SMALL DIAMETER CATHETER FOR INTRODUCTION INTO THE TRACHEA AND OTHER ORIFICES, AS WELL AS INTO PASSAGES THAT ARE DIFFICULT TO INTUBATE OR ACCESS

Abstract

A catheter includes: a tubular member having a first end, a second end, a body extending between the first end and the second end, and a first lumen in the body; a first flexible line having at least a segment located in the first lumen of the body; and a first anchor at an end of the first flexible line, the first anchor having a cross sectional dimension that is larger than a cross sectional dimension of the first lumen; wherein the first anchor is configured to apply a compression force against an exterior surface at the first end of the tubular member in response to tension applied through the first flexible line.

Claims

1. A catheter comprising: a tubular member having a first end, a second end, a body extending between the first end and the second end, and a first lumen in the body; a first flexible line having at least a segment located in the first lumen of the body; and a first anchor at an end of the first flexible line, the first anchor having a cross sectional dimension that is larger than a cross sectional dimension of the first lumen; wherein the first anchor is configured to apply a compression force against an exterior surface at the first end of the tubular member in response to tension applied through the first flexible line.

2. The catheter of claim 1, wherein, in a first operational mode, the first anchor is configured to engage against the first end of the tubular member to allow a bending of the tubular member to occur based on the tension applied through the first flexible line; and wherein, in a second operational mode, the first anchor is moveable away from the first end of the tubular member in response to a pushing force applied through the first flexible line.

3. The catheter of claim 1, wherein the tubular member comprises a second lumen in the body.

4. The catheter of claim 1, wherein the first anchor comprises a spherical configuration or an ellipsoidal configuration.

5. The catheter of claim 1, wherein the first anchor and the first flexible line are made from different respective materials.

6. The catheter of claim 1, wherein the first anchor and the first flexible line are made from a same material.

7. The catheter of claim 1, wherein the first anchor and the first flexible line have an unity configuration.

8. The catheter of claim 1, wherein the first anchor and the first flexible line are integrally formed together, and wherein the first anchor is a thickened tip of the first flexible line.

9. The catheter of claim 1, wherein the tubular member is configured to form a pig-tail configuration in response to the tension applied through the first flexible line.

10. The catheter of claim 1, wherein the tubular member is configured to form a reversible catheter-retaining hook in response to the tension applied through the first flexible line.

11. The catheter of claim 1, wherein the tubular member has a port at the first end of the tubular member, and wherein the first anchor is configured to close the port.

12. The catheter of claim 11, wherein the first anchor is configured to fluidly seal the port.

13. The catheter of claim 1, wherein the first anchor and/or at least a part of the first flexible line comprises a sampler.

14. The catheter of claim 13, wherein the sampler is configured to obtain a biological sample.

15. The catheter of claim 1, further comprising a second flexible line.

16. The catheter of claim 15, wherein the end of the first flexible line and an end of the second flexible line are configured to couple to the tubular member at different respective longitudinal positions along a longitudinal axis of the tubular member.

17. The catheter of claim 15, wherein the end of the first flexible line and an end of the second flexible line are configured to couple to the tubular member a same longitudinal positions along a longitudinal axis of the tubular member.

18. The catheter of claim 1, wherein the first anchor comprises a loop formed by an elongated element.

19. The catheter of claim 18, wherein the elongated element is an extension of the first flexible line.

20. The catheter of claim 19, wherein a first end of the loop extends to the first flexible line, and a second end of the loop extends to a second flexible line, and wherein a size of the loop is adjustable via manipulation of the first flexible line and/or the second flexible line.

21. The catheter of claim 20, wherein the loop has a bending limit that prevents the loop from being completely pulled inside the tubular member.

22. The catheter of claim 1, wherein the first anchor comprises a sphere or ellipsoid with a fluid delivery channel.

23. The catheter of claim 1, wherein the first flexible line comprises a fluid delivery lumen.

24. The catheter of claim 1, wherein the first end of the tubular member has a distal port on a distal tip surface, the distal tip surface forming an acute angle with respect to a longitudinal axis of the tubular member.

25. The catheter of claim 24, wherein the first end is configured to align a plane of the first anchor with a vocal cord of a patient.

26. The catheter of claim 1, further comprising a shaping element located at the first end of the tubular member, wherein the shaping element is coupled to a wall of the tubular member, and is configured to bend the first end of the tubular member.

27. The catheter of claim 26, wherein the shaping element is configured to apply tension or compression on one side of the tubular member.

28. The catheter of claim 1, further comprising a first port at the second end configured to accommodate the first flexible line.

29. The catheter of claim 28, further comprising a second port at the second end configured to allow fluid to be delivered therethrough.

30. The catheter of claim 29, further comprising a source of treatment fluid coupled to the second port.

31. A medical method, comprising: inserting a part of a tubular member into a patient, the tubular member having a first end, a second end, a body extending between the first end and the second end, and a first lumen in the body; and bending the tubular member using a first flexible line and a first anchor at an end of the first flexible line, wherein at least a segment of the first flexible line is located in the first lumen of the body, the first anchor having a cross sectional dimension that is larger than a cross sectional dimension of the first lumen, wherein the first anchor is configured to apply a compression force against an exterior surface at the first end of the tubular member in response to tension applied through the first flexible line.

32. The method of claim 31, further comprising moving the first anchor away from the first end of the tubular member by applying a pushing force through the first flexible line to expose a part of the first flexible line outside the tubular member.

33. The method of claim 31, wherein the tubular member is bent to form a pig-tail configuration in response to the tension applied through the first flexible line.

34. The method of claim 31, wherein the tubular member is bent to form a reversible catheter-retaining hook in response to the tension applied through the first flexible line.

35. The method of claim 31, wherein the tubular member has a port at the first end of the tubular member, and wherein the method further comprises closing the port using the first anchor.

36. The method of claim 31, further comprising collecting a biological sample using a sampler at the first anchor and/or at a part of the first flexible line.

37. The method of claim 31, further comprising delivering a substance to a location inside the patient using the first lumen or another lumen in the tubular member.

38. The method of claim 31, further comprising advancing the first end of the tubular member over an epiglottis of a patient, and advancing the first end of the tubular member into a trachea of the patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0079] The drawings illustrate the design and utility of embodiments, in which similar elements are referred to by common reference numerals. In order to better appreciate how the above-recited and other advantages and objects are obtained, a more particular description of the embodiments will be rendered, which are illustrated in the accompanying drawings. These drawings depict only typical embodiments and are not therefore to be considered limiting of its scope.

[0080] FIG. 1 is a schematic drawing of a dual lumen catheter with one of the lumina filled with a traction line. Traction applied on that line results in stiffening and curving of the catheter.

[0081] FIG. 2 is a schematic drawing of a triple lumen catheter with a first traction line exiting from an end of the catheter, and a second traction line exiting proximally from to the end of the catheter, which allows bending of the catheter independently at two locations and/or collection of samples from more than one sites at different locations along the catheter.

[0082] FIG. 3A is a schematic drawing of a part of a catheter that is reversibly formed into a pig tail configuration.

[0083] FIG. 3B is a schematic drawing of a part of a catheter that is reversibly formed into a securing hook.

[0084] FIG. 4 is a schematic drawing of a catheter's traction line whose distal portion is configured to facilitate sampling of uncontaminated biological specimens from sites that otherwise would be difficult to reach.

[0085] FIG. 5 illustrates a catheter with a loop tip at a distal end of the catheter and a tube attached to the loop.

[0086] FIG. 6 illustrates a catheter with a tip-blunting bead having a channel, and a tube attached to the bead.

[0087] FIG. 7A illustrates a catheter with a loop and a single line attached or extending to the loop.

[0088] FIG. 7B illustrates a catheter with a loop and a single line attached or extending to the loop.

[0089] FIG. 7C illustrates a catheter with a loop.

[0090] FIG. 8 illustrates a catheter with a tip-blunting bead having a channel, and a single line attached to the bead.

[0091] FIG. 9 illustrates a cross section of a catheter with a bending element configured to apply a tension on one side of the catheter to bend the catheter.

[0092] FIG. 10 illustrates a cross section of a catheter with a bending element configured to apply a compression on one side of the catheter to bend the catheter.

[0093] FIG. 11 illustrates a distal end of a catheter in accordance with some embodiments.

[0094] FIG. 12 illustrates a placement of a catheter in accordance with some embodiments.

DESCRIPTION OF THE EMBODIMENTS

[0095] Various embodiments are described hereinafter with reference to the figures. It should be noted that the figures are not drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated embodiment needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated.

[0096] This disclosure relates generally to catheter systems and methods to intubate orifices of the human or an animal's anatomy in order to deliver or extract liquids or substance, and more specifically, to introduce a stiffened, blunted catheter into a trachea and beyond the vocal cords of a premature neonate. These catheters may also be used in adults. It is disclosed herein design of thin and pliable catheters that facilitate their introduction into any orifices and body cavities that are difficult to intubate. These include, but are not limited to bronchi, sinuses, billiary and pancreatic duct, intestine, urethra, bladder, ureters, calices, vagina, uterus and anexa, as well as any other naturally occurring or created tracts.

[0097] Once in place, such catheters can serve as leads for larger catheters to be slid over. Alternatively, or additionally, such catheters may be used to provide treatment (such as delivery of medical substances and/or drainage), and/or to obtain biopsy.

[0098] In further embodiments the catheters according to this disclosure have more than one lumen filled with traction lines and those can exit at various locations proximal to the catheter's end. This arrangement allows for the catheters to be bent at different locations according to the site specific needs for proper navigation and advancement.

[0099] In some embodiments, a distal part of the catheter may have longitudinal or suitable partially circumferential thinnings or enforcements, so that upon traction on a traction line, the end of the catheter will coil into a reversible hook, pig tail, or any of other configurations, to retain the catheter in the bladder, pericardial, pleural or peritoneal space, and in any other cavity that needs to be drained and irrigated.

[0100] In further embodiments, traction line(s) in catheters according to this disclosure may have additionally treated, configured, or specifically covered surfaces that allow for the adherence and absorption of biological specimens for diagnostic purposes. Catheters with such traction line(s) may be used to collect relatively uncontaminated biological specimens from areas that are otherwise difficult to reach.

[0101] FIG. 1 illustrates a catheter in accordance with some embodiments. The catheter includes a tubular member 1 having a first end, a second end, a body extending between the first end and the second end. The catheter also includes a first lumen 2 in the body, a first flexible line 4 having at least a segment located in the first lumen 2 of the body, and a first anchor 5 at an end of the first flexible line 4. The first anchor 5 has a cross sectional dimension that is larger than a cross sectional dimension of the first lumen 2. The first anchor 5 is configured to apply a compression force against an exterior surface at the first end of the tubular member 1 in response to tension applied through the first flexible line 4.

[0102] The first flexible line 4 may be made from nylon, polyvinylidene, ultra-high-molecular-weight polyethylene, Dacron, or other suitable synthetic or natural material.

[0103] In some embodiments, in a first operational mode, the first anchor 5 is configured to engage against the first end of the tubular member 1 to allow a bending of the tubular member 1 to occur based on a tension applied through the first flexible line 4. In a second operational mode, the first anchor 5 is moveable away from the first end of the tubular member 1 in response to a pushing force applied through the first flexible line 4.

[0104] In the illustrated embodiments, the tubular member 1 also has a second lumen 3 in the body. The second lumen 3 may be used to deliver a substance into a body of a patient (e.g., delivery of surfactant to neonate or an adult), and/or to remove a substance (e.g., for drainage, biopsy, etc.). The second lumen 3 may also be used to deliver another medical device into the patient. In other embodiments, the tubular member 1 does not include the second lumen 3, and the catheter includes only a single lumen 2.

[0105] In other embodiments, the catheter may include more than two lumens (e.g., three lumens, four lumens, etc.).

[0106] During use, the catheter is inserted into a body of a patient through a natural opening or a man-made opening. The flexible line 4 may be pulled at the proximal end of the catheter to apply tension at the flexible line 4. The flexible line 4 functions as a traction line, which stiffens the tubular member 1 and bends the tubular member 1. The bending of the tubular member 1 steers the distal end (the first end) of the tubular member 1, thereby allowing the catheter to be navigated through bends in the human body. In the illustrated embodiments, the first anchor 5 is thicken so that it has a cross sectional dimension larger than the first lumen 2 to prevent the first anchor 5 from being pulled into the first lumen 2. After the catheter 1 has been desirably placed inside the patient, the flexible line 4 may be relaxed, and may be pushed distally to move the anchor 5 distally with respect to the distal end of the catheter, thereby opening the port at the distal end of the first lumen 2. Substance, such as medication (e.g., surfactant), may then be delivered from the distal end of the catheter to the distal end via the first lumen 2, and exits from the port at the distal end of the first lumen 2. Alternatively, if the catheter includes a second lumen 2, the anchor 5 may not need to be advanced distally, and may remain coupled to the distal end of the catheter. In such cases, the second lumen 2 may be used to deliver substance to the patient. In some cases, the first lumen 2 or the second lumen 2 may be used to collect substance from inside the patient. The substance may be biological fluid that is desired to be drained from the patient. Alternatively, the substance may be tissue that is desired to be collected as biological sample.

[0107] In some embodiments, the anchor 5 may be configured to form a seal to cover the port at the distal end of the lumen 2. In such cases, when the flexible line 4 is tensioned to pull the anchor 5 proximally, the anchor 5 functions as a sealing plug to close the port at the distal end of the lumen 2.

[0108] In some embodiments, the catheter may optionally also include a control at the proximal end of the tubular member 1 to regulate and/or maintain the tension of the flexible line 4. For example, such control may include a stopcock (e.g., a one way stopcock, two way stopcock, three way stopcock, etc.). Also, in some embodiments, the control may include a knob, wherein torsion applied to the knob will apply tension to the flexible line 4 and/or will clamp the flexible line 4 going through a valve. Accordingly, in some cases, manipulation of the control may simultaneously apply tension to the flexible line 4 and seal the lumen 2 via the anchor 5.

[0109] FIG. 2 illustrates a catheter in accordance with other embodiments. The catheter is the same as that described with reference to FIG. 1, except that the catheter includes a second flexible line 4. In particular, the tubular member 1 includes a second lumen, and the catheter includes a first flexible line 4 in a first lumen 2, and a second flexible line 4 in the second lumen 3 of the tubular member 1. The catheter also includes a second anchor 5 at the distal end of the second flexible line 4. During use, one of the two flexible lines 4 may be selectively pulled at the proximal end of the catheter to bend the distal end of the catheter in a desired direction. In the illustrated embodiments, the anchors 5 are at different longitudinal positions along a longitudinal axis of the catheter. This allows the catheter to be bent at separate longitudinal locations. In other embodiments, the anchors 5 may be at the same longitudinal position with respect to the longitudinal axis of the catheter. Such configuration allows the catheter to be bent towards different directions (e.g., opposite directions (180 apart), 90 apart, etc.).

[0110] The catheter may be configured to form different shapes in different embodiments upon tensioning of the flexible line(s) 4.

[0111] FIG. 3A illustrates an example of a catheter's end that is formed into a reversible pig tail configuration by applying tension to the proximal end of the first flexible line 4. In some embodiments, the wall at the distal end of the tubular member 1 may have a continuous thinning 300 extending longitudinally and in a spiral fashion, or may have individual discrete thinning(s) 300 disposed at different parts of the tubular member 1, that allows the tubular member 1 to coil into the pigtail configuration upon tensioning of the flexible line 4. The thinning(s) 300 may be implemented at the exterior surface or at the interior surface of the wall of the tubular member 1. The pigtail configuration may be utilized to secure the catheter inside the patient. For example, the pigtail configuration may secure the catheter in the bladder, the pericardial, pleural or the peritoneal space, and in any other cavity that needs to be treated, drained, and/or irrigated.

[0112] FIG. 3B illustrates an example of a catheter's end that is formed into a reversible hook configuration by applying tension to the proximal end of the first flexible line 4. In some embodiments, the wall at the distal end of the tubular member 1 may have a continuous thinning 300 extending longitudinally, or may have individual discrete thinning(s) 300 disposed at different parts of the tubular member 1, that allows the tubular member 1 to form into the hook configuration upon tensioning of the flexible line 4. The thinning(s) 300 may be implemented at the exterior surface or at the interior surface of the wall of the tubular member 1. The hook configuration may be utilized to secure the catheter inside the patient. For example, the hook configuration may secure the catheter in the bladder, the pericardial, the pleural or peritoneal space, and in any other cavity that needs to be treated, drained, and/or irrigated.

[0113] In some embodiments, the catheter described herein may have sampling capability. For example, the flexible line 4 and/or the anchor 5 may be configured to collect samples from inside the patient.

[0114] FIG. 4 illustrates a catheter in accordance with other embodiments, particularly showing the catheter having a sampler configured to adhere to or absorb biological samples. The sampler may include bumps and holes 402, perforated absorbent 404, no perforated layered or non-layered absorbent(s) 406, hydrophobic or hydrophilic mini hooks and loops 408, and any combinations thereof. In the illustrated examples, the sampler is implemented on the flexible line 4. In other embodiments, the sampler may be implemented on the anchor 5, or on other structure that may be inserted into the catheter and exits through the distal end of the catheter. In some embodiments, the flexible line(s) 4 may serve the dual function of stiffening and curving the catheter to allow for introduction into difficult to reach areas, to seal their respective lumina and to sample, in a sterile fashion, uncontaminated biological specimens through the catheter by the extrusion and subsequent retraction of their distal tips.

[0115] It should be noted that the anchor 5 is not limited to that described in the above embodiments, and that the anchor 5 may have other configurations in other embodiments.

[0116] FIG. 5 illustrates a catheter according to other embodiments. The catheter includes a tubular member 1 having a first end, a second end, and a body extending between the first end and the second end. The catheter also includes a lumen 2, a flexible line 4 located in the lumen 2, and an anchor 5 at the distal end of the flexible line 4. In the illustrated embodiments, the anchor 5 is a loop, and the flexible line 4 is a tube with a channel configured to deliver and/or extract substance. During use, the catheter is advanced inside the patient, and the loop protects against abrasion due to its smooth profile. As the catheter is being advanced, the flexible line 4 may be pulled from the proximal end to apply tension at the flexible line 4. The anchor 5 anchors against the distal tip of the tubular member 1 as the flexible line 4 is being pulled, thereby allowing the tubular member 1 to bend into a desired direction and configuration. The bending of the tubular member 1 may allow the catheter to be steered as the catheter is being advanced inside the patient. The bending of the tubular member 1 may also allow the catheter to be anchored against tissue after the catheter has been desirably advanced inside the patient. After the catheter has been desirably placed inside the patient, the channel in the flexible line 4 may deliver a substance (e.g., medication such as surfactant) into the patient. Additionally, or alternatively, the flexible line 4 may be used to extract substance from inside the patient. For example, suction may be applied at the proximal end of the flexible line 4 to extract substance (e.g., biological sample) at the distal end of the flexible line 4. The loop is advantageous because it allows substance to be delivered into the patient, or allows substance to be extracted from the patient, without obstruction of the flow.

[0117] In some embodiments, the loop may be made from the same material as that of the flexible line 4. In other embodiments, the loop and the flexible line 4 may be made from different materials. Also, in other embodiments, instead of the flexible line 4 being a tube, the flexible line 4 may be any elongated structure, such as a string, a fiber, a fishing wire, a nylon, etc. In such cases, the loop may be an extension of the elongated structure forming the flexible line 4. For example, one end of the loop may extend from the elongated structure forming the flexible line 4, and the other end of the loop may connects to the distal end of the flexible line 4. Alternatively, the other end of the loop may connects to, or extends from, another flexible line 4 which extends from the distal end of the tubular member 1 to the proximal end of the tubular member 1. In such cases, one or both of the flexible lines 4 may be pulled from the proximal end to adjust the size and shape of the loop. The loop may have a bending limit that prevents the loop from being completely collapsed into the lumen 2 housing one or both of the flexible lines 4. When the loop is collapsed into its smallest size, the loop functions as an anchor so that it anchors against an exterior tip surface of the tubular member 1. This allows the tubular member 1 to be bent in response to tension force applied at one or both of the flexible lines 4.

[0118] In one implementation, the first flexible line 4, the loop, and the second flexible line 4, may be implemented using a single elongated structure. For example, the elongated structure may extend along the length of the tubular member 1 to form the first flexible line 4, exits the distal end of the tubular member 1 to form the loop, and then loops back into the tubular member 1 and extends proximally to form the second flexible line 4.

[0119] In other embodiments, the tubular member 1 of the catheter of FIG. 5 may have a Y configuration ending in two separate ports. One of ports accommodates the flexible line 4. In particular, the flexible line 4 may exits through one of the ports, which allows for the bending and adjustment of the curvature of the tubular member 1. The other port may be used to deliver substance into the patient, and/or to extract substance from the patient.

[0120] In some embodiments, the catheter may be configured (e.g., sized and/or shaped) for insertion into a mouth of a patient, and for advancement over the epiglottis and into the trachea below the vocal cords. For example, the flexible line(s) 4 may be pulled from the proximal end of the catheter to bend the distal end of the catheter at a desired direction and with a desired curvature, to thereby allow passage over the epiglottis and into the trachea. Also, the flexible line(s) 4 may be pulled or pushed to adjust the size and plane of the loop in some embodiments. In addition, in some embodiments, the catheter may be configured to place the plane of the loop at a certain orientation. For example, the distal end of the tubular member 1 of the catheter may have a shape or profile (e.g., a U or V shape orifice facing a direction of bending of the tubular member 1) that biases the loop to orient in a certain direction when the flexible line 4 is pulled to place the loop in abutment with the distal end of the tubular member 1. In some embodiments, the above features may be implemented to place the plane of the loop to be parallel with the vocal cords when the catheter is inserted into a patient. This allows the distal end of the catheter to be easily slided over the epiglottis into the trachea of the patient.

[0121] In some embodiments, the junction 510 between the loop and the flexible line 4 may be made more rigid than the flexible line 4 and the loop. This may allow the loop to retain a certain shape and size, without being pulled into the lumen 2. In some embodiments, to stiffen and shape the loop, the part of the line that bends into the loop may have a larger cross sectional dimension than the rest of the line.

[0122] In other embodiments, the loop may have a bending limit that prevents the loop from being pulled into the lumen 2. For example, the loop may be made from an elongated structure that resists tight bending. In such cases, the ends of the loop will wedge themselves into the edge of the lumen 2 when the loop is pulled to its limit. In particular, the cross sectional dimension (e.g., diameter) of the elongated structure forming the loop may be properly sized, and the elongated structure may be made to have certain bending stiffness so that when the loop is collapsed to a certain size, the loop will reach the bending limit to prevent the loop from further being collapsed. As a result the ends of the loops will wedge into the edge of the lumen 2. In some embodiments, the loop may have a stopper to prevent the loop from being completely pulled into the lumen 2. For example, the elongated structure forming the loop may be used to tie a knot to form the stopper. Alternatively, a part of the elongated structure may be heated (e.g., by a cigarette lighter, a match, or a commercial heater) to form a blob that functions as a stopper.

[0123] FIG. 6 illustrates a catheter in accordance with other embodiments. The catheter is the same as that in FIG. 5, except that the anchor 5 is a bead. The bead may have a spherical configuration, or an ellipsoid configuration. The bead includes a channel extending therethrough, and is in fluid communication with the channel in the flexible line 4. During use, the catheter is advanced inside the patient, and the bead protects against abrasion due to its smooth profile. As the catheter is being advanced, the flexible line 4 may be pulled from the proximal end to apply tension at the flexible line 4. The anchor 5 anchors against the distal tip of the tubular member 1 as the flexible line 4 is being pulled, thereby allowing the tubular member 1 to bend into a desired direction and configuration. The bending of the tubular member 1 may allow the catheter to be steered as the catheter is being advanced inside the patient. The bending of the tubular member 1 may also allow the catheter to be anchored against tissue after the catheter has been desirably advanced inside the patient. After the catheter has been desirably placed inside the patient, the channel in the flexible line 4 may deliver a substance (e.g., medication such as surfactant) into the channel in the bead, and the substance then exits through a port at the bead. Additionally, or alternatively, the port at the bead may be used to extract substance from inside the patient. For example, suction may be applied at the proximal end of the flexible line 4 to extract substance (e.g., biological sample) through the channel of the bead. The channel in the bead is advantageous because it allows substance to be delivered into the patient, or allows substance to be extracted from the patient, without obstruction of the flow by the bead.

[0124] In other embodiments, the tubular member 1 of the catheter of FIG. 6 may have a Y configuration ending in two separate ports. One of ports accommodates the flexible line 4. In particular, the flexible line 4 may exits through one of the ports, which allows for the bending and adjustment of the curvature of the tubular member 1. The other port may be used to deliver substance into the patient, and/or to extract substance from the patient. In such cases, the bead may not include the channel, because the other port can be used for substance delivery.

[0125] FIG. 7A illustrates a catheter in accordance with other embodiments. The catheter is similar to that described with reference to FIG. 5, except that the flexible line 4 has a solid cross section, and it is not a substance delivery tube.

[0126] FIG. 7B illustrates an implementation of the catheter of FIG. 7A, particularly showing a single line 4 exiting the distal end of the tubular member 1 to form a loop (as the anchor 5). The end of the loop forms a small opening for allowing the single line 4 to extend therethrough.

[0127] FIG. 7C illustrates another implementation of the catheter of FIG. 7A, particularly showing a single line 4 exiting the distal end of the tubular member 1 to form a loop (as the anchor 5). After forming the loop, the line 4 extends back to the lumen 2 of the tubular member 1.

[0128] FIG. 8 illustrates a catheter in accordance with other embodiments. The catheter is the same as that described with reference to FIG. 6, except that the flexible line 4 has a solid cross section, and it is not a substance delivery tube.

[0129] It should be noted that in the embodiment in which the anchor 5 is a loop, the loop may be advanced distally with respect to the distal end of the tubular member 1. However, in other embodiments, such feature is not required, as the loop does not occlude the fluid delivery port at the distal end of the catheter. Thus, the loop may be maintained attached to the distal end of the tubular member, and the catheter can still deliver substance to within the patient. Similarly, in the embodiment in which the anchor 5 is a bead, the bead may be advanced distally with respect to the distal end of the tubular member 1. However, this feature may not be required if the bead has one or more channels for delivering substance to within the patient. On the other hand, if the bead does not have any channel, then the bead may be advanced distally to open up the fluid delivery port. In other embodiments, if there is a separate fluid delivery port that is different from the tube accommodating the flexible line 4 connecting to the bead, then the bead may or may not be attached to the distal end of the tubular member 1.

[0130] As discussed, in some embodiments, the catheter may include a control at its proximal end. In one implementation, two off-the-shelf three-way stopcocks may be coupled in a row to form the control. In such cases, one or two flexible lines 4 may be fed through the stopcocks at their now connected T sides. A syringe may be connected to the distal stopcock with the syringe containing the fluid to be instilled. A torsion/wedge may be implemented on the proximal stopcock for applying tension to the flexible line(s) 4, and/or maintaining the achieved tension. Accordingly, such control may be utilized to achieve a desired stiffness and curvature as the procedure proceeds.

[0131] Also, in some embodiments that include two flexible lines 4, the two flexible lines 4 may exit the tubular member 1 through a fluid tight split membrane exit port or other opening of similar function of sealing and arresting the flexible line(s). The proximal end of the tubular member 1 may be Y shaped, thus allowing for two separate entry/exit channels that merge towards the distal end (towards or in the patient, away from the operator) of the catheter. One of the arms of the Y ends in the port through which the flexible lines 4 exit. The other arm of the Y provides the entry port for the injection/aspiration of the substance (e.g., surfactant, other preparation, or biological fluid). Traction on either one or both of the flexible lines 4 that exit from a fluid sealed port may used to adjust the size of the distal loop, to put the loop's plane in the direction of the vocal cords, to bend the tubular member 1 in a desired way, or any combination of the foregoing. In some cases, the placement of the loop's plane in the direction of the vocal cords may be achieved with the assistance of the slanted distal tip surface (if it is available) of the tubular member 1.

[0132] In some embodiments, the catheter may optionally include a bending (shaping) element configured to pre-bend or bias the tubular member 1 in a certain direction. FIG. 9 illustrates a cross section of a catheter, particular showing the catheter having a bending element 900 coupled to the tubular member 1 of the catheter. The bending element 900 may be a stiffening structure that is secured to an exterior surface or to an interior surface of the tubular member 1. Alternatively, the bending element 900 may be embedded within the wall of the tubular member 1. The bending element 900 may extend at least along a segment (e.g., a distal segment) of the tubular member 1. In the illustrated embodiments, the bending element 900 is slightly shorter compared to the segment of the tubular member 1 to which the bending element is coupled. This has the effect of compressing one side (i.e., the side with the bending element 900) of the tubular member 1, causing the tubular member 1 to pre-bend or to bias towards the side with the bending element 900. In some embodiments, the pre-bending occurs at the distal end of the tubular member 1, and the flexible line(s) 4 may be used to further bend the tubular member 1 in a desired direction. In some cases, the bending element 900 may force the tubular member 1 into a curvature that facilitates its entry into the patient, e.g., into the tracheal.

[0133] FIG. 10 illustrates a cross section of a catheter, particular showing the catheter having a bending element 902 coupled to the tubular member 1 of the catheter. The bending element 902 may be a stiffening structure that is secured to an exterior surface or to an interior surface of the tubular member 1. Alternatively, the bending element 902 may be embedded within the wall of the tubular member 1. The bending element 902 may extend at least along a segment (e.g., a distal segment) of the tubular member 1. In the illustrated embodiments, the bending element 902 is slightly longer compared to the segment of the tubular member 1 to which the bending element is coupled. This has the effect of tensioning one side (i.e., the side with the bending element 902) of the tubular member 1, causing the tubular member 1 to pre-bend or to bias away from the side with the bending element 902. In some embodiments, the pre-bending occurs at the distal end of the tubular member 1, and the flexible line(s) 4 may be used to further bend the tubular member 1 in a desired direction. In some cases, the bending element 902 may force the tubular member 1 into a curvature that facilitates its entry into the patient, e.g., into the tracheal.

[0134] In the above embodiments of FIGS. 9 and 10, the bending (shaping) element provides a bended configuration for the tubular element 1. Accordingly, even without tensioning of the flexible line(s) 4, the tubular element 1 will have a curvature in its relaxed state. The relaxed curvature may indicate visually to an operator the direction the catheter will bend when the flexible line 4 is pulled. In other embodiments, the bending element is not required, and the tubular element 1 may not have any curvature when in its relaxed state.

[0135] In other embodiments, the shaping element may not apply a compression or tension force on one side of the tubular element 1. Instead, the shaping element may itself has a bent shape, e.g., a curvilinear shape. The shaping element may be stiffer than then tubular member 1. Accordingly, when the shaping element is coupled to the tubular element 1, the shaping element will bend the tubular element 1 and shape it according to the profile of the shaping element. In such cases, the shaping element is not required to be longer or shorter to the segment of the tubular element 1 to which it is coupled.

[0136] In further embodiments, the catheter may include both the bending element 900 and the bending element 902 on opposite sides of the tubular member 1.

[0137] In other embodiments, instead of using a bending (shaping) element, the tubular member 1 may have a thickened wall on one side compared to other sides. This would provide the tubular member 1 with a desired stiffness, biased-bending direction, and desired curvature.

[0138] As discussed, in some embodiments, the catheter may be configured to place the plane of the loop at a certain orientation. For example, the distal end of the tubular member 1 of the catheter may have a shape or profile (e.g., a U or V shape orifice facing a direction of bending of the tubular member 1) that biases the loop to orient in a certain direction when the flexible line 4 is pulled to place the loop in abutment with the distal end of the tubular member 1. FIG. 11 illustrates a distal (first) end of a tubular member of a catheter. As shown in the figure, the distal end of the tubular member 1 has a distal port on a distal tip surface, wherein the distal tip surface 1100 forming an acute angle with respect to a longitudinal axis of the tubular member. In some embodiments, the above features may be implemented to place the plane of the loop/bead to be parallel with the vocal cords when the catheter is inserted into a patient. This allows the distal end of the catheter to be easily slided over the epiglottis into the trachea of the patient. In some cases, the orientation of the distal tip surface 1100 may be achieved by making a slanted cut at the end of the tubular member 1. This creates an elongated slot that defines a plane of the anchor 5. During use, when the anchor 5 is pulled proximally, the elongated slot at the distal tip surface 1100 will guide and rotate the anchor 5 so that it is at a certain orientation with respect to the distal end of the tubular member 1.

[0139] As discussed, in some embodiments, the catheter described herein may be placed into the trachea below the vocal cords for delivering medication, such as surfactants, to a patient. FIG. 12 shows an example of the placement of the catheter in accordance with some embodiments. In the illustrated example, the catheter is inserted into the patient's mouth. As the catheter is advanced, the flexible line(s) 4 may be pulled at the proximal end to bend the distal end of the catheter. The catheter with the curvature is advanced and slided over the epiglottis, and into the trachea and below the vocal cords. The curvature of the catheter is advantageous because it ensures that the catheter is not advanced incorrectly into the esophagus. In some embodiments in which the catheter includes a loop, the plane of the loop may be aligned with the vocal cords and curvature of the tube. For example, the loop may be aligned with the split between the vocal cords. In some cases, the insertion of the catheter may be achieved by visualizing the epiglottis and taking advantage of the curvature of the catheter, and sliding the looped or otherwise blunted tip over the epiglottis into the trachea while avoiding the path into the esophagus. Also, in some embodiments, the tip of the catheter may not need to pass beyond the vocal cords. These normally open under inspiration (breathing in).

[0140] The features of the catheter described herein are advantageous because they facilitate the operator's control over the catheter in a challenging small operating field, and they make it easy for such a catheter to be introduced into the trachea and advanced beyond the vocal cords, or into any other part of a human or animal anatomy.

[0141] In some embodiments, the catheter described herein may be mass-manufactured. In other embodiments, the catheter described herein may be made ad-hoc at a field (e.g., battle field, jungle, village, etc.) using readily available items, such as fishing line, fiber, thin tubes, cigarette lighter, a match, etc. In one implementation, for emergency purposes, the catheter described herein may be made ad-hoc by inserting a fishing line into a thin tube. One end of the fishing line may be heated using the cigarette lighter or the match to form a melted blob that will function as the anchor 5. If a three-way stopcock is available, it may be attached to the proximal end of the fishing line, and functions as a control for bending the thin tube.

[0142] Once the catheter is made on the spot, it may be placed inside the patient, and the fishing line may be used to steer the distal end of the catheter as the catheter is being advanced inside the patient. Once the catheter is desirably placed inside the patient, it may be used to deliver a substance (e.g., medication), and/or it may be used to retrieve an item from the patient. For example, the catheter may be used to obtain biopsy from the patient, provide drainage, retrieve lost and/or foreign bodies from within the patient. By means of non-limiting examples, the catheter may be placed in the ear canal, esophagus, trachea, main stem bronchus, pleura and peritoneal space, vessels (e.g., to remove thrombi, blood clot, plague, etc.), liver, heart, lung, etc.

[0143] It should be noted that the applications provided by the catheter described herein are not limited to the examples mentioned above, and that the catheter may be used in other applications. For example, in other embodiments, the catheter may be used as a leading trocar for intubations, including those of a specific bronchus, over which suitable endotracheal or other tubes or catheters can be advanced to their desired location(s). In further embodiments, the catheter may be used as a feeding tube.

[0144] Although particular embodiments have been shown and described, it will be understood that they are not intended to limit the claimed inventions, and it will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the claimed inventions. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense. The claimed inventions are intended to cover alternatives, modifications, and equivalents.