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
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes

Definitions

• Non- vascular stents and catheters are commonly used to promote drainage in various parts of the body.
• ureteral stents are used to create a pathway for urinary drainage from the kidney to the bladder in patients with ureteral obstruction or injury or to protect the integrity of the ureter in a variety of surgical manipulations.
• -ureteral stents particularly the portion positioned in the ureter and the bladder, may produce adverse effects including hemorrhage, a continual urge to urinate, flank pain accompanying reflux of urine back up the ureter due to retrograde pressure when voiding, and chronic trigone irritation.
• Attempts to mitigate some of these problems associated with ureteral stents include administering systemic pharmaceuticals such as anti-spasmodic drugs. However, it is difficult to deliver such agents to the desired areas of treatment with conventional devices.
• the present invention relates to ureteral stents and catheters that elute a flui d containing a therapeutic agent.
• the invention may be applied to other stents and catheter applications, in other parts of the body, such as urethral stent and biliary stents.
• a device for placement within a body of a patient includes an elongated member and an inflatable member coupled to the elongated member.
• the elongated member has a first end portion and a second end portion and defines a lumen.
• the inflatable member is coupled to the elongated member between the first end portion of the elongated member and the second end portion of the elongated member.
• the inflatable member is configured to be inflated with a fluid and is configured to deliver the fluid to the body of the patient when the device is placed within the body.
• Figure 1 is a perspective and partial cross-sectional view of a ureteral stent according to one embodiment of the invention.
• Figure 2 is an enlarged detail view of the bladder end of the ureteral stent illustrated in Figure 1.
• Figure 3 is an enlarged detail view of the renal end of the ureteral stent illustrated in Figure 1.
• Figure 4 is plan view of the ureteral stent illustrated in Figure 1 in a clinical application according to one embodiment of the invention.
• Figure 5 is a partial cross-sectional view of a ureteral stent according to another embodiment of the invention.
• Figure 6 is plan view of a ureteral catheter according to one embodiment of the invention, where the ureteral catheter includes the stent illustrated in Figure 1 and is illustrated in a clinical application.
• FIGS 1-4 illustrate a ureteral stent 10 in accordance with one embodiment of the present invention.
• the ureteral stent 10 is a drainage device that, when positioned within the ureter of a mammal, assists in reducing fluid retention by facilitating the drainage of urine from the kidney through the ureter and into the urinary bladder.
• the ureteral stent 10 is used to create a pathway for urinary drainage from the kidney to the bladder in patients with ureteral obstruction or injury or to protect the integrity of the ureter in a variety of surgical manipulations.
• the stent 10 may be used to address a number of clinical conditions that can produce interruption in urine flow including, for example, intrinsic obstruction of the ureter due to tumor growth, stricture or stones, compression of the ureter due to extrinsic tumor growth, stone fragment impactation in the ureter following extracorporeal shock wave lithotripsy (ESWL), and ureteral procedures such as ureteroscopy and endopyelotomy.
• the stent 10 may be used to treat or avoid obstructions of the ureter (such as ureteral stones or ureteral tumors) that disrupt the flow of urine from the corresponding kidney to the urinary bladder.
• the ureteral stent 10 may also be used after endoscopic inspection of the ureter.
• the stent 10 may be placed in the ureter to facilitate the flow of urine from the kidney to the bladder and to enable the ureter to heal.
• the stent 10 is configured for implantation within the ureter of a patient, and includes a proximal or bladder portion 12, a distal or renal portion 14, and an elongated body portion 16 between the proximal and distal portions.
• the stent 10 includes a drainage lumen 18 that extends the length of the stent to facilitate the drainage of urine from the kidney through the ureter and into the urinary bladder.
• the ureteral stent 10 is preferably tubular in shape, terminating in two opposing ends: a kidney distal end and a urinary bladder proximal end.
• the stent 10 may have one or more drainage holes arranged along the length of the body portion 16 that provide fluid communication between the outside surface of the stent and the drainage lumen 18.
• a suture loop or other suitable structure may be included on the bladder portion 12 to facilitate removal of the stent 10 from the body after use.
• the length of the elongated body portion 16 ranges between about 18 cm and 30 cm and has an outside diameter of at least about 1.6 mm to 3.3 mm, preferably 2 mm (or French size 6).
• the stent 10 includes a tubular member 20 that extends from the proximal portion 12 to the distal portion 14 and that defines the drainage lumen 18.
• the thickness of a wall 21 of the tubular member 20 is at least about 0.05 mm to 0.35 mm.
• the tubular member 20 may be formed from a number of different biocompatible materials.
• the tubular member 20 may consist of one of these materials or may be formed, for example by extrusion, of two or more materials along its length.
• the tubular member 20 may be constructed from an extruded polymeric tubing, such as PERCUFLEX (Boston Scientific Corporation, Natick, Mass.), C-FLEX (Xomed- Trease, Inc.), FLEXIMA, or other polymer material including polytetrafluoroethylene (FIFE), silicone polyurethane, polyurethane plastics, polyethylene plastics, and thermoplastics, for example.
• PERCUFLEX Boston Scientific Corporation, Natick, Mass.
• C-FLEX Xomed- Trease, Inc.
• FLEXIMA or other polymer material including polytetrafluoroethylene (FIFE), silicone polyurethane, polyurethane plastics, polyethylene plastics, and thermoplastics, for example.
• FIFE polytetrafluoroethylene
• Additional suitable polymers for the tubular member 20 may be selected, for example, from the following: polycarboxylic acid polymers and copolymers including polyacrylic acids; acetal polymers and copolymers; acrylate and methacrylate polymers and copolymers (e.g., n-butyl methacrylate); cellulosic polymers and copolymers, including cellulose acetates, cellulose nitrates, cellulose propionates, cellulose acetate butyrates, cellophanes, rayons, rayon triacetates, and cellulose ethers such as carboxymethyl celluloses and hydroxyalkyl celluloses; polyoxymethylene polymers and copolymers; polyimide polymers and copolymers such as polyether block imides and polyether block amides, polyamidimides, polyesterimides, and polyetherimides; polysulfone polymers and copolymers including polyarylsulfones and polyethersulfones; polyamide polymers
• Patent No. 6,545,097 to Pinchuk polyvinyl ketones, polyvinylcarbazoles, and polyvinyl esters such as polyvinyl acetates; polybenzimidazoles; ethylene-methacrylic acid copolymers and ethylene- acrylic acid copolymers, where some of the acid groups can be neutralized with either zinc or sodium ions (commonly known as ionomers); polyalkyl oxide polymers and copolymers including polyethylene oxides (PEO); polyesters including polyethylene terephthalates and aliphatic polyesters such as polymers and copolymers of lactide (which includes lactic acid as well as d-,1- and meso lactide), epsilon-caprolactone, glycolide (including glycolic acid), hydroxybutyrate, hydroxyvalerate, para-dioxanone, trimethylene carbonate (and its alkyl derivatives), 1 ,4-dioxepan-2-one, l,5-
• the proximal or bladder portion 12 of the stent 10 includes a balloon 22, and the distal or renal portion 14 of the stent includes a balloon 24.
• the ends of the balloons 22, 24 are sealingly attached to the tubular member 20 such that the balloons can be inflated after implantation, preferably with a fluid, such as a liquid, semi-liquid, gel, or gas that contains a therapeutic agent.
• the balloons 22, 24 are filled with liquid saline containing a therapeutic agent.
• the balloons 22, 24 are illustrated in the inflated configuration in Figures 1-4.
• the balloon 22 serves to retain the proximal end of the stent 10 within the urinary bladder 30, while the balloon 24 serves to retain the distal end of the stent m tne renal cavity 04. ine balloons 22, 24 also act as reservoirs for fluids containing therapeutic agents that are directionally delivered by the stent 10 as described below.
• the stent 10 only includes one of the balloons 22, 24. Such an embodiment could also include one or more coiled retention end pieces, such as are described in U.S. Patent Application Publication US2003/0195456 Al, the entire disclosure of which is hereby incorporated by reference. Additionally, one embodiment of the stent 10 includes balloons 22, 24 and coils. For example, one or both of the ends of the stent 10 may also be coiled in a pigtail spiral or J-shape to further prevent the upward and/or downward migration of the stent in the lumen of the ureter due to, for example, day-to-day physical activity of the patient. A kidney end coil would help retain the stent within the renal pelvis and prevent stent migration down the ureter while a urinary bladder end coil positioned in the bladder would help prevent stent migration upward toward the kidney.
• the stent 10 includes one or more additional balloons located between the proximal portion 12 and the distal portion 14 of the stent.
• the stent 10 includes a similarly configured medial balloon that elutes an agent for treating the ureter.
• the balloons 22, 24 may be configured to inflate to any variety of desired shapes. Additionally, the balloons 22, 24 are preferably constructed from materials with similar properties to the tubular member 20, but should be compliant with a high percentage of elongation such as, for example, silicone or latex.
• the tubular member 20 includes a first inflation lumen 26 and a second inflation lumen 28, which are used to inflate the balloons 22, 24 with a fluid containing a therapeutic agent.
• the lumens 26, 28 run along a portion of the length or along the entire length of the tubular member 20 and are separate from the drainage lumen 18.
• the first lumen 26 is in fluid communication with the proximal balloon 22 via an inflation port 30, which is an opening into the lumen 26 between the opposing, sealed ends of the balloon 22.
• the inflation port 30 allows fluid to pass from the lumen 26 into the balloon 22 so as to inflate the balloon.
• the lumen 26 also receives a one way check valve 32, such as a duck-bill or ball-type valve, that only permits fluid flow in the lumen 26 along the direction of inflation flow/7.
• the check valve 32 is located upstream of the inflation port 30 with respect to the direction ot inflation flow/- 7 through the lumen 26.
• the lumen 26 also receives a filter 34, a metered orifice 36, and a plug 38, all of which are located successively downstream of the inflation port 30 with respect to the direction of inflation flow/7.
• the portion of the lumen 26 located downstream of the port 30 with respect to the direction of flow/7 functions as a conduit for the delivery of the fluid containing the therapeutic agent after the stent 10 has been implanted and the balloon 22 has been inflated with the fluid.
• the metered orifice 36 is a flow control device that permits the elution of the fluid containing the therapeutic agent from the balloon 22 at the proximal portion 12 of the stent.
• the metered orifice 36 is a glass tube having an outer diameter of approximately 0.020 inches and an inner, elongated flow chamiel 40 with a diameter of approximately 0.0005-0.010 inches, depending upon the desired rate of elution of the fluid containing the therapeutic agent.
• the filter 34 is a porous plug that helps prevent the metered orifice 36 from clogging.
• the lumen 26 includes delivery port 42, which delivers the fluid containing the therapeutic agent from the lumen 26 and balloon 22 to an area exterior of and immediately adjacent proximal portion 12 of the stent 10.
• the port 42 is located upstream of the plug 38 with respect to the direction of elution flow/2 through the lumen 26.
• the plug 38 is a device that seals the lumen 26 at a location downstream of the port 42 with respect to the direction of elution flow ?.
• the fluid containing the therapeutic agent is delivered from the stent 10 at the proximal portion 12 when the fluid flows or elutes from the interior of the balloon 22 through the port 30, through the filter 34, through the metered orifice 36, and finally out of the port 42.
• the second inflation lumen 28 is used to inflate the distal balloon 24 with a fluid containing a therapeutic agent.
• the lumen 28 runs the length of the tubular member 20 and is separate from the drainage lumen 18.
• the second lumen 28 is in fluid communication with the distal balloon 22 via an inflation port 42, which is an opening into the lumen 28 between the opposing, sealed ends of the balloon 24.
• the inflation port 42 allows fluid to pass from the lumen 28 into the balloon 24 so as to inflate the balloon.
• the lumen 28 also includes a one way check valve 44, such as a duck bill or ball type valve, that only permits fluid flow in the lumen 26 along the direction of inflation flow/5.
• the check valve 44 is located upstream of the inflation port 42 with respect to the direction of inflation flow/3 through the lumen 28.
• the lumen 28 also receives a filter 46 and a metered orifice 48, which are located successively downstream of the inflation port 42 with respect to the direction of inflation flow ⁇ .
• the filter 46 and the metered orifice 48 may be identical to or different than the filter 34 and orifice 36 associated with the proximal balloon 22.
• the orifice 48 may be configured to have a higher or lower fluid elution rate than that of the orifice 36.
• the portion of the lumen 28 located downstream of the port 42 with respect to the direction of flow/5 functions as a conduit for the delivery of the fluid containing the therapeutic agent after the stent 10 has been implanted and the balloon 24 has been inflated with the fluid.
• the metered orifice 48 is a flow control device that permits the elution of the fluid containing the therapeutic agent from the balloon 24 at the distal portion 14 of the stent.
• the metered orifice 48 is a glass tube having an outer diameter of approximately 0.020 inches and an inner, elongated flow channel 40 with a diameter of approximately 0.0005-0.010 inches, depending upon the desired rate of elution of the fluid containing the therapeutic agent.
• the filter 46 is a porous plug that helps prevent the metered orifice 48 from clogging.
• the lumen 28 tenninates at an opening at the distal end 23 of the tubular member 20.
• the distal opening of the lumen 28 functions as the delivery port for the fluid containing the therapeutic agent from the lumen 28 and balloon 24 to an area exterior of and immediately adjacent the distal portion 14 of the stent 10, i.e., such as the renal cavity.
• the balloon 24 is inflated by delivering the fluid containing the therapeutic agent to the lumen 28, through the valve 44, and through the port 42.
• the fluid containing the therapeutic agent is delivered from the stent 10 at the distal portion 14 when the fluid flows or eludes from the interior of the balloon 24 back through the port 42, through the filter 46, through the metered orifice 48, and finally out of the distal opening of the lumen 28.
• the balloons 22, 24 may be filled with identical or different fluids, such as gases, liquids, and mixtures of gases and liquids that contain one or more therapeutic agents.
• therapeutic agents may be contained within a saline solution.
• classes of therapeutic agents include anesthetics, antipasmodic agents, anti-cholinergic agents, chemotherapeutic agents, or agents for transfection of genes.
• “Therapeutic agents” as used herein include genetic therapeutic agents, non-genetic therapeutic agents, and cells. Therapeutic agents may be used singly or in combination. Therapeutic agents may be, for example, nonionic or they may be anionic and/or cationic in nature.
• Exemplary genetic therapeutic agents for use in connection with the present invention include anti-sense DNA and RNA as well as DNA coding for: (a) anti-sense RNA, (b) tRNA or rRNA to replace defective or deficient endogenous molecules, (c) angiogenic factors including growth factors such as acidic and basic fibroblast growth factors, vascular endothelial growth factor, epidermal growth factor, transfonning growth factor ⁇ and ⁇ , platelet-derived endothelial growth factor, platelet-derived growth factor, tumor necrosis factor ⁇ , hepatocyte growth factor and insulin-like growth factor, (d) cell cycle inhibitors including CD inhibitors, and (e) thymidine kinase ("TK”) and other agents useful for interfering with cell proliferation.
• angiogenic factors including growth factors such as acidic and basic fibroblast growth factors, vascular endothelial growth factor, epidermal growth factor, transfonning growth factor ⁇ and ⁇ , platelet-derived endothelial growth factor
• BMP's bone morphogenic proteins
• BMP-3, BMP-4, BMP-5, BMP-6 and BMP-7 are examples of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 and BMP-7.
• These dimeric proteins can be provided as homodimers, heterodimers, or combinations thereof, alone or together with other molecules.
• molecules capable of inducing an upstream or downstream effect of a BMP can be provided.
• Such molecules include any of the "hedgehog" proteins, or the DNA's encoding them.
• Vectors for delivery of genetic therapeutic agents include viral vectors such as adenoviruses, gutted adenoviruses, adeno-associated virus, retroviruses, alpha virus (Semliki Forest, Sindbis, etc.), lentiviruses, herpes simplex virus, replication competent viruses (e.g., ONYX- 015) and hybrid vectors; and non- iral vectors such as artificial chromosomes and mini- chromosomes, plasmid DNA vectors (e.g., pCOR), cationic polymers (e.g., polyethyleneimine, polyethyleneimine (PEI)), graft copolymers (e.g., polyether-PEI and polyethylene oxide-PEI), neutral polymers PVP, SP1017 (SUPRATEK), lipids such as cationic lipids, liposomes, lipoplexes, nanoparticles, or microparticles, with and without targeting sequences such as the protein transduction domain (PT
• Cells for use in connection with the present invention include cells of human origin (autologous or allogeneic), including whole bone marrow, bone marrow derived mono- nuclear cells, progenitor cells (e.g., endothelial progenitor cells), stem cells (e.g., mesenchymal, hematopoietic, neuronal), pluripotent stem cells, fibroblasts, myoblasts, satellite cells, pericytes, cardiomyocytes, skeletal myocytes or macrophage, or from an animal, bacterial or fungal source (xenogeneic), which can be genetically engineered, if desired, to deliver proteins of interest.
• progenitor cells e.g., endothelial progenitor cells
• stem cells e.g., mesenchymal, hematopoietic, neuronal
• pluripotent stem cells fibroblasts, myoblasts, satellite cells, pericytes, cardiomyocytes, skeletal myocytes or macrophag
• a wide range of therapeutic agent loadings can be used in connection with embodiments of the present invention, with the pharmaceutically effective amount being readily determined and ultimately depending, for example, upon the condition to be treated, the nature of the therapeutic agent itself, the tissue into which the dosage form is introduced, and so forth.
• therapeutic agents or additives in addition to those listed above include those listed in the following classes.
• Anti-inflammatory agents include steroidal and non-steroidal anti-inflammatory agents.
• non-steroidal anti-inflammatory drugs include aminoarylcarboxylic acid derivatives such as enfenamic acid, etofenamate, flufenamic acid, isonixin, meclofenamic acid, mefanamic acid, niflumic acid, talniflumate, terofenamate and tolfenamic acid; arylacetic acid derivatives such as acemetacin, alclofenac, amfenac, bufexamac, cinmetacin, clopirac, diclofenac sodium, etodolac, felbinac, fenclofenac, fenclorac, fenclozic acid, fentiazac, glucametacin, ibufenac, indomethacin, isofezolac, isoxepac, lonazolac, metiazinic acid, ox
• steroidal anti-inflammatory agents include 21- acetoxyprefhenolone, aalclometasone, algestone, amicinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, deflazacort, desonide, desoximetasone, dexamethasone, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flumehtasone, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, fluprednidene a
• Analgesic agents include narcotic and non-narcotic analgesics.
• Narcotic analgesic agents include alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, codeine methyl bromide, codeine phosphate, codeine sulfate, desomorphine, dextromoramide, dezocine, diampromide, dihydrocodeine, dihydrocodeinone enol acetate, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethlythiambutene, ethylmorphine, etonitazene, f
• Non-narcotic analgesics include aceclofenac, acetaminophen, acetaminosalol, acetanilide, acetylsalicylsalicylic acid, alclofenac, alminoprofen, aloxiprin, aluminum bis(acetylsalicylate), aminochlorthenoxazin, 2-amino-4-picoline, aminopropylon, aminopyrine, ammonium salicylate, amtolmetin guacil, antipyrine, antipyrine salicylate, antrafenine, apazone, aspirin, benorylate, benoxaprofen, benzpiperylon, benzydamine, bermoprofen, brofenac, p-bromoacetanilide, 5-bromosalicylic acid acetate, bucetin, bufexamac, bumadizon, butacetin, calcium acetylsalicylate, carbamazepine, carbi
• Local anesthetic agents include amucaine, amolanone, amylocaine hydrochloride, benoxinate, benzocaine, betoxycaine, biphenamine, bupivacaine, butacaine, butaben, butanilicaine, butethamine, butoxycaine, carticaine, chloroprocaine hydrochloride, cocaethylene, cocaine, cyclomethycaine, dibucaine hydrochloride, dimethisoquin, dimethocaine, diperadon hydrochloride, dyclonine, ecgonidine, ecgonine, ethyl chloride, beta-eucaine, euprocin, fenalcomine, fomocaine, hexylcaine hydrochloride, hydroxytetracaine, isobutyl p- aminobenzoate, leucinocaine mesylate, levoxadrol, lidocaine, mepivacaine, meprylcaine, metabutoxyca
• Antispasmodic agents include alibendol, ambucetamide, aminopromazine, apoatropine, bevonium methyl sulfate, bietamiverine, butaverine, butropium bromide, n- butylscopolammonium bromide, caroverine, cimetropium bromide, cinnamedrine, clebopride, coniine hydrobromide, coniine hydrochloride, cyclonium iodide, difemerine, diisopromine, dioxaphetyl butyrate, diponium bromide, drofenine, emepronium bromide, ethaverine, feclemine, fenalamide, fenoverine, fenpiprane, fenpiverinium bromide, fentonium bromide, flavoxate, flopropione, gluconic acid, guaiactamine
• Antimicrobial agents include biocidal agents and biostatic agents as well as agents that possess both biocidal and biostatic properties, such as triclosan, chlorhexidine, nitrofurazone, benzalkonium chlorides, silver salts and antibiotics such as rifampin, gentamycin and minocyclin and combinations thereof.
• Two anti-inflammatory and antispasmodic therapeutic agents for the practice of an embodiment of the present invention are (a) ketorolac and pharmaceutically acceptable salts thereof (e.g., the tromethamine salt thereof, sold under the commercial name Toradol®) and (b) 4-diethylamino-2-butynylphenylcyclohexylglycolate and pharmaceutically acceptable salts thereof (e.g., 4-diethylamino-2-butynylphenylcyclohexylglycolate hydrochloride, also known as oxybutynin chloride, sold under the commercial name Ditropan®).
• ketorolac and pharmaceutically acceptable salts thereof e.g., the tromethamine salt thereof, sold under the commercial name Toradol®
• 4-diethylamino-2-butynylphenylcyclohexylglycolate and pharmaceutically acceptable salts thereof e.g., 4-diethylamino-2-butynylphen
• the medical device of the present invention may also contain optional additives, including radio-opacifying agents, pigments, and other additives such as plasticizers and extrusion lubricants, within its structure.
• optional additives including radio-opacifying agents, pigments, and other additives such as plasticizers and extrusion lubricants, within its structure.
• the radio-opacifying agent facilitates viewing of the medical device during insertion of the device and at any point while the device is implanted.
• a radio-opacifying agent typically functions by scattering x-rays. The areas of the medical device that scatter the x-rays are detectable on a radiograph.
• radio-opacifying agents useful in the medical device of the present invention are included a bismuth salt such as bismuth subcarbonate, bismuth oxychloride, bismuth trioxide, barium sulfate, tungsten, and mixtures thereof, with bismuth salts typically being prefereed.
• Pigments include any biocompatible and pharmaceutically acceptable colorant, regardless of type or color, including titanium dioxide, phthalocyanine organic pigments, quinaridone organic pigments, carbon black, iron oxides, and ultramarines.
• ureteral stent 10 may be introduced to the body either percutaneously in an antigrade fashion, using for example, an adaptation of the Seldinger technique, or cystoscopically in a retrograde fashion.
• a pusher tube (not shown) is used to deliver the stent 10 through a cytoscope over a guide wire (not shown) and into the ureter 60.
• stent 10 is introduced endoscopically without the use of pusher tube.
• the deflated balloons 22, 24 are substantially the same diameter in the deflated form as the proximal and distal portions 12, 14 of the stent 10.
• the balloon 22 is inflated with the fluid containing the therapeutic agent to a suitable diameter, such as 3 to 10 mm, preferably 5 mm for retention of the proximal portion 12 of the stent 10 within the urinary bladder 50 and for delivery of the fluid containing the therapeutic agent to the urinary bladder.
• the balloon 24 is also inflated with the fluid containing the therapeutic agent to a suitable diameter, such as 3 to 10 mm, for retention of the distal portion 12 of the stent 10 within the renal pelvis or cavity 64 of the kidney 62 and for delivery of the fluid containing the therapeutic agent to the renal cavity 64, as best seen in Figure 4.
• a suitable diameter such as 3 to 10 mm
• the balloon 22 is positioned proximal to the bladder wall 52 thereby minimizing migration of stent 10 within the ureter 50 and maintaining the elongated body portion 16 in situ.
• the balloon 24 is positioned proximal to the wall of the renal cavity 64 thereby minimizing migration of stent 10 within the kidney 62 and maintaining the elongated body portion 16 in situ.
• the balloons 22, 24 are deflated via end-effector valves or other devices (not illustrated). Additionally, tne oanoons z, 24 can be deflated by piercing the check valves 32, 44 or by directly piercing and aspirating the balloons.
• FIG. 5 illustrates a ureteral stent 110 in accordance with an alternative embodiment of the invention.
• the stent 110 is a drainage device that, when positioned within the ureter of a mammal, assists in reducing fluid retention by facilitating the drainage of urine from the kidney through the ureter and into the urinary bladder.
• the stent 110 may be used in the same manner as the stent 10 described above and the foregoing discussion of the benefits and functions of the stent 10 also applies to the stent 110.
• the stent 110 illustrated in Figure 5 has been assigned corresponding reference numbers as the stent 10, increased by one hundred.
• the stent 1 10 illustrated in Figure 5 also include additional features and inherent functions, as described further below.
• the stent 110 is configured for implantation within the ureter of a patient, and includes a proximal or bladder portion 120, a distal or renal portion (not illustrated), and an elongated body portion 116 between the proximal and distal portions.
• the stent 110 includes a drainage lumen 118 that extends the length of the stent to facilitate the drainage of urine from the kidney through the ureter and into the ririnary bladder.
• the ureteral stent 110 is tubular in shape, terminating in two opposing ends: a kidney distal end and a urinary bladder proximal end.
• the stent 1 10 includes a tubular member 120 that extends from the proximal portion to the distal portion and that defines the drainage lumen 118.
• the proximal or bladder portion 112 of the stent 110 includes a balloon 122.
• the distal or renal portion of the stent may include a balloon identical to the balloon 122.
• the distal or renal portion of the stent 110 may include one or more coiled retention end pieces, as described above.
• the ends of the balloon 122 are sealingly attached to the tubular member 120 such that the balloons can be inflated after implantation, preferably with the fluid containing the therapeutic agent.
• the balloon 122 is illustrated in the process of being inflated in Figure 5.
• the balloon 122 serves to retain the proximal end of the stent 110 within the urinary bladder, and may be configured to inflate to any variety of desired shapes.
• the tubular member 120 includes a plurality of ports 130 that are used to inflate the balloon 122 with the fluid containing the therapeutic agent.
• the lumen 118 is in fluid communication with the balloon 122 via the ports 130, which are openings into the lumen 118 between the opposing, sealed ends of the balloon 122.
• the ports 130 allow fluid to pass from the lumen 126 into the balloon 122 so as to inflate the balloon.
• the stent 110 also includes a one way check valve 132, which is in the form of a flap over the ports 130.
• the check valve 132 may be duck-bill or ball-type valve located in the ports 130 that only permit fluid flow into the balloon, not out of the balloon.
• the tubular member also includes a metered orifice 136, which is a flow control device that permits the elution of the fluids containing therapeutic agent from the balloon 122.
• the metered orifice 136 is a slit or small port in the wall of the tubular member 120.
• the orifice 136 communicates the interior of the inflated balloon with the interior of the lumen 118 such that fluid can elute from the balloon into the lumen 118 after the stent has been implanted.
• the stent 110 can also include a filter (not shown) to prevent the metered orifice 136 from clogging.
• Figure 5 illustrates the balloon 122 being inflated with a fluid containing a therapeutic agent.
• a pushrod 170 is inserted into the stent 110.
• the pushrod 170 has a lumen 172 and openings 174. When the push rod is fully inserted into the stent 110, the openings 174 are aligned with the ports 130 such that the fluid containing a therapeutic agent can be delivered through the lumen 172, through the openings 174, through the ports 130, and into the balloon 122.
• the pushrod 170 is removed.
• Figure 5 also illustrates a guidewire 180 being used to guide the stent 110 during implantation. The stent 110 is positioned in the bladder and is passed into the ureter.
• the guidewire 180 is of sufficient stiffness and maneuverability and is inserted into the ureter under endoscopic guidance.
• the stent is introduced to the ureter over the wire by the pushrod 170 acting on the trailing or proximal edge of the stent.
• the guidewire and stent are positioned with imaging guidance, such as a direct vision scope or fluoroscopy.
• imaging guidance such as a direct vision scope or fluoroscopy.
• the fluid containing a therapeutic agent is delivered from the stent 110 at the proximal portion 112 when the fluid flows or eludes from the interior of the balloon 122 through the metered orifice 136 through the lumen 118, and finally out the proximal end of the tubular member.
• stents and catheters according to the present invention may be used in areas of the body other than in the ureter, such as in the urethra and gall bladder. Additionally, the therapeutic agent may vary depending upon the specific application.
• the previously described balloons 22, 24, 122 may not function to retain the stent in place.
• the stent may include other retention devices such that the balloons primarily function as reservoirs for fluid containing a therapeutic agent.
• the balloons 22, 24, 122 and/or the tubular member 20 may include valves to permit the bleeding of gases when the balloons are being inflated.
• the ureteral stent 10 defines part of a ureteral catheter.
• the stent 10 is attached to and in fluid communication with a ureteral access tube 66 that protrudes from the body of the patient.
• the access tube 66 has a hub 68 and internal lumens that are in fluid communication with the lumens 26, 28 such that a user can repeatedly inflate and/or drain the balloons 22, 24 as desired.
• the hub 68 has multiple luers for communication with the lumens of the tube 66 and for draining the balloons 22, 24. Hence, a portion of the access tube 66 and the hub 68 remain outside the body of the patient through the urethra.
• the stent 10 defines part of a nephrostomy catheter.
• the stent 10 is attached to and in fluid communication with a nephrostomy access tube that protrudes from the body of the patient.
• the nephrostomy access tube also has a hub and internal lumens that are in fluid communication with the lumens 26, 28 such that a user can repeatedly inflate and/or drain the balloons 22, 24 as desired.
• a portion of the nephrostomy access tube and the hub remain outside the body of the patient through a percutaneous incision.

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• Health & Medical Sciences (AREA)
• Urology & Nephrology (AREA)
• Ophthalmology & Optometry (AREA)
• Otolaryngology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Materials For Medical Uses (AREA)
• Prostheses (AREA)
• Micro-Organisms Or Cultivation Processes Thereof (AREA)

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• 2005
  • 2005-03-22 AU AU2005228951A patent/AU2005228951A1/en not_active Abandoned
  • 2005-03-22 CA CA002558922A patent/CA2558922A1/en not_active Abandoned
  • 2005-03-22 WO PCT/US2005/009335 patent/WO2005094930A1/en not_active Ceased
  • 2005-03-22 US US11/085,087 patent/US7445642B2/en not_active Expired - Fee Related
  • 2005-03-22 EP EP05729527A patent/EP1727583A1/en not_active Withdrawn
  • 2005-03-22 JP JP2007505061A patent/JP2007530148A/ja active Pending
  • 2005-04-19 ES ES05739527T patent/ES2359069T3/es not_active Expired - Lifetime

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