BRPI0611601A2 - anticoagulant resident catheter - Google Patents

Abstract

ANTICOAGULANT RESIDENT CATHETER. It is a catheter for providing blood flow that includes a wall defining at least one lumen extending between a distal end and a proximal end. The distal end portion of the catheter may be deformed to selectively open and close one or more openings in the wall to allow blood to flow into and out of the catheter lumen.

Description

"ANTICOAGULANT RESIDENT CATHETER"

BACKGROUND

Patients with advanced stage renal disease (ERSD) should routinely receive dialysis treatments in order to survive. Resident catheters are a useful dialysis access method for hemodialysis because they reduce the required number of repeated para- dialysis vein penetrations. Chronic central venous catheters for dialysis (CVCD) are the primary long-term access to dialysis for more than 25% of patients with RDS or hemodialysis.

In a standard direct flow dialysis system, the CVCD should provide a first blood removal route and a second blood return route at a rate of at least 300 ml / min. A CVCD for a standard direct flow dialysis system may be formed by inserting separate separate catheters into the jugular vein of a tunneling way through the clavicle. In this arrangement, the catheter tips are close to the junction of the superior vena cava and the right atrium. The tip of the blood removal catheter, or arterial catheter, is placed three centimeters and four cm above the tip of the downstream blood return catheter, or venous catheter, to prevent mixing of blood purified blood entering the catheter.

As an alternative to separating the catheter into the standard direct flow dialysis system, a single-body two-lumen catheter can be used for dialysis access. In this arrangement, the tip of the lumenarterial is placed between three and four cm above the venous dolmen tip. As with the standard direct flow arrangement, this arrangement also prevents the mixing of purified blood with blood entering the arterial lumen. Alternatively, dialysis can also be performed by using a single lumen single catheter. In this case, The dialysis machine distributes an amount of unpurified blood and then returns the purified blood to alternating cycles.

Blood enters and leaves the lumen of the catheter through openings or holes in the catheter. The design of these openings is highly variable, and similar concepts are employed in both the single lumen catheter and the lumen double catheter. A first example is a catheter lumen having a single opening at the tip for entering or exiting blood. A second example is a catheter lumen having the blood exchange opening located on the body side of the lumen toward its distal tip. Another example is a lumen decatheter having several axially shaped blood exchange openings placed around the side of the lumen body toward its distant tip. While all of the above CVCD projects work, there is room for improvement over time, and there are problems with all current opening projects for dialysis catheters.

Arterial catheter lumens that contain only one blood exchange opening, no matter where they are located, are at risk of obstruction of the opening by neighboring vein walls, coagulation of blood in the back opening, and the development of a surrounding fibrin lining. from the distal end of the lumen and the back opening. Venous catheter lumens that contain only one blood exchange opening, regardless of their location, are at risk of obstruction by blood coagulation in the exchange opening and the development of a fibrin lining around the distal end of the lumen and exchange cover. Blockage of the blood exchange opening prevents the desired rate of blood exchange from occurring at minus 300 ml / min. The degree of obstruction may render resident catheters ineffective for dialysis access.

Therefore, when this level of obstruction occurs, the resident catheters should be replaced.

Arterial catheter lumens containing various blood exchange openings around the distal catheter end reduce the occurrence of vein obstruction. However, the presence of multiple openings increases the risk of blood clot obstruction because the various openings allow blood to flow into the lumen when inactive, which may weaken the anticoagulant solution. Decreased presence of anticoagulant solution in the distal end of the catheter increases the amount of blood coaguland in the openings and in the lumen. Blockage of blood exchange openings prevents the desired blood exchange rate of at least 300 ml / min from occurring. The degree of obstruction may render resident catheters not effective for dialysis access. Therefore, when this level of obstruction occurs, the resident catheters should be replaced. Thus, there is a general need in the industry to provide methods and devices for preventing obstructions in the catheter blood exchange openings and around the distal end of the catheters. These methods and devices are intended to prevent lumen obstruction due to coagulation and fibrous sheath surrounding the catheter tip, as well as to maintain catheter anticoagulant blocking solution within the lumen for inactive periods between dialysis.

SUMMARY

The present invention is directed to a catheter resident. More particularly, but not exclusively, one aspect relates to a resident catheter adapted to prevent coagulation and coating of the distal catheter end. One catheter application includes non-exclusive use as a dialysis catheter (CVCD). Other applications are also contemplated.

Another aspect relates to a blood flow lumen catheter that includes a deformable wall portion to provide a path for blood flow in a first configuration and substantially closes the path when in a second configuration. Expanding the catheter walls will also loosen any fibrous coatings beginning to form around the catheter tip.

A further aspect relates to a catheter with a blood flow lumen which includes a wall portion that is deformed to open and close one or more openings in the wall portion by axially displacing a distal part of the catheter including one or more. more openings relative to a near part of the catheter.

A further aspect relates to a catheter with a blood flow lumen that includes a wall portion that is deformed to open and close one or more openings in the wall portion by radially deforming a distal part of the catheter including one or more. openings.

A further aspect relates to a catheter with a blood flow lumen that includes a wall portion that is deformed to open one or more wall openings by simultaneously axially and radially displacing a distal end of the catheter in recirculation. connection to a near part of the catheter.

Still another aspect relates to a catheter with a blood flow lumen that includes a wall portion having a first shape for providing a blood flow opening and a second shape that substantially closes the opening to prevent flow through the opening.

Another aspect relates to a blood flow lumen catheter that includes one or more openings that are opened by reducing a length of at least a portion of the catheter including one or more openings.

An additional aspect relating to a catheter includes an automatically closing aperture that retains a catheter locking solution in a closed catheter lumen and allows blood to flow through the passage when opened.

In another aspect, the catheter includes an extended body defining a pair of lumens, each for flow of fluid through it. Each of the lumens extends between a distal end and a proximal end and includes an aperture at the distal end thereof in communication with the lumen. The catheter also includes a pair of end caps at the distal ends of the respective lumens and an actuation mechanism at the proximal ends of the lumens. Each end cap is coupled as actuation mechanism with at least one actuation member extending on a wall along its lumen. The actuation mechanism is operable to independently and remotely move each end cap as respective actuation member toward and away from the respective lumen opening between closed and open conditions to allow fluid flow through the respective opening.

In another aspect, a catheter includes a flattened body extending between a distal end and a proximal end. The body includes a wall defining at least one lumen for fluid flow therethrough and at least one aperture at the distal end of the elongate body in communication with at least one lumen. The catheter also includes a distal end cap and a proximal end actuating mechanism. The end tip is coupled with the actuation mechanism with at least one actuation member extending into the wall along the lumen. The actuating mechanism is operable to remotely move the end cap away from the aperture to an open condition and to allow fluid flow through the opening and the actuating mechanism is additionally operable to remotely move the end cap toward the opening. distal end to a closed condition and seals with the body to prevent the flow of fluid through the opening.

In a further aspect, the catheter includes a body defining at least one lumen extending along a longitudinal geometric axis of the body. The body extends between a distal portion that can be positioned on a patient's vascular structure and a proximal end that can be positioned outside the patient with the distal part of the vascular structure. The distal part of the body includes several adjacent wall segments extending along the same length and located distal to the lumen. The wall segments together have a size and shape which substantially correspond to a lumen size and shape transversely to the longitudinal geometrical axis. Adjacent segments of the wall segments define an aperture therebetween. Each of the apertures includes a first closed condition formed by contact engagement of adjacent wall segments to prevent fluid flow between the lumen and vascular structure through the apertures.

The openings include a second open condition formed by the deformation of at least one of the wall segments to open at least one of the openings to allow deflected flow between the vascular structure and the lumen through the openings.

Various devices for opening and closing the open catheter are contemplated, including mechanical, pneumatic and hydraulic devices. The closure may be actuated remotely, so that the opening may remain within the patient while the opening is opened and closed.

These and other aspects are further discussed below.

BRIEF DESCRIPTION OF DRAWINGS

Fig. 1 is a perspective view of a partitioning of an open-opening catheter according to one embodiment of the invention.

Fig. 2 is an elevation of the catheter of Fig. 1 with openings in a closed condition.

Fig. 3 is an elevation of the catheter of Fig. 1 as doors in an open condition.

Fig. 4 is a cross-sectional view through the catheter body of Fig. 1 taken transversely to its longitudinal geometry axis.

Fig. 5 is a longitudinal section view of the actuation mechanism of an opening and closing embodiment of the catheter of Fig. 1.

Fig. 6 is a longitudinal section view of the actuation mechanism of another embodiment.

Fig. 7 is a cross-sectional view through line 7-7 of Fig. 6. Fig. 8 is a longitudinal cross-sectional navigator elevation view of the actuation mechanism of the other embodiment.

Fig. 9 is an elevation view of a tubular member comprising a part of the actuation mechanism of Fig. 8.

Fig. 10 is a perspective view of the actuation mechanism of another embodiment and its position when the apertures are in a closed condition.

Fig. 11 is a perspective view of the actuation mechanism of Fig. 10 and its position with the openings in an open condition.

Fig. 12 is an elevational view of a catheter partist of the other embodiment with its openings in a closed condition.

Fig. 13 is an elevational view of the daFig catheter. 12 with its openings in an open condition.

Fig. 14 is a sectional view through line 14-14 of Fig. 13.

Fig. 15 is a perspective view of a catheter partist of the other embodiment with its openings in a closed condition.

Fig. 16 is the distal part of the catheter of Fig. 15 with its doors in an open position.

Fig. 17 is a perspective view of a catheter partist of the other embodiment with its openings in a closed condition.

Fig. 18 is the distal part of the catheter of Fig. 17 with its openings in an open position.

Fig. 19 is a sectional view along line 19-19 of Fig. 17.

Fig. 20 is a sectional view along line 20-20 of Fig. 17.

Fig. 21 is a sectional view along line 21-21 of Fig. 18

Fig. 22 is a plan view of a distal part of the catheter of the other embodiment with its openings in a closed condition.

Fig. 23 is a sectional view taken along line 23-23 of Fig. 22.

Fig. 24 is a sectional view along line 24-24 of Fig. 22.

Fig. 25 is a perspective view of a catheter part of the other embodiment with its opening in an open condition.

Fig. 26 is a sectional view of the catheter part of Fig. 25.

Fig. 27 is a plan view of a catheter assembly showing the actuation mechanism of another embodiment.

DESCRIPTION OF ILLUSTRATED MODES

For the purpose of furthering an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe them. It will be understood that no limitation on the scope of the invention is thereby intended. Any further changes and modifications of the principles of the invention as illustrated or described herein are contemplated as commonly occurring for those skilled in the art to which the invention relates.

The present invention provides a catheter with a foot less an opening adjacent a distal end of the catheter which may be selectively opened and closed. Appeal at least one opening may be opened or closed while at least one opening is located in a patient's vascular structure, such as a vein or artery. One application of the catheter contemplates that it is used in dialysis procedures, although other applications of fixation on a person's body for a period of time are also contemplated. The at least one opening will be in the closed position between dialysis procedures to prevent blood from flowing through the opening and to prevent coagulation within the catheter tip. With at least one closed opening, the catheter can be injected with anticoagulant solution and the solution is retained within the catheter lumen.

It is contemplated that at least one aperture allows the flow of fluid to be easier than the one when closed. Thus, the anticoagulant concentration within the catheter's dolmen can be kept at the same level for several days or even weeks, when at least one opening is closed. During dialysis, at least one opening is opened by deformation of the wall adjacent to at least one opening to allow blood to enter through the opening and into the lumen of the catheter. It is contemplated that opening the at least one opening may suspend the distal end of the catheter from the neighboring vascular surface, preventing occlusion of at least one opening by a wall surface of the vessel structure. Additionally, the opening of the at least one opening may loosen any fibrous lining that is forming around the distal end of the catheter adjacent to the at least one opening. Repeated opening and closing of the at least one opening may provide a measure to prevent the formation of a fibrous lining around the distal end of the catheter.

The catheter may be made from any suitable biocompatible material including polyurethane silicone, polyurethane polycarbonate copolymer, or any other plastic or polymer material. The catheter may also include an antibacterial coating. The catheter may also be treated with an anti-infection agent, such as methylene blue, for example. The catheter may be of any size suitable for placement in a vessel structure, including sizes in the range of 22.32 to 38.1 centimeters (eight to fifteen inches). Other sizes are also included. The outer wall surface of the catheter may be cylindrical, D-shaped, double-D or split, for example. The catheter may also include a single lumen or several lumens.

Referring to Figs. 1 through 3, a distal part of catheter 10 including a body 12 and a distal end 14. is shown. One or more openings 16 are provided adjacent to the distal end 14, and extend through the wall 18 of the body 12 in communication with one another. the lumen20. The distal end 14 may be closed with one end or one end cap to prevent fluid flow through the same. In the embodiment illustrated, each aperture 16 is an elongate slit or rib generally extending parallel to the longitudinal geometrical shaft 13 of body 12. Other embodiments include other configurations for apertures 16, including slots extending transversely of the shaft. longitudinal geometrical axis 13 of body 12 and rounded openings with valve members that are open and closed.

In Figs. 1 to 3, three openings 16 are provided in wall 18 which extend along the longitudinal eixogeometric of body 12 and are spaced apart approximately 120 degrees apart from each other. Other embodiments include one or more apertures 16, including two apertures, four apertures, or five apertures. It is further contemplated that the openings may be equally spaced or differently spaced around the body 12. In the illustrated embodiment, each aperture 16 includes a spaced distal end a distance L1 from distal end 14, and extends along the geometry axis 13 by a length L2 to a proximal end of aperture 16. In a specific fashion, the length L1 is 5 millimeters and the length L2 is 15 millimeters. However, it should be understood that other distances to L1 and L2 are also contemplated, in the range from more than 0 millimeters to 20 or more millimeters.

The body 12 is comprised of a material of sufficient flexibility at least adjacent to the distal end 12 to facilitate manipulation of the wall 18 to open and close the openings 16. In Fig. 2, the body 12 is in a first configuration or condition. where the openings16 are closed. It is contemplated that the wall in closed condition 18 substantially seals opening 16 to prevent fluid flow from leaving or entering lumen 20 through apertures 16 under a low pressure gradient. During catheter injection, sufficient pressure is generated to cause the locking solution to escape from the closed openings. In Figs. 1 and 3, wall 18 has been manipulated to open one or more of doors 16 to provide fluid communication between lumen 20 and the exterior of body 12.

Manipulation of wall 18 may include displacing or deforming adjacent portions of wall 18 along aperture 16. Deformed wall portions may provide a round or bulbous shape along aperture 16. In one embodiment, apertures 16 are open by forming wall 18 along openings 16 to reduce length L2 to length L3. One or more parts of wall 18 along openings 16 may be radially expanded or separated from an adjacent wall part to open openings 16. Deformed wall parts 18 may loosen any fibrous coating formed thereon. Additionally, the deformation of the wall 18 may provide the openings 16 with sufficient size to accommodate any required blood flow through the lumen 20. When the openings 16 are closed, the portions of the wall 18 along the openings 16 contact each other along of the entire length of each opening 16 and strong enough to prevent fluid ingress and egress through wall 18 between lumen 20 and the vessel structure, and allows fluid to egress only under moderately positive pressure such as me when filling the catheter with a blocking solution.

It is further contemplated that a heat-mounting assembly may be provided to facilitate opening and closing of openings 16, and to maintain openings 16 in their open and closed condition. The actuation assembly may include an actuator adjacent to a proximal end portion of the catheter 10 so that the actuator is positioned outside the patient's body and readily accessible to the surgeon. The actuation assembly may additionally include one or more actuator members coupled with the actuator and extending along the catheter to a location adjacent openings 16. Actuator members are movable or operable with the actuator to manipulate the wall 18 and opened to close the openings 16 as desired.

In Fig. 4, a cross-section of the body 12 is grasped transversely to the longitudinal geometric axis 13 to illustrate one embodiment of an actuating member24. The wall 18 extends around the lumen 20 and closes the same from the outside of the body 12. A series of passages 22 are formed in the wall 18 and each is sized to receive an actuation member 24 therethrough. Although three acting members 24 are presented, it is also contemplated that one, two, or four or more acting members 24 may be provided. Actuation members 24 extend from a distal end of the same adjacent to the distal end 14 of the catheter 10 to a near end associated with an actuator, as further discussed below.

In the illustrated embodiment, the actuating members 24 extend through the respective enlarged portions 16 of the wall 18. The enlarged portions 16 protrude into the lumen 20 from the inner surface 30 of the wall 18, and provide a thickened wall region to accommodate the wall. insertion of actuation members 24 into the wall18. Actuating members 24 may be in the form of a wire, rope, cable, tendon, rod, connection, spring, or bar, for example. Actuation members 24 may be manufactured from stainless steel, titanium, polymer, shape commemorative material, or other suitable material. Actuating members 24 may be coated with antibacterial agents or lubricating material to facilitate movement in the wall 18. In other embodiments, it is contemplated that one or more actuating members 24 may extend through the lumen. 20

Actuation members 24 extend closely from a location adjacent distal end 14 and are coupled with an actuator at their proximal ends. It is contemplated that the distal ends of the actuating members 24 may be positioned proximate to the apertures 16, distantly to the apertures 16, or along the apertures 16. The actuator is positioned along a proximal portion of the catheter 10 and located outside. so that the distal part of the catheter 10 may be remotely manipulated with the actuator mechanism to selectively open and close the openings 16. In locations where the actuating members 24 enter and / or Outside the catheter body, locations may be sealed and treated to prevent fluid leakage and infection.

One embodiment of an actuator comprising an actuating mechanism with actuating members 24 is shown in Fig. 5 with a longitudinal cross section through actuator 50. Actuator 50 is positioned around the catheter body 12 and includes a hub 62 which may be engaged with a sliding locking mechanism 52. Hub 62 includes a central passageway 64 for receiving a portion of the sliding locking mechanism 52 and the catheter body 12. The hub 62 additionally includes a conical distal portion 68, and is securely secured to the catheter body 12. The sliding lock mechanism 52 includes a proximal portion 54 which may be manually grasped or grasped with a tool to facilitate displacement of the sliding lock mechanism 50 axial to the catheter body 12 and the hub62. Sliding locking mechanism 52 further includes a distal portion 56 extending into the hub passage 64 and around the catheter body 12. The distal part 56 includes a locking member 60 at a distal end thereof for engagement. with the proximal ends 25 of the acting members 24.

A series of locking surfaces 58 are formed along the length of the distal part 56 between locking member 66 and the proximal part 54. Hub 62 includes locking member 66 for engaging locking surfaces 58 with sufficient force. at any one of a series of positions along the locking surfaces58 and to keep the sliding locking mechanism 52 in the corresponding position relative to the hub 62. The locking member 66 is sufficiently elastic that the locking member 66 may be moved along the locking surface 58 to adjust a positioning of the sliding locking mechanism 52 relative to the hub 62.

Catheter wall 10 may be manipulated by displacement of the sliding locking mechanism 52, and the actuation members 24 are closely and axially relative to the hub 60 and catheter body 12. The actuating members 24 pull on the portions. from wall 18 adjacent the openings 16 to open the openings 16. The openings 16 may be closed by displacing the sliding lock mechanism 52, and thus the actuation members 24 distally and axially with respect to the hub 62 and the catheter body 12. Locking member 66 engages with the sliding lock mechanism 52 to hold the openings 16 in the open and closed position until sufficient force is applied to axially displace the locking mechanism 52 relative to the hub 62. The mechanism The actuator may additionally include one or more springs or other propensity members to facilitate keeping openings 16 open or closed.

Another embodiment of an actuator 150 that can be used with the catheter actuating mechanism 10 is shown in Figs. 6 and 7. Actuator 150 includes a hub 162 and a sliding locking mechanism 152. Sliding locking mechanism 152 includes a proximal portion 154 to be user-second, and a distal portion 156 extending within passage 166 of hub 162 Actuating members 24 are secured to the distal portion 156. Hub 162 includes locking surfaces formed by a pair of receptacles 170 formed therein in communication with passage 166.

Locking members 158 extend from the partitioning 156 and into the corresponding receptacles 170. Each of the receptacles 170 includes a proximate displacement portion 172 and a distal displacement portion 174.

To position and maintain the openings 16 in a closed position, the sliding lock mechanism 152 is distally advanced on the hub 162 and rotated to position the locking members 158 on the distal displacement portions174. To position and hold the openings 16 in an open position, the sliding lock mechanism 152 is drawn proximally from the hub 162 and rotated to position the locking members 158 on the next displacement portions 172. Positioning of the members The locking bolts158 in the displacement portions prevent axial movement of the sliding lock mechanism 152 relative to the hub 162.

It is also contemplated that the reciprocating displacement portions 170 may be provided between the proximal and distal displacement portions 172, 174 to provide a variation in the degree of openness of the apertures 16e for changes in the physical properties of the catheter body 12 and the acting member 24 over time.

Another embodiment of an actuator 250 for an actuation mechanism for catheter 10 is shown in Figs. 8 and 9. Actuator 250 includes a hub 262 and a sliding locking mechanism 252. Sliding locking mechanism 252 includes one or more locking members 254 extending therefrom. Actuation members 24 are secured to and movable with locking slide mechanism 252.

Hub 262 includes a pair of opposite end portions 263 that can be engaged with the catheter body 12. Hub 262 additionally includes a pair of opposed slit doors 264 and a pair of opposite side walls 265 extending between doors with opposed slits 264. At least one receptacle 266 extends through at least one of the side walls 265. The receptacle 266 includes a displacement portion 268 at a proximal end thereof.

The sliding locking mechanism 252 is positioned between the sidewalls 265 and movable therebetween axially along the catheter body 12. The locking member 254 extends into the receptacle 266, and is movable therethrough with the movement of the mechanism slide slider 252 for positioning within displacement portion 268 to hold openings 16 in an open condition. A second distal displacement receptacle portion (not shown) may be provided for securing openings 16 in a closed condition, and displacement portions may be provided along the length of receptacle 266 to accommodate variation in length. opening the openings 16 and the physical properties of the catheter body 12 and the acting members 24.

The actuator of another embodiment 350 is shown in Figs. 10 and 11. In Figs. 10 and 11, the proximal end of the catheter 10 is provided with a sheath 40 that can be positioned below skin level to help maintain the catheter in the patient and prevent leakage around the catheter 10.

The proximal end of catheter 10 further includes an Iuer locking fitting 42. Actuator 350 includes tube member 352 through which actuating member 24 extends. Pipe member 352 extends transversely from one side of a distal portion 43 of socket 42.

The portion of tube member 352 closest to hub 43 includes a plastics material, such as silicone glue, namesma, to serve as a seal around actuating member 24. Actuating member 24 extends through tube 352 and plastics material up to an enlarged end member 26 at the proximal end of actuating member 24. Each member 26 is connected with a tube member352 and ensures that actuating member 24 moves with the expansion and compression of tube member 352. Tube member 352 includes an accordion-like shape along its length, with a wall that folds over itself to allow expansion and contraction of the length of tube member 352. A tube member 352 may be glued or sealed at each end. to prevent contamination.

Figs. 12 through 14 illustrate various views of a distal part of a catheter according to another embodiment. Catheter 410 includes a catheter body 412 with a lumen 420. Distal end 413 of body 412 is sealed with a lid 414, which may be integral. with body 412 or a separate member sealedly engaged therewith. Body 412 includes a wall 418 extending around dolmen 420. Wall 418 includes one or more openings 416, which may be elongated slots or grooves as discussed in FIG. above with respect to the catheter 10.

Wall 418 additionally includes an inflating lumen 422 formed therein for dispensing a fluidotal such as saline, air, gas, or other suitable fluid to inflate an enlargement member 428. A widening member 428 is positioned lumen 420, and are shown in a reduced size configuration in Fig. 12 and in an enlarged configuration in Figs. 13 and 14. Flare member 428 may be in the form of a balloon, pouch, bladder, diaphragm or other device capable of opening and closing openings 416 as it is enlarged or reduced.

End cap 414 and distal end 413 define a pocket 424 therebetween. An inflation tube or rod 426 extends through lumen 420 from distal end 413. Rod 426 includes an internal passageway in fluid communication with bag 424 and flare member 428. Accordingly, fluid may be moved through the tube. insufflation lumen 422 to pocket 424 and through stem 426 to flare member 428 to selectively widen or shorten flare member 428.

One or more arms 430 extend between an enlargement member 428 and an inner surface 419 of wall 418 at wall portions 432 adjacent openings 416. As shown in Fig. 14, an arm 430 is provided between each opening 416. As the member Widening 428 is widened, arms 430 pushes outwardly to radially deform wall parts 432 of wall 418 and separate adjacent wall parts 432 and opening each opening 416. In the illustrated embodiment, three arms 430 are provided. , three doors 416, and three wall portions 432 between adjacent doors 416.

The arms 430 spacing the widened widening member wall portions 432 to provide a path for blood flow through the openings 416 and around the widened widening member 428 within lumen 420. When fluid is removed from the widening member. widening 428, its size is reduced and arms 430 pull wall portions 432 for alignment with catheter body 412, closing openings 416 to prevent flow therethrough. To effect a positive force between the adjacent sides of the wall portions 432 to sealably close openings 416, a negative pressure may be applied to the flange member 428 by pulling the wall portions 432 radially inwardly. in contact with each other.

Other configurations for apertures 416 are also contemplated, including a single aperture 416 with a pair of wall portions 432 positioned adjacent to the sides thereof. In another embodiment, a pair of doors 416 is provided on opposite sides of the body 412, and a pair of wall portions 432 is centrally spaced between opposite openings 416.

In an additional embodiment four or more doors 416, with a corresponding number of wall parts positioned between adjacent openings, are contemplated. Any or all of the wall portions of the embodiments may be provided with an arm extending between the wall portion and the flare member.

Other embodiments are also contemplated for dispensing fluid to widen the widening member 428. For example, one or more of the arms 430 may include a passage for distributing fluid to the widening member428. In another embodiment, the enlargement member 428 is in direct fluid communication with the enlargement lumen 422.

The catheter embodiment in Figs. 12 through 14 uses pneumatic or hydraulic devices to manipulate catheter 410 face 418 to selectively open and close openings 416. When openings 416 are closed, blood flow is prevented from entering lumen 420 and a locking solution may be retained in lumen 420 to prevent coagulation.

Other variations for stem 426 and arms430 are also contemplated. For example, stem 426 may include an accordion-like bellows or other suitable configuration that may be axially expanded or otherwise compressed or otherwise axially movable to reposition rod 426 into lumen 420. Arms 430 may include a wire form or other pivotal shape structure connected with the rod 426 and the wall portions 432. When the rod 426 is in a first axial configuration, and positioned relative to the wall portions 432, the arms 430 are angled between rod 426 and wall portions 432 to maintain openings 416 in a closed condition. When the rod 426 is moved to a second axial configuration, the ends of the arms 430 connected with the rod 426 move with it, and as the arms become more orthogonally oriented relative to the rod 426, the arms430 radially push out the wall portions 432 to open the openings 416.

In yet another embodiment, arms 430 extend along their geometric axes between rod 426 and wall portions 432 to move wall portions 432 apart to open openings 416. Arms 430 are flexible along of its geometrical axes to move wall portions 432 towards each other and close openings 416. In this embodiment, rod 426 may be non-expandable and / or non-movable. In one form, the arms 430 include an accordion or bellows configuration along its length. In another form, the arms 430 include a balloon-like configuration and are at least expandable in shape, and may also be expandable in shape.

Figs. 15 and 16 present a distal portion of the catheter of the other embodiment. In Fig. 15 the distal openings of the catheter are in a closed condition, and in Fig. 16 the distal openings are in an open condition. Catheter 510 includes a catheter body 512 with a central lumen520 defined by a first wall 518. The distal end 513 of the first wall 518 may be opened to allow fluid to flow therethrough, and may be closed to prevent fluid. to flow through it. First wall 518 includes one or more openings 516, which may be elongated slots or ribs extending to distal end 513. Adjacent doors 516 are separated by wall portions 519 extending therebetween.

A second wall 522 extends through the lumen 520 and forms a second lumen 524. The second lumen 524 is open at the distal end 526 of the second wall 522. The second wall 522 includes a series of end members 528 which are normally bent into position. closed to prevent fluid flow from entering second lumen 524. Pressure from fluid in second lumen 524 causes end members 528 to move away from each other, allowing fluid to eject from dolmen 524 through the end. 526. Other embodiments contemplate that lumen 524 is not used for blood flow. Still other embodiments contemplate that catheter 510 is provided without a lumen 524.

The second wall 522 additionally includes an enlargement member 530 formed around it, close to the end members 528. The enlargement member 530 is received in lumen 520, and has a flexible or small size configuration as Fig. 15, and an enlarged or expanded configuration as shown in Fig. 16. The second wall 522 may include a lumen inflation (not shown) in fluid communication with an interior of the enlargement member 530, for fluid delivery and removal. from flare member 530. The fluid may be saline, air, gas, or other suitable fluid to inflate or widen flare member 530.

Enlargement member 530 may be in the form of a balloon, pouch, bladder, diaphragm, or other device capable of opening and closing openings 516 as it is enlarged or reduced. When in the unexpanded condition daFig. 15, adjacent wall portions 519 contact each other such that openings 516 are closed. Fluid flowing into second lumen 524 may exit dolmen 524 through opening the distal end of second wall 522 since fluid pressure is sufficient to open distal end 526 by separating end members 528. If fluid ingress into the dolmen 520 is desired, the fluid may be distributed to flare member 530 to cause it to widen or expand. As it expands, it acts upon wall portions 519 to radially deform wall 518 and cause openings 516 to open as wall portion 519 separates.

The arms 532 may be provided between an enlargement member 530 and the wall portions 519 to facilitate radial deformation of the wall 518, to secure closure of the openings 516, and to prevent the wall portions 518 from spacing from the widening member 530. The arms 532 connect the wall parts 519 with the widening member 530. In one embodiment, there is zero space between an enlargement member 530 and the wall portions 519, and the flow flow is directed through the openings 516 near the distal end 513. The arms 532 are provided with sufficient elasticity to traverse the different radii of curvature. between the distal ends of the wall portions 519 and the widened widening member 530. In another embodiment, the arms 532 maintain separation between the inner wall surface 518 and the widening member 530, facilitating fluid flow through the distal end opening of the first wall 518 and also through the openings 516 between the wall portions. adjacent wall 519.

In the illustrated embodiment, arms 532 extend radially from respective wall portions 519 and contact a widening member 530. It is also contemplated that one or more of arms 532 may also be located within lumen 520, and may include any configuration as discussed above with respect to arms 430. In the illustrated embodiment, three arms 532, three doors 516, and three wall portions 519 are provided between adjacent doors 516.

The wall portions 519 may or may not be spaced from the enlarged widening member 530. When an enlargement member 530 is widened, open apertures 516 provide a path for blood flow therethrough and around widened member 530 into lumen 520. When fluid is removed from enlargement member 530 , their size reduces and the wall portions 519 flex in alignment and engage with contact with each other, closing the openings 516 to prevent flow therethrough. In one embodiment, the arms 532 may be engaged with the widening member 530 and the wall portions 519 to pull the wall portions 519 into the closed condition. Arms 532 can ensure positive closure of openings 516 when widening member 530 is in its reduced size configuration. In another embodiment, the wall portions 519 are naturally biased via an integrated hinge connection with the wall 518 for the closed condition.

In a further embodiment, the arms 532 may be held close to the distal ends of the wall portion 519 at one end of each of the arms 532 and include an opposite end that rides or floats along the enlargement member 530 as it is expanded or reduced. In yet another embodiment, arms 532 may extend along their geometrical axes between an enlargement member 530 and wall portions 519 to move wall portions 519 apart to open apertures 516 as fluid is distributed to each other. arms 532. Arms 532 may be flexible along their geometric axes to move wall portions 519 towards each other and close openings 516. In this fashion, the enlargement portion 530 may be unexpanded or may not widen. In one form, the arms 532 include an accordion or bellows configuration along their lengths. In another form, arms 532 include a balloon-like configuration and are at least axially expandable, and may also be radially expandable.

Other configurations for apertures 516 are also contemplated, including a single aperture 516 with a pair of wall portions 519 positioned adjacent to the laterals thereof. In another embodiment, a pair of doors 516 is provided on opposite sides of the body 512, and a pair of wall portions 519 are centrally spaced between opposite openings 516. In an additional embodiment, four or more openings 516 with a corresponding number of wall parts. positioned between adjacent openings are contemplated. For either embodiment, one or more arms 532 may be provided between a widening member and one or more wall portions, or no arm 532 is provided.

The catheter embodiment in Figs. 15 and 16 use pneumatic or hydraulic devices to manipulate catheter wall 510 of selectively open and close openings 516. When openings 516 are closed, blood flow is prevented from entering lumen 520 and a locking solution may be retained in lumen 520 to prevent coagulation. The blocking solution may also be maintained at 524 lumen to prevent clotting.

Figs. 17 through 21 show a distal portion of the catheter of the other embodiment 610. In Fig. 17, the distal openings of catheter 610 are in a closed condition, and in FIG. 18 the distal openings are in an open condition.

Catheter 610 includes a catheter body 612 having a first lumen 620 defined by a first wall 618. The distal end 613 of the first wall 618 is closed, and one or more openings 616 are formed in the first wall 618 in communication with the first lumen 620. Adjacent doors 616 are separated by the first wall portions 619 extending therebetween. The apertures 616 may be opened by deforming the wall portions 619 to allow fluid to flow therethrough, and may be closed to prevent fluid ingress or egress from the lumen 620. At one or more openings 616 may be slits or elongate ribs extending along first wall 618 to a location near distal end 613.

The body 612 also includes a second wall 622 and extending around a second lumen 624. The second lumen 624 is closed at the distal end 626 of the second wall 622. The second wall 622 includes a series of openings 628 separated by the portions of wall 637 between the same. The apertures 628 are usually biased toward the closed position to prevent fluid flow therethrough.

The pressure of fluid in the second lumen 624 causes the wall parts 637 to move away from each other and split to open the openings 628 allowing fluid to flow in and egress from the lumen 624 through the openings 628.

A common wall portion 625 extends between and to the lumens 620, 624. In the illustrated embodiments, the first and second walls 618, 622 form the shaped lumens of D 620, 624. Other embodiments contemplate other formats for the lumens 620, 624, including circular, oval, polygonal and irregular shapes, for example. Other modalities contemplate the non-existence of a common wall part between the lumens 620, 624. Instead, each of the lumens is circumscribed by a separate wall. Separate walls may be separated or divided at least along the distal portion of catheter 610. Otherwise, the walls may be engaged with each other although they may still be divided to allow the walls to be separated from each other. , if desired.

First wall 618 includes a first flaring member 629, and second wall 622 includes a second flaring member 630. Flaring members 629,630 may be received in respective lumens 620, 624 and have a flexed or reduced size configuration as shown in Fig. 17, and an enlarged or expanded configuration as shown in Fig. 18. At least one of the first and second walls 618, 622 or common wall 625 may include a communicating inflation lumen 635 in communication. fluid with an interior of the enlargement members 629,630 for dispensing and removing fluid from the enlargement members 629, 630. The fluid may be saline, air, gas, or other suitable fluid to inflate or otherwise drop the widening members 629, 630.

Inflating lumen 635 may be provided in communication with the interiors of one or more of the flaring members 629, 630 to provide a path for fluid distribution therein and removal from the same to selectively widen and reduce the size of the widening members. 629, 630. The inflation lumen 635 may be extended between communicating with each of the interiors of the enlargement members 629, 630, so that the enlargement members 62 9, 630 may be simultaneously enlarged or simultaneously reduced in size. Other modalities include a separate insufflation lumen in communication with the respective widening members 62 9,630. Insufflation lumen 635 is shown in common wall 625. Other embodiments include one or more insufflation lumens in first wall 618 and / or second wall 622.

Enlargement members 629, 630 may be in the form of a balloon, pouch, bladder, diaphragm, or other device capable of opening and closing openings 616, 628 as it is enlarged or reduced. When in the non-expanded condition of Fig. 17, adjacent wall portions 619, 637 contact each other such that openings 616, 628 are closed. The fluid may be distributed to the enlargement member 629 to cause it to widen or expand. As it expands, it lifts onto wall parts 619 to radially deform first wall 618 and cause openings 616 to open as wall parts 619 separate.

Similarly, fluid may be delivered to the enlargement member 630 to cause it to widen or expand. As it expands, it acts on wall parts 637 to radially deform second wall 622 and cause openings 628 to open as wall parts 637 separate from each other. Pneumatic or hydraulic devices may be used to manipulate flare member 629, 630 to selectively open and close openings 616, 628. When openings 616, 628 are closed, blood flow is prevented from entering the lumens 620, 624 and a blocking solution may be retained at lumens 620, 624 to prevent coagulation.

One method of making catheter 610 is to shape the body 612 so that the distal ends of the lumens 620, 624 are initially open. The extension members 629, 630 are inserted in a bent condition through the respective distal end openings. A plug is then positioned in each of the distal end openings. The cap and catheter body material is again drained or otherwise sealed to seal the widening members in their lumens. A pin or other hole forming device is inserted through the wall or walls to form a passageway between the interior of the flare member and one or more inflating lumens. The hole is then capped or sealed to seal the flare lumen and flare members.

Arms 632, 633 may be provided on wall portions 619, 637 along respective openings 616, 628. Arms 632, 633 may include shape-recovering properties to facilitate closure of openings 616, 628 upon release of the force of deformation of the wall portions 619, 637. The arms 632, 633 may be embedded in the wall portions 619, 637, and have the form of a wire or other bendable member that moves with the wall portions. 619, 637 when deformed to open the openings. The shape recovery properties of the arms 632,633 keep the doors 616,628 in a positively closed condition to allow the blockage or other fluid to be contained in the lumens 620,624. Various shapes for the arms 632,633 are contemplated. including spring steel, nickel and titanium alloy (nitinol), or other suitable material. Other embodiments contemplate that wall portions 619, 937 are made from material having shape recovery properties for effecting positive closure of the openings.

When the widening members 629, 630 are released, the openings 616, 628 provide a path for blood flow therethrough and the widened widening members 629, 630. When fluid is removed from flare members 629, 630, its size is reduced and wall parts 619, 637 flex in alignment and engage engagement with one another, closing openings 616, 628 to prevent flow therethrough. The arms 632, 633 can provide positive closure of the openings 616, 628 when the widening members 62 9, 630 are in a reduced size configuration.

In another embodiment, the wall parts 619, 637 are naturally prone to the closed position via an integrated hinge connection with the walls 618, 622 or by the material properties of the wall parts 619, 637.

Other configurations for apertures 616, 628 are also contemplated, including a single aperture between a pair of adjacent wall parts. In another embodiment, a pair of openings are provided on opposite sides of the respective wall parts. In an additional embodiment, four or more openings are provided in respective wall portions with a corresponding number of wall portions between adjacent openings. For either embodiment, the wall portions may have the same number of openings, or may have a different number of openings. The openings also extend non-longitudinally to the respective walls.

Referring to Figs. 22 through 24, a distal part of a lumen part 710 of a catheter 700 including a body 712 and a distal part 714 is shown. One or more openings 716 are provided along the distal parts 714, and extend through the wall 718 of the body 712 in communication with a lumen 720. The distal part 714 may be closed with an integral tip or cap 719 at its distal end to prevent fluid flow therethrough. In the illustrated embodiment, each opening 716 is an elongated slot or rib extending generally parallel to the longitudinal geometry axis 713 of body 712. It should be understood that a second lumen portion 710 of catheter 700 could be provided adjacent to lumen portion 710. which is similar to lumen 710. Together, lumen parts 710 provide separate flow paths for fluid inlet and fluid outflow. Other embodiments contemplate that the 720 light could be divided into several separate lumens.

Three doors 716 are provided on the wall 718 which radially extend through the distal portion 714 approximately 90 degrees apart from the central opening 716a. Other embodiments contemplate one or more apertures 716 including two apertures, four apertures, or five or more apertures. It is further contemplated that the openings may be equally spaced or evenly spaced around the distal part 714. The distal part 714 may be made of a material with sufficient flexibility so that the wall segments 722, 724, 726 between the openings 716 can be bent or deformed to open and close the openings 716. In Fig. 22, the distal part 714 is in a first configuration or condition where the openings 716 are closed. It is contemplated that under the closed condition, wall 718 substantially seals openings 716 to prevent fluid flow from leaving or entering lumen 720 through openings 716. In Fig. 24, wall 18 has been manipulated to open one or more of openings 716 to provide communication. flow between lumen 720 and an exterior of body 712 through apertures 716.

Manipulation of wall 718 may include displacing or deforming adjacent wall segments 722, 724, 726 along openings 716. In one embodiment, openings 716 are opened by deforming wall segments 722,724, 726 along openings 716 to reduce distal part length 714 from a first undeformed length to a shorter deformed length.

One or more wall segments 722, 724, 726 along openings 718 may be expanded or separated from an adjacent wall segment 722, 724, 726 to open openings 716. Deformed portions of wall segments 722, 724, 726 may loosen. any fibrosoform lining around wall 718 adjacent openings 716.

Additionally, the deformation of the wall segments 722,724,726 may provide the openings 716 with sufficient size to accommodate any required blood flow through the lumen 720. When the openings 716 are closed, the wall segments 722, 724, 726 along openings 716 contact each other along the entire length of each opening 716 and hard enough to prevent fluid ingress and fluid ingress through openings 716 between lumen 720 and the frame It is further contemplated that a deactivation mechanism may be provided to facilitate opening and closing of openings 716, and to maintain openings 718 in their open and closed condition. The actuation mechanism may include an actuator adjacent to a proximal end portion of catheter 700 such that the actuator is positioned outside the patient's body and readily accessible to the surgeon. The actuation mechanism may additionally include one or more actuation members 730 coupled with the actuator and extending along the catheter to a location adjacent the openings 716. One or more actuation members 730 are movable or operable with the actuator. manipulating wall segments 722, 724, 726 and opening or closing openings 716 as desired.

In Figs. 22 through 24, actuation member 730 is positioned in a lumen 712 along a side wall 734 of body 712. Rounded wall 736 extends between opposite sides of side wall 734, and may include additional but not additional actuation members. in the illustrated embodiment. Actuation member 730 may be in the form of an embedded wire or wrapped by sidewall 734, or which is positioned in a lumen formed on sidewall 734. Such a lumen to receive actuation member 730 could be formed of a stainless steel flat wire winding or nitinol. Actuation member 730 may also be manufactured from stainless steel, nitinol or from any suitable material. Actuation member 730 extends through distal part 714 between wall segments 722, 724, 726 to distal cap 719. Actuation member 730 may be wrapped around cap 719 to prevent it from being pulled out. datamp 719.

The openings 716 are positively closed by distally moving the actuating member 730 toward the cover 719, stretching the distal portion 714 and forcing the wall segments 722, 724, 726 to contact engagement with one another. Since wall segments 722, 724, 726 substantially cover the entire cross-sectional area of distal part 714, more surface area is provided along and between adjacent wall segments 722, 724,726 to form a positive seal than would be. provided if lumen 720 was carried through the distal part 714 in the same size and shape as provided in the body 712. The openings 716 are opened by tensioning the actuation member 730, compressing the distal part 714 between the cover 719 and the body 712. Other embodiments include that the openings are normally closed by the material properties and configuration of the wall segments 722,724, 726. and open in response to fluid pressure, for example. In addition, wall segments 722, 724, 726 may include tapered portions 729 at proximal ends thereof that taper inwardly toward openings 716 to facilitate fluid flow therethrough from lumen 720 without sudden changes to the profile.

In Figs. 25 and 26, another catheter 800 is shown. Catheter 800 includes a lumen portion 810 having a body 812 formed by a wall 818 extending around a lumen 820. Lumen 820 opens at a distal end of body 812. to form an opening 816 for fluid flow ingress and / or egress. It should be understood that catheter 800 may include one or more lumen parts 810 which may provide additional lumens for fluid inlet or egress.

In addition, catheter 800 includes an end cap 830 associated with body 812 and movable relative to it from an open position, as shown in FIG. 25 to a closed position. The opening 816 may be opened by deforming catheter 800 from its closed position by moving the distal end cap 830 from its closed position to the open position.

In the open position, the cap 830 is spaced from the distal end 822, resulting in a change in the length of the catheter 800 so that the aperture 816 is opened to allow fluid passage into and out of the lumen820. End cap 820 is coupled to body 812 with one or more actuating members 834 extending between body 812 and end cap 830. Actuating members 834 may be in the form of a wire in adjacent wall 818. or at the junction of the linear portion 819 and the rounded convex portion 821. Each actuation member 834 may be positioned in a lumen formed on the wall 818. Such a lumen to receive the respective actuation member 834 could be formed by a flat wire winding of stainless steel or nitinol. Actuation members 834 can also be manufactured from stainless steel, nitinol or any suitable material. Actuation member 834 may be located at other locations around wall 818, and lumen part 810 may include one, two or three or more actuation members 834.

End cap 830 may be moved for closed position from the open position by moving axially and proximally to end cap 830 towards opening 816 along longitudinal longitudinal axis 811 and for sealed engagement with body 812. Members 834 may be coupled with an actuation mechanism to allow displacement of the actuation members 834, and thus end cap 830, along the geometry axis 811 to the closed position. To open the opening 816, actuation members 834 are distally displaced with the actuator mechanism for displacing cap 830 distally along axis 811 and with respect to aperture 816 and body 812. End cap 830 may include a tapered proximal part 832 which can facilitate reception through the 816 lumen opening 820. The tapered part 832 may also allow the cap 830 to automatically center relative to opening 816 and provide sealed engagement with wall 818.

Referring now to Fig. 27, an example of an actuation mechanism 900 which may be employed with catheters 700, 800 or with other catheter modalities discussed herein is shown. Catheters 700, 800 include lumen portions 719, 810 which are coupled together in a proximal hub 902. Proximal hub 902 may include a Y-shape separating the two lumen portions for connection with fluid sources or with other equipment at connectors 904, 906. In one embodiment, one of the lumen parts 710, 810 may be designed to provide fluid flow to the patient's body and the other lumen part 710,810 may be designed to receive flow. fluid from the patient's body as indicated by arrow 908, 910.

Actuation members 730, 834 of lumen parts 710, 810 may be coupled with adjacent actuator hub902.

The actuator may include the first and second slide buttons 912, 914. Each slide button is coupled with one or more actuator members 730, 834 of respective lumen part 710, 810. Slide buttons 912,914 allow the movement of the actuation members of the respective lumen portion 710, 810 along the wall of the lumen portion. Separate sliding knobs 912, 914 may be moved axially in the near or distal direction as desired to effect the corresponding independent and remotely activated movement of the distal part 714 or datamp 830, depending on the lumen part 710, 810. employed with actuator mechanism 900. Such movement permits the selective opening and closing of one or more parts to allow fluid flow therethrough.

While the invention has been illustrated and described in detail in the drawings and the foregoing description, they are to be considered illustrative and not restrictive in nature. For example, for any modality catheter, actuation mechanisms are contemplated that include micro-motors or other automatic or mechanical systems for opening and closing fluid flow openings. It is desired that all changes and modifications arising within the scope of the invention be protected.

Claims (36)

1. Catheter, characterized in that it comprises: a body defining at least one lumen extending along a longitudinal geometrical axis of the dithibody, said lumen for fluid flow passage therethrough, said body extending between a distal part may be positioned in a vascular structure of a patient and a proximal end which may be positioned outside the patient with said distal part in the vascular structure, said distal part of said body including several adjacent wall segments extending along the same distance from said lumen, said wall segments together having a size and shape which substantially corresponds to a size and shape of the dictolum transversely to said longitudinal longitudinal axis where said segments of adjacent walls define an opening therebetween, each of said openings including a first closed condition formed by engaging said contacts adjacent wall segments to impede fluid flow between said lumen and the vascular structure through said openings, said openings including a second open condition formed by deforming at least one of said wall segments to open at least one. said openings to allow flow of fluid between the vascular structure and said lumen through said openings. Catheter according to Claim 1, characterized in that said body includes an actuation member in a wall of said body, said actuation member extending through said distal part and being secured in a located cap. distal to the so-called partisan. Catheter according to claim 2, characterized in that said actuation member is a wire and said wire includes a distal end wrapped around the cap. Catheter according to claim 2, characterized in that in said closed condition, said actuating member tensions said body and has said adjacent wall segments for contact engagement with each other. Catheter according to claim 2, characterized in that in said open position said actuating member compresses said wall segments between said cap and said body of said catheter. Catheter according to claim 2, characterized in that said actuation member extends between said wall segments. Catheter according to claim 1, characterized in that said various wall segments include three wall segments. A catheter according to claim 1, characterized in that each of the wall divisions and said body defines a D-shaped transverse section along said longitudinal longitudinal axis. Catheter according to claim 1, characterized in that it further comprises: a second body defining at least one second lumen for flow and flow therethrough, said second body extending between a second portion thereof; may be positioned on the patient's vascular structure and a second proximal end that may be positioned outside the patient with said distal part in the vascular structure, said second distal part of said second body including several adjacent wall segments extending therein distal to said second lumen and said adjacent wall segments defining an aperture therebetween, which is movable between the open and closed positions, with an actuation member coupled with a close actuator mechanism. 10. Catheter, characterized in that it comprises: an elongate body extending between a distal end and a proximal end, said body including a wall defining at least one lumen for flow through it, wherein said body includes at least at least one aperture at said distal end of said spaced body in communication with said at least one lumen, and additionally comprising an end cap at said distal end and a mechanism of actuation at said near end, said cap. the end being coupled with said actuation mechanism with at least one actuation member extending on said wall along said lumen, wherein said actuation mechanism is operable to remotely move said end cap away from said aperture to a condition open and allow fluid flow through said aperture and said actuation mechanism is additionally operable to remotely move said cap the end towards said distal end for a closed condition in sealed engagement with said body to prevent fluid flow through said aperture. Catheter according to claim 10, characterized in that said elongate body extends along a longitudinal geometrical axis and the end cap is movable along said longitudinal geometrical axis between said longitudinal axis. open condition and said closed condition. Catheter according to claim 10, characterized in that said end cap includes a proximal conical portion which may be positioned within said lumen through said aperture in said closed condition. Catheter according to claim 10, characterized in that said at least one actuation member includes a first actuation member along one side of said body and a second actuation member along an opposite side. of said body, each of said first and second actuation members extending between and being coupled with said end cap and with the actuation dithomechanism. Catheter according to claim 13, characterized in that each of said actuating members is coupled with a sliding knob of said actuating mechanism. Catheter according to claim 10, characterized in that each of said wall and said lumen defines a D-shape. A catheter according to claim 10, further comprising: a second elongate body extending between a distal end and a proximal end, said second body including a second wall defining at least one second lumen for blood flow through the even, wherein said second body includes at least a second distal end opening in said second elongate body in communication with said at least one second lumen, and additionally comprising a second end cap on said distal end and an actuation mechanism is undone. near end of said second body, said second end cap being coupled with said actuation mechanism with at least one second actuation member and extending on said second wall along said second lumen, wherein said actuation mechanism is operable to move said second parallel end cap of said s In the second opening to an open condition and allowing fluid flow through said second opening, said actuation mechanism is additionally operable for moving said second end cap towards said distal end to a closed condition in sealed engagement with said second opening. second elongate body to prevent fluid flow through said second aperture. Catheter according to claim 16, characterized in that said actuation members are coupled with the respective first and second sliding buttons of said actuating mechanism, said sliding buttons being movable to displace said resins. -looking actuating member and end cap between open and closed conditions. Catheter according to claim 17, characterized in that said elongate bodies are joined in a cube at said ends near the elongate said bodies adjacent to said actuating mechanism. 19. Catheter, characterized in that it comprises: an elongate body defining a pair of lumens, one for fluid flow therethrough, each of the lumens extending between a distal end and a near end, where each of the said lumens include an opening at said distal end thereof in communication with said lumen, and additionally comprising a pair of end caps at said distal ends of said respective lumens and a mechanism of actuation at said proximal ends of said lumens, each of said caps. coupling with said actuating mechanism with at least one actuating member extending into a wall along said respective lumen, wherein said actuating mechanism is operable to independently and remotely move each one of said end caps with said respective actuating member away from said opening of said respective lumen to a open condition and permit fluid flow through said aperture, and wherein said actuation mechanism is operable to independently and remotely move each of said end caps toward said open said respective lumen to a closed condition in engagement with said body for preventing fluid flow through said opening of said respective lumen. Catheter according to claim 19, characterized in that said actuation mechanism includes a pair of sliding buttons, each associated with a respective lumen of said pair of lumens, each of said pair of buttons. the respective actuation member of said at least one actuation member and being operable to move said end cap between said open and closed conditions. Catheter, characterized in that it comprises: a body defining at least one lumen for passing blood flow therethrough, said body extending between a distal end which may be positioned in a vascular structure of a and a proximal end which may be positioned outside the patient with the distal end in the vascular structure, said body including a wall having adjacent wall portions defining at least one aperture adjacent to said distal end, said at least an opening including a first closed condition formed by the contact engagement of said wall parts to prevent blood flow through said opening into said lumen, said opening including a second open condition formed by radially deforming at least one of the said wall portions to open said at least one aperture and allow blood to flow through said aperture into said lumen, where ad The wall of said body defines said at least one lumen, and said body further comprises a second wall defining a second lumen, said first and second lumens extending in side by side relationship with one another. Catheter according to claim 21, characterized in that said wall terminates at a first distal end and said second wall ends at a second distal end, said first distal end being spaced close to said second end. get away. Catheter according to claim 22, characterized in that said second wall includes at least one opening in communication with said second lumen, said at least one opening of said second wall extending along said second wall and located at said second wall. distal form of said first distal end. The catheter of claim 23 further comprising a first enlargement member adjacent said at least one lumen and a second enlargement member adjacent said second lumen, said first enlargement member being removable. for deforming said wall and opening said at least one opening of said wall and said second widening member may be enlarged to deform said second wall and opening said at least one opening of said second wall. Catheter according to claim 21, characterized in that it further comprises a common wall between said at least one lumen and said second lumen. Catheter according to claim 21, characterized in that each of said lumens includes a D-shaped portion. 27. Catheter, characterized in that it comprises: a body defining at least one lumen for passing blood flow therethrough, said body extending between a distal end portion which may be positioned in a vascular structure of a patient. and a proximal end that may be positioned outside the patient with the distal end portion in the vascular structure, said body including at least one wall having adjacent wall portions defining at least one opening said distal end portion in communication with said at least one lumen, said at least one opening including a first closed condition formed by engaging contact of said wall portions to prevent blood flow through said at least one opening, wherein said body includes a limb. adjacent to the dipstick at least one opening, said enlarging member having a reduced size configuration when said at least one opening The opening is in said closed condition and the enlargement member may be widened to a widened configuration to deform at least one of said wall portions and to place said at least one opening in an open condition to allow blood flow through the at least one dictaphone. opening, wherein said wall of said body defines said at least one lumen and said body further comprising a second wall defining a second lumen, said first and second lumens extending side by side with each other. Catheter according to claim 27, characterized in that it further comprises a common wall between said at least one lumen and said second lumen. A catheter according to claim 27, characterized in that each of said lumens includes a D-shape at least along said distal end portion of said body. A catheter according to claim 27, characterized in that said wall ends at a first distal end and said second wall ends at a second distal end, said first distal end being spaced close to said second end. get away. Catheter according to claim 30, characterized in that said first and second distal ends are closed. A catheter according to claim 31, characterized in that said second wall includes at least one opening in communication with said second lumen, said at least one opening of said second wall extends along said second wall and is in contact with said second wall. located distal form of said first distal end. A catheter according to claim 32, characterized in that it further comprises a second enlargement member in said second lumen, said second enlargement member being enlarged to deform said second wall and placing said at least one open said second second member. wall in an open condition. A catheter according to claim 33, characterized in that said at least one widening member is located between said first distal end and said at least one lumen and said second widening member is located between the said second distal end and said second lumen. Catheter according to claim 33, characterized in that each of said wall and said second wall includes an arm embedded therein adjacent to a respective opening of said openings, said arms including shape recovery properties. to provide active closure of said doors when said widening members are in a reduced size configuration. Catheter according to claim 33, characterized in that said body includes at least one insufflation lumen in fluid communication with each of said enlargement members.