Patent Publication Number: US-2022226607-A1

Title: Drainage or infusion catheter and method of use

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 16/390,291, filed Apr. 22, 2019, which is a continuation of U.S. patent application Ser. No. 15/810,480, filed Nov. 13, 2017, which claims priority to U.S. Provisional Patent Application No. 62/528,737, filed Jul. 5, 2017. The entire disclosure contents of these applications are herewith incorporated by reference into the present application. 
    
    
     BACKGROUND 
     Catheters are one of the most commonly used medical devices and have application for a number of diagnostic and therapeutic procedures. The tip of current drainage or infusion systems is typically made of a sealed piece of tubing with a series of holes in the sides and/or the end. The fluid or air flows through these holes into or out of the lumen of the tubing. When choroid plexus, or other substances (blood, proteins, etc.), enters into the holes, it tends to bridge in the lumen of the tubing causing an obstruction. When the lumen of the tube is obstructed, replacement or revision is required. 
     Technologies that mitigate accurate placement, and decrease obstruction and/or migration can limit the distress and expenses associated with repeated catheter implantation procedures, as well as potentially reduce the chance of infection. 
     Thus, there is a need for a drainage and/or infusion catheter having a shape that will slow catheter obstruction. By preventing catheter obstruction, malfunctions can be greatly reduced and obviate the need for procedures or even surgery to address the catheter failure. 
     SUMMARY 
     In one embodiment, a method for inserting a drainage or infusion catheter into a cavity of a subject is provided. The method includes providing a catheter comprising a tube body defining a passageway therethrough, the tube body having a proximal end and a distal end, and a plurality of ports arranged along the tube body from the distal end to the proximal end. The distal end of the tube body is deformed around itself in a 3D shape so as to cover at least one of the plurality of ports located near the proximal end of the tube body. The method further includes inserting an introducer within the tube body of the catheter such that the 3D shape at the distal end is straightened, inserting the catheter into the cavity, and removing the introducer from the catheter such that when the introducer is removed, the distal end of the tube body re-forms into the 3D shape. 
     In another embodiment, a method for inserting a drainage or infusion catheter into a cavity of a subject is disclosed, the method includes providing a catheter comprising a tube body defining a passageway therethrough, the tube body having a proximal end and a distal end, a plurality of ports arranged along the tube body from the distal end to the proximal end, and at least two apertures arranged within the tube body between the distal end and the proximal end. The method further includes inserting the catheter into the cavity, and inserting an intraluminal catheter within the tube body of the catheter, the intraluminal catheter having a flap. The flap erupts from the at least two apertures and extends outwardly around the tube body so as to cover at least one of the plurality of ports located near the proximal end of the tube body. 
     In another embodiment, a drainage and/or insertion catheter is disclosed. The drainage and/or insertion catheter includes a tube body defining a passageway therethrough, the tube body having a proximal end and a distal end, and a plurality of ports arranged along the tube body from the distal end to the proximal end. The distal end of the tube body is configured to deform around itself into a substantially spiral shape so as to cover at least one of the plurality of ports located near the proximal end of the tube body. 
     In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Exemplary embodiments are illustrated in the drawings. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive. 
         FIG. 1  is a perspective view of a catheter in accordance with one embodiment of the present disclosure. 
         FIG. 2  is a perspective view of an alternate embodiment of the catheter of the present disclosure. 
         FIG. 3  is a perspective view of the catheter shown in  FIG. 1  with an introducer being inserted therethrough. 
         FIGS. 4A-4F  show the catheter of  FIG. 1  being inserted into a subject. 
         FIGS. 5A-5D  show the catheter of  FIG. 2  being inserted into a subject. 
         FIG. 6  is a perspective view of the catheter of  FIG. 1  inserted in a subject over time. 
     
    
    
     DETAILED DESCRIPTION 
     For the purposes of promoting an understanding of the principles of the disclosure, reference will now be made to preferred embodiments and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended, such alteration and further modifications of the disclosure as illustrated herein, being contemplated as would normally occur to one skilled in the art to which the disclosure relates. 
     As used herein, the term “subject” and “patient” are used interchangeably herein and refer to both human and nonhuman animals. The term “nonhuman animals” of the disclosure includes all vertebrates, e.g., mammals and non-mammals, such as nonhuman primates, sheep, dog, cat, horse, cow, chickens, amphibians, reptiles, and the like. In some embodiments, the subject is a human patient that is in need of having fluid drained from an organ or tissue. In certain embodiments, the subject is a human patient suffering from hydrocephalus. 
     “About” is used to provide flexibility to a numerical range endpoint by providing that a given value may be “slightly above” or “slightly below” the endpoint without affecting the desired result. 
     Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. 
     The drainage and/or infusion catheters described herein demonstrate consistently improved resistance to occlusion. The catheter includes a deformation in the form of a 3D shape at the distal end of the tube body that, after insertion and upon withdrawal of the introducer, re-shapes into the original 3D shape. The catheter provides improved resistance to occlusion and slows catheter obstruction and drifting out of position. Such catheters can fit into the existing clinical pathway and procedure, require no extensive training, and will reduce revisions. By preventing ingrowth of tissue, catheter malfunctions can be greatly reduced and obviate the need for replacement. 
       FIG. 1  shows a drainage and/or infusion catheter  100  in accordance with one embodiment. The catheter  100  may be used for, e.g., the drainage of cerebrospinal fluid (“CSF”) or pleural effusion or air from the pleural space, drainage of bile from the gallbladder, the use of peritoneal dialysis in the abdomen, the drainage of an abscess, or the drainage of urine from the bladder, the drainage or infusion of food/nutrients in the GI system as a G or J tube, or for the infusion of drugs, blood, chemotherapic agents, either in a body cavity or intravascularly either in a vein or an artery, etc. This type of catheter can also be used as part of a cannula for the circulation of blood in and out of the body. As shown in  FIG. 1 , the catheter  100  comprises a tube body  102  having a first or proximal end  104  and a second or distal end  106 . In one embodiment, the tube body  102  comprises a tubular/circular shape. In some embodiments, the tube body  102  may define a fluid passageway  105  therethrough, and may be any length that is sufficient to provide for the insertion of the proximal end  104  into a cavity of a subject or patient. In some examples, the cavity may be a cranial cavity. 
     In one embodiment, the tube body  102  comprises a length of about 5 cm to about 100 cm. In another embodiment, the tube body  102  comprises an outer diameter of about 1 mm to about 80 mm. In certain embodiments, such as for intravascular or ventricular indications, the outer diameter is about 2 mm to about 3.5 mm. In another embodiment, the tube body  102  comprises an inner diameter of about 1 mm to about 40 mm. In certain embodiments, such as for drainage of a loculated collection or drainage/infusion of blood in the form of a cannula, the inner diameter is about 0.5 mm to about 2 mm. 
     The tube body  102  may further include a plurality of entrance ports or slots  108  that provide access to the interior portion of the tube body  102 . In some embodiments, the entrance ports/slots  110  comprise a width of about 0.1 mm to about 2 mm and a length of about 1.5 mm to about 12 mm. In certain embodiments, the entrance ports/slots  108  comprise a width of about 0.2 mm to about 5 mm and a length of about 3 mm to about 20 mm. 
     The distal end  106  of the tube body  102  is configured to deform. In one embodiment, the distal end  106  is twisted or coiled around itself to create a 3D shape  110 . In some embodiments, the 3D shape may comprise a loop, a “j”, a knot, a spiral, or a coil, for example. Other suitable shapes are possible as well. The 3D shape  110  allows for the physical protection or cover of one or more of the entrance port(s)  108  located closest to the proximal end  104  of the drainage catheter  100  from being externally blocked, ultimately decreasing the amount of clogging the catheter experiences. 
     In one embodiment, the 3D shape  110  is made of a shape memory material which allows the distal end  106  to remain in its deformed state. In another embodiment, a wire or string (not shown) can hold the 3D shape  110  in place. In such an embodiment, a distal fixation point of the string or wire helps hold the catheter angulation under tension. Once the catheter is to be removed, the string or wire can be cut distally to loosen the tension in the skin, therefore allowing the catheter to become deformable. 
     Additionally, the 3D shape  110  effectively increases the surface area of the catheter that is within the cavity, which enables the tube body  102  to have more entrance ports  108 . For example, in one embodiment, at least forty ports are located along the tube body  102 . The existence of additional entrance ports  108  decreases the likelihood of a blockage of all of the entrance ports  108 , thereby increasing the likelihood of the catheter maintaining its proper function. 
     Still further, the 3D shape  110  produces an anchoring shape, such as a knot, for example, which limits catheter drifting over an extended period of time, while still maintaining a shape permissible to fluid flow. 
     In another embodiment, shown in  FIG. 2 , the 3D shape  110  of the distal end  106  of the catheter  100  includes a flap  112 . Similar to the embodiment shown in  FIG. 1 , the flap  112  is also configured to protect the proximal holes or entrance ports  108  of the catheter  100  from blockage/occlusion. In this embodiment, the catheter  100  may have at least two apertures  103  (shown in  FIGS. 5A-5C ) arranged in the tube body  102  between the proximal end  104  and the distal end  106 . In some examples, the tube body may include additional apertures  103 . In one embodiment, the flap  112  is attached to the catheter  100  through an intradiameter or intraluminal catheter  101  (shown in  FIGS. 5A-5D ) that allows the introduction of the protective flap  112  through the apertures  103 . The catheter  100  is slid over the intradiameter catheter  101 . Once the correct orientation is reached, the flap  112  can erupt from the apertures  103  located in the tube body  102  of the catheter  100  and extend outwardly around the tube body  102  so as to cover at least one of the plurality of ports  108  located near the proximal end  104  of the tube body. In addition to the flap  112 , the catheter  100  may also include the 3D shape  110  at the distal end that shapes back to protect the entrance ports  108  from external obstruction, such as shown in  FIG. 1 . 
     In another embodiment, the flap  112  can be attached to a string or wire (not shown) that allows for the flap to deploy upon insertion. In this embodiment, a pre-built strap is fixed under a string or wire tension or shape memory tension, is released once the catheter is in the correct position. The flap  112  protects one or more entrance ports  108  located closest to the proximal end  104  of the catheter from outside obstruction. 
     In one embodiment, the flap  112  may be constructed of shape memory material. It should be understood that the flap  112  could be constructed of any biocompatible material suitable for medical use. In some embodiments, the flap  112  is constructed of the same material as the tube body  102  of the catheter  100 . In alternate embodiments, the flap  112  is constructed of a different material than the tube body  102 . 
     The drainage and/or infusion catheter and associated components of the present disclosure may be made of any biocompatible material suitable for medical use. In certain embodiments, the material, or combination of materials, meet the requirements as outlined above. Examples include, but are not limited to, (a) polyurethanes, including but not limited to, polycarbonate-based polyurethanes, polyether-based polyurethanes (e.g., aliphatic, aromatic, etc.), and thermoplastic polyurethanes (e.g., polyvinyl chloride (PVC), etc.); (b) polyamides; (c) fluoropolymers, including but not limited to, polytetrafluoroethylene (PTFE), FEP, ETFE, PFA and MFA; (d) polyolefins (e.g., high density polyethylene, etc.); (e) polyimides; (f) thermoplastic polymers, such as polyaryletherketone (PAEK) and polyether ether ketone (PEEK); (g) polycarbonate; (h) polycarbonate urethane; (i) silicone; (j) acrylic compounds; (k) thermoplastic polyesters; (l) polypropylene; (m) low-density polyethylenes; (n) nylon; (o) sulfone resins; (p) high density polyethylenes; (q) silicone, and silicone-based materials and (r) other synthetic biocompatible polymers; and combinations thereof. 
     In certain embodiments the drainage and/or infusion catheter comprises a shape memory material. In some embodiments, the shape memory material comprises a shape memory alloy(s). In certain embodiments, the shape memory alloy is selected from the group consisting of NiTi, CuZn, AuCd, CuSn, TiPd, NiAl, InTi, NiTiCu and CuZnAl. In other embodiments, the shape memory material comprises a shape memory polymer. In certain embodiments, the shape memory polymer is selected from the group consisting of poly(ε-caprolactone) dimethacrylate, n-butyl acrylate, star-shaped oligoesters of rac-dilactide and diglyceride, multiblock copolyesters from poly(ε-caprolactone) and PEG, oligo (ε-caprolactone) diols, oligo (p-dioxanone) diols, diisocyanate, multiblock copolymers containing poly(L-lactide), poly [glycolide-co-(ε-caprolactone)]-segments, and combinations thereof. 
     The drainage and/or infusion catheters of the present disclosure may further comprise an additive. The additive can be in the form of a coating or embedded within the catheter material itself. For example, in some embodiments, the inflow catheter may be capable of being made radiopaque. A typical way of accomplishing this is by compounding in radiopaque filler. The filler and the amount of it used should not negatively affect the physical and mechanical characteristics of the polymer. Further, the percentage of radiopaque filler should be sufficient to show up on x-ray and on fluoroscope. For example, thermoplastic polyurethanes can be loaded with up to 40% by weight of radiopaque filler. 
     The amount and type of radiopaque filler influence both the effect on physical properties and x-ray response and thus is dependent on the specific use of the catheter, however, once known can be readily determined by one skilled in the art. For example, barium sulfate has a lower x-ray response than bismuth subcarbonate. It takes more barium sulfate to get the same x-ray response as bismuth subcarbonate. Because the density of barium sulfate is about half that of bismuth subcarbonate, it takes up more volume in the polymer mix. The greater the volume that the radiopaque filler takes up in the polymer mix, the greater the reduction in physical properties. In some embodiments, the occlusion-resistant catheter of the present disclosure further comprises a radiopaque filler selected from the group consisting of bismuth subcarbonate, barium sulfate, tantalum, and combinations thereof. 
     In other embodiments, the material selected for the drainage and/or infusion catheter of the present disclosure is able to accept coatings. In some embodiments, the coatings consist of a moisture-sensitive polymer that becomes lubricious when wetted by blood. Such coatings may include, but are not limited to, bactericides, antibodies, lubricants, and combinations thereof. 
     In some cases, the surface of the drainage and/or infusion catheter will need to be treated so that the coatings will adhere. In such cases, to achieve good adhesion, the surface of the catheter may have to be treated. Examples of treatments are chemical etchants, plasma treatments, and corona surface treatments. 
     The drainage and/or infusion catheters of the present disclosure may be manufactured by any number of methods, including, but not limited to, injection molding, 3D-printing, and the like. 
     The drainage and/or infusion catheters of the present disclosure may comprise various other alterations/embodiments that are intended to fall within the scope of the present disclosure. Such embodiments include, but are not limited to, the following: (a) having the drainage and/or infusion catheter comprise various durometers; (b) having the drainage and/or infusion catheter and various components comprise of bioabsorbable materials; and (c) having the drainage and/or infusion catheter and components comprise different materials (e.g., the primary length of the catheter comprises silicone and the distal end comprising a secondary material, such as a shape memory polymer). 
     In another embodiment, referring to  FIG. 3 , the drainage and/or infusion catheter may be inserted into a cavity  300  of a patient or subject using an introducer  200 . This can be done with or without the use of a wire and dilators (Seldinger technique) or by direct placement. When the introducer  200  is placed inside the tube body  102  from the proximal end  104  and thread through the tube body, the 3D shape or configuration  110  deforms at the distal end to provide easier insertion of the catheter  100  into the ventricle. For example, as shown in  FIG. 3 , when the introducer  200  is placed inside the tube body  102  from the proximal end  104 , the distal end  106  straightens (i.e., the 3D configuration is deformed) to provide easier insertion of the catheter into the cavity  300 . As shown in  FIGS. 4A-4F , when the introducer  200  is removed, the distal end  106  returns to its original 3D shape  110 . 
     The introducer  200  may comprise any length sufficient to extend through the tube body  102  and deform the 3D shape  110  at the distal end  106 . In some embodiments, the overall length of the introducer  200  ranges from about 5 cm to about 60 cm. In other embodiments, the overall length of the introducer  200  ranges from about 8 cm to about 50 cm. In yet other embodiments, the overall length of the introducer  200  ranges from about 10 cm to about 46 cm. In some embodiments, the introducer  200  is cylindrical in shape. However, it should be understood that the introducer  200  can be of any general shape, such as rectangular, cylindrical, triangular, square and the like, so as to fit within the tube body  102  of the catheter  100 . 
     In some embodiments, the diameter/width of the introducer ranges from about 0.1 mm to about 2 mm across. In other embodiments, the diameter/width of the introducer ranges from about 0.3 to about 1.5 mm across. In yet other embodiments, the diameter/width of the introducer ranges from about 0.5 mm to about 1.0 mm across. 
     The introducer  200  may comprise varying material properties, including but not limited to, metal, polymer of various durometers, polymer or metal coatings, and the like. 
     For removal of the catheter  100 , the introducer  200  is threaded through the catheter to the first turn of the coil. The catheter  100  is then retracted and unwinds over the rigid introducer  200 . Once fully straightened, the catheter and introducer are withdrawn from the cavity together. 
     Another aspect of the present disclosure provides a method for inserting the drainage and/or infusion catheter  100  as described herein into a cavity  300  a subject. The catheter  100  can be used in any cavity of a subject to drain fluid or infuse agents to a subject in need thereof. Suitable agents for infusion include, but are not limited to, drugs, chemotherapeutic agents, biological fluids, blood, saline, and the like. In some embodiments, the cavity comprises a ventricle and the drainage and/or infusion catheter drains CSF. In another embodiment, the cavity comprises an abdominal cavity, the gallbladder, pleural space, and others. In yet another embodiment, the cavity comprises a vessel in which the catheter is used for infusion of an agent. 
       FIGS. 3 and 4A-4F  show the steps involved in such a method. The method includes inserting the introducer  200  inside the tube body  102  of the drainage and/or infusion catheter  100  such that the 3D shape  110  at the distal end  106  is deformed (e.g., straightened), and then inserting the drainage and/or infusion catheter  100  into a cavity  300 , as shown in  FIG. 3 . Next, as shown in  FIG. 4A , the inserter  200  is removed from the drainage and/or infusion catheter  100  back through the proximal end  104 , as indicated by the arrow. As the introducer  200  is withdrawn from the catheter  100 , the distal end  106  of the catheter begins to deform/re-form back into its 3D shape  110 , as shown in  FIGS. 4B-4E . In some embodiments, a user can draw the introducer  200  partially out of the tube body  102 , which allows only a portion of the distal end  106  to reconfigure into the 3D shape  110 . Doing so allows for more space for more insertion of the catheter within the cavity  300  of the subject. 
     When the introducer  200  is fully removed, the 3D shape  110  is re-formed at the distal end  106  of the tube body  102 , as shown in  FIG. 4F . Additionally, one or more entrance ports  108  located closest to the proximal end  104  of the catheter  100  are covered/protected by the 3D shape  110 . 
     The method further provides the optional step of attaching the drainage and/or infusion catheter available at different lengths to suction or infusion ports or part of a shunt system with or without a valve. 
     Referring now to  FIGS. 5A-5D , the steps of inserting a catheter with a flap  112  are shown. The catheter  100  can be directly placed in open procedures, or inserted over a wire and/or introducer as discussed above.  FIG. 5A  shows the catheter  100  with apertures  103  and entrance ports  108 . In  FIG. 5B , the catheter  100  is slid over the intradiameter catheter  101  having a flap  112 . Once the correct orientation is reached, the flap  112  can erupt through the apertures  103 , as shown in  FIG. 5C . The flap  112  then may spread around the catheter  100 , creating a protective shield around one or more entrance ports  108  located closest to the proximal end  104 , as shown in  FIG. 5D  and  FIG. 2 . 
       FIG. 6  shows the catheter  100  of the present application in use after insertion. Although many of the plurality of entrance ports  108  are blocked, such as by choroid plexus, surrounding organs, clots or other,  400 , two entrance ports  109 ,  111  which are located closest to the proximal end  104  of the catheter  100  are still open since they are covered/protected by the 3D shape  110 . Thus, the original catheter  100  maintains its proper function and does not require reparation or replacement. 
     Another aspect of the present disclosure provides a kit comprising a drainage catheter as provided herein, an introducer and instructions for use. In some embodiments, the kit may further comprise items selected from the group consisting of additional tubing, sterile gloves, sterilization pads, additional members configured to be inserted into the drainage catheter such as diagnostic testing implements or devices, structural support elements, or other devices and implements used in conjunction with drainage catheters and combinations thereof. 
     Any patents or publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. These patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. In case of conflict, the present specification, including definitions, will control. 
     One skilled in the art will readily appreciate that the present disclosure is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent therein. The present disclosure described herein is presently representative of preferred embodiments, are exemplary, and are not intended as limitations on the scope of the invention. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the disclosure as defined by the scope of the claims.