so that a fl~llng port may be inte~ated into that regiOn in a manner that ~ 9 relatlvely u~dete~table by feel, thereby not eonstStuting a po3~ible source of irrltation or discom~ort. A9 w~ll be more fully descrlbed with respect to Fl~ures 6 and ~, the fllllng port can ha~e a rsi~ed or lowered ring ox other ~hape to ~unctlon a~ a bet~er target for the ~urgeon, though t~e preferred method of lmplantation of the present $nvention envision~ flnal fllling of the prosthe~i~ before lmplant~tion of the cyl~nder as~e~blSe~ when v~sibillty, etc. are at a maxlmum.
21~ ,Q~9 Of course the filling port may be provided with a needle guard for safety purposes, as is well known in the art, and may be of any of a variety of types which are well known in the art, including a compression port if desired.
S The pump 14 and valve assembly 42 are constructed so that fluid may be supplied to the cylinders 12 by squeezing and releasing the pump housing 38 one or more times. ~he valve $s constructed in the form of a release valve, as is known in the art, allowing fluid to return from the cylinder assemblies to the reservoir upon manual squeezing of the valve assembly 14.
The entire assembly is provided preassembled, purged of most air and partially filled with the intended working fluid.
The fluid is preferably isotonic, and may include but is not limited to a saline solution or PVP. The volume of fluid within the assembly 10 is such that most of the fluid may be forced into the cylinders, either by successive operation of the pump or by simultaneous squeezing of the reservoir and the valve assembly, so that the reservoir 32 will be sufficiently deflated to be inserted into the pelvic cavity of a patient. The volume of the prefill fluid will depend on the size of the reservoir, pump, cylinders and tubing utilized for the particular patient, though in general the volume of prefill fluid in the system may be from somewhat less t~an the fluid capacity of the pump, cylinders and tubing, to somewhat more than the fluid capacity of the pump, cylinders and tu~ing, as desired. In that regard, a reservoir which has some fluld therein will "hourglass" as it 2~ 9 is passed through a small opening, thereby limiting the deqree to which it must be emptied for convenient implantation. Thus the amount of prefill fluid is preferably limited on the upper end to an amount which does not encourage overstressing of the cylinders and pump to remove sufficient fluid from the reservoir to allow easy implantation thereof - perhaps 5 cc of fluid left in the reservoir still ma~ing the reservoir easily implantable.
On the lower end, it is desirable to have sufficient fluid in the system to displace the air while avoiding sharp wrinkles in an overly deflated system, and preferably to have sufficient fluid in the system to allow final filling by a single in~ection of fluid.
The prosthesis 10 is provided to the surgeon in the assem~led, partially filled condition shown and described above.
lS To install the assembly 10, an incision is made at the base of the penis next to the inquinal ring. The incision provides access to the pelvic cavity, scrotum and corpora cavernosa regions of the patient. The reservoir 32 is then substantially deflated by opening the valve 42 and squeezing the contents out of the reservoir, thereby forcing fluid within the reservoir 32 to flow into the rest of the assembly 10. After the reservoir 32 is substantially collapsed, the reservoir is lnserted into the pelvic cavlty.
After the reservoir 32 is implanted into the patient, a filling device, such as syringe 40 as shown in Figure 2, is used to fill the system to its operable volume, which, as is known ln 2~ ~9 the art, varies depending upon the size of the system and the particular patient. Typically about 40 to 75 cc of fluid is the standard operating volume. The filllng port can be almost anywhere in the system as described above, including the pump, S the tubing or the base of the cylinders, although it is preferably not in the inflatable part of the cylinders or the reservoir. As stated before, in the presently preferred embodiment, the injection port is in the base portion 20 of the cylinders 12, where material thickness is greater and mechanical cycling is lower than the other components of the assembly 10.
Once the assembly ls filled to the operating level of fluid, the syringe 40 i5 removed, the valve squeezed and a substantial part of the fluld allowed to pass back into the reservoir. As shown in Figure 3, the cylinders 12 and pump 14 lS are then implanted into the corpora cavernosa regions of the penis and the scrotum, respectively. The installation of the cylinders 12 and pump lg into these regions can be performed by surgical procedures known in the art. It will be appreciated, however, that utilizing the present invention for implantation, the steps of evacuating air from the system, and of reliably connecting the tubing together as was required in prior art three piece systems are eliminated.
As shown in Figures 4 and ~, cne present invention can be used to erect a male penis. The cylinder~ 12 are disposed within the corpus cavernosa of the penis and are shown in a deflated Qtate in Figure 4. The cylinders 12' are lnflated in 2 ~ Q 9 Figure 5. Conversely, the reservoir 32' is inflated in Figure 4 and reservoir 32 is deflated in Figure 5.
Now referrinq to Figure 6, a cross section of the base portion 20 of a cylinder illustratinq the details of injection port 44 of Figures 1 through 3 may be seen. The body of base portion is a flexible material, typically a silicon rubber, molded as a single piece, with the injection port location being circumscribed by a ring or raised portion 48 to help the surgeon better locate and confine the location of the tip of the injection needle. Disposed therein is a relatively rigid, substantially conical member 50 having an inward projecting lip 52 at the larger end thereof. A conical slug of soft and flexible silicon rubber 59 is disposed in the end of the conlcal member 50, and is retained therein under compression by another substantially rigid, hollow conical member 56 slotted from the larger end thereof so as to have sufficient flexibility to pass under lip 52 for assembly purposes, to snap back and to be retained thereby to retain the conical slug of soft and flexible silicon rubber 54 under compression. In this way, the thin end of the body of base portion 20 and the conical slug of soft and flexible silicon rubber 54 may be easily pierced by a needle for in~ection of working fluid into the prosthesis, with the resulting opening in the conical sluq of soft and flexible silicon rubber 54 immed~ately resealing upon withdrawal of the needle.
2~
Now referring to Figure 7, a cross section of the pump 14 illustrating the details of one possi~le design of an injection port 46 on the pump 14 of Figures 1 through ~ may be seen. In this injection site, a substantially rigid cup 58 having an S opening on the side thereof for fluid communication with the internal parts of the pump is presseed into the flexible body of the pump, and retains a slug of soft and flexible silicon rubber 60 under compression, again to immediately reseal upon withdrawal of the needle. In this injection site, the cup bottom forms a readily detectable stop for the needle, facilitating appropriate placement of the needle before injection.
In the foregoing embodiment, the prosthesis is purged of at least most air and partially prefilled at the t~me of lS manufacture~ thereby relieving the surgeon of the same rather mechanical tasks at the time of implantation and allowing the same to be done under the less costly and more easily and uniformly controlled factory conditions. However, there are still substantial advantages to be gained by providing to the surgeon a preassembled but not partially prefilled prosthesis, as such a preassembled unit will still eliminate the time required to cut the tubes to length, to assemble connectorQ, etc., and will more readily facilitate the pursing of air from the system, primarily by what is now the simultaneous purging of 2S all "pieces" and the elimination of the opportunity for reintroduction of alr into the system as in the prior art when ~ s ~ 9 the tubes to the multiple pieces are opened for connection together. Such a nonprefilled assembly also eliminates the possibility of eventual connector failure, a substantial advantage in itself.
While certain exemplary embodiments have been described in detail and one exemplary embodi~.ent shown in the accompanying drawings, it is to be understood that such embodiments are merely illustrative of and not restrictive on the broad invention, and that this invention not be limited to the specific constructions and arrangements shown and described, since various other modificat$ons may occur to those skilled in the art.
A penile prosthesis is typically installed in a patient to remedy erectile impotence. One common type of penile prosthesis, termed an inflatable penile prosthesis or IPP, is provided with three separate functional elements, namely a sinqle cylinder or more commonly a pair of inflatable cylinders for insertion into the corpus cavernosa regions of the penis, a reservoir for disposition in the abdominal cavity and a pump for disposition in the scrotum, together with tubinq which is trimmed to length and used to interconnect all of the elements at the time of surgery. Specifically, there is typically one tube for connection from the pump to each cylinder and one tube for connection from the pump to the reservoir. In operation after implantation, the cylinders are filled with a fluid from the reservoir that inflates the cylinders, there~y causing the penis to erect When fluid is dra.ned from the cylinders back to the reservoir, the cylinders and penis return to a relaxed position (flacid state~. For inflation of the cylinders, the pump is manually activated to add f~uid from the reservoir to 2~ 9 the cylinders, with a valve being provided with the pump to permit and restrict the flow of fluid to and from the cylinders.
Such devices are described in various prior art references such as U.S. Patent No. 3,855,122, ~,954,102, 4,009,711, 4,201,202, S 4,235,227 and 4,318,39~. (The foregoing types of prostheses are commonly referred to as "three piece" penile prostheses, which terminology is preserved in the description of the present invention to distinguish over "two piece" penile prostheses wherein the pump also functions as the reservoir, though as shall be seen, the present invention does not have separate "pieces" but rather is one integrated assembly requiring no further interconnection at the time of implantation, in a preferred embodiment, a partially prefilled assembly substantially free of air and ready for implantation and final filling.) ~ he reservoir is usually a flexible bag for volume expansion and contraction primarily through shape chan~es as opposed to material stretching. For one method of implantation, the reservoir is typically inserted through the inguinal ring and implanted into the abdominal cavity behind the muscles of the lower abdomen of the patient. In that regard, the reservoir is senerally too large to be pushed throuqh the inguinal ring if it is filled with the intended working fluid, so the reservoir is usually substantially deflated before implantation.
Present surgical procedures include implanting the cylinders in the penis and filling them to test the resultant 2~
erection, and then emptying the cylinders, implanting an empty or substantially empty reservoir into the pelvic cavity, filling the reservoir with the filling fluid, implantinq the pump and then connecting all of the ele~ents together with the tubing.
In connecting the tubing from the reservoir to the pump, an extra long length of tubing is generally supplied. The tubing must be clamped off and trimmed to the proper length for the individual patient. The pump is then implanted into the scrotum and the cylinders are inserted into the penis pendulum.
As indicated above, the reservoir must be devoid of most fluid in order to be implanted through the inguinal ring, and the pump, cylinders and tubing do not have sufficient volume to retain all of the fluid needed in the system. Therefore, the prior art inflatable penile implant systems must remain unconnected, and are typically unfilled until after the reservoir is installed. This is because a filled reservoir, if first connected, cannot be sufficiently temporarily drained into the remaining components for implantation into a patient. ~hus, in order to properly install a prior art IPP of this type, it is necessary to first trim the tubing to length and fill the reservoir to purge most air therefrom, then to substantia~ly empty the reservoir and clamp the tubing without reintroducing air, then to pass the reservoir through the inguinal ring and into the abdominal cavity, and then to fill the reservoir through the unconnected tubing before the remainder of the device is installed and connected together. The air purging, -2^, ~9 etc. of the reservoir prior to its implantation and its refllling after implantation in the abdominal cavity is time consuming, thereby not only increasing implantation time, but also the cost and risk associated with implantation.
S Another problem with prior art penile implants of this type is that the attachment of the pump and cylinder to the reservoir often traps air within the system. Excessive air is undesirable because it is compressible, will leak throuqh a valve at a much higher rate than the intended fluid and has other undesirable effects such as possibly creating noise when beinq pumped with the fluid. Air also usually is present in lieu of an approximately equal amount of additional working fluid, thereby reducing the total amount of the working fluid present, potentially below the minimum required for proper operation of the system. Since the air will slowly disperse by osmosis through the implant wall over a period of time, an implant that works satisfactorily immediately after implantation on the comblnation of the intended working fluid and air functioninq for the time being as additional working fluid may not work properly after a period of time. Thus the presence of air should be minimized. To purge the assembled prosthesis of air, a small volume of fluid is added to the system. The surgeon must then wait while the trapped air separates from the fluid.
A needle is then inserted into the pocket of air and the air is withdrawn from the system. This procedure is repeated until all visible air is removed. The pump is then implanted into the JL~ ~! ' P . ~
2 " ~ ~ J . ~ ~ 9 ~crotum and t~e cyl~nder 18 inserted lnto the penl-~ pendulum.
~he a~sem~ly of the progthe~l~ and the sub~equent purg$ng of air are ~lqo tlme co~sum$ng step~ that extend the length o~ ~urgery.
~ddltionally, w~th ~he p~$or art methods, lt 1B diffi~ult to S ln~ure that all of the alr is removed from the prosthesiR
a~sem~ly as desi~ed.
The interconnection of the components of the prlor art pen$1e lmplant~ i8 al80 problçm~tlc. ~onnectors such a~ those descrl4ed in U.S. Patent No. 4,53~,183 have been used ~n the pa~t for thl3 purpo~e.) The tube~ must connect the ~omponent~
together a~ descr~bed above, but thi~ lnterconnect~on i8 time consumin~ and labor ~nten81ve, ~hereby ~l~o lncrea~lng the time requlred for the operation and the a~oclated r$sk3 of extendlng the tlme of the operat~on. Further, the ¢onnectoro pre~ent a step c~ge ~rom the ~lexi~l$ty o~ the tubeg, cre~lng ~tre~
concentration~ at the point of att~chment of the tu~e~ to ~he conneator~ and prov~dlng a posslblo sou~ce of fa$~ure over a perlod of tlme bec~u~e of repeated 1exing a~ those polnt~.
Elimination of the connec~or~ wo~ld el~minate thi~ potential 2~ source of failure, a4 a length o~ flexi~le tublng ~ntegral with th~ ~ame adjAcent tu~ing 1~ ltself extremely reliablo, In U.S. Patent No. 4,597,765, 8 method ~nd ~pp~r~tus for pac~ag$ng a fl~id filled pro8thes~s i3 dlsclo~ed uh~ch ~llows the p~efilltng of a prosthe3is at the fac~ory and ~h~ pment ~nd ~torage of the prosthesls in the f luid f ~ lled state, desplte the tenden~y fvr fluid mi~ra~lon through the wa~ 18 of the devlce, by __5__ 1 ~ !L ~ --_ ~ ~ - --Y P . -~ 1 1 establis~ing ma~s trangfer equ~l~br~um w~thin the pac~age. The method disclosed works well for two p~ece penile prostheses, particularly tho-~e adversely effected by sllght fluld 108~, but is not applicable to three plece pro~theses, a~ the re~ervo~r o~
a pref~lled ~hree piece prosthe~i~ generally cannot b~
~dequately coll~pse~ for lmpl~nt~tlon purpoSes.
It would thereforo be deQlr~ble to have a penile prosthe~l~
and 8 method of in~talling the same that would m~ke ~t easier and faste~ to implant, and which would eliminate the connector~
and thus a potential ~ourco of deteriora~ion and ~ailure ln the operatlng 3y~tem, thereby greatly reducing surgery tlme and fa~lure a~ter ~ome per$od o~ u~e, to the adv~nt~ge of the p~tlent and ~urgeon alike.
T~IL ~1, '9~ ~O~l P. 5~ 11 2f' ~ 9 The present ~nvention is a factory prea~sembled, prefer~bly part~ally pro~$11ed three plece penile pro~thesls that can ~e implanted ln a patlent a~ on- prs-a3æembled unit and fllled 5 wi~hout any requlred further Connection or purg$n~ of a~r. The p~osthes~s has a pa~r of ~n~latable cylinder~ that can be implanted l~to the corpora c~verno~a regions of the peni~, the lnflatable cyllnders preferably being attached to ~ ~ol~d rear portion to which the various tu~ing i5 connected. The 10 prosthe~l~ also ha~ a reservolr for lmpl~ntatlon ~nto the a~domen, a pump for implsntatlon ~nto th- ~crotum for transferrlng ~luld from the reservolr $nto th- cyl~nders, and a controlla~le v~lve a~soclated wlth the pump for reteln~ng the fluld within the cyllnder~ and ~or controllably ~llow~ng lt to 15 esc~pe from the cylinder~ ~ack into thc re3e~vo~r when desired.
When fluld 1~ pumped ~nto the cyl~nders, tho cyl~nder8 are infl~ted to encourag~ th~ penls to an erect po~it~on. When the ~luld ~8 subse~uently released from the cylinders, thC cylind-rs de~late to allow th~ penls to return to a relaxad poQitlon. The t 20 volume of flu~d wlthin the preoperativ~ p~osthesl~ a~em~ly i~
auch that sufficient fluld m~y be readlly dl~placed from the reser~olr into ~he pump and cylinders to allow the reservoir to ~e inser~ed lnto t~e pelvic cavity of a patlent without di~connectlng th~ pump and cyllnders.
T~IL ~ 1~ ' P. 6 1 1 2~ . ~f'~9 Accordlngly, a fllling port i~ provided on the prosthes~3, preferably $n the rear portlon, though on the pump or ln the a~soclated tu~ing lf de8ired, to ~ac~lltste fill~ng of the prosthesl8 to its operating volume after the re~ervoir is S lmplantod. A reseala~lo ~llling port 19 preferably prcvided ~or ea3y and ~ast filling wlth mlnimum opportunity for leakage.
~ he assemblcd prosthe4i~ 18 l~stalled by flr3t de~lating the reservolr by displaclng most of the fluid from the ~e8ervoir to tha pump and cyllnder~ and $n~ert~ng the oollap-~ed re~ervo~ r into the pelvle ~svl~y o~ the p8tient. The 8880mbly 19 then ln~ec~ed, typ~cally wlth ~ predetermlned amount of fluid, until tho prosthesis i~ fllled wlth ~n operatl~g volume of flu~d. The cyl~nde~s a~d pump ar- ~ub~equently lmplanted into the penls and scrotum, re3~ect~ely. Ther- 1~ no need for the surgoon to connect the var~ou~ component~, or pur~e air there~rom 28 wa~
re~ulred ln the prior art, as thi~ has already been done under closely controlled ~actory condltions.
Th~refore it 1~ sn ob~at o~ thio lnvention to provlde a three plece penlle pro~thesi~ that can be lnstalled lnto a pat~ent a~ a ~ingle unlt.
,. .
St ls also an ob~ect of thi~ invention to prov~de a thr~e plece penile prosthesls tha~ ~an ~e implanted and u~ed wlthout havlng to purge the ~ygtem of air ~t ~he ~lme o~ ~mplantatlon.
l ~IL ~ ' ' F ., 11 2~ 3~9 It 1~ also ~n ob~ect of the pre~ent ln~ention ~o prov~dc three p~ece penlle prosehesi~ that can be pack~ged and shlpped ln a pre-~ntexconnected ~t~te 90 t~Bt no connec~lon or as~embly i8 required upon lmplantation.
lt 1~ ~140 an o~ect of the present lnvention to provlde a three p~ece p~nlle pro~hesiJ that ca~ ~e fllled wLth~ut having to connect or d~connect any of the as~ociated ele~ents, lnclu~ing the tub~n~.
~t i~ another ob~-ct of the pre~ent invention to provlde three plece penlle pro~the8ig containing ~ volume of operatlng ~luld which can be all or mo~tly contfllned within ~he lnflatable cylln~ers, pump and asJoc~at-d tublnq ~uch that the oy~tem nee~
not be ~i~connected ln order to implant the reservo~r, It 1~ yet another ob~ect o~ the present $nventlon to p~ovlde a ~ully asse~led, part~ally fluid filled three pie~e penile prosthesi~ whlch 1~ blo wlthout Any disas~embly.
In another embodiment, lt 1~ yet another ob~ect o~ the pre~¢nt ln~entlon to prov~de ~ fully assembled, unfilled three plece penile pro3thesi~, the same being ~ree of ~he u~ual conne~torQ and thus fro- o~ a recognized and qubstantial ~ource of fallures of such lmpl~nt~, an~ ~urt~er be~ng more qu~ckly purged of mo~t a~r ~nd readlly l~planted without the ~ime con~uming a~sembly ~ ~h~ tlme o~ lmpl~ntat~on characteri8t~c of prlor art three piece penlle ~mplant5.
__9__ ~TLIL ~ `l P. 8~ 11 2~ S~ 9 Tho ob~ects and advantage~ of the pre~ent inventlon wlll become mo~e readlly ~pparent to those skilled ln t~e arS 8fter .reviewing the follo~lng detalled ~esorlptlon ~nd accompanylng S drawins3, whereln:
Flgure 1 1~ a ~lde vlew of A penlle pro3thesl3 a~sembly of the pre~ent ~nv~n~lon;
Figure ~ 1~ a slde view of the penlle pro~the~i~ asaembly o~ Flgure 1, where~n the reservo~r 18 implanted into the pelvlc cavlty of a patlent and t~e p~o~thosls a~embly ls ~elng ln~ected wlth a~d~tlonal worklng ~luld~
.~ Figure 3 is a ~ide vl~w o~ the penlle prosthe~s ~sembly of ~i~ure 2 with ~ho p~p of tho assembly $mp1anted lnto the 8crotum and the ~yllnder~ l~s~rted lnto the penl~ o~ the lS patient.
Flgure 4 i8 8n anatomlc draw~ng of the penlle pro~the~l~ ln a patient in a ~laccid ~ondltion.
Figure 5 ~9 an anatomlc draw~ng o~ the penile pro3tbe~i~ ln a patient ln an erect condi~io~.
Flgure 6 1~ a ~ross sectlon of the base portio~ 20 of a cyllnder illustratlng the deta~ls of injec~lon port 44 of F~gu~e~ l through 3.
JUL 1:1~ ' 9~ r~ P . 9 1 1 .`Q9 Figure 7 1s a c~os~ sect~on o~ the pump 14 ~llustratlng the details of ln~ectlor~ port 46 o~ Flgures 1 throuqh 3.
i ~ P . 1 ~ 1;
2 ~ 5 ~ . ! ~ 9 First referrlng to Figure ~, a penlle pro~the~i3 assembly 10 ~n 3ccordance with the present ~nvent~on may be seen. The a~embly 10 ha~ two ~nfl~table cylinders 12, each pars of ~
cyl~nde~ As~embly 18 ~nd connected to a pump 14 by a p~lr of fir~t tubes 16. Although two cyl~nder a38emblies 18 are ~hown, it ~s to ~e ~nderstood that only one cylinder 12 may be used i~
de81red.
The portion of ~he ~sse~bly ~mplanted in the penl~ ls the cylln~er asse~blleq 18, whlch comprise an lnflst~ble cyllnder 12 and a base portlon 20. In the preferred embodlment, betweon ach cyl~nder 12 and the respec~lve bas~ portion 20 is an exten~on member 23 hav~ng a bollow~ 24 there~n cons~r~cte~ ~o i. be extend~ble wleh the addltlon of a ~luid to ~he l.nterlor thereof. A d~tensi~le 81eeve 26 ls dlJpo~od over the bellow~
24 and attache~ ~h~ b~e portlon 20 to the cyll~der 12 ~o that when ~lu$d 1~ added to the bellows 24 to extond the ~am~, the 31eeve 26 ~s lt3elf ~tretched lnto ~n ex~ended po~l~lon, Sub8equent relea~e of a vAlve holdlng the fluld ln the bellow~
allow~ the game to retract, with the stretched sleeve 26 helping to expel fluid therefro~ and pull the cyllnder 12 b~ck to the relaxed posltion. ~hls 3heath and bellows lnflatable cyl~nder, ~;- wh$ch is one fo~m o~ ln~latable cylinder which may be used in t~e pre~ent invent~on, ~g described in deta~l ~n copending U.S.
P~tent Appl~catlon, Serlal No. 0~73~,426, T~IL ~ 5~1 P. 11- 11 2~ ~ 9 Fluid communScatlon bet~een the first tubes 16 and ~nfl~table cyl$nder 18 ~s establi~hed by sn openlng 28 loca~ed in the base portion 20, w$th stem 30 pro~dng a mean~ of ~ttachment for the tube 16. The pump 14 ls connected to the reservo~r ~2 by a ~econd tubo 3~, which l s contlnuou3 and without any ~onnectorY. ~he reservoir 32 1~ m~de from a flex~ble bag materlAl ~o that the vol~me of the reservoir 32 can lncrease and decrea~e aJ requlred. Whlle the re8exvolr 32 may have a port 36 which provlde3 polnt of entry for a needle tha~
can supply ~lu~ to the res~volr 32, the fllllng port for the ~y3tem 1~ el~ewhere, ~uch a~ fllllng port 44 ln the ~a~e portlon 20 of the ¢yllnder a~3embllo~, or ~ltornatively for ln~tance, rillin~ port 46 ln the pump hou~lng 38. (Typlcally both port8 wi11 not be u~ed on any one prosth¢31s, but could be lf deslred.) The fllling port ~s prefera~ly d~posed ln the ba~e portlon 20 ~ecau~e tha~ portlon i9 of sub~tantlal ssze and thlcknes~ already and not sub~ect to substantial flexlng tn use, so that a fl~llng port may be inte~ated into that regiOn in a manner that ~ 9 relatlvely u~dete~table by feel, thereby not eonstStuting a po3~ible source of irrltation or discom~ort. A9 w~ll be more fully descrlbed with respect to Fl~ures 6 and ~, the fllllng port can ha~e a rsi~ed or lowered ring ox other ~hape to ~unctlon a~ a bet~er target for the ~urgeon, though t~e preferred method of lmplantation of the present $nvention envision~ flnal fllling of the prosthe~i~ before lmplant~tion of the cyl~nder as~e~blSe~ when v~sibillty, etc. are at a maxlmum.
21~ ,Q~9 Of course the filling port may be provided with a needle guard for safety purposes, as is well known in the art, and may be of any of a variety of types which are well known in the art, including a compression port if desired.
S The pump 14 and valve assembly 42 are constructed so that fluid may be supplied to the cylinders 12 by squeezing and releasing the pump housing 38 one or more times. ~he valve $s constructed in the form of a release valve, as is known in the art, allowing fluid to return from the cylinder assemblies to the reservoir upon manual squeezing of the valve assembly 14.
The entire assembly is provided preassembled, purged of most air and partially filled with the intended working fluid.
The fluid is preferably isotonic, and may include but is not limited to a saline solution or PVP. The volume of fluid within the assembly 10 is such that most of the fluid may be forced into the cylinders, either by successive operation of the pump or by simultaneous squeezing of the reservoir and the valve assembly, so that the reservoir 32 will be sufficiently deflated to be inserted into the pelvic cavity of a patient. The volume of the prefill fluid will depend on the size of the reservoir, pump, cylinders and tubing utilized for the particular patient, though in general the volume of prefill fluid in the system may be from somewhat less t~an the fluid capacity of the pump, cylinders and tubing, to somewhat more than the fluid capacity of the pump, cylinders and tu~ing, as desired. In that regard, a reservoir which has some fluld therein will "hourglass" as it 2~ 9 is passed through a small opening, thereby limiting the deqree to which it must be emptied for convenient implantation. Thus the amount of prefill fluid is preferably limited on the upper end to an amount which does not encourage overstressing of the cylinders and pump to remove sufficient fluid from the reservoir to allow easy implantation thereof - perhaps 5 cc of fluid left in the reservoir still ma~ing the reservoir easily implantable.
On the lower end, it is desirable to have sufficient fluid in the system to displace the air while avoiding sharp wrinkles in an overly deflated system, and preferably to have sufficient fluid in the system to allow final filling by a single in~ection of fluid.
The prosthesis 10 is provided to the surgeon in the assem~led, partially filled condition shown and described above.
lS To install the assembly 10, an incision is made at the base of the penis next to the inquinal ring. The incision provides access to the pelvic cavity, scrotum and corpora cavernosa regions of the patient. The reservoir 32 is then substantially deflated by opening the valve 42 and squeezing the contents out of the reservoir, thereby forcing fluid within the reservoir 32 to flow into the rest of the assembly 10. After the reservoir 32 is substantially collapsed, the reservoir is lnserted into the pelvic cavlty.
After the reservoir 32 is implanted into the patient, a filling device, such as syringe 40 as shown in Figure 2, is used to fill the system to its operable volume, which, as is known ln 2~ ~9 the art, varies depending upon the size of the system and the particular patient. Typically about 40 to 75 cc of fluid is the standard operating volume. The filllng port can be almost anywhere in the system as described above, including the pump, S the tubing or the base of the cylinders, although it is preferably not in the inflatable part of the cylinders or the reservoir. As stated before, in the presently preferred embodiment, the injection port is in the base portion 20 of the cylinders 12, where material thickness is greater and mechanical cycling is lower than the other components of the assembly 10.
Once the assembly ls filled to the operating level of fluid, the syringe 40 i5 removed, the valve squeezed and a substantial part of the fluld allowed to pass back into the reservoir. As shown in Figure 3, the cylinders 12 and pump 14 lS are then implanted into the corpora cavernosa regions of the penis and the scrotum, respectively. The installation of the cylinders 12 and pump lg into these regions can be performed by surgical procedures known in the art. It will be appreciated, however, that utilizing the present invention for implantation, the steps of evacuating air from the system, and of reliably connecting the tubing together as was required in prior art three piece systems are eliminated.
As shown in Figures 4 and ~, cne present invention can be used to erect a male penis. The cylinder~ 12 are disposed within the corpus cavernosa of the penis and are shown in a deflated Qtate in Figure 4. The cylinders 12' are lnflated in 2 ~ Q 9 Figure 5. Conversely, the reservoir 32' is inflated in Figure 4 and reservoir 32 is deflated in Figure 5.
Now referrinq to Figure 6, a cross section of the base portion 20 of a cylinder illustratinq the details of injection port 44 of Figures 1 through 3 may be seen. The body of base portion is a flexible material, typically a silicon rubber, molded as a single piece, with the injection port location being circumscribed by a ring or raised portion 48 to help the surgeon better locate and confine the location of the tip of the injection needle. Disposed therein is a relatively rigid, substantially conical member 50 having an inward projecting lip 52 at the larger end thereof. A conical slug of soft and flexible silicon rubber 59 is disposed in the end of the conlcal member 50, and is retained therein under compression by another substantially rigid, hollow conical member 56 slotted from the larger end thereof so as to have sufficient flexibility to pass under lip 52 for assembly purposes, to snap back and to be retained thereby to retain the conical slug of soft and flexible silicon rubber 54 under compression. In this way, the thin end of the body of base portion 20 and the conical slug of soft and flexible silicon rubber 54 may be easily pierced by a needle for in~ection of working fluid into the prosthesis, with the resulting opening in the conical sluq of soft and flexible silicon rubber 54 immed~ately resealing upon withdrawal of the needle.
2~
Now referring to Figure 7, a cross section of the pump 14 illustrating the details of one possi~le design of an injection port 46 on the pump 14 of Figures 1 through ~ may be seen. In this injection site, a substantially rigid cup 58 having an S opening on the side thereof for fluid communication with the internal parts of the pump is presseed into the flexible body of the pump, and retains a slug of soft and flexible silicon rubber 60 under compression, again to immediately reseal upon withdrawal of the needle. In this injection site, the cup bottom forms a readily detectable stop for the needle, facilitating appropriate placement of the needle before injection.
In the foregoing embodiment, the prosthesis is purged of at least most air and partially prefilled at the t~me of lS manufacture~ thereby relieving the surgeon of the same rather mechanical tasks at the time of implantation and allowing the same to be done under the less costly and more easily and uniformly controlled factory conditions. However, there are still substantial advantages to be gained by providing to the surgeon a preassembled but not partially prefilled prosthesis, as such a preassembled unit will still eliminate the time required to cut the tubes to length, to assemble connectorQ, etc., and will more readily facilitate the pursing of air from the system, primarily by what is now the simultaneous purging of 2S all "pieces" and the elimination of the opportunity for reintroduction of alr into the system as in the prior art when ~ s ~ 9 the tubes to the multiple pieces are opened for connection together. Such a nonprefilled assembly also eliminates the possibility of eventual connector failure, a substantial advantage in itself.
While certain exemplary embodiments have been described in detail and one exemplary embodi~.ent shown in the accompanying drawings, it is to be understood that such embodiments are merely illustrative of and not restrictive on the broad invention, and that this invention not be limited to the specific constructions and arrangements shown and described, since various other modificat$ons may occur to those skilled in the art.
Claims (32)
1. An inflatable penile prosthesis which can be implanted into a pelvic cavity, scrotum and penis of a patient, comprising:
at least one inflatable cylinder;
a flexible reservoir adapted to supply fluid to said cylinder;
a pump constructed to transfer fluid from said reservoir to said cylinder;
first connecting means connecting said pump and said reservoir;
second connecting means connecting said pump and said inflatable cylinder;
a fluid within said cylinder, said pump and said reservoir, said fluid having a volume that allows said reservoir to be inserted into the pelvic cavity of the patient while said pump and said cylinder are attached to said reservoir, wherein said cylinder, said reservoir, said pump and said first and second connecting means are provided interconnected.
at least one inflatable cylinder;
a flexible reservoir adapted to supply fluid to said cylinder;
a pump constructed to transfer fluid from said reservoir to said cylinder;
first connecting means connecting said pump and said reservoir;
second connecting means connecting said pump and said inflatable cylinder;
a fluid within said cylinder, said pump and said reservoir, said fluid having a volume that allows said reservoir to be inserted into the pelvic cavity of the patient while said pump and said cylinder are attached to said reservoir, wherein said cylinder, said reservoir, said pump and said first and second connecting means are provided interconnected.
2. The prosthesis as recited in claim 1, wherein said penile prosthesis has a port that allows fluid to be injected therein cylinder to increase said fluid volume of said penile prosthesis to an operating volume.
3. The prosthesis as recited in claim 2, wherein said port is disposed in said inflatable cylinder.
4. The prosthesis as recited in claim 1, wherein there are two cylinders.
5. The prosthesis as recited in claim 1, wherein said cylinder has a substantially rigid base portion and an inflatable portion.
6. The prosthesis as recited in claim 5, wherein said base portion further comprises a port that allows fluid to be injected therein cylinder to increase said fluid volume of said penile prosthesis to an operating volume.
7. The prosthesis as recited in claim 1, wherein said penile prosthesis contains only as much fluid as can be retained in said inflatable cylinder, said pump and said connecting means.
8. An inflatable penile prosthesis which can be implanted into a pelvic cavity, scrotum and a penis of a patient, comprising a unitary preassembled assembly comprising:
two inflatable cylinders;
a flexible reservoir adapted to supply fluid to said cylinders;
a pump connected to said cylinders by a pair of first tubes and connected to said reservoir by a second tube, said pump being constructed to transfer fluid from said reservoir to said cylinders; and, a fluid within said cylinders, said tubes, said pump and said reservoir, said fluid having a volume that allows said reservoir to be inserted into the pelvic cavity of the patient while said pump, said tubes and said cylinders are attached to said reservoir.
two inflatable cylinders;
a flexible reservoir adapted to supply fluid to said cylinders;
a pump connected to said cylinders by a pair of first tubes and connected to said reservoir by a second tube, said pump being constructed to transfer fluid from said reservoir to said cylinders; and, a fluid within said cylinders, said tubes, said pump and said reservoir, said fluid having a volume that allows said reservoir to be inserted into the pelvic cavity of the patient while said pump, said tubes and said cylinders are attached to said reservoir.
9. The prosthesis as recited in claim 8, wherein said cylinders have a port that allows fluid to be injected therein to increase said fluid volume of said cylinders, said pump and said reservoir to an operating volume.
10. The prosthesis as recited in claim 8, wherein said pump has a port that allows fluid to be injected into said pump to increase said fluid volume of said cylinder, said pump, said tubes and said reservoir to an operating volume.
11. The prosthesis as recited in claim 8, wherein said cylinders have a substantially rigid base portion and an inflatable portion
12. A method of implanting an inflatable penile prosthesis which can erect a penis of a patient having a pelvic cavity and a scrotum, comprising the steps of:
providing a preassembled prosthesis assembly that includes:
at least one inflatable cylinder;
a flexible reservoir adapted to supply fluid to said cylinder;
a pump connected to said cylinder and said reservoir, said pump being constructed to transfer fluid from said reservoir to said cylinder;
a fluid within said cylinder, said pump and said reservoir, said fluid having a volume that allows said reservoir to be inserted into the pelvic cavity of the patient while said pump and said cylinders are attached to said reservoir;
inserting said reservoir into the pelvic cavity of the patient;
filling said prosthesis assembly with fluid such that said prosthesis assembly has an operating volume of fluid; and implanting said cylinder into the penis and said pump into the scrotum of the patient.
providing a preassembled prosthesis assembly that includes:
at least one inflatable cylinder;
a flexible reservoir adapted to supply fluid to said cylinder;
a pump connected to said cylinder and said reservoir, said pump being constructed to transfer fluid from said reservoir to said cylinder;
a fluid within said cylinder, said pump and said reservoir, said fluid having a volume that allows said reservoir to be inserted into the pelvic cavity of the patient while said pump and said cylinders are attached to said reservoir;
inserting said reservoir into the pelvic cavity of the patient;
filling said prosthesis assembly with fluid such that said prosthesis assembly has an operating volume of fluid; and implanting said cylinder into the penis and said pump into the scrotum of the patient.
13. The method as recited in claim 12, wherein said prosthesis is filled through a filling port disposed in said penile prosthesis.
14. The method as recited in claim 12, wherein said filling port is disposed in said cylinder.
15. The method as recited in claim 12, wherein there are two cylinders each installed into the penis.
16. The method as recited in claim 14, wherein said fluid is injected into said pump.
17. The method as recited in claim 12, further comprising the step of deflating said reservoir before said reservoir is inserted into the pelvic cavity of the patient.
18. A method of implanting an inflatable penile prosthesis which can erect a male penis of a patient having a pelvic cavity and a scrotum, comprising the steps of:
providing a preassembled prosthesis assembly that includes:
two cylinders;
a flexible reservoir adapted to supply fluid to said cylinders;
a pump connected to said cylinders by a pair of first tubes and connected to said reservoir by a second tube, said pump being constructed to transfer fluid from said pump to said cylinders;
a fluid within said cylinders, said tubes, said pump and said reservoir, said fluid having a volume that allows said reservoir to be inserted into the pelvic cavity of the patient while said pump and said cylinders are attached to said reservoir;
inserting said reservoir into the pelvic cavity of the patient;
injecting said prosthesis assembly with fluid such that said prosthesis assembly has an operating volume of fluid; and, implanting said cylinders into the penis and said pump into the scrotum of the patient.
providing a preassembled prosthesis assembly that includes:
two cylinders;
a flexible reservoir adapted to supply fluid to said cylinders;
a pump connected to said cylinders by a pair of first tubes and connected to said reservoir by a second tube, said pump being constructed to transfer fluid from said pump to said cylinders;
a fluid within said cylinders, said tubes, said pump and said reservoir, said fluid having a volume that allows said reservoir to be inserted into the pelvic cavity of the patient while said pump and said cylinders are attached to said reservoir;
inserting said reservoir into the pelvic cavity of the patient;
injecting said prosthesis assembly with fluid such that said prosthesis assembly has an operating volume of fluid; and, implanting said cylinders into the penis and said pump into the scrotum of the patient.
19. The method as recited in claim 18, wherein said cylinders have a port that allows said fluid to be injected into said cylinders.
20. The method as recited in claim 18, further comprising the step of deflating said reservoir before said reservoir is inserted into the pelvic cavity of the patient by transferring said fluid from said reservoir to said cylinders and said pump.
21. A partially fluid filled, pre-packaged, pre-assembled three piece penile prosthesis which requires no assembly, comprising:
a penile implant package containing:
at least one inflatable cylinder;
a flexible reservoir adapted to supply fluid to said cylinder;
a pump connected to said cylinder and said reservoir, said pump being constructed to transfer fluid from said reservoir to said cylinder, and, a fluid within said cylinder, said pump and said reservoir, said fluid having a volume that allows said reservoir to be inserted into the pelvic cavity of the patient while said pump and said cylinder are attached to said reservoir;
whereby implantation of said prosthesis can be achieved by a surgeon without having to connect any of said cylinder , said reservoir and said pump together.
a penile implant package containing:
at least one inflatable cylinder;
a flexible reservoir adapted to supply fluid to said cylinder;
a pump connected to said cylinder and said reservoir, said pump being constructed to transfer fluid from said reservoir to said cylinder, and, a fluid within said cylinder, said pump and said reservoir, said fluid having a volume that allows said reservoir to be inserted into the pelvic cavity of the patient while said pump and said cylinder are attached to said reservoir;
whereby implantation of said prosthesis can be achieved by a surgeon without having to connect any of said cylinder , said reservoir and said pump together.
22. An inflatable penile prosthesis which can be implanted into a pelvic cavity, scrotum and penis of a patient, comprising:
at least one inflatable cylinder;
a flexible reservoir adapted to supply fluid to said cylinder;
a pump constructed to transfer fluid from said reservoir to said cylinder;
first connecting means connecting said pump and said reservoir; and second connecting means connecting said pump and said inflatable cylinder;
wherein said cylinder, said reservoir, said pump and said first and second connecting means are provided interconnected and are free of any connectors for interconnection thereof.
at least one inflatable cylinder;
a flexible reservoir adapted to supply fluid to said cylinder;
a pump constructed to transfer fluid from said reservoir to said cylinder;
first connecting means connecting said pump and said reservoir; and second connecting means connecting said pump and said inflatable cylinder;
wherein said cylinder, said reservoir, said pump and said first and second connecting means are provided interconnected and are free of any connectors for interconnection thereof.
23. The prosthesis as recited in claim 22, wherein said penile prosthesis has a port that allows fluid to be injected therein to increase said fluid volume of said penile prosthesis to an operating volume.
24. The prosthesis as recited in claim 23, wherein said port is disposed in said inflatable cylinder.
25. The prosthesis as recited in claim 23, wherein said cylinder has a substantially rigid base portion and an inflatable portion, and said port is disposed in said rigid base portion.
26. The prosthesis as recited in claim 23, wherein said port is disposed in said pump.
27. An inflatable penile prosthesis which can be implanted into a pelvic cavity, scrotum and a penis of a patient, comprising a unitary preassembled assembly comprising:
two inflatable cylinders;
a flexible reservoir adapted to supply fluid to said cylinders;
a pump connected to said cylinders by a pair of first tubes and connected to said reservoir by a second tube, said pump being constructed to transfer fluid from said reservoir to said cylinders; and a filling port disposed in said prosthesis that allows fluid to be injected therein to provide said fluid volume to fill said cylinders, said pump and said reservoir to an operating volume; and wherein said cylinders, said reservoir, said pump and said first and second tubes are provided interconnected and are free of any connectors for interconnection thereof.
two inflatable cylinders;
a flexible reservoir adapted to supply fluid to said cylinders;
a pump connected to said cylinders by a pair of first tubes and connected to said reservoir by a second tube, said pump being constructed to transfer fluid from said reservoir to said cylinders; and a filling port disposed in said prosthesis that allows fluid to be injected therein to provide said fluid volume to fill said cylinders, said pump and said reservoir to an operating volume; and wherein said cylinders, said reservoir, said pump and said first and second tubes are provided interconnected and are free of any connectors for interconnection thereof.
28. The prosthesis as recited in claim 27, wherein said cylinders have a substantially rigid base portion and an inflatable portion, and said port is disposed in said base portion.
29. A method of implanting an inflatable penile prosthesis which can erect a penis of a patient having a pelvic cavity and a scrotum, comprising the steps of:
providing a preassembled, interconnected prosthesis assembly that includes:
at least one inflatable cylinder;
a flexible reservoir adapted to supply fluid to said cylinder;
a pump connected to said cylinder and said reservoir, said pump being constructed to transfer fluid from said reservoir to said cylinder; and a filling port disposed in said prosthesis assembly that allows fluid to be injected therein to provide said fluid volume to fill said cylinders, said pump and said reservoir to an operating volume;
inserting said reservoir into the pelvic cavity of the patient;
filling said prosthesis assembly through said filling port with fluid such that said prosthesis assembly has an operating volume of fluid; and implanting said cylinder into the penis and said pump into the scrotum of the patient.
providing a preassembled, interconnected prosthesis assembly that includes:
at least one inflatable cylinder;
a flexible reservoir adapted to supply fluid to said cylinder;
a pump connected to said cylinder and said reservoir, said pump being constructed to transfer fluid from said reservoir to said cylinder; and a filling port disposed in said prosthesis assembly that allows fluid to be injected therein to provide said fluid volume to fill said cylinders, said pump and said reservoir to an operating volume;
inserting said reservoir into the pelvic cavity of the patient;
filling said prosthesis assembly through said filling port with fluid such that said prosthesis assembly has an operating volume of fluid; and implanting said cylinder into the penis and said pump into the scrotum of the patient.
30. The method as recited in claim 29, wherein said filling port is disposed in said cylinder.
31. The method as recited in claim 29, wherein said filling port is disposed in said pump.
32. The method as recited in claim 29, wherein there are two cylinders each installed into the penis.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/758,738 US5250020A (en) | 1991-09-12 | 1991-09-12 | Unitary inflatable penile prosthesis |
| US758,738 | 1991-09-12 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2078099A1 true CA2078099A1 (en) | 1993-03-13 |
Family
ID=25052905
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002078099A Abandoned CA2078099A1 (en) | 1991-09-12 | 1992-09-11 | Unitary inflatable penile prosthesis |
Country Status (3)
| Country | Link |
|---|---|
| US (1) | US5250020A (en) |
| EP (1) | EP0532162A1 (en) |
| CA (1) | CA2078099A1 (en) |
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-
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- 1992-09-11 CA CA002078099A patent/CA2078099A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| EP0532162A1 (en) | 1993-03-17 |
| US5250020A (en) | 1993-10-05 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |