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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
• • 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
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
• • 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
  • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
• • 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
  • A61M25/1011—Multiple balloon catheters
  • A61M2025/1015—Multiple balloon catheters having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• • 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
  • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
• • 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
  • A61M2025/1081—Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• • 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
  • A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics

Definitions

• the present invention generally relates to a multi-cannula catheter, and more specifically, to an assembly having a catheter with a distal end that is movable relative to the distal end of another catheter.
• a conventional catheter is a flexible tube having one or more lumens extending longitudinally therethrough.
• the distal end of a catheter is typically inserted into a body lumen, such as a blood vessel, and advanced to a site where a medical treatment is to be administered that often involves the infusion of medicinal fluids, withdrawal of bodily fluids, or the monitoring of pressure via the lumens formed in the catheter.
• Catheters are also frequently used to support a medical device, such as an angioplasty balloon or a sensor for monitoring pO 2 or pCO 2 .
• the lumens in a catheter may serve as passages through which electronic leads extend to such a sensor, or can be used for conveying a fluid that inflates a balloon.
• fluid can be administered to a specific treatment site within a patient's body through a lumen in a catheter.
• Certain kinds of diseases of the vascular system are best treated locally rather than systemically.
• a systemically administered medication can have undesired effects on a patient, particularly if administered in sufficient concentration to be therapeutically effective at the diseased site in a vessel.
• a medication spreads throughout the patient's body and becomes diluted in the blood stream; however, a substance can also become too concentrated in an organ such as the kidney.
• the benefit of a medication will be optimized and its adverse effects minimized if the medication is administered at the site where the therapeutic benefit of the medication is needed most.
• a conventional catheter is capable of administering a medication to a diseased site in a blood vessel or other body lumen.
• the medication is generally not retained at the site where it is administered via the catheter. Instead, once the medication is infused through a lumen in a catheter at the site within the vascular system, the blood flowing through the vessel will cause the medication to be dispersed into other parts of the patient's body.
• the blood flowing through the vessel will cause the medication to be dispersed into other parts of the patient's body.
• it is often the case that concomitant damage will occur in other parts of the body in which blood flowing through the vessel circulates. In such cases, it may be desirable to simultaneously administer different medications to treat both the diseased vessel and the damage to another portion of the patient's body caused by the diseased vessel.
• catheter system there is no catheter system available that can be advanced through a vessel, particularly a vein, and provide different medicinal fluids to disparate sites within the vessel.
• a balloon disposed adjacent a distal end of a catheter is sometimes used to block blood flow past the catheter during administration of a medication or during some other procedure, the balloon must be inflated with an external source of fluid that is conveyed through one of the lumens of the catheter.
• an alternative mechanism for blocking blood flow through a vessel around a catheter would be very useful - both on a catheter that enables medicinal fluids to be infused at disparate sites within a body lumen, and on other types of catheters. It would also be desirable to allow the simultaneous delivery of medicinal fluids without mixing these fluids to avoid causing potential reactions (crystallization, for example) in the catheter.
• a catheter assembly is defined that is usable for administering a first liquid to a first site in a body lumen of a patient and a second liquid to a second site in the body lumen, where the second site is substantially spaced apart from the first site.
• the catheter assembly includes a first tube that is flexible and elongate, having a guide lumen extending at least along part of its length.
• the first tube has a proximal port adapted to introduce the first liquid into a lumen, and a distal port coupled in fluid communication with the lumen and thus adapted to supply the first liquid to the first site.
• a second tube that is flexible and elongate has a lumen extending therethrough it, and the lumen couples a proximal port in fluid communication with a distal port on the second tube.
• the second tube is smaller in cross-sectional size than the guide lumen of the first tube. This configuration enables a position of the distal port of the second tube to be adjusted in the body lumen relative to a position of the distal port of the first tube, by sliding the second tube through the guide lumen to adjust its position relative to the first tube.
• the first liquid can be administered to the first site through the lumen and the distal port of the first tube, and the second liquid can be administered to the second site through the lumen and the distal port of the second tube.
• the distal port of the first tube is disposed in a wall of the first tube.
• the guide tube comprises the lumen through which the first liquid is administered.
• the distal port of the first tube comprises a gap defined between the outer surface of the second tube and an inner surface of the guide lumen of the first tube.
• a seal on the proximal end of the first tube preferably includes an adjustable compression fitting that is engaged to lock the second tube at a desired position in the guide lumen of the first tube.
• the second tube includes at least one additional lumen extending longitudinally through it.
• the first tube includes at least one additional lumen extending longitudinally through it.
• the assembly includes a skirt having a distal end and a proximal end.
• the proximal end of the skirt is attached in sealing relationship around an outer surface of the first tube, adjacent to its distal end, while the distal end of the skirt is adapted to seal against an internal surface of a body lumen in which the catheter apparatus is inserted, thereby preventing bodily fluid from flowing past the distal end of the first tube in a direction toward the proximal end of the first tube.
• the skirt includes a biasing element that acts on the skirt, forcing at least a portion of the skirt radially outward into sealing relationship with the inner surface of the body lumen when the skirt is enabled to unfurl.
• the biasing element comprises a helical coil spring disposed radially within an interior of the skirt.
• Another embodiment includes a biasing element that comprises a super elastic alloy having a radially expanded memory shape.
• the skirt is wrapped around the catheter and deploys into a lily-like shape.
• a plurality of struts extend distally from a distal edge of the skirt and are connected to the outer surface of the catheter to prevent the skirt from prolapsing.
• Still another embodiment employs a skirt having a generally spherical shape that remains collapsed until released and enabled to expand outwardly into contact with the inner surface of the body lumen. It may be preferable to include a sleeve that encompasses the skirt, keeping the skirt furled about the outer surface of either the first or the second tube while the catheter assembly is being advanced through a body lumen.
• the sleeve may extend proximally of the patient's body or alternatively, a line can be connected to the sleeve and extend outside the body lumen to enable the sleeve to be pulled from the skirt so that the skirt can unfurl to obstruct the flow of the bodily fluid through the body lumen.
• the sleeve can be withdrawn from the skirt after the distal port of the first tube or second tube is disposed proximate the corresponding first site or second site. It will be apparent that the skirt can also be used on a catheter assembly that does not include a plurality of cannulas.
• a method for administering first and second fluids respectively to disparate first and second sites within a body lumen is defined.
• the method includes steps generally corresponding to the functions of the elements discussed above.
• FIGURE 1 is a side view of portions of a catheter assembly including an inner catheter and an outer catheter, in accord with the present invention
• FIGURE 2 is an enlarged side view of a portion of the catheter assembly shown in FIGURE 1, at a distal end of the outer catheter;
• FIGURE 3 is a cross-sectional view of the catheter assembly taken along section line 3-3 in FIGURE 2;
• FIGURE 3' is an alternative cross-sectional view of the catheter assembly taken along section line 3-3 in FIGURE 2;
• FIGURE 4 is a side view of portions of an embodiment of a catheter (e.g., the inner catheter) showing a skirt that is unfurled to block blood flow past the catheter in a vessel;
• FIGURE 5 is a side view of portions of another embodiment of a skirt on a catheter
• FIGURE 6 is an enlarged cross-sectional view of a portion of the catheter and the skirt shown in FIGURE 5;
• FIGURE 7 is an enlarged side view of a different embodiment of the skirt on a portion of a catheter;
• FIGURE 8 is an enlarged view of the distal end of the embodiment of the skirt and catheter shown in FIGURE 7;
• FIGURE 9 is an enlarged side view of yet another embodiment of the skirt on a portion of a catheter;
• FIGURE 10 is an enlarged side view of still another embodiment of the skirt on a portion of a catheter
• FIGURE 11 is an enlarged side view of an embodiment of a skirt that includes a helical spring biasing coil and a portion of a catheter;
• FIGURES 12A and 12B are respectively an enlarged side view and an end view of a portion of a catheter and an embodiment of a skirt that is lily shaped and extends around the catheter;
• FIGURE 13 is an enlarged view of a portion of a catheter and a generally spherical shaped embodiment of a skirt;
• FIGURE 14 is a cross-sectional longitudinal view of a blood vessel showing a catheter assembly having an inner and outer catheter being advanced through the blood vessel;
• FIGURE 15 is a cross-sectional longitudinal view of the blood vessel of FIGURE 14, showing a skirt around the inner catheter unfurled to block blood flow through the blood vessel;
• FIGURE 16 is a side view of portions of an alternative embodiment of a multi-cannula catheter assembly, in accord with the present invention.
• Multi-cannula catheter assembly 20 includes an inner catheter 22 and an outer catheter 24. While the embodiment of the present invention shown in these Figures depicts inner catheter 22 extending concentrically along the longitudinal axis of outer catheter 24, it will be appreciated that a guide lumen within outer catheter 24 for use in guiding inner catheter 22 may be offset to one side of the longitudinal axis of outer catheter 24, as would likely be the case if the outer catheter includes a plurality of lumens.
• outer catheter 24 can include additional lumens besides the guide lumen through which the inner catheter is slidably disposed. Suitable materials for fabricating these and other catheters discussed below include PEBAXTM, high-density polyethylene (HDPE),
• Outer catheter 24 includes an external portion 26 having a side tube 28 that is connected in fluid communication with the guide lumen in this embodiment. If additional lumens are provided in outer catheter 24, corresponding additional side tubes similar to side tube 28 would typically be included, generally one for each of the lumens provided in the catheter that convey a fluid, or through which a lead or some other element is threaded.
• Side tube 28 includes a female Luer fitting 30 adapting the side tube to connect to a tube set having a corresponding male Luer fitting (not shown). Fluid can either be introduced or withdrawn from the guide lumen (or other lumens provided with similar side tubes) via the side tube that is connected in fluid communication with that lumen.
• a medicinal fluid can be supplied to a treatment site from an external source of the fluid that is coupled to side tube 28.
• the fluid is introduced into and conveyed through the lumen to the distal port disposed at the treatment site.
• a seal 32 is compressively engaged around inner catheter 22, forming a fluid-tight seal that prevents fluid introduced through side tube 28 from leaking past inner catheter 22 where it extends through the seal.
• the proximal portion of inner catheter 22 includes at least one side tube 48, which is provided with a female Luer fitting 50 for engaging a tube having a corresponding male Luer fitting.
• a seal 52 is adapted to compressively engage a guide wire (not shown in FIGURE 1). The guide wire, which is initially inserted into a body lumen and advanced through the body lumen at least to a site where the distal end of the inner catheter will be disposed, is threaded through at least one lumen of the inner catheter and serves to guide the catheter assembly to this site within the body lumen.
• distal port 36 which is formed in the side wall of the outer catheter, is optional.
• guide wire 54 disposed within a central lumen 56 at the distal portion of inner catheter 22.
• FIGURE 3' an embodiment is shown in which a lumen 56' and a lumen 56" are formed within inner catheter 22 in side-by-side relationship.
• a guide wire 54' extends through lumen 56' in this embodiment.
• Gap 60 is again provided to enable fluid passing through the guide lumen of outer catheter 24 to be infused into the body lumen at the distal end of the outer catheter (as an alternative to being infused through distal port 36).
• inner catheter 22 can be slidably adjusted within the outer catheter so that the distal end of the inner catheter and its distal port 44 are spaced apart from distal end 38 of outer catheter 24 by a desired extent.
• the spacing between the distal ends (or distal ports) of the inner and outer catheters is adjustable to enable different fluids to be separately administered to different treatment sites within a body lumen through multi-cannula catheter assembly 20.
• one of the catheters is moved relative to the other catheter either before or after the multi-cannula catheter assembly is inserted within the body lumen of a patient's body.
• the whole assembly will typically be advanced along the guide wire until the distal port of the inner catheter is at its desired site within the body lumen, and then the outer catheter will be drawn back over the inner catheter until the distal port (or distal end) of the outer catheter is disposed at its desired site in the body lumen.
• Use of bands 40 enable the disposition of the distal ports or ends of the inner and outer catheter to be determined within the patient's body with imaging modalities so that they can be positioned within the body lumen at the desired sites.
• Each of the catheters may be used to deliver specific drugs, blood, gene therapies, or therapeutic agents to the treatment site where the distal port of each of the respective catheters is ultimately disposed within the patient's body.
• a third or more catheters can be added and similarly threaded through either a lumen of a concentrically outer catheter, or through a different lumen in outer catheter 24, to treat additional sites within the body lumen at different spaced-apart locations. The disposition of the sites will depend upon the anatomical variations and differences in the disease locations from patient to patient, and the adjustable nature of the multi-cannula catheter assembly permits the fluids to be administered to the appropriate sites.
• FIGURE 16 illustrates an alternative embodiment of a multi-cannula catheter assembly 150 that includes catheters 152 and 154.
• the same components are provided at the proximal ends of the two catheters that remain outside the patient's body as in the embodiment first discussed above.
• a distal end 156 of catheter 152 extends through a relatively short distal portion 158 of catheter 154 in which the guide lumen is disposed.
• catheter 154 includes a much longer section 160 through which a lumen (not specifically shown) extends, in fluid communication with side tube 28. Fluid administered through side tube 28 and flowing through this lumen exits from a distal port 162 of distal portion 158.
• catheter 152 includes proximal to the distal end of catheter 152 .
• Fluid administered through side tube 48 of catheter 152 flows through a lumen in the catheter (not separately shown) and exits the lumen through distal port 44, at the distal end of the catheter.
• Catheter 152 is freely slidable through the guide lumen within distal portion 158 of catheter 154, so that the distal ends and distal ports of each catheter may be spaced apart within a body lumen to deliver different fluids to correspondingly spaced-apart sites through the distal ports of the two catheters.
• the relatively short guide lumen in distal portion 158 serves the dual function of providing a path for the coaxial delivery of catheter 152 and of serving as a sleeve for keeping skirt 90 furled until the skirt is advanced from within the guide lumen sufficiently to enable the skirt to unfurl. If a skirt is provided on distal portion 158, another sleeve would likely be provided to keep that skirt furled until catheter 154 is disposed at a desired position to administer fluid into the body lumen. Because of the relatively short length of distal portion 158, catheter 152 can be shorter and still enable catheter 154 to be positioned where desired.
• multi-cannula catheter assembly 150 can be included in multi-cannula catheter assembly 150, by providing an additional guide lumen on the distal portion of catheter 154 for each added catheter, or by providing multiple catheters like catheter 154, each having a distal portion 158 threaded over catheter 152 and disposed at a different position along it.
• FIGURES 4 and 9 illustrate an embodiment of a skirt 100 used for preventing or substantially reducing fluid flow past inner catheter 22. While each of the following embodiments of such a skirt are illustrated disposed proximate the distal end of inner catheter 22, it will be understood that each embodiment of the skirt can be included on outer catheter 24, or on distal portion 158 of catheter 154, or on a single catheter that is not part of a multi-cannula catheter system.
• skirt Although the different embodiments of the skirt illustrated and discussed below have substantially different physical configurations, they are each generically referred to herein and in the claims that follow as a "skirt,” since the function and purpose of these embodiments are substantially identical regardless of the configuration of the embodiment.
• Each skirt has two states, referred to herein as “furled” and “unfurled,” respectively. When a skirt is furled, it has a relatively smaller radial extent, being fitted relatively compactly about the outer surface of the catheter to which it is attached. In contrast, when a skirt is unfurled, the radial extent of the skirt is substantially greater than when furled, enabling a distal end of the skirt or some other portion of the skirt to come into contact with an inner surface of the body lumen in which the catheter has been inserted.
• the function or purpose of the skirt when unfurled, is to at least partially block the flow of a bodily fluid through the body lumen in which the catheter and skirt are disposed.
• the most common body lumen in which a catheter is used is a blood vessel, although it should be emphasized that the catheter can be used in other types of body lumens that are not blood vessels. Accordingly, when a catheter with a skirt in accord with the present invention is advanced through a blood vessel with the skirt furled, it may be preferable to interrupt the flow of blood through the vessel by applying a standard pressure cuff to a limb of the patient in which the blood vessel extends, as is well known to those of ordinary skill in the medical arts.
• the pressure cuff applies pressure to the blood vessel, preventing the blood from flowing in a direction opposite that to which the catheter and skirt is advanced through the vessel with the skirt in its furled state.
• venous valves if present, to relax in an open position, facilitating easy passage of the catheter through a vein and minimizing risk of trauma to venous valves.
• the pressure cuff When used in a blood vessel, after the skirt is unfurled, the pressure cuff is released to allow blood to again flow within the blood vessel, but flow of the blood past the unfurled skirt is prevented or minimized, since the skirt effectively obstructs (or at least partially obstructs) the blood vessel, preventing most of the blood from flowing past the position on the catheter at which the skirt is disposed.
• the skirt is normally disposed behind the distal port on the catheter to which the skirt is attached. Therefore, it will be apparent that administration of a medicinal fluid or other liquid into the body lumen through the distal port while the skirt is unfurled will prevent blood or other bodily fluids from washing the fluid away from the site to which it has thus been administered.
• administration of a medicinal fluid or other liquid into the body lumen through the distal port while the skirt is unfurled will prevent blood or other bodily fluids from washing the fluid away from the site to which it has thus been administered.
• a therapeutic agent of other medicinal fluid infused under pressure in the retrograde direction through the catheter into the body lumen reaches body tissue that is otherwise not accessible.
• the microvasculature of diseased tissue has greater permeability characteristics to take up and perfuse a therapeutic agent or medicinal fluid that is delivered in the retrograde direction through the body lumen.
• the unfurled skirt ensures that the therapeutic agent or medicinal fluid is infused through the body lumen in the retrograde direction, which may be important in treating diseased and/or ischemic tissue.
• skirt 100 is fabricated from a relatively thin-walled polymer material that is "welded,” adhesively bonded, shrink affixed, or otherwise mounted over distal portion 42 of the catheter. Suitable materials for use in fabricating this and other thin-walled skirts described below include polyethylene terephthalate (PET), fluoropolymer, NYLONTM, urethane, or PVC plastics. Skirt 100 is formed to have a generally conical shape when unfurled, as shown in FIGURE 9. To provide a biasing force that causes skirt 100 to change from its furled state to its unfurled state, a plurality of thin metal rods or bars 104 are bonded to the inner surface of skirt 100.
• the metal rods or bars are made of stainless steel, corrosion resistant spring steel, or super-elastic metal, such as Nitinol, or alternatively, may be formed of an elastomeric polymer. These rods or bars create a spring biasing force directed radially outward so as to cause skirt 100 to assume a generally conical shape.
• the relatively wider diameter or radius of skirt 100 at its distal end brings it into contact with an internal surface of the body lumen in which the catheter is inserted. Flow of bodily fluids such as blood past skirt 100 is prevented by the unfurled state of skirt 100 blocking fluid flow through the body lumen, as will be evident from an exemplary application of a skirt discussed below.
• FIGURES 5-8 Other embodiments of a skirt having a generally conical shape are illustrated in FIGURES 5-8.
• a skirt 74 having a conical portion 76 that extends radially outward from the surface of the catheter on which it is mounted is illustrated.
• the polymeric material from which the skirt is fabricated has an inherent elastomeric bias that provides a radially outward directed forced tending to cause the skirt to change from its furled to unfurled state so that the distal end of conical portion 76 contacts the inner surface of the body lumen.
• a plurality of tethers 80 extend distally of skirt 74 and are bonded to the outer surface of the catheter.
• a skirt 90 having a conical portion 92 may be formed to include integral tethers 94 that are coupled distally to the outer surface of the catheter and define relatively large openings 96 between adjacent tethers 94 as shown in FIGURES 7 and 8. Skirt 90 is also shown in FIGURE 16.
• skirt 120 having a conical portion 122 that is expanded radially outward by a helical internal coil spring 124 when allowed to unfurl.
• the helical internal coil spring extends between different sections of distal portion 42 of the catheter and can be fabricated from stainless steel or spring steel, Nitinol, or a suitable elastomeric polymer. Fluid can readily exit the distal portion of the catheter through the coils of helical spring 124.
• skirt 120 is furled, the coils of helical spring 124 assume a smaller diameter configuration with skirt 120 furled around the outer surface of the helical spring and catheter.
• a skirt 110 also has a conical section 112 when unfurled. However, instead of using a spring force to bias the skirt into its unfurled state, it comprises a Malecot type structure that is selectively urged to its unfurled state by a user pulling a proximal end of a line 118 that is coupled to relatively stiff struts 114 and extends beyond the proximal end of the catheter. Struts 114 extend from the distal edge of conical-shaped portion 112 and into slots 116 that are spaced apart around a lumen of the catheter through which line 118 extends.
• the line may be fabricated from adhesively-bonded fibers of polyethylene, or other suitable thin, high-tensile strength material such as KEVLARTM, polycarbonate, polyether sulfone, polyetheretherketone (PEEK), or aligned PET.
• line 1 18 is pulled proximally, struts 114 are forced radially outward, thereby unfurling conical portion 112 of skirt 110 into contact with the inner surface of the body lumen in which the catheter has been inserted.
• this particular construction for skirt 110 will apply a small dilating force onto the inner surface of the body lumen or blood vessel, depending upon the amount of tension exerted on line 118.
• skirt 1 10 shown in FIGURE 10 is useful in the multi-cannula catheter assembly only upon the inner catheter, or the innermost catheter of an assembly having more than two catheters.
• FIGURES 12 and 13 illustrate two further embodiments for the skirt.
• a skirt 130 generally has a shape like a lily when unfurled.
• the thin polymer material from which the skirt is fabricated includes a supporting rib 132 formed of a metallic wire or appropriate polymer plastic extending around its outer edge.
• skirt 130 When unfurled, skirt 130 tries to assume the shape shown in FIGURE 12 and thereby readily adapts to the interior cross-sectional dimension of a body lumen such as a blood vessel, sealing against the interior surface of the body lumen to partially obstruct flow of fluid therethrough.
• This skirt embodiment tends not to dilate the body lumen in which it is used, since any outward force delivered by rib 132 will not be directed radially, in a concentric direction.
• skirt 140 is illustrated in its "unfurled” state, a dash line 142 indicating the furled radial extent of skirt 140.
• Skirt 140 can be fabricated from silicone or other elastic materials that can be deployed without the influence of any surrounding fluid pressure. This embodiment tends to cause minimal dilation of the body lumen with which it is in contact, due to its relatively moderate radially directed elastic force.
• conical-shaped skirt 74 an advantage of employing conical-shaped skirt 74 will be evident. If one or more distal ports 82 are provided in the wall of the catheter in the portion of the catheter encompassed by conical portion 76 (or by corresponding conical portions of the other embodiments discussed above), it will be apparent that fluid exiting through distal ports 82 will impinge directly on the inner surface of the conical portion of the skirt and not on the inner surface of the body lumen. Thus, possibility of damage due to the force of the fluid impinging upon the inner surface of the body lumen is substantially reduced.
• skirt 90 is included on the distal portion of catheter 152.
• catheter 152 When catheter 152 is initially inserted into a body lumen, such as a blood vessel, skirt 90 will be furled within distal portion 158 of catheter 154.
• catheter 154 Once distal port 44 of catheter 150 has been advanced to a desired site within the body lumen, catheter 154 will be drawn back relative to catheter 152, enabling skirt 90 to unfurl, bringing conical portion 92 of the skirt into contact with the interior surface of the body lumen to obstruct the flow of bodily fluid, e.g., blood, past the catheter.
• bodily fluid e.g., blood
• a sleeve (not shown in this Figure) or other retainer will be required to maintain the skirt in its furled state until distal port 162 has been positioned at the site where fluid will be administered to the body lumen.
• the sleeve can then be withdrawn from the skirt to enable it to unfurl into sealing contact with the interior surface of the body lumen and will preferably be designed to split near side tube 48 upon removal from the patient's body.
• FIGURE 14 illustrates how a multi-cannula catheter assembly 161 that is provided with a skirt 100 around both an inner catheter 164 and an outer catheter 163 is advanced through a blood vessel 151 with both of the skirts in a furled state.
• it is used for treating both vascular disease and ischemic tissue of a patient's lower limb and providing treatment of an infected ulcer in the patient's foot due to poor circulation caused by some form of metabolic or vascular disease or associated complications of these diseases.
• Multi-cannula catheter assembly 161 is inserted into blood vessel 151 through an introducer after blood flow through the blood vessel has been impeded by a pressure cuff (not shown) applied to the patient's leg.
• a pressure cuff (not shown) applied to the patient's leg.
• the physiological valves in the veins of the leg will relax in the open position, and blood flow through the vein in which the multi-cannula catheter assembly is inserted will be substantially reduced.
• a guide wire is threaded in retrograde fashion across valves in the vein and advanced to a site of the intended treatment in the foot.
• the multi-cannula catheter assembly is advanced coaxially over the guide wire to the furthest distal treatment site in the foot.
• the arrow at the left-hand side of the blood vessel indicates the normal direction of blood flow through the vessel.
• the inner catheter is positioned with conical portion 102 of the skirt substantially within a distal opening 168 of a distal end 166 of the outer catheter.
• the overlying portion of distal end 166 on the outer catheter maintains conical portion 102 of skirt 100 furled so long as the inner catheter is substantially contained within the guide lumen of outer catheter 163.
• Skirt 100 on outer catheter 163 is retained in its furled state by use of a sleeve 170 that is slipped over the skirt, generally retaining conical portion 102 of the skirt against the outer surface of outer catheter 163.
• Sleeve 170 can be sufficiently long to extend proximally outside the patient's body, but in this embodiment is connected to a line 174 where the line is fused to the sleeve at a point 172.
• Line 174 extends back into outer catheter 163 and through one of the lumens of the outer catheter to a point outside the patient's body.
• the multi-cannula catheter assembly is advanced through blood vessel 151 over the guide wire so as to bring distal port 44 of inner catheter 164 to a desired position at the treatment site in the foot, as illustrated in FIGURE 15.
• the inner catheter is then held constant at that position while the outer catheter and sleeve 170 are drawn back from the inner catheter as a single unit, enabling conical portion 102 of skirt 100 on the inner catheter to achieve its furled state, bringing the distal portion of skirt 100 into contact with the inner surface of blood vessel 151.
• a sleeve like sleeve 170 can be provided over a skirt disposed on the inner catheter to keep that skirt furled until the sleeve is pulled back from the skirt.
• providing a sleeve over the skirt on the inner catheter is an alternative to using the outer catheter to keep the skirt on the inner catheter furled.
• the outer catheter and sleeve 170 are then drawn back over the inner catheter to the site at the mid-calf in the patient's leg, for example, where vascular disease has occurred in adjacent tissue and is impeding blood flow to the foot, which may be a causative factor in causing the infected foot ulcer.
• This position is where the fluid is to be administered through distal port 168 on the outer catheter.
• line 174 is drawn back, pulling sleeve 170 away from skirt 100 on the outer catheter, enabling the conical portion of the skirt to come into contact with the inner surface of blood vessel 151 to prevent any further blood flow past that point within the blood vessel.
• the pressure cuff can be released, allowing blood to flow through the blood vessel up to skirt 100 on the inner catheter.
• Different medicinal fluids can then be separately infused into blood vessel 151 through distal ports 44 and 168, respectively, to administer the fluid to the sites in the foot and in the mid-calf of the leg.
• an antibiotic can be administered to distal port 44 through the inner catheter to treat the infected foot ulcer, while an appropriate drug is delivered through distal port 168 in outer catheter 163 to treat the vascular disease in the adjacent diseased and/or ischemic tissue.
• Another lumen in the inner and/or outer catheters can be used for infusing other fluids, such as genetically modified agents or growth factor into same of other treatment sites to aid in the revascularization of the foot and/or leg or to enhance the healing factors at the different treatment sites.
• other fluids such as genetically modified agents or growth factor into same of other treatment sites to aid in the revascularization of the foot and/or leg or to enhance the healing factors at the different treatment sites.
• the inner catheter is drawn back through blood vessel 151 until sleeve 100 on the inner catheter is encompassed within distal port 168, again causing sleeve 100 on the inner catheter to be furled within the outer catheter.
• sleeve 100 on outer catheter 163 is not furled, but instead, is drawn back through the blood vessel in its furled state, since sleeve 170 cannot be readily forced back over skirt 100 on the outer catheter.
• skirt 100 on the inner catheter can be again drawn back into distal port 168 on the outer catheter to furl the skirt, thereby enabling the multi-cannula catheter assembly to be repositioned to a different site within blood vessel 151.
• the outer catheter can again be drawn back from the skirt, enabling the skirt on the inner catheter to unfurl and obstruct blood flow through blood vessel 151.
• the obstructive skirts can be deployed and then again furled, leaving no sha ⁇ edges exposed, producing a low-profile cross section for the catheter assembly when it is necessary to move it within the body lumen. It is unnecessary to provide an inner lumen on the catheter assembly to convey an inflation fluid to deploy an obstructive element such as a balloon, as in prior art devices.
• Most of the embodiments for the skirt discussed above do not cause dilation of the body lumen and are not abrasive to the endothelial layer within a blood vessel or other body lumen, thereby minimizing the risk of damage to the vessel and reducing the likelihood of thrombus formation.
• the skirts are generally conformal, they do not require sizing for different applications to minimize the risk of vessel dilation.

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• 2000
  • 2000-08-30 WO PCT/US2000/024339 patent/WO2001017589A1/en not_active Application Discontinuation
  • 2000-08-30 JP JP2001521375A patent/JP2003508163A/ja not_active Withdrawn
  • 2000-08-30 AU AU71145/00A patent/AU7114500A/en not_active Abandoned
  • 2000-08-30 CA CA002382021A patent/CA2382021A1/en not_active Abandoned
  • 2000-08-30 EP EP00959902A patent/EP1207924A1/de not_active Withdrawn

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