Peritoneal dialysis catheter with expandable structure

Abstract

A peritoneal dialysis catheter is disclosed that includes a distal region including a perforated portion and one or more expandable members configured to float the catheter in dialysate within a patient's peritoneal cavity, and a method for using the catheter.

Description

Technical Field

[0001] (Cross - reference to related applications) This application claims the benefit of priority of U.S. Patent Application No. 63 / 223,452, filed on July 19, 2021, U.S. Patent Application No. 63 / 282,558, filed on November 23, 2021, and U.S. Patent Application No. 63 / 312,739, filed on February 22, 2022, the entire contents of each of which are incorporated herein by reference.

[0002] This disclosure relates to a medical device for use in peritoneal dialysis and a method of using such a device.

Background Art

[0003] End - stage renal disease (ESRD) is the final stage of chronic kidney disease (CKD) and occurs when the kidneys cannot support the body's demands. When this happens, dialysis is required to help remove impurities and waste products from the blood. The most commonly performed types of dialysis are hemodialysis and peritoneal dialysis.

[0004] For hemodialysis patients, the formation of vascular access in the form of an arteriovenous fistula (AVF) or arteriovenous graft (AVG) is important. However, these vascular access points take time (6 weeks to 4 months) to mature. During this time, patients still need an outlet for performing dialysis, which is usually achieved by using a central venous catheter (CVC) as the initial dialysis access for hemodialysis. This type of catheter has problems because of its high infection rate and negative impact on the patient's quality of life. CVC infections are dangerous, expensive, and can cause complications leading to sepsis and death. Catheter - related bloodstream infections (CRESI) caused by CVCs are also a major cause of nosocomial infections in the United States.

[0005] CVC is also used in patients with acute kidney injury (AKI) or acute early chronic kidney disease (ACKD). In this case, the disadvantage of CVC is the decrease in estimated glomerular filtration rate (eGFR), which is even more rapid compared to hemodialysis using AVF.

[0006] Compared to hemodialysis, peritoneal dialysis can better preserve residual renal function (RRF). Starting peritoneal dialysis is advantageous for healing the kidneys and restoring their function.

[0007] Peritoneal dialysis utilizes a dialysate solution, which is injected into the patient's peritoneal cavity. The dialysate comes into contact with the patient's peritoneum within the abdominal cavity. Waste, toxins, and excess water enter the dialysate from the patient's bloodstream through the peritoneum. The movement of waste, toxins, and water from the bloodstream to the dialysate occurs by diffusion and osmosis. Used dialysate is drained from the patient's peritoneal cavity to remove waste, toxins, and water from the patient, and can then be replaced in additional dialysis cycles.

[0008] In current peritoneal dialysis, a peritoneal dialysis catheter (PDC) is used as an alternative to hemodialysis. The peritoneal dialysis catheter is used to deliver fresh dialysate into the peritoneal cavity and remove used dialysate from the cavity. The PDC is placed in the abdominal cavity and uses the peritoneum as a medium for exchanging waste products. The PDC is inserted into the abdominal cavity through the skin, subcutaneous fat, rectus muscle, and parietal peritoneum. To promote better adhesion to the surrounding tissue, DACRON cuffs may be positioned in contact with the rectus muscle. A healing period of 2-3 weeks is required to prevent inflammation and infection of the exit site and tunnel area. The fluid (dialysis fluid) is introduced into the abdominal cavity through the PDC and then retained in the cavity by closing the proximal end of the catheter to prevent fluid leakage. Waste products from the body are drawn into the peritoneal cavity through the peritoneum and absorbed into the dialysate. After some residence time, the proximal end of the PDC is opened and the fluid is drained from the peritoneal cavity.

[0009] Typically, peritoneal catheters are implanted in the peritoneal cavity and remain in place for extended periods. For example, an average catheter may remain in place for approximately 18 to 24 months, but it is not uncommon for catheters to remain in place for more than two years.

[0010] While many complications exist associated with PDCs, slow drainage is particularly unpleasant. Slow drainage occurs when the dialysate level drops and the intestines cover the small hole at the distal end of the PDC. Generally, 1 to 3 liters of dialysate are introduced into the patient's abdomen. For proper fluid and electrolyte balance, the patient needs to drain this entire volume. However, drainage can be hindered if there is not enough dialysate fluid to prevent the intestines from temporarily blocking the hole in the PDC as the fluid is drained. Modern PDCs are made of silicone rubber and sink into the lowest part of the body (the most dependent portion), which increases the likelihood of the intestines blocking the hole. [Overview of the project] [Problems that the invention aims to solve]

[0011] To provide more complete fluid drainage, it is desirable to develop improved peritoneal dialysis catheters. [Means for solving the problem]

[0012] One embodiment is a long tubular member comprising a proximal region, a distal region, and a wall defining a first lumen and a second lumen extending from the proximal region to the distal region. and The wall portion located in the distal region comprises a perforation that fluidly communicates with a first lumen, and an expandable member located in a tubular member that fluidly communicates with a second lumen, wherein the first lumen is a fluid lumen, and the second lumen is an expansion lumen. Device To provide.

[0013] In several embodiments, the expandable member may be arranged longitudinally along a portion of the distal region. The expandable member may be sized to completely enclose at least a portion of the elongated tubular member; for example, the expandable member may be sized to enclose at least a portion of the circumference of at least a portion of the elongated tubular member.

[0014] In several embodiments, the expandable member may be located at the distal end of the tubular member, and the wall portion containing the multiple perforations may be located proximal to the expandable member. In other embodiments, the wall portion containing the multiple perforations may be located along the distal elongated tubular member of the expandable member.

[0015] In some embodiments, the wall containing multiple perforations has a curved shape, such as a spiral shape.

[0016] The expandable member may include materials selected from the group consisting of nylon, polyamide, polyolefin, polyester, polyurethane, fluoropolymer, polyethylene, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyvinyl chloride, latex, natural rubber, synthetic rubber, elastomer, silicone, and mixtures and copolymers thereof.

[0017] In some embodiments, the elongated tubular member further comprises at least one cuff, such as first and second cuffs, which are positioned on the wall of the elongated tubular member in a proximal region.

[0018] In several embodiments, the expandable member includes a balloon, or the expandable member includes an elastomer sheath defining a cavity and an open-cell foam inside.

[0019] In several embodiments, the wall of the elongated tubular member further comprises a radiopaque stripe extending from the proximal region to the distal region. The elongated tubular member may further comprise a retractable sheath.

[0020] In several embodiments, the elongated tubular member may further include a fitting mechanism operably engaged with the proximal region of the elongated tubular member, the fitting mechanism capable of controlling the flow of fluid through the first lumen. The fitting mechanism may include a passage for fluid communication with the first lumen and / or a passage for fluid communication with a second lumen.

[0021] In a particular embodiment, the apparatus comprises an elongated tubular member, an expandable member, a first cuff and a second cuff, the elongated tubular member comprising a proximal region, a distal region and a wall including a radiopaque stripe extending from the proximal region to the distal region, the wall defining a first lumen and a second lumen extending from the proximal region to the distal region, the first lumen being a fluid lumen and the second lumen being an expansion lumen, and the portion of the wall located at the distal end of the distal region being helical The expandable member is shaped to include a plurality of perforations that are in fluid communication with the first lumen, and is positioned longitudinally of the tubular member so as to completely enclose at least a portion of the elongated tubular member along a portion of the distal region located proximal to the perforated portion of the wall, and the expandable member comprises a sheath defining a cavity containing open-cell foam that is in fluid communication with the second lumen, and the first and second cuffs are spaced apart on the wall of the elongated tubular member in the proximal region.

[0022] In this embodiment, the elongated tubular member may further include a joint mechanism operably engaged with the proximal end of the elongated tubular member, the joint mechanism comprising a first passage that is in fluid communication with a first lumen and capable of controlling the flow of fluid through the first lumen, and a second passage that is in fluid communication with a second lumen.

[0023] Another aspect provides a kit including the above-described device and a fitting mechanism configured to engage with the device, the fitting mechanism being capable of controlling the flow of fluid through a first lumen when engaged with the device. The coupling mechanism may include a passage configured to be in fluid communication with the first lumen and / or a passage configured to be in fluid communication with a second lumen.

[0024] In a particular embodiment of the kit, the device includes an elongate tubular member, an expandable member, a first cuff and a second cuff, the elongate tubular member including a proximal region, a distal region, and a wall including a radiopaque stripe extending from the proximal region to the distal region, the wall defining a first lumen and a second lumen extending from the proximal region to the distal region, the first lumen being a fluid lumen and the second lumen being an inflation lumen, a wall portion disposed at the distal end of the distal region being helical in shape and including a plurality of perforations in fluid communication with the first lumen, the expandable member being disposed along a portion of the distal region disposed proximal to the perforated portion of the wall so as to completely enclose at least a portion of the elongate tubular member in the longitudinal direction of the tubular member, the expandable member including a sheath defining a cavity including a continuous bubble foam in fluid communication with the second lumen, and the first cuff and the second cuff being spaced apart and disposed on the wall of the elongate tubular member in the proximal region. The coupling mechanism is configured to operably engage with the proximal end of the elongate tubular member, the coupling mechanism including a first passage and a second passage configured to be in fluid communication with the first lumen, the coupling mechanism being capable of controlling the flow of fluid through the first lumen when the coupling mechanism is engaged with the proximal end, and being configured to be in fluid communication with the second lumen when the coupling mechanism is engaged with the proximal end.

[0025] An embodiment of the kit may further include a stylet to guide insertion of the catheter into the peritoneal cavity of a subject and / or a cutting tool to create an opening into the peritoneal cavity for insertion of the catheter.

[0026] Another aspect is a method for performing peritoneal dialysis, the method comprising: inserting a distal region of the above-described device, including any embodiment, through an opening in the abdominal wall of a subject requiring dialysis; expanding an expandable member through a second lumen; introducing fluid into the abdomen through a first lumen; maintaining the fluid in the abdomen for a time sufficient for waste to diffuse from the blood vessels surrounding the abdomen into the fluid; and removing the fluid from the abdomen through the first lumen.

[0027] Yet another aspect is a method for treating a subject requiring peritoneal dialysis, the method comprising: inserting a distal region of the device according to any one of claims 1 to 20 through an opening in the abdominal wall of the subject; expanding an expandable member through a second lumen; introducing fluid into the abdomen through a first lumen; maintaining the fluid in the abdomen for a time sufficient for waste to diffuse from the blood vessels surrounding the abdomen into the fluid; and removing the fluid from the abdomen through the first lumen.

[0028] In some embodiments of any of these methods, the device may further comprise a retractable sheath, and the method may further comprise retracting the retractable sheath before expanding the expandable structure.

[0029] In some embodiments of any of these methods, the method may further comprise contracting the expandable member after the fluid has been removed from the abdomen. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The present invention can be more fully understood by reading the following description in conjunction with the drawings. [Figure 1A] FIG. 1A shows a schematic view of one embodiment of a catheter according to an exemplary embodiment of the disclosed subject matter. [Figure 1B] FIG. 1B shows a schematic view of one embodiment of a catheter according to an exemplary embodiment of the disclosed subject matter. [Figure 2A]Figure 2A shows a schematic diagram of another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 2B] Figure 2B shows a schematic diagram of another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 3A] Figure 3A shows a schematic cross-sectional view of another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 3B] Figure 3B shows a schematic cross-sectional view of another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 4A] Figure 4A shows a schematic side view of another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 4B] Figure 4B shows a schematic side view of another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 5A] Figure 5A shows a schematic diagram of a curved embodiment of a catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 5B] Figure 5B shows a schematic diagram of a curved embodiment of a catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 5C] Figure 5C shows a schematic diagram of a curved embodiment of a catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 6A] Figure 6A shows a schematic diagram of another curved embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 6B] Figure 6B shows a schematic diagram of another curved embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 7A] Figure 7A shows a schematic cross-sectional view of another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 7B] Figure 7B shows a schematic cross-sectional view of another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 8A]Figure 8A depicts an alternative embodiment of a catheter having two expandable structures on the distal region of the PDC, according to an exemplary embodiment of the subject matter disclosed. [Figure 8B] Figure 8B depicts an alternative embodiment of the catheter, according to an exemplary embodiment of the subject matter disclosed, which includes two expandable structures on the distal region of the PDC. [Figure 9A] Figure 9A shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 9B] Figure 9B shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 9C] Figure 9C shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10A] Figure 10A shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10B] Figure 10B shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10C] Figure 10C shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10D] Figure 10D shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10E] Figure 10E shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10F] Figure 10F shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10G] Figure 10G shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10H] Figure 10H shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10I] Figure 10I shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10J]Figure 10J shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10K] Figure 10K shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10L] Figure 10L shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10M] Figure 10M shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10O] Figure 10O shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10P] Figure 10P shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10Q] Figure 10Q shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 10R] Figure 10R shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 11A] Figure 11A shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 11B] Figure 11B shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 11C] Figure 11C shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 11D] Figure 11D shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 11E] Figure 11E shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 11F] Figure 11F shows another embodiment of the catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 12A] Figure 12A shows an embodiment of a catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 12B]Figure 12B shows an embodiment of a catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 12C] Figure 12C shows an embodiment of a catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 12D] Figure 12D shows an embodiment of a catheter according to an exemplary embodiment of the subject matter disclosed. [Figure 13] Figure 13 shows a schematic diagram of a PDC according to an exemplary embodiment of the disclosed subject, which is inserted into the peritoneal cavity of a patient for peritoneal dialysis. [Modes for carrying out the invention]

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art in which the present invention pertains. In case of any conflict, including definitions, this document shall prevail. Preferred methods and materials are described below, but similar or equivalent methods and materials may be used in carrying out or testing the present invention. The materials, methods, and examples disclosed herein are illustrative and not intended to limit the scope of the invention.

[0032] As used herein, the terms “comprise,” “include,” “having,” “has,” “can,” “contain,” and their variations are intended to be open-ended transitional phrases, terms, or words that do not preclude the possibility of additional acts or structures. This disclosure also contemplates other embodiments that “include,” “essentially consist of,” and “consist of” the embodiments or elements presented herein, whether expressly described or not.

[0033] The advantages of indwelling catheter systems include home treatment options, lower costs compared to hemodialysis, and clinical efficiency.

[0034] Conventional peritoneal dialysis (PD) catheter products are single-lumen catheters designed to allow a consistent bidirectional flow of dialysate into and out of the abdominal cavity. One or more cuffs are attached to the catheter tube to allow for internal tissue growth to maintain catheter placement. Catheters may have various lengths and cuff configurations, including straight, curled, and swan-neck catheter styles. Catheters are fabricated from a translucent silicone rubber tube containing a radiopaque stripe, along with a felt cuff, which is used to stabilize the catheter through internal tissue growth. Current challenges for indwelling catheter systems include intestinal obstruction, pain, and incomplete drainage.

[0035] This specification provides a peritoneal dialysis system with a buoyant catheter that facilitates catheter positioning to minimize the possibility of catheter obstruction by the intestine. The catheter system described herein is adapted for acute and chronic peritoneal dialysis. The peritoneal dialysis catheter may be inserted using open surgery, laparoscopy, or percutaneous surgical techniques.

[0036] As used herein, the terms “proximal” and “distal” are used to describe opposing axial ends in a device, as well as the axial ends of various component features of the device. The term “proximal” is used in its conventional sense to refer to the end of the device (or component of the device) that is closer to the healthcare professional during use of the device. The term “distal” is used in its conventional sense to refer to the end of the device (or component of the device) that is first inserted into the patient, or the end that is further away from the healthcare professional during use of the device. For illustrative purposes, the distal region of a catheter described herein is inserted into the patient’s peritoneal cavity, and fluid is transported in and out of the peritoneal cavity via the proximal end.

[0037] As used herein, the terms “expandable member” or “expandable structure” as used interchangeably herein refer to a flexible or elastomer sheath that can be stretched or expanded from a compressed state with a small volume to an expanded state with a larger volume. As a result, the expandable structure in the expanded state is less dense than its compressed state structure, allowing the expandable structure to float in a body cavity filled with bodily fluids. In particular, the sheath is fluid-seal and airtight to prevent leakage of fluid into or from the structure.

[0038] As used herein, the term “balloon” refers to an inflatable member or structure including an inflatable, flexible, or elastomer bag or sheath, defining an internal cavity that, in its inflated state, can be filled with a gas such as helium, hydrogen, nitrous oxide, oxygen, or air. Specifically, the interior of the sheath contains no material, and the interior of the sheath contains only gas when in its expanded state. In several embodiments, the balloon is configured in a flat, pleated, wrinkled, or folded state, first minimizing the cavity for insertion into a body cavity of an object, and then being inflated using a gas such as air introduced, for example, through an expansion lumen in a catheter.

[0039] Alternatively, the expandable member may comprise an expandable sheath defining a cavity containing open-cell foam. In several embodiments, the open-cell foam is held in a compressed state for insertion into a body cavity and then inflated or expanded after insertion. In several embodiments, the open-cell expandable structure can be inflated like a balloon using gas introduced through an expansion lumen. In other embodiments, the open-cell structure is compressed by vacuum through an expansion lumen. When the vacuum is released, air enters the expansion lumen and then into the open-cell structure, thereby expanding the open-cell structure. In other embodiments, the open-cell structure may be self-expanding, in which case the open-cell foam maintains its compressed state until the compression is released. For example, rapid expansion of the open-cell foam can be enabled by opening a valve or by generating a vacuum that draws gas from the expansion lumen into the expanding open-cell foam.

[0040] In any of the embodiments described above, the catheter may further comprise a retractable non-elastomer or non-expandable sheath, which is radially positioned around the expandable member and prevents the expandable member from expanding until it is desired that the expandable member expand. For example, the non-expandable sheath may be retracted from around the expandable member after insertion into the object. When the non-expandable sheath is retracted, it allows the balloon or open-cell foam to expand with gas introduced through the expansion lumen. In self-expanding embodiments, the retraction of the non-expandable sheath can function as a "valve" that allows the compressed open-cell foam to expand.

[0041] The expandable structure described herein provides a portion of the catheter to the distal region of the catheter where density is reduced, allowing the distal region of the catheter to float near the upper part of the peritoneal fluid in the abdominal cavity to facilitate drainage.

[0042] For the purpose of facilitating an understanding of the principles and characteristics of the catheter and its method of use, certain terms are used to describe the embodiments shown in the drawings. Nevertheless, the scope of the apparatus is not limited to the specific language used, and modifications and alterations to the illustrated apparatus, as well as further applications of the features of the catheter illustrated herein, will be contemplated as would ordinarily conceivable to those skilled in the art to which the invention relates.

[0043] The apparatus described herein can take many different forms, but preferred embodiments are described in this disclosure and shown in the accompanying drawings. This disclosure exemplifies the principles of the disclosed apparatus and does not limit the broad range of apparatuses and methods for use to only the embodiments described herein.

[0044] Aspects of this disclosure provide a medical device or catheter for performing peritoneal dialysis.

[0045] Referring here to Figures 1A and 1B, a first embodiment of such a device is shown. The catheter 10 includes a flexible elongated tubular member 11 having a first internal lumen (not shown) extending from a proximal region 12 to a distal region 13. The lengths and shapes of sections 11, 12, and 13 can be modified depending on the embodiment of the catheter. For ease of presentation, the length of the elongated tubular member is shown with a break along its length, and the length of the tubular member can be dimensioned to fit within the patient's abdominal cavity. The walls of the elongated tubular member 11 in the proximal and distal regions do not have openings providing a fluid pathway between the first lumen and the outside of the device, except for a perforated segment in the distal region which will be described further below. The catheter 10 is made of flexible medical-grade tubing suitable for implantation in the patient's body. In various embodiments, the wall thickness along at least a portion of the elongated tubular member is 2 mm to 0.25 mm, or 2 mm to 0.5 mm, or 1.5 mm to 0.5 mm, or 1.0 mm to 0.5 mm, or 2 mm to 1.0 mm, or 0.25 mm to 0.5 mm, or 0.25 mm to 0.4 mm, or 0.25 mm to 0.3 mm.

[0046] The proximal region 12 of the catheter 10 provides a function for connecting the catheter 10 to a dialysate supply and removal system, such as an automated peritoneal dialysis system (not shown). The proximal region 12 is provided with an end 14, which is configured to be attached to the dialysate supply and removal system via a connector fitting and tubing. The lumen can then transport fluid between the peritoneal cavity and the dialysate supply and removal system. An external tube or lumen (not shown) is located outside the patient and is connected to the automated peritoneal dialysis system and the proximal region 12, providing fluid communication between them. The catheter 10 may generally have a vertical orientation when implanted in the patient with the distal region 13 positioned upward toward the upper region of the peritoneal cavity. The proximal region 12 may be positioned downward toward the bottom of the peritoneal cavity.

[0047] The proximal region 12 may also provide for securing the catheter 10 to the patient. The catheter 10 is secured to the patient by one or more implantable cuffs 15, 16 positioned on the wall of the elongated tubular member in the proximal region 12. The catheter 10 is implanted in the patient with the cuff 15 positioned just below the patient's skin and the cuff 16 embedded in the patient's rectus muscle.

[0048] The cuff can improve the sealing of the catheter inlet opening. The cuff may be formed from a material including, for example, polyethylene terephthalate (e.g., DACRON) or another biocompatible polymer material. The implant cuffs 15, 16 may be polyester felt or other material that allows for internal tissue growth within the cuff. Subcutaneous tissue can grow within the implant cuffs 15, 16 to secure the catheter 10 to the patient.

[0049] In other embodiments, the cuff includes a remodelable material. Such a remodelable material can remodel or promote cell growth and / or promote the regrowth and healing of damaged tissue structures. The presence of such a remodelable material may promote internal cell growth and fixation of the catheter to the rectal sheath. This may help stabilize the catheter and provide an improved seal of the opening. In other embodiments, the remodelable material is present on the surface of the elongated member or incorporated into the structure of the elongated member.

[0050] Reconstructible materials may include, for example, extracellular material (ECM), small intestinal submucosa (SIS), reconstructible foam or collagen foam, foamed ECM, lyophilized SIS, or vacuum-pressed SIS. A non-limiting example of a suitable reconstructible material is SURGISIS® and BIODESIGN®, commercially available from Cook Incorporated, Bloomington, Ind. Another suitable reconstructible material is the graft prosthesis material described in U.S. Patent No. 6,206,931, incorporated herein by reference.

[0051] When the catheter 10 is implanted inside the patient, the portion of the catheter 10 from the proximal end 14 near the cuff 15 is outside the patient and can be considered the external patient portion. The remaining portion of the catheter 10 is implanted inside the patient and can be considered the implantable portion. As shown in Figures 1A and 1B, the implantable portion may have a nearly nonlinear shape, although the portion of the implantable portion may be substantially linear. Because the tube is flexible, a configuration that fits into the peritoneal cavity may be employed.

[0052] In some embodiments, radiopaque stripes may extend along the length of the catheter 10. Under X-ray conditions, the radiopaque stripes indicate the position of the catheter 10 inside the patient.

[0053] The distal region 13 comprises a plurality of perforations or holes 17 that are in fluid communication with the first lumen, and an expandable member or expandable structure. The number and size of the perforations 17 are not limited, but they may be configured to allow extracellular fluid to pass into the first lumen but not cellular material.

[0054] In several embodiments, the expandable member comprises an expandable structure such as a balloon. Therefore, the apparatus also includes at least one inflation tube in a second lumen (not shown) for inflating the expandable structure. The inflation tube typically extends from the proximal region 12 of the apparatus to the expandable structure and is in fluid contact with the interior of the expandable structure. For example, the elongated tubular member 11 may have at least two lumens: a larger first lumen for the passage of the dialysis fluid and a smaller second lumen for providing inflation of the expandable structure. As described above, the expandable structure may include a balloon or an open-cell foam structure.

[0055] In the embodiments shown in Figures 1A and 1B, multiple perforations are located at the distal end of the distal region 13, and the expandable member is located proximal to the multiple perforations.

[0056] Figure 1A shows the expandable structure in a contracted or compressed state 18a, positioned proximal to the multiple perforations 17. Using a retractable sheath (not shown) around the expandable structure 18a can protect the contracted expandable structure during catheter insertion into the patient's abdomen. Figure 1B shows the expandable structure in an expanded state 18b. After inflation, the expandable structure acts as a float to hold the distal region 13 of the catheter 10 near the upper level of fluid in the patient's abdomen, so that the catheter does not sink and is not obstructed by the patient's intestines. The expandable structure may also hold the distal portion of the sheath away from the surface of the intestines to further reduce the possibility of the intestines blocking the perforation area.

[0057] In several embodiments, the expandable structure is arranged longitudinally along the length of the distal region 13.

[0058] The expandable structure of the device may be manufactured from any material typically used in the manufacture of expandable structures. For example, the expandable structure may include materials such as nylon, polyamide, polyolefin, polyester, polyurethane, fluoropolymer, polyethylene, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyvinyl chloride, latex, natural rubber, synthetic rubber, elastomer, silicone or mixtures and copolymers of these materials or two or more of these materials.

[0059] Foams are materials formed by trapping gas in a liquid or solid. During the expansion and curing of open-cell foams, the bubbles used in their manufacture are released into the atmosphere rather than being fixed in place as in closed-cell foams. Open-cell foams are foams in which compartments within the material are broken down, allowing air to occupy the internal spaces. Open-cell foams contain pores that connect to each other, forming a relatively soft interconnected network with a spongy appearance. Typically, open-cell foams are lighter, less dense, and more expandable than closed-cell foams. There are arrays of open-cell foam materials, which are generally made from polyurethane, mesh polyurethane, PVC / nitrile, ethylene propylene diene monomer (EPDM) rubber, etc. A notable material is medical-grade silicone open-cell foam.

[0060] As shown in Figures 1A and 1B, the distal region 13 of the catheter may be curved in a spiral or "pigtail" shape, etc., to stabilize the catheter. In such curved embodiments, the curve may be the result of shape memory formed within the catheter during manufacturing. During insertion, the curved portion can be "straightened" by passing the catheter through a straight stylet. After insertion, when the straight stylet is removed from or retracted from the catheter 10, the distal region 13 can revert to its curved shape. Alternatively, a retractable sheath can hold the catheter in a straight configuration for insertion.

[0061] Figures 2A to 6B show aspects of other embodiments of the catheter 10 shown herein. In these embodiments, the elongated tubular member 11 and the proximal region 12 are substantially the same as those shown in Figures 1A and 1B, and are therefore not shown in Figures 2A to 6B for the sake of simplicity of presentation.

[0062] In the embodiments shown in Figures 2A and 2B, the distal region 23 comprises an expandable structure located at the distal end of the distal region 23, and a plurality of perforations 27 located proximal to the expandable structure and adjacent to the unperforated region of the elongated tubular member 11. In Figure 2A, the expandable structure 28a is in a contracted or compressed state. In Figure 2A, the expandable structure 28b is in an expanded or expanded state.

[0063] In other embodiments, the expandable structure and the perforation occupy separate sections along substantially the same length of the distal region, with the expandable structure located in a first portion of the circumference of the distal region and the multiple perforations located in a second portion of the circumference of the distal region. In these embodiments, the expandable structure may be located along the entire length of the perforated portion of the distal region of the PDC. Schematic cross-sections of the catheter 10 according to these embodiments are shown in Figures 3A and 3B. In Figure 3A, the distal region 33 includes a partition 34, which divides the tubular member 11 into a first lumen 35 and a second lumen 36, each extending from the proximal region 12 to the distal region 33, which is the length of the catheter 10. The first lumen 35 is in fluid communication with a perforation region 37 containing multiple perforations, similar to the perforation 17 shown in Figure 1A. The second lumen 36 is in fluid communication with the expandable structure shown in the contraction configuration 38a of Figure 3A. As the gas passes through the second lumen 36, the expandable structure expands, as shown in the expanded state 38b in Figure 3B.

[0064] Figures 4A and 4B show side views of the distal region 33, as shown in Figures 3A and 3B, along line A shown in Figure 3A. In these figures, the distal region 33 has a simple "linear" configuration, but as should be noted, the catheter is flexible, and the linear configuration can actually bend and curve when deployed to the patient. The perforation region 37 occupies the first circumferential portion of the distal region 33, and the expandable structure occupies the second circumferential portion of the distal region 33 in the contracted configuration 38a in Figure 4A and the inflated configuration 38b in Figure 4B.

[0065] Figures 5A–5C show schematic diagrams of a curved embodiment of the catheter viewed along line A shown in Figure 3A. In Figure 5A, the distal region 33 has a curved configuration, in which the perforated portion 37 of the distal region 33 occupies the inner (smaller) radius of the curved configuration, and the contractible / expandable structure 38a occupies the outer (larger) radius of the curved configuration. Figure 5B shows the same catheter with the expandable structure in its expanded state 38b. Figure 5C shows the helical shape of the distal region 33 with the expandable structure shown in its expanded state. As described above, the curvature shown in Figures 5A–5C is not limited, and the curvature is not fixed because the catheter contains a flexible material, and it can be straightened for insertion into the patient and then reformed after insertion.

[0066] In other embodiments not shown, the expandable structure may occupy the inner radius of the curved distal region.

[0067] Figures 6A and 6B show another embodiment of the curved distal region. In this embodiment, the distal region is viewed along line B in Figure 3A and includes cross-sections as shown in Figures 3A and 3B. In this embodiment, the expandable structure occupies the “top” of the catheter with respect to the axis of the catheter's curve, and the perforation region occupies the “bottom” of the catheter with respect to the axis of the catheter's curve. In Figure 6A, the catheter is viewed from the bottom along line B parallel to the axis of curvature. The expandable structure in Figure 6A is in a contracted state and is therefore not visible behind the perforation portion 37. In Figure 6B, the expandable structure is in an expanded state 38b and is visible behind the perforation portion 37.

[0068] Figures 7A and 7B show schematic cross-sectional views of another embodiment of a catheter having two expandable structures positioned diametrically opposite each other on the distal region of the PDC. The catheter comprises a tubular member 70 having two partitions 71 and 72 that divide the tubular member 70 into a larger (first) lumen 73 and two smaller lumens 74 and 75. The lumen 73 is in fluid communication with two perforated portions 76 and 77 that are diametrically opposite each other in the tubular member 70. The lumen 73 extends along the length of the tubular member and is configured to carry dialysate between the proximal region 12 of the catheter and the distal portion shown. Lumens 64 and 75 also extend along the length of the tubular member and are configured to carry expansion gas from the proximal region 12 of the catheter to the expandable structures. In Figure 7A, the expandable structures are shown in a deflated or compressed state 78a and 79a. In Figure 7B, the expandable structures are shown in an inflated or expanded state 78b and 79b.

[0069] Figures 8A and 8B show alternative embodiments of a catheter having two expandable structures on the distal region of the PDC. In this embodiment shown in Figure 8A, the PDC comprises a distal region 83 having a first expandable structure 86a in a compressed state located distal to the perforation region 87 and a second expandable structure 88a in a compressed state located proximal to the perforation region 87. Figure 8B shows the same distal region 83 with the expandable structures in expanded states 86b and 88b, resulting in a “barbell” configuration.

[0070] Figures 7A, 7B, 8A, and 8B show, but are not limited to, two expandable structures. In some embodiments, the PDC may have multiple expandable structures.

[0071] Figures 9A, 9B, and 9C show an aspect of one embodiment of a peritoneal dialysis catheter, with its distal end shown extending linearly. One embodiment of the catheter 90 includes two main features. First, as shown in detail in Figure 9B, the catheter 90 comprises a dual-lumen silicone tube 91, which includes one lumen 92 for injecting and draining dialysate and another lumen 93 for transmitting or carrying vacuum or air to collapse or expand the silicone balloon or sheath using a foam insert. Second, the catheter 90 includes a silicone balloon or sheath 94 with a compressible foam insert (not shown) attached near the distal end of the catheter, which is placed inside the peritoneal cavity after insertion. The foam insert inside the balloon inflates with air, providing buoyancy during dialysis and improving the drainage of dialysate. The distal end 95 of the catheter includes a laser-ablated baffle with perforations in the fluid lumen, which includes a plurality of laser-ablated holes arranged along the perforation region of the catheter. The perforation provides fluid communication from the peritoneal cavity to the fluid lumen 92 of the catheter. The distal end 95 is shown in an extended linear configuration for insertion into the peritoneal cavity of the target, but as mentioned above, the distal end 95 can adopt a curved or spiral configuration after insertion.

[0072] In several embodiments, the distal tip 96 of the catheter is configured to minimize contact between the distal working end of the catheter and the surface of the intestine, bladder, or peritoneum. As shown in detail in Figure 9C, the distal end comprises a crenellate tip 96 having a plurality of alternating longitudinal projections or peaks 96a and longitudinal depressions or valleys 96b. In the illustrated embodiments, the tip comprises, but is not limited to, two diametrically arranged projections or peaks and two diametrically arranged depressions or valleys.

[0073] Furthermore, as shown in Figure 9A, the catheter is equipped with one or more internal growth cuffs 97 near the proximal end of the catheter. These cuffs provide a base for internal tissue growth and facilitate the fixation of the proximal end of the catheter 90 near the peritoneal wall of the target. The cuffs can be prepared from polyethylene terephthalate (DACRON) fibers and are positioned around the catheter.

[0074] A silicone balloon or sheath 94 having a compressible foam insert may be placed into the peritoneal cavity through a removable sleeve or a retractable sleeve. Initially, the balloon is folded for insertion into the abdomen. During implantation, the system is kept under vacuum to keep the buoyancy balloon compressed. Exposure to the atmosphere through the lumen 93 causes the balloon to expand. Once the negative pressure is removed, air enters the foam insert, allowing the balloon to expand.

[0075] Another embodiment of the catheter is shown in Figures 10A–10R. Figures 10A and 10B show the catheter 1000 in an assembled and disassembled state, respectively. The catheter 1000 comprises a dual-lumen catheter body 1001 having a silicone balloon or sheath 1004 positioned near the distal end 1005. Inside the balloon 1004 is a foam insert 1008. Two internal growth cuffs 1007 are positioned around the catheter body. A vacuum adapter 1100 is positioned at the proximal end of the catheter, and the vacuum adapter 1100 is configured to engage with the proximal end 1009 of the catheter body 1001 and provide a connection to a fluid handling system for moving dialysate in and out of the peritoneal cavity. Figure 10C shows a non-coiled (non-spiral) diagram of the catheter 1000 with typical dimensions of the components shown. In the illustrated embodiment, the length of the catheter in its uncoiled state is 625 mm, the outer diameter of the catheter is 4.75 mm, and the wall thickness is 1.0 mm. Considering the air lumen, this results in a cross-sectional area of ​​5.4 mm for fluid passage. The silicone balloon 1004 has an outer diameter of 12.5 mm in its expanded or uncompressed state. During implantation, the system is kept under vacuum to keep the buoyancy balloon compressed. As shown in Figure 10D, when vacuum is applied to the proximal end of the air lumen for insertion into the peritoneal cavity of the target, the outer diameter of the balloon 1004 is compressed to approximately 8 mm. The distal end 1005 of the catheter is positioned uncoiled for insertion and held within a removable sleeve. Figure 10E shows the catheter after it has been placed in the peritoneal cavity. When the negative pressure is removed, the balloon inflates, and air can enter the foam insert. The distal end 1005 is shown in its coiled (spiral) state.

[0076] Figure 10F shows that the catheter comprises an extruded portion having a cross-section of the catheter at AA shown in Figure 10E. The cross-section shows a fluid lumen 1002 and a vacuum / air lumen 1003. A radiopaque stripe 1010 co-extruded with the dual lumen is also shown. Figure 10G shows a cross-section of the catheter at BB shown in Figure 10E with the foam insert 1008 expanded. The foam comprises open-cell foam. Multiple larger diameter holes arranged around the catheter provide an open space that can be folded when a vacuum is applied through the lumen 1003 or expanded when air is applied through the lumen 1003. Although not shown, the lumen 1003 is perforated in the area of ​​the catheter that is in contact with the foam insert 1008 in order to provide fluid (air) communication between the lumen 1003 and the foam 1008.

[0077] In several embodiments, the tip of the catheter is configured to minimize contact between the distal working end of the catheter and the surface of the intestine, bladder, or peritoneum. In these embodiments, the tip comprises an end opening and a plurality of openings arranged around the catheter. As shown in Figure 10H, the distal tip 1006 comprises, but is not limited to, two elongated openings 1006a arranged diametrically on both sides of the tip and an end opening 1006b. The distal end 1005 includes a plurality of laser-ablated holes 1005a arranged along its length.

[0078] Figure 10I shows a cutaway side view of the catheter 1000 in the balloon portion along line CC shown in Figure 10C. The foam 1008 is positioned around the catheter 1001 and inside the balloon 1004. The balloon 1004 is attached to the outside of the catheter using solvent bond or adhesive. A V-cut 1012 into the vacuum lumen 1003 provides fluid communication from the lumen 1003 to the foam 1008. The distal tip 1006 is also shown.

[0079] Figure 10J shows the catheter lumen 1001 without other components of the catheter. The distal end is represented by a helical coil having a length of approximately 330 mm and an outer diameter of approximately 50 mm. The distal end has multiple laser-ablated holes spaced approximately 10 mm apart. Figure 10K shows a cross-section of the lumen at line EE in Figure 10J. Figure 10L shows a side view and perspective view of the balloon 1004. Figure 10M shows a side view and perspective view of the foam insert 1008. The foam 1008 can be assembled from multiple shorter side-by-side segments configured around the catheter. This allows for the preparation of catheters with expandable structures of different lengths. Figure 10N shows a front view of the balloon 1004, and Figure 10O shows a front view of the foam insert 1008. Figures 10P, 10Q, and 10R show a front view, side view, and perspective view of the internal growth cuff 1007, respectively.

[0080] Figures 11A–11F show embodiments of a vacuum adapter 1100 that engages with the proximal end of a catheter to provide fluid communication from the peritoneal cavity of a target to other extraperitoneal fluid handling structures of a target via the catheter 1000. Figure 11A shows a side view of the vacuum adapter 1100. The vacuum adapter is equipped with a male Luer connector 1102 on its proximal end 1101 for mounting a syringe or other fluid handling system. The central section 1103 of the adapter is equipped with a vacuum check valve. The distal end 1104 of the adapter 1100 is configured to engage with the proximal end of a dual-lumen catheter 1000. Figure 11B shows a cross-sectional view of the adapter 1100 along line WW in Figure 11A. As shown in Figure 11B, the proximal end 1101 and distal end 1104 engage with each other to define a fluid passage 1005 that allows the fluid of the dialysate to pass through. They engage to provide a vacuum check valve 1103. The diameter of the passage 1105a at the proximal end 1101 is sized to engage with the outer tube, thereby allowing it to be configured to lock onto the male Luer connector 1102 using a female Luer connector. The diameter of the passage 1105b at the distal end 1104 is sized to engage with the outer diameter of the catheter 1000. The small passage 1006 is inserted into the lumen 1003 of the catheter 1000 and is configured to transmit air or vacuum into the lumen 1003 from the outside of the catheter. Figures 11C and 11D show perspective views of the vacuum adapter 1100. Figure 11E shows a view of the proximal end of the adapter 1100. Figure 11F shows a view of the distal end of the adapter 1100.

[0081] Figures 12A to 12D show photographs of the catheter 1000 and adapter 1100. Figure 12A shows the proximal end of the catheter 1000 and the distal end of the vacuum adapter 1100 side by side. It can be seen that the air passage 1105b is sized to engage with the outer diameter of the catheter 1000, thereby enabling fluid communication with the fluid lumen 1002. It can also be seen that the air passage 1106 is sized to be inserted into the lumen 1003.

[0082] Figure 12B shows the distal end 1005 of catheter 1000 and balloon 1004 in a compressed state. The surface of balloon 1004 is wrinkled or folded, indicating that it is not expanded. A radiopaque stripe 1010 extending the length of the distal end 1005 is also shown. Figure 12C shows the distal end 1005 of catheter 1000 and balloon 1004 in an expanded state. The surface of balloon 1004 is smoother than in Figure 12B, indicating that the foam insert inside the balloon has expanded and inflated balloon 1004. Figure 12D shows catheter 1000 in a pool of water. The expanded balloon 1004 is floating on the surface of the water, while the distal end 1005 and proximal end 1009 are submerged. This demonstrates that the expandable structure (e.g., balloon 1004) provides sufficient buoyancy to orient the catheter 1000, thereby allowing the distal end to be positioned near the upper part of the fluid in the peritoneal cavity of the target.

[0083] The expandable structure can be inflated by a physician after standard laparoscopic, open, or percutaneous implantation of the catheter system. Peritoneal dialysis can be performed by healthcare providers and / or patients via standard techniques. Dialysis fluid is injected into the peritoneal cavity by connecting a dialysis fluid bag to the catheter. The device achieves a current standard flow rate of 6 L / hr. This catheter system can be used for APD or CAPD. The balloon remains inflated due to an expanding continuous / closed-cell foam insert (scaffold). In several embodiments, the catheter is fabricated from a translucent silicone rubber tube containing a radiopaque stripe, along with a felt cuff, which is available to stabilize the catheter through internal tissue growth.

[0084] Furthermore, a kit is provided comprising the catheter described herein and a transfer fitting or vacuum adapter described herein, optionally further comprising a stylet for guiding the insertion of the catheter into the target peritoneal cavity, and optionally further comprising a cutting tool such as a scalpel for creating an opening into the peritoneal cavity for insertion of the catheter. The kit may further comprise instructions for the use of the catheter.

[0085] Another aspect of the present invention provides a method for performing peritoneal dialysis. As shown overall in Figure 13, the distal end of the catheter device disclosed above is inserted through an opening in the abdominal wall of a patient requiring dialysis. During this interim procedure, the expandable member, including the expandable structure, is typically in a deflated or compressed configuration. For example, the expandable structure may be confined within the lumen of the delivery sheath.

[0086] During use, the distal end of the device is first inserted through an opening in the abdominal wall so that the distal region containing the expandable structure and multiple perforations are positioned within the abdominal cavity. The expandable structure is typically deflated or compressed during this stage of the procedure. In some embodiments, the expandable structure is compressed by applying a vacuum through an air lumen. After inserting the elongated member to the desired length, the expandable structure can be inflated. For example, the expandable structure can be inflated through an expansion tube(s) using a gas such as air or helium.

[0087] The dialysis fluid is delivered from the proximal end 12 of the elongated member 11 to the distal end of the device, and then to the abdominal cavity through the first lumen. Thus, the first lumen provides a leak-free route from the outside to the patient's abdomen.

[0088] In embodiments where the distal region of the catheter includes a curved portion, the catheter is inserted into the abdomen using a straight stylet, and when the stylet is removed, the catheter curves or bends.

[0089] The expandable structure can then be expanded by gas transported from the proximal region of the device to the expandable structure via an expansion tube in the second lumen. The gas for expanding the expandable structure can be supplied from the automated peritoneal dialysis system or from another device, usually a syringe, connected to the second lumen in the proximal region of the catheter. In one embodiment, the expandable structure can be expanded after insertion into the abdomen and before the introduction of dialysate. Alternatively, the expandable structure can be expanded after the introduction of dialysate. The expandable structure can be expanded before or after the introduction of dialysate to maximize drainage during the drainage period. Alternatively, the expandable structure may remain expanded for the lifespan of the indwelling PDC (up to several years).

[0090] A certain volume of dialysate is introduced into the abdomen through the first lumen of the elongated member. Typically, the volume of fluid introduced is about 1–3 liters, and the fluid is introduced over a period of about 10–15 minutes. The fluid remains in the abdominal cavity, and waste products diffuse into the fluid within the peritoneal cavity, crossing the peritoneum from the underlying blood vessels. After a variable period depending on the treatment, typically 4–6 hours, the fluid is removed through the lumen of the device while the expandable structure is inflated. This air-filled expandable structure system is positioned adjacent to the perforation portion of the PDC in the distal region to suspend the PDC above the dialysate. This maximizes contact between the PDC and the dialysate (away from the intestine) as the level drops due to drainage. The expandable structure described herein—the PDC—floats until the fluid is completely removed.

[0091] This process can be performed automatically while the patient is asleep (automated peritoneal dialysis), or by continuously maintaining 1-3 liters of fluid in the abdominal cavity and exchanging the fluid 4-6 times a day (continuous portable peritoneal dialysis).

[0092] Automated peritoneal dialysis is similar to continuous peritoneal dialysis in that the dialysis treatment involves at least one drain, refill, and retention cycle. However, the dialysis machine typically automatically performs 1 to 5 cycles, such as 3 to 5 cycles of peritoneal dialysis treatment overnight while the patient sleeps. It can be understood that the retention time is variable depending on the number of cycles expected during the dialysis treatment. The dialysis machine is fluidically connected to an implanted catheter. The dialysis machine is also fluidically connected to a source of fresh dialysate, such as a bag of dialysate solution, and to a fluid drain. The dialysis machine drains used dialysate from the peritoneal cavity through the catheter to the drain. The dialysis machine then pumps fresh dialysate from the dialysate source through the catheter into the patient's peritoneal cavity. The dialysis machine allows the dialysate to remain in the cavity to transfer waste products, toxins, and excess water from the patient's bloodstream to the dialysate solution. The dialysis machine is computer-controlled so that the dialysis treatment is performed automatically, for example, overnight, when the patient is connected to the dialysis machine. Multiple drain, refill, and retention cycles occur during treatment. Furthermore, at the end of automated dialysis treatment, a final filler is typically used, thereby disconnecting the patient from the dialysis machine and allowing them to continue their daily functions while the dialysate remains in the peritoneal cavity. Automated peritoneal dialysis can improve the patient's dialysis treatment and quality of life by freeing the patient from manually performing the drain, retention, and filler processes. Further rounds of dialysis treatment using the PDC described herein may be performed over a long period of time.

[0093] A catheter may be used as a temporary means to provide dialysis to maintain blood homeostasis, while waiting for another form of dialysis treatment to begin, to allow the kidney to recover from trauma, or while waiting for a hemodialysis access point to heal. In other embodiments, the catheter may be used permanently for peritoneal dialysis.

[0094] When the need for peritoneal dialysis ends, such as when alternative dialysis treatment is initiated or when a kidney is transplanted to the patient, the expandable structure can be deflated and the catheter removed from the patient.

[0095] The fluids used typically contain sodium salts such as sodium chloride, sodium lactate, or sodium bicarbonate, along with a high percentage of glucose, to ensure high osmotic pressure. The amount of dialysis that occurs depends on the volume of fluid, the regularity of the exchange, and the concentration of the fluid. The presence of a catheter presents a risk of peritonitis because it can introduce bacteria into the abdomen. Peritonitis can be treated by directly injecting antibiotics into the abdominal cavity via fluid.

[0096] The aspects of the subject matter to be disclosed include the following:

[0097] One aspect of the subject matter disclosed provides an apparatus comprising a long tubular member, the long tubular member comprising a proximal region, a distal region, a first lumen having a wall extending from the proximal region to the distal region and having no openings providing a fluid path between the first lumen and the outside, wherein the proximal region is configured to engage with a transfer joint for controlling the flow of fluid through the first lumen, the distal region comprises an expandable member having a plurality of perforations in fluid communication with the first lumen and an expandable structure, and the second lumen comprises an expansion tube extending from the proximal region to the expandable structure of the apparatus.

[0098] Multiple embodiments of the apparatus include, individually or in any combination, the following:

[0099] A device in which multiple perforations are located at the distal end of the distal region, and an expandable structure is located proximal to the multiple perforations.

[0100] A device with a curved distal end containing multiple perforations.

[0101] A device in which the distal end, which contains multiple perforations, is configured in a spiral shape.

[0102] A device in which an expandable structure is located at the distal end of the distal region, and a perforation is located proximal to the expandable structure.

[0103] A device in which an expandable structure is arranged longitudinally along a portion of the distal region.

[0104] A device in which an expandable structure is located on a first portion of the outer circumference of the distal region, and multiple perforations are located on a second portion of the outer circumference of the distal region.

[0105] A device with a curved distal region.

[0106] A device in which the distal region is structured as a spiral.

[0107] Apparatus having an expandable structure comprising a material selected from the group consisting of nylon, polyamide, polyolefin, polyester, polyurethane, fluoropolymer, polyethylene, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyvinyl chloride, latex, natural rubber, synthetic rubber, elastomer, silicone, and mixtures and copolymers thereof.

[0108] The device further includes a cuff positioned on the wall of a long tubular member in the proximal region.

[0109] The device further comprises a second cuff positioned on the wall of a long tubular member in the proximal region.

[0110] A device in which an expandable structure includes a balloon.

[0111] An apparatus comprising an expandable structure, including a sheath that defines a cavity containing an open-cell foam.

[0112] A device further comprising a retractable, non-expandable sheath positioned radially outward from the expandable structure.

[0113] Another embodiment is a method for performing peritoneal dialysis, comprising the steps of: inserting the distal region of the above-mentioned device through an opening in the abdominal wall of a person requiring dialysis; introducing fluid into the abdomen through a first lumen; maintaining the fluid in the abdomen for a time sufficient for waste products to diffuse into the fluid from the blood vessels surrounding the abdomen; expanding an expandable structure; and removing the fluid from the abdomen through the first lumen.

[0114] This method further includes, either individually or in combination, the following embodiments.

[0115] A method comprising the step of contracting an expandable structure after the fluid has been removed from the abdomen.

[0116] The method further comprises a retractable sheath positioned around an expandable structure, wherein the device further includes retracting the retractable sheath before expanding the expandable structure.

[0117] Furthermore, a method is provided for treating a patient requiring peritoneal dialysis, comprising the steps of: inserting the distal region of the above-described device through an opening in the abdominal wall of the patient; inflating an expandable structure through a second lumen; introducing fluid into the abdomen through a first lumen; maintaining the fluid in the abdomen for a sufficient time for waste products to diffuse into the fluid from the blood vessels surrounding the abdomen; and removing the fluid from the abdomen through the first lumen.

[0118] This method further includes, either individually or in combination, the following embodiments.

[0119] A method comprising the step of contracting an expandable structure after the fluid has been removed from the abdomen.

[0120] The method further comprises a retractable sheath positioned around an expandable structure, wherein the device further includes retracting the retractable sheath before expanding the expandable structure.

[0121] While preferred embodiments of the present invention have been described, it should be understood that the present invention is not limited in this way and can be modified without departing from the present invention. The scope of the present invention is defined by the appended claims, and all devices included in the meaning of the claims, either literally or equivalently, are intended to be encompassed therein. Furthermore, the advantages described above are not necessarily the only advantages of the present invention, and it is not necessarily expected that all of the advantages described will be achieved in all embodiments of the present invention.

Claims

1. An elongated tubular member comprising a proximal region, a distal region, and a wall defining a first lumen and a second lumen extending from the proximal region to the distal region, wherein a portion of the wall located in the most distal region of the elongated tubular member includes a plurality of perforations that fluidly communicate with the first lumen, and An expandable member is positioned on the proximal side of the portion of the wall having the plurality of perforations, and is in fluid communication with the second lumen, and is airtight and fluid-sealing, and comprises a sheath defining a cavity containing open-cell foam, and is configured in a compressed state for insertion into a body cavity. A device that includes, The first lumen is a fluid lumen, and the second lumen is an expansion lumen. The expandable member is configured as a float for the distal region to float at a higher level than the peritoneal fluid in the abdominal cavity of the target.

2. The apparatus according to claim 1, wherein the expandable member is arranged longitudinally along a portion of the distal region.

3. The apparatus according to claim 1 or 2, wherein the expandable member is sized to enclose at least a portion of the circumference of at least a portion of the long tubular member.

4. The apparatus according to any one of claims 1, 2, or 3, wherein the expandable member completely encloses at least a portion of the long tubular member.

5. The apparatus according to any one of claims 1 to 4, wherein the wall including the plurality of perforations has a curved structure, and the distal region has shape memory, which causes the distal region to expand and take on a curved shape after insertion into the abdominal cavity of the target.

6. The apparatus according to any one of claims 1 to 5, wherein the elongated tubular member further comprises at least one cuff disposed on the wall of the elongated tubular member in the proximal region.

7. The apparatus according to any one of claims 1 to 6, wherein the wall of the long tubular member further comprises a radiopaque stripe extending from the proximal region to the distal region.

8. The apparatus according to any one of claims 1 to 7, wherein the long tubular member further comprises a retractable sheath, the retractable sheath is configured to compress and hold the long tubular member in a linear configuration for insertion into the abdominal cavity of a target.

9. The apparatus according to any one of claims 1 to 8, further comprising a joint mechanism which is operably engaged with the proximal region of the elongated tubular member, and the joint mechanism is capable of controlling the flow of fluid through the first lumen.

10. The apparatus according to claim 9, wherein the joint mechanism comprises a passage that communicates fluid with the first lumen.

11. The apparatus according to claim 9, wherein the joint mechanism comprises a passage that communicates fluidly with the second lumen.

12. An elongated tubular member comprising a proximal region, a distal region, and a wall including a radiopaque stripe extending from the proximal region to the distal region, wherein the wall defines a first lumen and a second lumen extending from the proximal region to the distal region, the first lumen being a fluid lumen, and the second lumen being an expansion lumen, and a portion of the wall located at the distal end of the distal region being configured in a helical shape and including a plurality of perforations that fluidly communicate with the first lumen, An expandable member is positioned along the longitudinal direction of the tubular member so as to completely enclose at least a portion of the long tubular member, along a portion of the distal region located proximal to the perforated portion of the wall, wherein the expandable member is in fluid communication with the second lumen, is airtight and fluid-sealed, and comprises a sheath defining a cavity containing open-cell foam, The first cuff and the second cuff are spaced apart on the wall of the long tubular member in the proximal region, The apparatus according to claim 1, comprising:

13. The apparatus according to claim 12, wherein the elongated tubular member further comprises a joint mechanism operably engaged with the proximal end of the elongated tubular member, the joint mechanism comprising a first passage for fluid communication with the first lumen and a second passage for fluid communication with the second lumen, and the apparatus is capable of controlling the flow of fluid through the first lumen.

14. A kit comprising the apparatus according to any one of claims 1 to 8, and a coupling mechanism configured to engage with the apparatus, wherein the coupling mechanism can control the flow of fluid through the first lumen when engaged with the apparatus.

15. The kit according to claim 14, wherein the joint mechanism comprises a passage configured to communicate fluidly with the first lumen.

16. The kit according to claim 14, wherein the joint mechanism comprises a passage configured to communicate fluidly with the second lumen.

17. The kit according to any one of claims 14 to 16, further comprising a stylet for guiding the insertion of the device into the peritoneal cavity of the target.

18. The kit according to any one of claims 14 to 17, further comprising a cutting tool for forming an opening in the peritoneal cavity of a target in order to insert the device.

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