This disclosure relates generally to catheter systems and methods to intubate and to aspirate or instill therapeutic formulations or diagnostic specimens into or from the trachea as well as other orifices and passages that are difficult to intubate or access. In some embodiments, features described herein may be implemented as additions and/or modifications to existing pliable, small diameter single or multi-lumen catheters, which allow such catheters to be converted into temporarily less pliable and curved configurations in order to facilitate their insertion into orifices and body conduits that are difficult to catheterize. Some of the embodiments specifically relate to systems and methods for the tracheal intubation of premature neonates and also adults to instill surfactant. Further embodiments relate to bending of the catheter tips into pliable hook or pig tail configurations in order secure such catheters in the bladder, the pericardium, the peritoneal or pleural space, and any other cavity that requires irrigation and drainage. These catheters and the ends of their traction lines may also be modified to collect one or more uncontaminated biological specimens from areas that are otherwise difficult to reach.
Approximately four million infants are born each year in the United States to a population of approximately 330 million. About 10% of all infants are delivered prematurely and approximately 1% of all neonates exhibit a respiratory distress syndrome that is common in infants of less than 30 weeks of gestation and under 1,200 gm. of birth weight. This respiratory distress syndrome is caused by lung immaturity and insufficient generation of surfactant.
Worldwide about 72 million infants each year require surfactant administration and endotracheal intubation. However some of the neonates can be treated successfully with less invasive respiratory assistance which is administered by continuous positive airway pressure (CPAP), initially applied to an infant's airways through a nose or face mask. With CPAP, and in absence of an endotracheal tube, the surfactant has to be instilled into the trachea through a small catheter. This is difficult to accomplish and is currently done through a small umbilical catheter or a thin feeding tube, which range in size from 3.0 to 9.0 French. [The French (Fr) number corresponds to three times the outer diameter of a catheter measured in millimeters].
The above referred to tubes and catheters have the disadvantage of not being made for this purpose and they are very soft and pliable, which makes it exceedingly difficult to maneuver them over the small epiglottis into the trachea of a premature neonate.
This hinders the above less invasive technique for administering surfactant from being used routinely and leads to otherwise unnecessary intubations with their sometime detrimental long term consequences.
Some embodiments described herein allow for the proposed catheters to be retained in the bladder, the pericardium, the peritoneal or pleural space, and any other cavity that requires irrigation and drainage by reversibly bending the catheter's end into a pliable hook or pig tail configuration.
Further embodiments of the end of the traction lines within the proposed catheter according to this disclosure allow for the collection of uncontaminated diagnostic specimens from areas that are otherwise difficult to reach.
A solution for difficult intubations is disclosed that stiffens and curves thin catheters for this purpose. The end of the catheter(s), according to embodiments of this disclosure, can be coiled into reversible pig tail or hook configurations for retention within the bladder, the pericardial space, the pleural space, the peritoneal space, abscesses, and other spaces that need to be irrigated or drained.
The proposed catheters containing the lines can be used for the sampling of uncontaminated specimens from areas that are otherwise difficult to reach.
In general, any single or multi-lumen thin, soft and all too pliable catheter is stiffened from within with a fitting thin line in one or more of its lumina, The fitting line is made of nylon®, polyvinylidene, ultra-high-molecular-weight polyethylene, Dacron® or other suitable material of sufficient diameter, length, and tensile strength known to those skilled in this art.
Such a line(s) that is/are introduced into the lumen of a single or multi-lumen catheter(s) exit(s) at the distal end of the catheter, or in embodiments according to this proposal, where a catheter has more than two lumina and lines, these from hereon called traction lines, exit at additional suitable distance(s) proximal to the catheter's end.
The tips of the line(s) are affixed to or contiguous (i.e. consist of molted line material) to a thickened ball- or football shaped structure that in some embodiments can have perforations to allow flow from and into the catheter.
The distal thickenings of the line(s) are larger in diameter than the lumen housing the line(s) to prevent the line(s) from being pulled into their respective lumina, and in some embodiments smooth enough to seal their lumina during the catheter's introduction.
Traction on the line(s) stiffens the thin and floppy single or multi-lumen catheter(s), and curves them for easy introduction, and in some embodiments as described above into hook or pigtail configurations for a-traumatic retention.
In some embodiments, one or more of the catheters described herein allow for distal end of the catheter to, under traction, form pigtail configuration or otherwise diagonal footprint with enlarged configuration that would retain the catheter relative to the patient. The atraumatically secured catheter may then be removed from the patient atraumatically, after releasing the traction with the catheter's end straightening out.
In some embodiments selected catheter segments can be curved by tensing additional lines in a multi-lumen catheter with those additional tension lines exiting and being engaged proximally from a catheter's tip and proximal to the catheter segments to be curved.
In other embodiments portions at the tip of the catheter are thinned on one side in a linear or in a spiral-like fashion, so that the additional tension on a line results in the formation of a reversible relatively soft hook or pig tail configuration of to secure and retain a catheter in the bladder, the pericardium, the pleural or peritoneal space, or any other cavity that requires irrigation and drainage.
All lines exit through suitable proximal ports for each lined lumen of a catheter and enter into a continuously affixed or connected device of a known design, that allow for the tensing of a line and maintaining it under tension as needed.
In one embodiment, the device suggested is a one way stopcock, where a the rotation of the valve entraps and arrests a line, while also closing the respective conduit to the outside so that nothing can enter into or escape from that conduit.
In a further embodiment of this proposal the distal part of a line is configured to seal its respective lumen upon traction and the distal segment has small perforations, dimples, riffles, mini hooks, bristles, loops, layered and non layered absorbents, a suitable arrangement of hydrophobic and hydrophilic surfaces that are known to and can be selected by those skilled in the art in order to collect biological samples. These samples would be relatively uncontaminated and can be collected from areas that are otherwise very difficult to reach.
These uncontaminated samples are collected by first extruding and then retracting line(s) followed by removal of a catheter.
One or more embodiments of the catheters according to this proposal can serve as a lead over which larger catheters can be slid in order to reach their destinations.
In some embodiments, a catheter or, in general, a pliable tube, is disclosed herein, wherein the tube may be stiffened internally with an elongated structure, such as a thin nylon, polyvinylidene, ultra-high-molecular-weight polyethylene, Dacron®, or any of other lines made from different materials. Such a line may loop out from a distal exit port of the tube, where the loop will be in plane with the vocal cords aided by a slanted distal tip surface (e.g., a V or U shaped incision on the concave side) of the tube. This relatively soft loop has the function of providing the tube with a blunt advancing end that facilitates the tip's introduction into a human body (e.g., into the trachea and advancement to below the vocal cords, or into other body site(s)). The line forming the loop may go back into the tube. The part of the line that bends into the loop may have a larger cross sectional dimension (e.g., diameter) than the rest. The two parallel lines exit the proximal end of the tube through a fluid tight split membrane exit port, or other opening of similar function to seal and arrest the lines. The proximal end of the tube is Y shaped, allowing for two separate entry/exit channels that merge towards the distal (in or towards the patient) end of the tube. One of these arms of the Y-portion that ends proximally of the tube, end in a port through which the lines exit. Either one or both of the lines may be pulled to adjust the size of the loop at the distal end of the catheter, and/or to adjust a tube stiffness and curvature to facilitate intubation. The other one of the arms of the Y-portion is the entry port for the injection or aspiration of a substance (e.g., the surfactant or other preparation or biological fluid). In some embodiments, the insertion of the catheter into the patient may be done by visualizing the epiglottis and taking advantage of the curvature of the tube, and by sliding the loop or otherwise blunted tip over the epiglottis into the trachea, thereby avoiding entry into the esophagus. In some embodiments, the blunted tip of the catheter may be oriented so that the plane of the tip is in plane of the vocal cords. In lieu of forming a loop, the flexible line may also be threaded through, or attached to a suitably sized bead outside of the tip of the catheter or tube, thus rendering the similar function of blunting the advancing end of the tip of the tube and preventing the line(s) from being pulled into the tube, while the tube's optimal pliability and curvature is adjusted by traction on the exiting line(s). Such a ball or bead may have perforation(s) to facilitate the passage of the injected or aspirated surfactant or other preparation or biological fluid. In other embodiments, the catheter may include a single line forming the distal loop or attaching to the above mentioned ball or bead. In some embodiments, the tube or catheter may optionally have a thickened cross section (e.g., by thickening the wall or by adding a shaping element to the wall) that extends continuously or intermittently longitudinally along the tube. The thickened cross section may be implemented on the inner curvature (i.e., the side of the tube that undergoes compression during bending) and/or may be implemented on the exterior curvature (i.e., the side of the tube that undergoes tension during bending). The thickened cross section provides the tube or catheter with the desired stiffness and curvature. The choice of these alternative embodiments may be influenced by the anatomical dimensions of the intended application(s), the materials for the tube(s) and the line(s), and the corresponding considerations for economic production and the size of the market to be served or created.
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.
Optionally, 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 a 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.
Optionally, the tubular member comprises a second lumen in the body.
Optionally, the tubular member comprises a third lumen in the body.
Optionally, the first anchor comprises a spherical configuration or an ellipsoidal configuration.
Optionally, the first anchor and the first flexible line are made from different respective materials.
Optionally, the first anchor and the first flexible line are made from a same material.
Optionally, the first anchor and the first flexible line have an unity configuration.
Optionally, 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.
Optionally, in the first operational mode, the tubular member is configured to form a pig-tail configuration in response to the tension applied through the first flexible line.
Optionally, in the first operational mode, the tubular member is configured to form a reversible catheter-retaining hook in response to the tension applied through the first flexible line.
Optionally, 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 when in the first operational mode.
Optionally, the first anchor is configured to fluidly seal the port when in the first operational mode.
Optionally, the first anchor and/or at least a part of the first flexible line comprises a sampler.
Optionally, the sampler is configured to obtain a biological sample.
Optionally, the sampler comprises bumps and/or holes.
Optionally, the sampler comprises an absorbent.
Optionally, the absorbent is perforated.
Optionally, the sampler comprises hydrophilic loops and/or hooks.
Optionally, the sampler comprises hydrophobic loops and/or hooks.
Optionally, the catheter further includes a second flexible line.
Optionally, 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.
Optionally, 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.
Optionally, the catheter further includes a second anchor at an end of the second flexible line.
Optionally, the first anchor comprises a loop formed by an elongated element.
Optionally, the elongated element is an extension of the first flexible line.
Optionally, 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.
Optionally, the loop has a bending limit that prevents the loop from being completely pulled inside the tubular member.
Optionally, the first anchor comprises a sphere or ellipsoid with a fluid delivery channel.
Optionally, the first flexible line comprises a fluid delivery lumen.
Optionally, 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.
Optionally, the first end is configured to align a plane of the first anchor with a vocal cord of a patient.
Optionally, the catheter further includes 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.
Optionally, the shaping element is configured to apply tension or compression on one side of the tubular member.
Optionally, the catheter further includes a first port at the second end configured to accommodate the first flexible line.
Optionally, the catheter further includes a second port at the second end configured to allow fluid to be delivered therethrough.
Optionally, the catheter further includes a source of treatment fluid coupled to the second port.
A medical method includes: 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.
Optionally, the method further includes 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.
Optionally, the tubular member is bent to form a pig-tail configuration in response to the tension applied through the first flexible line.
Optionally, the tubular member is bent to form a reversible catheter-retaining hook in response to the tension applied through the first flexible line.
Optionally, 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.
Optionally, the method further includes collecting a biological sample using a sampler at the first anchor and/or at a part of the first flexible line.
Optionally, the method further includes delivering a substance to a location inside the patient using the first lumen or another lumen in the tubular member.
Optionally, the method further includes 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.
A medical method includes: 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; 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 engage against the first end of the tubular member; and 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.
Optionally, the tubular member is bent to form a pig-tail configuration in response to tension applied through the first flexible line.
Optionally, the tubular member is bent to form a reversible catheter-retaining hook in response to tension applied through the first flexible line.
Optionally, 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.
Optionally, the act of closing the port comprises using the first anchor to fluidly seal the port.
Optionally, the method further includes collecting a biological sample using a sampler at the first anchor and/or at the part of the first flexible line.
Optionally, the method further includes delivering a substance to a location inside the patient using the first lumen or another lumen in the tubular member.
Optionally, the tubular member is also bent using a second flexible line and a second anchor at an end of the second flexible line.
Other and further aspects and features will be evident from reading the following detailed description of the embodiments.
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.
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.
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.
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.
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.
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.
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.
The first flexible line 4 may be made from nylon, polyvinylidene, ultra-high-molecular-weight polyethylene, Dacron®, or other suitable synthetic or natural material.
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.
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.
In other embodiments, the catheter may include more than two lumens (e.g., three lumens, four lumens, etc.).
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.
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.
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.
The catheter may be configured to form different shapes in different embodiments upon tensioning of the flexible line(s) 4.
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.
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.
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.
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.
In other embodiments, the tubular member 1 of the catheter of
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.
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.
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.
In other embodiments, the tubular member 1 of the catheter of
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.
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.
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.
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.
In the above embodiments of
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This application claims priority to, and the benefit of, U.S. Provisional Patent Application No. 62/834,933 filed on Apr. 16, 2019, and U.S. Provisional Patent Application No. 62/681,727 filed on Jun. 7, 2018. The entire disclosures of the above applications are expressly incorporated by reference herein.
Number | Date | Country | |
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62834933 | Apr 2019 | US | |
62681727 | Jun 2018 | US |