CA1317844C - Infusion stent system - Google Patents
Infusion stent systemInfo
- Publication number
- CA1317844C CA1317844C CA000604149A CA604149A CA1317844C CA 1317844 C CA1317844 C CA 1317844C CA 000604149 A CA000604149 A CA 000604149A CA 604149 A CA604149 A CA 604149A CA 1317844 C CA1317844 C CA 1317844C
- Authority
- CA
- Canada
- Prior art keywords
- stent
- guide tube
- tube member
- infusion
- proximal end
- 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.)
- Expired - Fee Related
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
- A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
- A61M27/008—Implant devices for drainage of body fluids from one part of the body to another pre-shaped, for use in the urethral or ureteral tract
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
Abstract
ABSTRACT OF THE DISCLOSURE
The infusion stent system includes a stent member having a plurality of openings provided in the wall of the stent along the entire length of the stent. An imperforate open ended guide tube member used for installation and infusion of the stent accommodates a core member that stiffens the guide tube member. The core member is relatively moveable in the guide tube member to provide selective flexibility at a proximal end of the guide tube member. The stent is position in the renal cavity, the ureter and bladder by being pushed along the guide tube member by a push catheter. Fluid is infused through a proximal end of the guide tube member when the core member is removed. The proximal end of the guide tube member can be located at any selected position within the stent. Thus fluid can be infused to any selected location in the stent by positioning the proximal end of the guide tube member at a desired location in the stent. Openings in the stent that are bypassed by the guide tube member are not infused with fluid.
The infusion stent system includes a stent member having a plurality of openings provided in the wall of the stent along the entire length of the stent. An imperforate open ended guide tube member used for installation and infusion of the stent accommodates a core member that stiffens the guide tube member. The core member is relatively moveable in the guide tube member to provide selective flexibility at a proximal end of the guide tube member. The stent is position in the renal cavity, the ureter and bladder by being pushed along the guide tube member by a push catheter. Fluid is infused through a proximal end of the guide tube member when the core member is removed. The proximal end of the guide tube member can be located at any selected position within the stent. Thus fluid can be infused to any selected location in the stent by positioning the proximal end of the guide tube member at a desired location in the stent. Openings in the stent that are bypassed by the guide tube member are not infused with fluid.
Description
- 1317~4~
I~FDsT~N S~F~T 5~STR~
p~C~GRO~D O~ T~_IW 2~TIQ~ .
This invention relates to ureteral ~tlents, and more particularly to a novel infusion ~tent Bystem that permits infusion of fluid at any ~elected locatio~ ih the stent.
Ureteral stents have long been u~ed for such purposes as draining fluid fro~ the renal pelvi ~o the bladder, and for providing support to a collapsed or restr~cted ur~ter.
~ Ureteral stents may also be used in conjunction with extracorporeal shock wave lithotropsy (ESWL), a procedure for pulverizing kidney stones without surgery. During ESWL, a device known as a lithotripter emits high frequency electrohydraulic vaves that destroy the kidney stones. The 15 waves are administered to a patient submerged in a bath of ~ater. ~lectrodes are attached to brass disk behind the patient and~when the l$thotripter is activated, up to 1500 electrohydraulic waves travel ~hrough the wa~er to Grush the ~tone ~o infiniteslmal fr~gment6 that ~he patient c~n then 20 pass naturally~ ~he n~tur~l pas~1ng of the stone i8 faclli~ated w~th a aten'c.
One known stent used in ESWL procedures, designated the Rwart ~:etro-Inject Stent manufactured by Cook l:lrolQgical of Spencer, Indiana, and iden'cified by Model Nos. 003600 and ' 1 3 1 7~44 003700, includes a sy~tem comprising a sten~ a solid core wire guide, an inserter and a release sleeve. The stent is normally coiled or looped at opposite ends and includes perforations along the length of the stent.
In using the Rwart Retro-lnject Stent Set, the wire quide is positioned in the patient and the atent is pu~hed on the wire guide into the renal cavity by the inserter.
The inserter is pushed into the stent a distance of approximately 5 mm thus forming a tubular extension of the stent.
~ fter the stent is positioned in the patien~, the wire guide is removed to allow the ~tent coils or loop to re-form in the renal pelvis. Fluid is injected through the inserter and into the stent during an ESWL procedure to disclose ~tones or stone ragments for targeting. The stent can also be left in place for intern~1 drainage.
One of the problems with the Rwart Retro-Inject ~tent ~ystem is that infusion of fluid through the in~erter cannot be ~pecifically directed outwardly of ~he ~tent at any selected portion of the ~tent. Fluid i~ iniected into one end of the 6tent through the in~erter~ The ~njected fluid traver~e~ t~e stent exiting throu~h any or all of the openings in the stent.
Another known stent set manufactured by Cook ~rological under the designation Wegenke ~xchange/Retrograde . I t-1 31 7~
~reteral Stent 5et Model No. 0046, ia also unable to direct fluid ~o any ~elected part of the s~ent. Fluid injected into one end of the stent traverse~ the stent to whatever openings are provided therein.
S Still another known stent set made by Van-Tec of Spencerf Indiana, under Model No~ SI1726l also re~uires injeetion of fluid through one end of the stent for passage within the stent to any available openings in the stent or an open end of the stent. Since fluid can only be injected through an end of the stent, fluid infuæion cannot be focused outwardly of the stent at any one location in the stent if opening~ are distributed along ~he length of the ~tent.
It ~s thus desirable to provide an infusion stent ~ystem which can be used to infuse fluid at any selected location in a stent and which also has optimal drainage capability when the tent is left as an indwellinq member.
OB~IEK:TS A~ S~RY 0~ laTIQI i Among the ~ever~l o~jects of 'the invention may be noted the provision of a novel infusion ~ent ~y8tem, a novel infusion ~e~t syst m which permits fluid to be infu ed into the stent at ~ny se~ected location in the ~tent, a novel infusion stent 8y~tem which permit~ fluid to be infused outwardly of a stent at ~elected locations in the 1 3 1 7~44 stent and also permits maximum drainage of fluid into the stent when the stent i~ left as an indwelling member, a novel infu~ion 6tent system which include~ an adjustable bypass member that bypasses opening~ in the stent to direct outward infusion of fluid from the stent beyond uch bypassed openings, and a no~el method of infu~ing fluid in the renal cavity.
Other objects and features of the invention will be in part apparent and in part pointed out hereinafter.
In accordance with the pre~ent invention, the infusion stent system includes a flexible sten~ member having a main body portion with a normally curved proximal end portion and a normally looped distal end portion.
Openings can be provided in the wall of the stent along the :15 entire lengt~ thereof includins the main body portion and the proximal and distal end por~ions.
The ~ystem further includes a hollow, fle~ible guide tube member open at oppo~ite ends and having an imperforate ; ~11. The stent ~ember i8 sized to be drawn over the guide 20 tube ~aember for relative ~lidable move~Dent be~ween the stent member and the ~de tube me~er.
A flexible core member i5 slidably received in the guide tube member- to ~tiffen the guide tube member. The core member has an enlarged portion at one end to limit insertion in the guide tube member and a terminal portion at the opposite end. The terminal portion has a reduced cross-section relative to the cross-section of a main body portivn of the core member. A free end of the core member ad~ace~t the terminal portion ha~ an enlargement that i~ of greater ~agnitude in cross-section than the terminal portion but of le ser magnitu~e in cros~-section than the main body portion.
The core member can be selectively retracted from the guide tube member to provide varying degrees of flexibility of the guide tube member at a proximal end portion thereof.
The infusion stent system further includes a push catheter member that i~ also drawn onto the guide tube member for relative slidable movement between the push catheter member and the guide tube member.
Location of the infusion stent ~ystem in a patient ~ usually begins wi~h full enga~e~ent of ~he core ~ember in ; the guide tube member. The stent member is dra~n onto the guide tube membe~ af ter the core member has been pos~tioned in the guide tube member.
The fle~ibility of the core member and the guide tube member are ~elected ~o ~s to enable the normally curled proximal end portion and the normally coiled distal end portion of the sten~ to ~ubs~ntial ly straig~ten when drawn onto the guide tube member and core member combination.
It should be noted that the guide tube member by 1 31 7~4 itself is too flexible to ~traighten the curled proximal end and coiled distal end portions of the stent member. Thus ~hen -the core member ls withdrawn from the guide tube member while the ~tent member is di~posed on the guide tube ~ember, the curled proximal end portion and the coiled distal end portion will tend to reform.
Before the ~tent member i~ positioned in the renal cavity, the ureter and the bladder, ~he guide tube member and core member are positioned therein. The ~tent member is urged along the guide tube member and core member combination into the bladder, the ureter and the renal cavity by movement of the push catheter along the guide tube ~ember against the distal end portion of the stent.
Once the stent member has been adequately positioned in the renal cavity, the ureter and the bladder, the core Dember can be removed from the suide tube member, enabling the curved proximal end portion and the coiled distal end portion of the ~tent member to reform in the renal cavity and the bladder. Remo~al of the core member opens an infusion channel through the guiae tube member into the ~tent.
If ~he proximal end of the guide tube member i5 located at t~e proxi~al end portion of t~e ~ent member, infusion can be directed into the renal cavity. Since the ~all of the yuide tube member is imperforate, openings in ;~ 25 the stent member that are bypassed by the proximal end of the guide tube member are generally not infused with fluid from the guide tube member.
The guide tube member can be retracted from thè
proximal end of the stent member toward ~he di.stal end of S the stent member to locate the proximal end o,E the guide tube member in any ~elected position relative to the ~tent member. Thus, location of the proximal end of the guide tube member in the main body portion of the stent will permit infusion of fluid in the ureter as well as the renal cavity. Location of the proximal end of the guide tube ~ember at the distal end of the stent will permit infusion to take place through openings provided along the entire-length of the stent~
When the infusion process is completed, the guide tube member can be removed from the stent member. The stent ~ember can then be left as an indwelling member and furnishes optimal drainage capability because of the provi ion of openings ~long ~he entire length of the ~tent~
Sut~r~s provided at a distal end of the stent member extend outwardly of a patient to permit non~urgical remova}
o the ~tent member when ~uch removal is desired.
The invention accordingly comprises the constructions and method hereinaf~er described, the ~cope of the invention being indicated in the claims.
~ 31 7~4 ~C91;~
In the accompanying drawings, - FIG. 1 is a ~implified schematic view of the infusion stent 8y tem in ~ patient;
.
S FIG. 2 i~ a simplified perpective view thereof;
FIG. 3 is a s1de view thereof prior to straightening of the sten~ ~eD~er;
FIG. 4 is a view similar ~o FIG. 3 after the stent ~ Dember has been straightened;
FIG. 5 is a ~impli~ied schematic view of a guide tube member and a core member thereof;
FIG. 6 is an enl2rged fragmentary detail, partly shown in section, of the guide tube member and core member thereof;
lS FIG. 7 iB an enlarged fragmentary sec~ional view thereof with the guide tube member and core ~ember po~itioned in the ~tent;
FI~. 8 i~ an enlarged fragmentary ~ectional view ~;~ thereof during infu~ion, with the core member removed therefromi FIG. 9 is an enlar~ed fragmentary vie~, partly shown in ~ection, o~ the p~imal end of the guide tube member and the core me=her thereof:
1 3 1 7~44 FIG~ 10 is a simplified schematic view thereof during initial installation in the renal cavi.ty, the ureter and the bladder;
FIG. 11 is a view similar to FIG. 10 with the core member partially retracted from the guide tube member;
and, FIG. 12 is a view similar to ~IGo 10 with the core member and guide tube member entirely removed from the stent member.
Corresponding reference characters indicate corresponding parts throughout the several views of the drawings.
~~TAIL~ D~SCRIPTIO~ OF T~ T~VENTIO~
An infusion ~tent system incorporating one embodiment of the invention is generally indicated by the reference number 10 in ~i~s. 1 and 2.
The ureteral tent ~y~tem 10 includes a stent member 12 having a normally curl-~haped proximal end portion 14, a normally loop-~haped di~tal end portion 16 and a elongated main body ~ection 18 intermediate the proximal and distal end portions 14 and 16.
The tent ~2, which is formed of a soft, flexible, biocompatible material ~uch as silicone, has a generally tubular wall 20 with an internal passageway or lumen 22. A
plurality of openings 24 are provided in the wall 20 at the proximal and di~tal end portion~ 14 and 16, and in the main body section 18. The proximal end portion 14 has a tapered or reduced free end 26 which i~ open a~ 28. The dis~al end portion 16 has a ~lightly flared free end 30 which i~ open ~t 32~ A suture 34 attached to the di~tal endl portion 16 extends from the opening 3~.
The system 10 further includes an elongated, hollow, open ended, flexible guide tube member 36 which the sten~
: ~ember 12 can slidably accommodate. Referring ~o Fig. 6, the guide tube me~ber 36 has an internal passageway or lumen 38 and an imperforate wall 40. The guide tube member 36 i~
preferably formed of a fluorinated polymer material such as Teflon, reinforced with atainle~s steel wire. Preferably, the ~tainless steel wire i~ a fla~, rectangular, Teflon coated wrap.
Referring to Fig. 8, ~he wire reinforcement 42 can be termina~ed before a proximal end 44 of the guide tube ~ember 36 enabling ~he proximal end ~4 to be slightly reduced as ~hown in Fig. 9. The guide tube ~ember al 80 includes an opposite dis~al end 4~.
A flexible, elongated core member 46, preferably formed of ~tai~e~s steel, ~ slidably insertable in the guide tube ~ember.36 and include~ a main body por~ion 48, an enlar~ed di~tal end portion 50 and a proximal end portion 52. The enlarged distal end portion 50 is sized to be nonreceivable in the guide tube member 36 to limit insertion of the core member 46 in the guide tube member 36.
The main body portion 48 has a substantially uniform cro~s-sectional magnitude ~hat per~its slidable reception in the guide tube member 36. The proximal end portion 52 of the core member 46 has a reduced terminal section 54 of lesser cros -sectional magnitude ~han the main body portion 48. An enlargement 56 formed at the free end of the proxi~al end portion 52 joins the terminal ~ection 54. The enlargement 56 i8 of greater cross-sectional magnitude than the terminal section 54 and substantially equivalent in cross-sectional magnitude to the main body portion 48. The terminal section 54 is progressively reduced toward the enlargement 56, a~ ~or e~ample by reduced æteps 58, 60 and 62, or by a continuous tapering toward the enlargement 56~
A flexible, tubular pu~h-ca~heter member 64, ~ormed of a suitable biocompatible polyethylene material, iB
~lidably accommodated on the guide tube ~ember 36. A8 ~hown in Figs. 7 and 8, ~ p~oximal end 66 of the catheter ~ember 64 i~ sized to butt agains~ ~he distal end 16 of ~he stent oember 12. Preferably the ~o~bined lenqth of the s~ent ~ember 12 and ~he push-catheter member 64 iQ les~ than the length of the guide tube member 36.
The precise dimension~ of the stent system 10 may vary ba5ed on the dimensional characteristics of particular pa~ients. Neverthele~s, to exemplify the ~agnltudes being dealt with, the outside diameter of the stent can range f~om 2.0 to 2.8 mm. The in~ide diameter of the stent can r~nge fro~ 1.3 to 1.8 mm. The length of the stent can range from 12 to 30 cm. The openln~s in the ~tent can be provided approximately every 2 cm. along the main body of the ten~
and have a diameter of approximately 1.3 mm. The proximal : and dictal end portions of the ~tent would al~o con~ain openings ~paced at approximately 0.8 cm. ~owever ~uch opening~ would be o~ a larger diameter such as 2.2 mm. The ~utures 34 can have a 75 cm. trail from the stent.
. The gui~e tube member 36 can have an outside diameter of approximately .965 mm. and an inside diameter of approximately .635 mm. The length of the guide tube member 36 can be approximately 148 cm.
The core ~ember 46 can have an overall length of appro~cima'cely 147.5 cm. fro~ the enlarged di~tal end portion 50 to the enlarge~ent 5S at the free end of the proximal end portion 52. The enlargement 50 c~n be appro~imately 44.5 mm. long with an out~ide diameter of appro~imately .965 mm.
The terminal ~ection 54 and enlarge~ent 56 can be approximately 10.2 cm. long wi~h the enlargement being approximately 1.22 m~. long and .457 mm. in diameter. ~he final core d~meter before the enlargement 56 i~
` 25 approximately .178 mm.
' 1 3 1 78ll ~
The pu~h ca~heter 64 can have an overall length of approximately 70 cm. with an in~ide diameter of approximately 1.2 mm. and an out~ide diameter of approximately 2.9 ~m, In using the stent sys~em 10 for fluid infu~ion, the core member 46 i8 inserted in the guide tube member 36 in the manner hown in Fig. 5. Thus, the enlarge~en~ 56 at the proximal free end of the core ~ember 4S i8 in~erted into the distal end 45 of tbe guide tube member 36 until the enlarged distal end portisn 50 of the core member 46 abut6 the dital end 45 of the guide tube member 36.
The guide tube member 36 and the core member 46 are sized such that the enlargement 56 at the proximal free end of the core member 46 does not project beyond ~he pro~imal end 44 of the guide tube member 36 when the enlarged distal end portion 50 of the core member 46 abuts the di~tal end 45 of the guide tube member 36. The desired relationship between the enlargement S6 dt the proximal ~ree end of the core ~ember 46 and the proximal end 44 o the guide tube ~ember 36, when t~e core member 46 i8 fully inserted in the guide tube member 36, i shown in Fig. 9.
~ he ~tent member 12 i8 drawn over the proximal end ~4 of the guide tube member 36 and core member 46 combination. Drawinq of the s~ent member 12 on the guide tube member 36-core member 46 combination ~erves ~o 2~ ~ubstantially ~traighten the normally curl-shaped proximal 1317~44 end portion 14 and the nvrmally loop-~haped di~tal end portion 16 of the stent 12 in the manner shown in Fig. 4.
The push catheter 64 i8 likeWiRe drawn onto the gu~de tube member 36 elther before or after the tent 12 iR
--5 in place on the guide tube member 36 to provilde the arrangement ~hown in Fig. 4.
A luer hub 68 of any ~ui~ab~e known structure such as a Touhy Borst luer lock i~ joined to the distal end 45 of the quide tube member in the manner ~hown in Fig. 7.
The stent member 12 and the push catheter 64 are ~lid along the guide tube member toward the luer hub 68 to expose a predetermined length of the guide tube member 36 tarting from the proximal end 44.
The ~uide tube ~ember 46 i8 then po~itioned in a patient usi~g known technique~ ~uc~ that the proximal end portion 44 of the guide ~u~e member 36 i~ located in the xenal cavity 70 ~Fig. 10). The remaining length of the guide tube member 36 extends through the ureter 72, the bladder 74 and externally of the patient.
I~ ~hould ~e no~ed that ~he negotiation or ioning of the guide tube ~ember 36 and core member 46 ¢ombination in ~:he renal c~vity 70, the ureter 72 and bladder 74 i8 facilitated by selectively retracting the core ~ember 46 from the guide tube member 36 predetermined 25 ~ amounts to enhance the flexibil ity of the proximal end 44 of 1317~44 the guide tube member 36. Thus, a selec~ive ahifting of the core member 46 within the guide tube member 36 by ~anipulation of the enlarged distal portion 5ID enables the proximal end portion of the guide tube member 36 to be 5 softened or ~tiffened ~8 needed to aid in nego'cia~ing ~ovement of ~he guide tube me~ber 36 and core member 46 combination through the ureter.
The reduced terminal section 54 of the core member 46 affords the gu~de tube ~ember 36 a greater flexibility at 10 the proximal end portion 44 than at the distal end portion ~5. The flexibility of the proximal end portion 44 of the guide tube member 36 is further enhanced by retracting the core member 46 from the proximal end 44 of the guide tube ~ember 36 to further aid in negotiating movement of the guide tube membe~ 3C through ~he ureter 72.
After the guide tube member 36 and core me~ber 46 combination h~ve been adequa~ely located in the renal cavity 70, the ureter 72 and ~he bladder 74, the atent member 12 .
can be po~itioned in the renal cavity 70, the ureter 72 and the bladder 74 by the pu~h catheter 64. In ac¢ordance ~ith known techniques, the pro~imal end 6C of the push catheter 64 is urged against the d~s~l end 16 of ~he s~ent member 12 for move~ent ~f the stent member 12 along the guide tube member 36 ~o the desired position in a pa~ient. The stent ~ember 12 retains a ~ubstantially straightened 1 31 7g~4 configuration, such a~ 2hown in Fig. ~0, during movement on the guide tube member 36.
: When the proximal end portion 1~ of the ~tent ~ember 12 i8 adequately located in ~he renal cavity 70, ~he core ~ember 46 can be withdrawn from the guide tube member 36 by ~aintaining the proximal end 66 of the push catheter 64 again~t the di~tal end 16 of the stent 12 and ~ithdrawing the core member 46. As the core member 46 i8 withdrawn, the normally curl-shaped proxima1 end portion 14 of the stent member 12 ~ub tantially reform~, overcoming any re~raint imposed by the presence of the guide tube member 36 in the stent member 1~
Complete withdrawal of the core member 46 from the guide tu~e member 36 enables the normally loop-~haped distal end portion 16 of the stent 12 to reform in the manner shown in Fig. ï2. The loo~æhaE~ed distal end portion 16 of the stent 12 ~ubstantially reform~ aya~nst any re~traints due to the : pre~ence of the gu~de tube member 36 ~n the ~tent me~ber 12.
Thu~ the gui~e tube m~ber 36 by ~t~elf iB
insufficient to maintain the proxi~al and di~tal end portions of t~e stent member 12 in a ~traightened condi~ion.
The pre~ence of the core member 46 in ghe guide tube member 36 provide~ the necessary restra~nt to ~$raighten the prox~mal and di~tal end portion 14 and 16 of the ~tent 12 during po~itioning in a patient.
1 3 1 78~4 During and after in~tallation of the s~ent 12 in a patient, the sutures 34 are directed alongside the push catheter 64 and extend outside the patient.
To infuse fluid to ~he stent 12, a ~yringe 76 or any o~her ~ui~able source of fluid ia connected to the luer hub 68. Fluid 1~ ~hus lnjec~ed through the lumen 38 of the guide tube member 36. Since the wall 40 of the guide tube member 36 iæ imperforate, any fluid infu~ed through the distal end 45 of the guide tube member 36 will exit through the proximal end 44 of the guide tube member 3~. Thus ~he location of ~he proximal end 44 of the guide tube member 36 in the ~tent 12 determines the point a~ which fluid will be distributed outwardly of the stent 12.
For example, if the proximal end 44 of the yuide tube member i located at the proxi~al end portion 14 of the ~ten 12 a~ ~hown in Fig. 8, the fluid infused through ~he guide tube member 36 ~ill dlqperse through the openlngs 24 in the sten~ that are located beyond the proxi~al end 44 of the guide tube me~er 36.
The opening~ 24 in the stent member 12 that are bypas~ed by the pr~xl~l end 44 oî the guide tube member 36 general ly do not disp~r~e flo~d infu~ed through the guide tube member 36.
The guide tube mer~ber 36 ~hus ~unctions a~ an infusion channel and an adju table bypas~ member.
Accordingly, the guide tube member 36 directs flu$d outwardly of the stent through openings beyond any ~elected location in the ~tent.
If it i~ de~ired to infuse fluid outwardly of the stent in an area atarting in the ureter, the guide tube member 36 i~ retrac~ed from the pro~imal end 1~ of the ~tent 12. Such retraction i8 accompli3hed by maintaining the proximal end 66 of the push catheter 64 again~t the distal end 16 of the stent 12 and withdrawing the guide tube member 36 a predetermined amount to po~ition the pro~imal end 44 of the guide tube member 36 at a selected location within the ~tent 12.
The positioning of the pYoximal end 44 of the guide tube member 36 at a ~elected relative po~ition within the stent 12 is accompli~hed using known monitoring techniques.
Since there i8 sufficient ~learance be'cween the stent 12 and guide tube memb~r 36, the relative adju~tment of the two c:omponent~ i8 ea~ily accompli~hed.
A~ the guide tube member 36 i~ r~tracted fro~ tbe proximal end 14 toward the distal end 16 of the sten~ 12, the openings 24 in the stent 12 that ~ere previou~ly bypas~ed by ~he quide tube member 36 become unob~tructed for purposes of f~uid infu~ion. Thus, if it i8 de~ired to inf~se fluid into the bladder 74 a well a~ the ureter 72 and the renal cavity 70, the proximal end 44 of the guide 1 3 1 7~4 tube member 36 can be located at the di~tal end 16 of the stent 12.
Since the openings 24 are provided in the ~tent 12 throughout the entire leng~h o~ the sten~, any fluid infused 5 at the di~tal end 16 of the stent 12 would tend to disperse through openings 24 starting ~t the di~tal end 16 of the stent 12.
When ~luid infusion i~ no longer desired in the s~ent 12 and there iR a need for the stent ~o perform a 10 drainage function, the guide tube member 36 can be completely removed from the patient by engaging the pu~h catheter 64 again~t the distal- end 16 of the stent while the guide tube member 36 i8 withdrawn. The Rtent 12 can thus be left as an indwelling member for drainage of fluid from the renal cavity 70 ~o the bladder 74. The openings 24 provided throughout the length of ~he stent 12 includin~ openings 24 provided in the proxi~al and di~tal end portions 14 and 16, optimize the drainage function of the ~tent 12.
When it i8 des~red to remov~ the sten~ 12 from the 20 patient, withdrawal i~ ea~ily acco~oplished by non~urgical techn~ques: using the sutureB 34 which extend outwardly of -the p~tient.
In ~ome instarlce~ it ~ay be desirable to infuse through a ~tent mem~er that has no perforation~ therein.
25 ~rhus infu~on with the guide tube member wil 1 enable 1uid 1317~44 to be directed into the ~tent member at any ~elected location.
Some advantage~ of the pre~ent lnven~ion evident from the foregoing de~cription include an infu~ion stent --5 ~ystem that directs fluid ~o any selected loca~ion within the fitent through a guide tube me~ber that is movable relative to the ~tent. The gulde tube member ha~ a ~ultiplicity of func~ions serving as a guide for po~itioning of the stent in a patient, an infusion channel for passage of fluid to the ~ent and an adjustable bypass member to selectively obstruct drainage openings in the stent when infusion is required.
Installation of the infusion ~tent ~ystem ~8 advantageously facilita~ed by use of a removable core member ~hat can be ~elec~ively located in the guide tube me~ber ~o selectively soften and ~tiffen the proximal tip of the guide ~tube ~ember and a~d in negotiation of tbe ureter during positioning of the stent. A further advantage of the infusion stent Bystem i8 that the stent can function a~ an indwelling drainage ~em~er af~er infusion i~ completed, and ~ill provide optimal drainage becau~e of the pre~ence of opening~ alon~ ~e e~tlre length of the tent.
I~ ~iew of the ~ove, ~ will be seen th~t the ~everal objects of the present invention are achieved and 25 ~ other advantageous re~ult~ at~ained.
1 ~ 1 7~4 A~ variou changes can ~e made ln the above constructions and method wi~hout ~eparting from the ~cope of the invention, it is intended ~hat all matter contained in the above description or shown in the aocompanying dr~w~n~s 5 shall be interpreted a illustrative and not in a limiting sen~e .
I~FDsT~N S~F~T 5~STR~
p~C~GRO~D O~ T~_IW 2~TIQ~ .
This invention relates to ureteral ~tlents, and more particularly to a novel infusion ~tent Bystem that permits infusion of fluid at any ~elected locatio~ ih the stent.
Ureteral stents have long been u~ed for such purposes as draining fluid fro~ the renal pelvi ~o the bladder, and for providing support to a collapsed or restr~cted ur~ter.
~ Ureteral stents may also be used in conjunction with extracorporeal shock wave lithotropsy (ESWL), a procedure for pulverizing kidney stones without surgery. During ESWL, a device known as a lithotripter emits high frequency electrohydraulic vaves that destroy the kidney stones. The 15 waves are administered to a patient submerged in a bath of ~ater. ~lectrodes are attached to brass disk behind the patient and~when the l$thotripter is activated, up to 1500 electrohydraulic waves travel ~hrough the wa~er to Grush the ~tone ~o infiniteslmal fr~gment6 that ~he patient c~n then 20 pass naturally~ ~he n~tur~l pas~1ng of the stone i8 faclli~ated w~th a aten'c.
One known stent used in ESWL procedures, designated the Rwart ~:etro-Inject Stent manufactured by Cook l:lrolQgical of Spencer, Indiana, and iden'cified by Model Nos. 003600 and ' 1 3 1 7~44 003700, includes a sy~tem comprising a sten~ a solid core wire guide, an inserter and a release sleeve. The stent is normally coiled or looped at opposite ends and includes perforations along the length of the stent.
In using the Rwart Retro-lnject Stent Set, the wire quide is positioned in the patient and the atent is pu~hed on the wire guide into the renal cavity by the inserter.
The inserter is pushed into the stent a distance of approximately 5 mm thus forming a tubular extension of the stent.
~ fter the stent is positioned in the patien~, the wire guide is removed to allow the ~tent coils or loop to re-form in the renal pelvis. Fluid is injected through the inserter and into the stent during an ESWL procedure to disclose ~tones or stone ragments for targeting. The stent can also be left in place for intern~1 drainage.
One of the problems with the Rwart Retro-Inject ~tent ~ystem is that infusion of fluid through the in~erter cannot be ~pecifically directed outwardly of ~he ~tent at any selected portion of the ~tent. Fluid i~ iniected into one end of the 6tent through the in~erter~ The ~njected fluid traver~e~ t~e stent exiting throu~h any or all of the openings in the stent.
Another known stent set manufactured by Cook ~rological under the designation Wegenke ~xchange/Retrograde . I t-1 31 7~
~reteral Stent 5et Model No. 0046, ia also unable to direct fluid ~o any ~elected part of the s~ent. Fluid injected into one end of the stent traverse~ the stent to whatever openings are provided therein.
S Still another known stent set made by Van-Tec of Spencerf Indiana, under Model No~ SI1726l also re~uires injeetion of fluid through one end of the stent for passage within the stent to any available openings in the stent or an open end of the stent. Since fluid can only be injected through an end of the stent, fluid infuæion cannot be focused outwardly of the stent at any one location in the stent if opening~ are distributed along ~he length of the ~tent.
It ~s thus desirable to provide an infusion stent ~ystem which can be used to infuse fluid at any selected location in a stent and which also has optimal drainage capability when the tent is left as an indwellinq member.
OB~IEK:TS A~ S~RY 0~ laTIQI i Among the ~ever~l o~jects of 'the invention may be noted the provision of a novel infusion ~ent ~y8tem, a novel infusion ~e~t syst m which permits fluid to be infu ed into the stent at ~ny se~ected location in the ~tent, a novel infusion stent 8y~tem which permit~ fluid to be infused outwardly of a stent at ~elected locations in the 1 3 1 7~44 stent and also permits maximum drainage of fluid into the stent when the stent i~ left as an indwelling member, a novel infu~ion 6tent system which include~ an adjustable bypass member that bypasses opening~ in the stent to direct outward infusion of fluid from the stent beyond uch bypassed openings, and a no~el method of infu~ing fluid in the renal cavity.
Other objects and features of the invention will be in part apparent and in part pointed out hereinafter.
In accordance with the pre~ent invention, the infusion stent system includes a flexible sten~ member having a main body portion with a normally curved proximal end portion and a normally looped distal end portion.
Openings can be provided in the wall of the stent along the :15 entire lengt~ thereof includins the main body portion and the proximal and distal end por~ions.
The ~ystem further includes a hollow, fle~ible guide tube member open at oppo~ite ends and having an imperforate ; ~11. The stent ~ember i8 sized to be drawn over the guide 20 tube ~aember for relative ~lidable move~Dent be~ween the stent member and the ~de tube me~er.
A flexible core member i5 slidably received in the guide tube member- to ~tiffen the guide tube member. The core member has an enlarged portion at one end to limit insertion in the guide tube member and a terminal portion at the opposite end. The terminal portion has a reduced cross-section relative to the cross-section of a main body portivn of the core member. A free end of the core member ad~ace~t the terminal portion ha~ an enlargement that i~ of greater ~agnitude in cross-section than the terminal portion but of le ser magnitu~e in cros~-section than the main body portion.
The core member can be selectively retracted from the guide tube member to provide varying degrees of flexibility of the guide tube member at a proximal end portion thereof.
The infusion stent system further includes a push catheter member that i~ also drawn onto the guide tube member for relative slidable movement between the push catheter member and the guide tube member.
Location of the infusion stent ~ystem in a patient ~ usually begins wi~h full enga~e~ent of ~he core ~ember in ; the guide tube member. The stent member is dra~n onto the guide tube membe~ af ter the core member has been pos~tioned in the guide tube member.
The fle~ibility of the core member and the guide tube member are ~elected ~o ~s to enable the normally curled proximal end portion and the normally coiled distal end portion of the sten~ to ~ubs~ntial ly straig~ten when drawn onto the guide tube member and core member combination.
It should be noted that the guide tube member by 1 31 7~4 itself is too flexible to ~traighten the curled proximal end and coiled distal end portions of the stent member. Thus ~hen -the core member ls withdrawn from the guide tube member while the ~tent member is di~posed on the guide tube ~ember, the curled proximal end portion and the coiled distal end portion will tend to reform.
Before the ~tent member i~ positioned in the renal cavity, the ureter and the bladder, ~he guide tube member and core member are positioned therein. The ~tent member is urged along the guide tube member and core member combination into the bladder, the ureter and the renal cavity by movement of the push catheter along the guide tube ~ember against the distal end portion of the stent.
Once the stent member has been adequately positioned in the renal cavity, the ureter and the bladder, the core Dember can be removed from the suide tube member, enabling the curved proximal end portion and the coiled distal end portion of the ~tent member to reform in the renal cavity and the bladder. Remo~al of the core member opens an infusion channel through the guiae tube member into the ~tent.
If ~he proximal end of the guide tube member i5 located at t~e proxi~al end portion of t~e ~ent member, infusion can be directed into the renal cavity. Since the ~all of the yuide tube member is imperforate, openings in ;~ 25 the stent member that are bypassed by the proximal end of the guide tube member are generally not infused with fluid from the guide tube member.
The guide tube member can be retracted from thè
proximal end of the stent member toward ~he di.stal end of S the stent member to locate the proximal end o,E the guide tube member in any ~elected position relative to the ~tent member. Thus, location of the proximal end of the guide tube member in the main body portion of the stent will permit infusion of fluid in the ureter as well as the renal cavity. Location of the proximal end of the guide tube ~ember at the distal end of the stent will permit infusion to take place through openings provided along the entire-length of the stent~
When the infusion process is completed, the guide tube member can be removed from the stent member. The stent ~ember can then be left as an indwelling member and furnishes optimal drainage capability because of the provi ion of openings ~long ~he entire length of the ~tent~
Sut~r~s provided at a distal end of the stent member extend outwardly of a patient to permit non~urgical remova}
o the ~tent member when ~uch removal is desired.
The invention accordingly comprises the constructions and method hereinaf~er described, the ~cope of the invention being indicated in the claims.
~ 31 7~4 ~C91;~
In the accompanying drawings, - FIG. 1 is a ~implified schematic view of the infusion stent 8y tem in ~ patient;
.
S FIG. 2 i~ a simplified perpective view thereof;
FIG. 3 is a s1de view thereof prior to straightening of the sten~ ~eD~er;
FIG. 4 is a view similar ~o FIG. 3 after the stent ~ Dember has been straightened;
FIG. 5 is a ~impli~ied schematic view of a guide tube member and a core member thereof;
FIG. 6 is an enl2rged fragmentary detail, partly shown in section, of the guide tube member and core member thereof;
lS FIG. 7 iB an enlarged fragmentary sec~ional view thereof with the guide tube member and core ~ember po~itioned in the ~tent;
FI~. 8 i~ an enlarged fragmentary ~ectional view ~;~ thereof during infu~ion, with the core member removed therefromi FIG. 9 is an enlar~ed fragmentary vie~, partly shown in ~ection, o~ the p~imal end of the guide tube member and the core me=her thereof:
1 3 1 7~44 FIG~ 10 is a simplified schematic view thereof during initial installation in the renal cavi.ty, the ureter and the bladder;
FIG. 11 is a view similar to FIG. 10 with the core member partially retracted from the guide tube member;
and, FIG. 12 is a view similar to ~IGo 10 with the core member and guide tube member entirely removed from the stent member.
Corresponding reference characters indicate corresponding parts throughout the several views of the drawings.
~~TAIL~ D~SCRIPTIO~ OF T~ T~VENTIO~
An infusion ~tent system incorporating one embodiment of the invention is generally indicated by the reference number 10 in ~i~s. 1 and 2.
The ureteral tent ~y~tem 10 includes a stent member 12 having a normally curl-~haped proximal end portion 14, a normally loop-~haped di~tal end portion 16 and a elongated main body ~ection 18 intermediate the proximal and distal end portions 14 and 16.
The tent ~2, which is formed of a soft, flexible, biocompatible material ~uch as silicone, has a generally tubular wall 20 with an internal passageway or lumen 22. A
plurality of openings 24 are provided in the wall 20 at the proximal and di~tal end portion~ 14 and 16, and in the main body section 18. The proximal end portion 14 has a tapered or reduced free end 26 which i~ open a~ 28. The dis~al end portion 16 has a ~lightly flared free end 30 which i~ open ~t 32~ A suture 34 attached to the di~tal endl portion 16 extends from the opening 3~.
The system 10 further includes an elongated, hollow, open ended, flexible guide tube member 36 which the sten~
: ~ember 12 can slidably accommodate. Referring ~o Fig. 6, the guide tube me~ber 36 has an internal passageway or lumen 38 and an imperforate wall 40. The guide tube member 36 i~
preferably formed of a fluorinated polymer material such as Teflon, reinforced with atainle~s steel wire. Preferably, the ~tainless steel wire i~ a fla~, rectangular, Teflon coated wrap.
Referring to Fig. 8, ~he wire reinforcement 42 can be termina~ed before a proximal end 44 of the guide tube ~ember 36 enabling ~he proximal end ~4 to be slightly reduced as ~hown in Fig. 9. The guide tube ~ember al 80 includes an opposite dis~al end 4~.
A flexible, elongated core member 46, preferably formed of ~tai~e~s steel, ~ slidably insertable in the guide tube ~ember.36 and include~ a main body por~ion 48, an enlar~ed di~tal end portion 50 and a proximal end portion 52. The enlarged distal end portion 50 is sized to be nonreceivable in the guide tube member 36 to limit insertion of the core member 46 in the guide tube member 36.
The main body portion 48 has a substantially uniform cro~s-sectional magnitude ~hat per~its slidable reception in the guide tube member 36. The proximal end portion 52 of the core member 46 has a reduced terminal section 54 of lesser cros -sectional magnitude ~han the main body portion 48. An enlargement 56 formed at the free end of the proxi~al end portion 52 joins the terminal ~ection 54. The enlargement 56 i8 of greater cross-sectional magnitude than the terminal section 54 and substantially equivalent in cross-sectional magnitude to the main body portion 48. The terminal section 54 is progressively reduced toward the enlargement 56, a~ ~or e~ample by reduced æteps 58, 60 and 62, or by a continuous tapering toward the enlargement 56~
A flexible, tubular pu~h-ca~heter member 64, ~ormed of a suitable biocompatible polyethylene material, iB
~lidably accommodated on the guide tube ~ember 36. A8 ~hown in Figs. 7 and 8, ~ p~oximal end 66 of the catheter ~ember 64 i~ sized to butt agains~ ~he distal end 16 of ~he stent oember 12. Preferably the ~o~bined lenqth of the s~ent ~ember 12 and ~he push-catheter member 64 iQ les~ than the length of the guide tube member 36.
The precise dimension~ of the stent system 10 may vary ba5ed on the dimensional characteristics of particular pa~ients. Neverthele~s, to exemplify the ~agnltudes being dealt with, the outside diameter of the stent can range f~om 2.0 to 2.8 mm. The in~ide diameter of the stent can r~nge fro~ 1.3 to 1.8 mm. The length of the stent can range from 12 to 30 cm. The openln~s in the ~tent can be provided approximately every 2 cm. along the main body of the ten~
and have a diameter of approximately 1.3 mm. The proximal : and dictal end portions of the ~tent would al~o con~ain openings ~paced at approximately 0.8 cm. ~owever ~uch opening~ would be o~ a larger diameter such as 2.2 mm. The ~utures 34 can have a 75 cm. trail from the stent.
. The gui~e tube member 36 can have an outside diameter of approximately .965 mm. and an inside diameter of approximately .635 mm. The length of the guide tube member 36 can be approximately 148 cm.
The core ~ember 46 can have an overall length of appro~cima'cely 147.5 cm. fro~ the enlarged di~tal end portion 50 to the enlarge~ent 5S at the free end of the proximal end portion 52. The enlargement 50 c~n be appro~imately 44.5 mm. long with an out~ide diameter of appro~imately .965 mm.
The terminal ~ection 54 and enlarge~ent 56 can be approximately 10.2 cm. long wi~h the enlargement being approximately 1.22 m~. long and .457 mm. in diameter. ~he final core d~meter before the enlargement 56 i~
` 25 approximately .178 mm.
' 1 3 1 78ll ~
The pu~h ca~heter 64 can have an overall length of approximately 70 cm. with an in~ide diameter of approximately 1.2 mm. and an out~ide diameter of approximately 2.9 ~m, In using the stent sys~em 10 for fluid infu~ion, the core member 46 i8 inserted in the guide tube member 36 in the manner hown in Fig. 5. Thus, the enlarge~en~ 56 at the proximal free end of the core ~ember 4S i8 in~erted into the distal end 45 of tbe guide tube member 36 until the enlarged distal end portisn 50 of the core member 46 abut6 the dital end 45 of the guide tube member 36.
The guide tube member 36 and the core member 46 are sized such that the enlargement 56 at the proximal free end of the core member 46 does not project beyond ~he pro~imal end 44 of the guide tube member 36 when the enlarged distal end portion 50 of the core member 46 abuts the di~tal end 45 of the guide tube member 36. The desired relationship between the enlargement S6 dt the proximal ~ree end of the core ~ember 46 and the proximal end 44 o the guide tube ~ember 36, when t~e core member 46 i8 fully inserted in the guide tube member 36, i shown in Fig. 9.
~ he ~tent member 12 i8 drawn over the proximal end ~4 of the guide tube member 36 and core member 46 combination. Drawinq of the s~ent member 12 on the guide tube member 36-core member 46 combination ~erves ~o 2~ ~ubstantially ~traighten the normally curl-shaped proximal 1317~44 end portion 14 and the nvrmally loop-~haped di~tal end portion 16 of the stent 12 in the manner shown in Fig. 4.
The push catheter 64 i8 likeWiRe drawn onto the gu~de tube member 36 elther before or after the tent 12 iR
--5 in place on the guide tube member 36 to provilde the arrangement ~hown in Fig. 4.
A luer hub 68 of any ~ui~ab~e known structure such as a Touhy Borst luer lock i~ joined to the distal end 45 of the quide tube member in the manner ~hown in Fig. 7.
The stent member 12 and the push catheter 64 are ~lid along the guide tube member toward the luer hub 68 to expose a predetermined length of the guide tube member 36 tarting from the proximal end 44.
The ~uide tube ~ember 46 i8 then po~itioned in a patient usi~g known technique~ ~uc~ that the proximal end portion 44 of the guide ~u~e member 36 i~ located in the xenal cavity 70 ~Fig. 10). The remaining length of the guide tube member 36 extends through the ureter 72, the bladder 74 and externally of the patient.
I~ ~hould ~e no~ed that ~he negotiation or ioning of the guide tube ~ember 36 and core member 46 ¢ombination in ~:he renal c~vity 70, the ureter 72 and bladder 74 i8 facilitated by selectively retracting the core ~ember 46 from the guide tube member 36 predetermined 25 ~ amounts to enhance the flexibil ity of the proximal end 44 of 1317~44 the guide tube member 36. Thus, a selec~ive ahifting of the core member 46 within the guide tube member 36 by ~anipulation of the enlarged distal portion 5ID enables the proximal end portion of the guide tube member 36 to be 5 softened or ~tiffened ~8 needed to aid in nego'cia~ing ~ovement of ~he guide tube me~ber 36 and core member 46 combination through the ureter.
The reduced terminal section 54 of the core member 46 affords the gu~de tube ~ember 36 a greater flexibility at 10 the proximal end portion 44 than at the distal end portion ~5. The flexibility of the proximal end portion 44 of the guide tube member 36 is further enhanced by retracting the core member 46 from the proximal end 44 of the guide tube ~ember 36 to further aid in negotiating movement of the guide tube membe~ 3C through ~he ureter 72.
After the guide tube member 36 and core me~ber 46 combination h~ve been adequa~ely located in the renal cavity 70, the ureter 72 and ~he bladder 74, the atent member 12 .
can be po~itioned in the renal cavity 70, the ureter 72 and the bladder 74 by the pu~h catheter 64. In ac¢ordance ~ith known techniques, the pro~imal end 6C of the push catheter 64 is urged against the d~s~l end 16 of ~he s~ent member 12 for move~ent ~f the stent member 12 along the guide tube member 36 ~o the desired position in a pa~ient. The stent ~ember 12 retains a ~ubstantially straightened 1 31 7g~4 configuration, such a~ 2hown in Fig. ~0, during movement on the guide tube member 36.
: When the proximal end portion 1~ of the ~tent ~ember 12 i8 adequately located in ~he renal cavity 70, ~he core ~ember 46 can be withdrawn from the guide tube member 36 by ~aintaining the proximal end 66 of the push catheter 64 again~t the di~tal end 16 of the stent 12 and ~ithdrawing the core member 46. As the core member 46 i8 withdrawn, the normally curl-shaped proxima1 end portion 14 of the stent member 12 ~ub tantially reform~, overcoming any re~raint imposed by the presence of the guide tube member 36 in the stent member 1~
Complete withdrawal of the core member 46 from the guide tu~e member 36 enables the normally loop-~haped distal end portion 16 of the stent 12 to reform in the manner shown in Fig. ï2. The loo~æhaE~ed distal end portion 16 of the stent 12 ~ubstantially reform~ aya~nst any re~traints due to the : pre~ence of the gu~de tube member 36 ~n the ~tent me~ber 12.
Thu~ the gui~e tube m~ber 36 by ~t~elf iB
insufficient to maintain the proxi~al and di~tal end portions of t~e stent member 12 in a ~traightened condi~ion.
The pre~ence of the core member 46 in ghe guide tube member 36 provide~ the necessary restra~nt to ~$raighten the prox~mal and di~tal end portion 14 and 16 of the ~tent 12 during po~itioning in a patient.
1 3 1 78~4 During and after in~tallation of the s~ent 12 in a patient, the sutures 34 are directed alongside the push catheter 64 and extend outside the patient.
To infuse fluid to ~he stent 12, a ~yringe 76 or any o~her ~ui~able source of fluid ia connected to the luer hub 68. Fluid 1~ ~hus lnjec~ed through the lumen 38 of the guide tube member 36. Since the wall 40 of the guide tube member 36 iæ imperforate, any fluid infu~ed through the distal end 45 of the guide tube member 36 will exit through the proximal end 44 of the guide tube member 3~. Thus ~he location of ~he proximal end 44 of the guide tube member 36 in the ~tent 12 determines the point a~ which fluid will be distributed outwardly of the stent 12.
For example, if the proximal end 44 of the yuide tube member i located at the proxi~al end portion 14 of the ~ten 12 a~ ~hown in Fig. 8, the fluid infused through ~he guide tube member 36 ~ill dlqperse through the openlngs 24 in the sten~ that are located beyond the proxi~al end 44 of the guide tube me~er 36.
The opening~ 24 in the stent member 12 that are bypas~ed by the pr~xl~l end 44 oî the guide tube member 36 general ly do not disp~r~e flo~d infu~ed through the guide tube member 36.
The guide tube mer~ber 36 ~hus ~unctions a~ an infusion channel and an adju table bypas~ member.
Accordingly, the guide tube member 36 directs flu$d outwardly of the stent through openings beyond any ~elected location in the ~tent.
If it i~ de~ired to infuse fluid outwardly of the stent in an area atarting in the ureter, the guide tube member 36 i~ retrac~ed from the pro~imal end 1~ of the ~tent 12. Such retraction i8 accompli3hed by maintaining the proximal end 66 of the push catheter 64 again~t the distal end 16 of the stent 12 and withdrawing the guide tube member 36 a predetermined amount to po~ition the pro~imal end 44 of the guide tube member 36 at a selected location within the ~tent 12.
The positioning of the pYoximal end 44 of the guide tube member 36 at a ~elected relative po~ition within the stent 12 is accompli~hed using known monitoring techniques.
Since there i8 sufficient ~learance be'cween the stent 12 and guide tube memb~r 36, the relative adju~tment of the two c:omponent~ i8 ea~ily accompli~hed.
A~ the guide tube member 36 i~ r~tracted fro~ tbe proximal end 14 toward the distal end 16 of the sten~ 12, the openings 24 in the stent 12 that ~ere previou~ly bypas~ed by ~he quide tube member 36 become unob~tructed for purposes of f~uid infu~ion. Thus, if it i8 de~ired to inf~se fluid into the bladder 74 a well a~ the ureter 72 and the renal cavity 70, the proximal end 44 of the guide 1 3 1 7~4 tube member 36 can be located at the di~tal end 16 of the stent 12.
Since the openings 24 are provided in the ~tent 12 throughout the entire leng~h o~ the sten~, any fluid infused 5 at the di~tal end 16 of the stent 12 would tend to disperse through openings 24 starting ~t the di~tal end 16 of the stent 12.
When ~luid infusion i~ no longer desired in the s~ent 12 and there iR a need for the stent ~o perform a 10 drainage function, the guide tube member 36 can be completely removed from the patient by engaging the pu~h catheter 64 again~t the distal- end 16 of the stent while the guide tube member 36 i8 withdrawn. The Rtent 12 can thus be left as an indwelling member for drainage of fluid from the renal cavity 70 ~o the bladder 74. The openings 24 provided throughout the length of ~he stent 12 includin~ openings 24 provided in the proxi~al and di~tal end portions 14 and 16, optimize the drainage function of the ~tent 12.
When it i8 des~red to remov~ the sten~ 12 from the 20 patient, withdrawal i~ ea~ily acco~oplished by non~urgical techn~ques: using the sutureB 34 which extend outwardly of -the p~tient.
In ~ome instarlce~ it ~ay be desirable to infuse through a ~tent mem~er that has no perforation~ therein.
25 ~rhus infu~on with the guide tube member wil 1 enable 1uid 1317~44 to be directed into the ~tent member at any ~elected location.
Some advantage~ of the pre~ent lnven~ion evident from the foregoing de~cription include an infu~ion stent --5 ~ystem that directs fluid ~o any selected loca~ion within the fitent through a guide tube me~ber that is movable relative to the ~tent. The gulde tube member ha~ a ~ultiplicity of func~ions serving as a guide for po~itioning of the stent in a patient, an infusion channel for passage of fluid to the ~ent and an adjustable bypass member to selectively obstruct drainage openings in the stent when infusion is required.
Installation of the infusion ~tent ~ystem ~8 advantageously facilita~ed by use of a removable core member ~hat can be ~elec~ively located in the guide tube me~ber ~o selectively soften and ~tiffen the proximal tip of the guide ~tube ~ember and a~d in negotiation of tbe ureter during positioning of the stent. A further advantage of the infusion stent Bystem i8 that the stent can function a~ an indwelling drainage ~em~er af~er infusion i~ completed, and ~ill provide optimal drainage becau~e of the pre~ence of opening~ alon~ ~e e~tlre length of the tent.
I~ ~iew of the ~ove, ~ will be seen th~t the ~everal objects of the present invention are achieved and 25 ~ other advantageous re~ult~ at~ained.
1 ~ 1 7~4 A~ variou changes can ~e made ln the above constructions and method wi~hout ~eparting from the ~cope of the invention, it is intended ~hat all matter contained in the above description or shown in the aocompanying dr~w~n~s 5 shall be interpreted a illustrative and not in a limiting sen~e .
Claims (19)
1. An infusion stent system comprising a. a flexible stent member of a first predetermined length, said stent member having a main body portion with a proximal end portion and a distal end portion, b. a hollow flexible guide tube member of a second predetermined length greater than said first predetermined length, said guide tube member being infusible with fluid and receivable in said stent member such that said stent member and said guide tube member are relatively slidable with respect to each other, said guide tube member having a proximal end that is positionable in said stent member at any selected location within said stent member, such that when the proximal end of said guide tube member is at any said selected location in said stent member infusion of fluid through said guide tube member is directed outwardly of said guide tube member at any said selected location in said stent member, said guide tube member being removable from said stent member.
2. The infusion stent system as claimed in claim 1 wherein said guide tube member is substantially imperforate.
3. The infusion stent system as claimed in claim 1 wherein said guide tube member is formed of a fluorinated polymer.
4. The infusion stent system as claimed in claim 3 wherein said guide tube member is formed with a wire reinforcement.
5. The infusion stent system as claimed in claim 1 including a flexible core member of a third predetermined length greater than said second predetermined length, said core member being sized for slidable reception in said guide tube member, said core member including insertion limiting means nonreceivable in said guide tube member to limit insertion of said core member in said guide tube member.
6. The infusion stent system as claimed in claim 5 wherein said flexible core member has a proximal free end positionable in said guide tube member at any selected location within said guide tube member, said flexible core member being removable from said guide tube member.
7. The infusion stent system as claimed in claim 6 wherein said flexible core member has a terminal section of predetermined extent up to the proximal free end of said core member and a first substantially uniform cross section between said insertion limiting means and said terminal section, said terminal section having a reduced cross-section with respect to said first substantially uniform cross-section.
8. The infusion stent system as claimed in claim 7 wherein the proximal free end of said core member has an enlargement with a cross-sectional magnitude that is greater than the cross-sectional magnitude of said terminal section and approximately equivalent to the cross-sectional magnitude of said first substantially uniform cross-section.
9. The infusion stent system as claimed in claim 7 wherein the terminal section of said flexible core member is tapered toward the proximal free end of said core member to a minimum tapered cross-section, the proximal free end of said core member having an enlargement with a cross-sectional magnitude that is greater than the cross-sectional magnitude of said minimum tapered cross-section and approximately equivalent to the cross-sectional magnitude of said first substantially uniform cross-section.
10. The infusion stent system as claimed in claim 5 wherein said stent member has normally curved proximal and distal end portions, and wherein the flexibility of said guide tube member and said core member are selected such that said curved proximal and distal end portions are substantially straightened when said stent member is disposed on said guide tube member with said core member engaged in said guide tube member, the flexibility of said guide tube member permitting said normally curved proximal and distal end portions of said stent member to re-form when said core member is disengaged from the guide tube member at the area of disposition of said stent member on said guide tube member.
11. The infusion stent system as claimed in claim 2 including a hollow, tubular, flexible, push catheter member of a fourth predetermined length, said fourth predetermined length being of lesser magnitude than said third predetermined length, said push catheter member being sized for slidable engagement on said guide tube member and having a wall thickness that interferes with the distal end portion of said stent member to permit said push catheter to abut said distal end portion of said stent member such that movement of said push catheter member against said stent member causes said stent member to move along said guide tube member.
12. The infusion stent system as claimed in claim 2 wherein said stent member has a plurality of openings along the length thereof such that when the proximal end of said guide tube member is at any said selected location in said stent member infusion of fluid through said guide tube member is directed outwardly of said stent member through openings in said stent member beyond said selected location.
13. The infusion stent system as claimed in claim 2 wherein said stent member has a plurality of openings along the length thereof and wherein the proximal end of said guide tube member is positionable at the proximal end of said stent member to bypass selected said openings in said stent member up to the proximal end portion of said stent member and permit infusion of fluid outwardly of said stent member substantially only at openings in the proximal end portion of said stent member that are not bypassed by said guide tube member.
14. The infusion stent system as claimed in claim 2 wherein said stent member has a plurality of openings along the length thereof and wherein the proximal end portion of said guide tube member is positionable in said stent member intermediate said proximal and distal end portions of said stent member to bypass openings in said tent member up to the location of the proximal end portion of said guide tube member and permit infusion of fluid outwardly of said stent member substantially only at openings in said stent member that are not bypassed by said guide tube member.
15. An infusion stent system comprising a. a flexible hollow imperforate guide tube member having a proximal end with an infusion opening;
b. a flexible hollow tent member slidable on said guide tube member;
c. a flexible hollow push catheter member slidable on said guide tube member for pushing said stent member along said guide tube member to a predetermined position in the renal cavity, ureter and bladder, said push catheter member being removeable from said guide tube member, and d. said hollow flexible guide tube member being moveable relative to said stent member when said stent member is in said predetermined position, such that the proximal end of said guide tube member is positionable at selected predetermined locations in said stent member to permit infusion of fluid outwardly of said guide tube member at said selected predetermined locations in said stent member.
b. a flexible hollow tent member slidable on said guide tube member;
c. a flexible hollow push catheter member slidable on said guide tube member for pushing said stent member along said guide tube member to a predetermined position in the renal cavity, ureter and bladder, said push catheter member being removeable from said guide tube member, and d. said hollow flexible guide tube member being moveable relative to said stent member when said stent member is in said predetermined position, such that the proximal end of said guide tube member is positionable at selected predetermined locations in said stent member to permit infusion of fluid outwardly of said guide tube member at said selected predetermined locations in said stent member.
16. The infusion stent system as claimed in claim 15 wherein said stent member includes a plurality of perforations, the proximal end of said guide tube member being positionable at said selected predetermined locations in said stent member to bypass selected perforations in said stent member and permit infusion of fluid outwardly of said stent member substantially only at perforations in said stent member that are not bypassed by said guide tube member.
17. The infusion stent system as claimed in claim 15 further including a flexible core member slidably engageable in said guide tube member to selective positions within said guide tube member up to the proximal end of said guide tube member.
18. The infusion stent system as claimed in claim 17 wherein said core member has a terminal section and a main body section, said terminal section having a lesser cross-sectional magnitude than the main body section.
19. The infusion stent system as claimed in claim 18 wherein said teminal section has a free end with an enlargement of greater cross-sectional magnitude than said terminal section and lesser cross-sectional magnitude than said main body section,
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/215,077 US4913683A (en) | 1988-07-05 | 1988-07-05 | Infusion stent system |
| US215,077 | 1988-07-05 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1317844C true CA1317844C (en) | 1993-05-18 |
Family
ID=22801546
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000604149A Expired - Fee Related CA1317844C (en) | 1988-07-05 | 1989-06-28 | Infusion stent system |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US4913683A (en) |
| JP (1) | JPH0271765A (en) |
| CA (1) | CA1317844C (en) |
| DE (1) | DE3922126A1 (en) |
| FR (1) | FR2633835B1 (en) |
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-
1988
- 1988-07-05 US US07/215,077 patent/US4913683A/en not_active Expired - Lifetime
-
1989
- 1989-06-28 CA CA000604149A patent/CA1317844C/en not_active Expired - Fee Related
- 1989-06-30 FR FR898908775A patent/FR2633835B1/en not_active Expired - Fee Related
- 1989-07-05 JP JP1172110A patent/JPH0271765A/en active Pending
- 1989-07-05 DE DE3922126A patent/DE3922126A1/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| FR2633835A1 (en) | 1990-01-12 |
| JPH0271765A (en) | 1990-03-12 |
| FR2633835B1 (en) | 1992-05-22 |
| US4913683A (en) | 1990-04-03 |
| DE3922126A1 (en) | 1990-01-11 |
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Legal Events
| Date | Code | Title | Description |
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| MKLA | Lapsed |