WO2022125870A1 - Ureteral access peritoneal catheter - Google Patents
Ureteral access peritoneal catheter Download PDFInfo
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- WO2022125870A1 WO2022125870A1 PCT/US2021/062770 US2021062770W WO2022125870A1 WO 2022125870 A1 WO2022125870 A1 WO 2022125870A1 US 2021062770 W US2021062770 W US 2021062770W WO 2022125870 A1 WO2022125870 A1 WO 2022125870A1
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- Prior art keywords
- catheter
- subject
- needle
- guidewire
- pelvis
- Prior art date
Links
- 238000000034 method Methods 0.000 claims abstract description 64
- 210000000626 ureter Anatomy 0.000 claims abstract description 46
- 210000000244 kidney pelvis Anatomy 0.000 claims abstract description 37
- 210000001931 lesser pelvis Anatomy 0.000 claims abstract description 33
- 238000000502 dialysis Methods 0.000 claims abstract description 31
- 210000004303 peritoneum Anatomy 0.000 claims abstract description 26
- 238000002604 ultrasonography Methods 0.000 claims description 16
- 239000003550 marker Substances 0.000 claims description 13
- 239000002872 contrast media Substances 0.000 claims description 12
- 238000002594 fluoroscopy Methods 0.000 claims description 11
- 210000004379 membrane Anatomy 0.000 claims description 10
- 239000012528 membrane Substances 0.000 claims description 10
- 239000003795 chemical substances by application Substances 0.000 claims description 7
- 210000000494 inguinal canal Anatomy 0.000 claims description 5
- 210000003708 urethra Anatomy 0.000 claims description 5
- 238000003780 insertion Methods 0.000 claims description 4
- 230000037431 insertion Effects 0.000 claims description 4
- 210000001015 abdomen Anatomy 0.000 claims description 2
- 210000001519 tissue Anatomy 0.000 claims description 2
- 230000005641 tunneling Effects 0.000 claims description 2
- 210000003734 kidney Anatomy 0.000 abstract description 3
- 102000009123 Fibrin Human genes 0.000 description 6
- 108010073385 Fibrin Proteins 0.000 description 6
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 6
- 229950003499 fibrin Drugs 0.000 description 6
- 230000008021 deposition Effects 0.000 description 4
- 230000007257 malfunction Effects 0.000 description 4
- 210000000056 organ Anatomy 0.000 description 4
- 239000012530 fluid Substances 0.000 description 3
- 230000002572 peristaltic effect Effects 0.000 description 3
- 210000003200 peritoneal cavity Anatomy 0.000 description 3
- 238000011282 treatment Methods 0.000 description 3
- 230000003187 abdominal effect Effects 0.000 description 2
- 230000014509 gene expression Effects 0.000 description 2
- 238000001631 haemodialysis Methods 0.000 description 2
- 230000000322 hemodialysis Effects 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 238000013508 migration Methods 0.000 description 2
- 230000005012 migration Effects 0.000 description 2
- 210000004197 pelvis Anatomy 0.000 description 2
- 229920000049 Carbon (fiber) Polymers 0.000 description 1
- 238000004873 anchoring Methods 0.000 description 1
- 238000002399 angioplasty Methods 0.000 description 1
- 239000004917 carbon fiber Substances 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 238000007912 intraperitoneal administration Methods 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- VNWKTOKETHGBQD-UHFFFAOYSA-N methane Chemical compound C VNWKTOKETHGBQD-UHFFFAOYSA-N 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 210000000664 rectum Anatomy 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 238000013519 translation Methods 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 210000004291 uterus Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
- A61M1/285—Catheters therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0007—Epidural catheters
Definitions
- PD chronic peritoneal dialysis
- a catheter configured for unrestricted inflow and outflow of a dialysate solution, which is circulated through the catheter inside the peritoneal cavity of a patient.
- catheter malfunctions due to factors such as catheter migration, kinking, fibrin deposition, omental wrapping, obstruction secondary to intraperitoneal adhesions, and the like often reduce the efficacy of dialysis treatments. There are therefore needs for improved peritoneal dialysis catheters and methods of use.
- An exemplary method may comprise the steps of advancing a needle into the renal pelvis of the subject; confirming that the needle is within the renal pelvis of the subject; advancing the needle to the ureter of the subject, typically the distal ureter; advancing a guidewire from within the needle to the true pelvis and/or peritoneum of the subject; and advancing the needle over the guidewire and into the true pelvis and/or peritoneum of the subject.
- One aspect provided herein is a method of peritoneal dialysis on a subject.
- the method may comprise: (a) advancing a needle into the renal pelvis of the subject; (b) confirming that the needle is within the renal pelvis of the subject; (c) advancing a catheter to the distal ureter of the subject; (d) advancing a guidewire from within the catheter to the true pelvis and/or peritoneum of the subject; and (e) advancing the catheter over the guidewire and into the true pelvis and/or peritoneum of the subject.
- the needle is advanced into the renal pelvis of the subject from the back or side of the subject.
- confirming that the needle is within the renal pelvis of the subject comprises: using ultrasound guidance; using fluoroscopy; injecting a contrast agent into the renal pelvis; measuring a flow resistance; covering at least a portion of the needle with a radio-opaque marker; or any combination thereof.
- the method further comprises confirming that the catheter is within the ureter of the subject.
- confirming that the catheter is within the distal ureter of the subject comprises: using ultrasound guidance; using fluoroscopy; injecting a contrast agent into the renal pelvis; measuring a flow resistance; performing a pyelography; covering at least a portion of the catheter with a radio-opaque marker; or any combination thereof.
- the method further comprises confirming that the catheter is within the true pelvis and/or peritoneum of the subject of the subject.
- confirming that the catheter is within the true pelvis and/or peritoneum of the subject of the subject comprises: using ultrasound guidance; using fluoroscopy; injecting a contrast agent into the renal pelvis; measuring a flow resistance; performing a pyelography; covering at least a portion of the catheter with a radio-opaque marker; or any combination thereof.
- the guidewire is advanced from within the catheter and into the true pelvis and/or peritoneum of the subject between the iliac vessel and the bladder of the subject.
- the method further comprises expanding a stent in the distal ureter of the subject before step (d).
- the method further comprises collapsing the stent.
- the method further comprises removing the stent.
- the guidewire is advanced from within the catheter at an angle of about 25 degrees to about 65 degrees with respect to the catheter.
- the guidewire is advanced into the true pelvis and/or peritoneum of the subject at an angle of about 25 degrees to about 65 degrees with respect to the peritoneal membrane.
- the method further comprises replacing the guidewire with floppy tip wire after step (e).
- the method further comprises exchanging the catheter while disrupting a fibrin sheath after step (e).
- the method further comprises closing the distal ureter after step (e).
- the distal ureter is closed by a mechanical obstruction, scissoring agent, application of energy such as RF energy, or combinations thereof.
- the needle has a size of 15 gauge to 25 gauge. In some embodiments, at least a portion of a tip of the needle is straight. In some embodiments, at least a portion of a tip of the needle is curved.
- the catheter is tunneled.
- the device may comprise: a needle configured for insertion into the renal pelvis of the subject; a catheter configured for advancement to the distal ureter of the subject; and a guidewire for translation within the catheter.
- the needle, the catheter, or both are further configured to: enable ultrasound guidance; inject a contrast agent into the renal pelvis; measure a flow resistance; or any combination thereof.
- the device further comprises a radio-opaque marker covering at least a portion of the needle, the catheter, or both.
- the needle has a size of 15 gauge to 25 gauge.
- at least a portion of a tip of the needle is straight.
- at least a portion of a tip of the needle is curved.
- the catheter is tunneled.
- the device further comprises stent coupled to the catheter.
- the stent is expandable, collapsible, removable, or any combination thereof.
- the stent is coupled to a distal end of the catheter.
- the guidewire is configured to advance from within the catheter at an angle of about 25 degrees to about 65 degrees with respect to the catheter.
- the guidewire is configured to advance into the true pelvis and/or peritoneum of the subject at an angle of about 25 degrees to about 65 degrees with respect to the peritoneal membrane.
- an assembly comprising the herein and one or more of: a floppy tip wire configured to replace the guidewire; a further catheter configured to replace or exchange with the (first) catheter; a mechanical obstruction configured to close the distal ureter; a scissoring agent configured to close the distal ureter; and/or an energy applicator, for instance an RF energy applicator, to close the distal ureter.
- the further catheter may be the catheter to perform the peritoneal dialysis.
- FIG. 1 shows an illustration of an exemplary method of performing peritoneal dialysis on a subject, in accordance with embodiments described herein;
- FIG. 2 shows a detailed illustration of an exemplary method of performing peritoneal dialysis on a subject, in accordance with embodiments described herein.
- Leaking and other malfunctions associated with migration of current catheters include kinking, fibrin deposition, omental wrapping, obstructions, or any combination thereof. Such malfunctions can cause inadequate dialysis, dialysis insecurity (e.g., uncertainty of where and how next dialysis treatment will occur) and may require a temporary or permanent transition from PD to hemodialysis. Further, current catheters may be dislodged or damaged by the peristaltic movement of the bowel, and are difficult to drain. Such malfunctions can induce pain and missed dialysis treatments.
- the methods and devices herein employ utilizes an existing anatomic structure or lumen to provide a tunneled abdominal sheath for access to the peritoneum.
- the existing anatomic structure or lumen is the ureter, the urethra, the femoral canal, or the inguinal canal.
- the methods and devices herein employ insertion of a percutaneous catheter into the peritoneal cavity within the pelvis via an anatomic lumen.
- the anatomic lumen is accessed by tunneling through tissue of the subject.
- the anatomic structure or lumen is the ureter, the urethra, the femoral canal, and/or the inguinal canal.
- the methods herein bypass exposure to peristaltic movement of the bowel by using the tunneled abdominal sheath as conduit to the pelvis.
- the anatomic structure or lumen is the ureter, wherein the methods and devices herein access the ureter by cannulating the renal pelvis, advancing a guidewire to the distal ureter, through the ureteral wall, and into the true pelvis and/or peritoneum.
- a catheter is advanced over the guidewire into the true pelvis and/or peritoneum.
- the catheter is anchored to the ureter via a stent.
- the devices and methods herein are configured for immediate placement, use, and exchange without dialysis disruption. In some embodiments, the devices and methods herein improve exchangeability of a peritoneal dialysis catheter inside of an interventional suite. In some embodiments, the ability of the catheters herein to be reliably located in the true pelvis and/or peritoneum, without kinking, enables its immediate placement. Further the catheters herein are configured to reduce infection and subcutaneous leakage by minimizing exposure in the abdomen.
- Such reduced exposure prevents the development of adhesions, omental wrapping, fibrin deposition, obstructions, or any combination thereof to ensure regular and adequate dialysis and prevents the need for the subject to temporarily or permanently transfer to hemodialysis. Additionally, the methods and devices herein are secured within the anatomic structure or lumen to prevent dislodgement and/or damage by the peristaltic movement of the bowel.
- the method comprises: (a) advancing an introducer needle 110 into the renal pelvis 210 of the subject; (b) confirming that the needle 110 is within the renal pelvis 210 of the subject; (c) advancing a catheter 120 to the distal ureter 250 of the subject; (d) advancing a guidewire 130 from within the catheter 120 to the true pelvis 230 of the subject; and (e) advancing the catheter 120 over the guidewire 130 and into the true pelvis 230 of the subject. [0026] As shown in FIG.
- the ureter 250 is a duct through which urine passes from the kidney to the bladder 240 or cloacae. Further, the true pelvis 230 (or lesser pelvis) encloses the peritoneal space between bladder 240 and rectum or uterus.
- the needle 110 is advanced into the renal pelvis 210 of the subject from the back or the side of the subject. In some embodiments, the needle 110 is advanced into the renal pelvis 210 of the subject from the back or the side of the subject using a drape to maintain sterilization. In some embodiments, the needle 110 is advanced into the renal pelvis 210 of the subject from the back or the side of the subject as the renal vessels are closes to an anterior of the subject. In some embodiments, the guidewire 130 is advanced from within the catheter 120 and into the true pelvis 230 of the subject between the iliac vessel 220 and the bladder 240 of the subject.
- the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the catheter 120 of about 25 degrees to about 65 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the catheter 120 of about 25, 30, 35, 40, 45, 50, 55, 60, or 65 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the catheter 120 of at most about 25, 30, 35, 40, 45, 50, 55, or 60 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the catheter 120 of about 30, 35, 40, 45, 50, 55, 60, or 65 degrees.
- the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the peritoneal membrane of about 25 degrees to about 65 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the peritoneal membrane of about 25, 30, 35, 40, 45, 50, 55, 60, or 65 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the peritoneal membrane of at most about 25, 30, 35, 40, 45, 50, 55, or 60 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the peritoneal membrane of about 30, 35, 40, 45, 50, 55, 60, or 65 degrees. In some embodiments, a distal tip of the guidewire 130 comprises a micro-puncture. In some embodiments, the micro-puncture punctures the peritoneal membrane.
- confirming that the needle 110 is within the renal pelvis 210 of the subject comprises: using ultrasound guidance; using fluoroscopy; injecting a contrast agent into the renal pelvis 210; measuring a flow resistance covering at least a portion of the needle 110 with a radio-opaque marker; or any combination thereof.
- the method further comprises confirming that the catheter 120 is within the distal ureter 250 of the subject.
- confirming that the catheter 120 is within the distal ureter 250 of the subject comprises: using ultrasound guidance; using fluoroscopy; injecting a contrast agent into the renal pelvis 210; measuring a flow resistance performing a pyelography; covering at least a portion of the catheter 120 with a radio-opaque marker; or any combination thereof.
- the method further comprises confirming that the catheter 120 is within the true pelvis 230 of the subject of the subject.
- confirming that the catheter 120 is within the true pelvis 230 of the subject of the subject comprises: using ultrasound guidance; using fluoroscopy; injecting a contrast agent into the renal pelvis 210; measuring a flow resistance performing a pyelography; covering at least a portion of the catheter 120 with a radioopaque marker; or any combination thereof.
- ultrasound guidance comprises performing an ultrasound, X-ray, fluoroscopy, or other imaging while injecting the needle 110 or catheter 120, wherein contrast between the needle 110 or catheter 120 and the subject’s organs enables proper placement.
- the contrast agent is a fluorographic dye that enhances contrast between the needle 110 or catheter 120 and the subject’s organs under X-ray or fluoroscopy.
- the contrast agent is an echogenic agent that enhances contrast between the needle 110 or catheter 120 and the subject’s organs under ultrasound.
- the radio-opaque marker is a dye that enables contrast between the needle 110 or catheter 120 and the subject’s organs under radio waves.
- the method further comprises expanding a stent 140 in the distal ureter 250 of the subject before step (d).
- the stent 140 is expanded by a trocar.
- the method further comprises collapsing the stent 140.
- the method further comprises removing the stent 140.
- the stent 140 is an angioplasty balloon. In some embodiments, advancing the guidewire 130 from within the catheter 120 to the true pelvis 230 of the subject comprises piercing or passing the guidewire 130 through the stent 140. In some embodiments, expanding the stent 140 in the distal ureter 250 of the subject reduces fibrin deposition on the catheter 120 when in the peritoneal cavity.
- the method further comprises replacing the guidewire 130 with floppy tip wire after step (e).
- the floppy tip wire prevents internal damage that the sharp tipped guidewire 130 may induce during use.
- the method further comprises replacing the catheter 120 with a further catheter after step (e).
- the further catheter may be the catheter to perform the peritoneal dialysis.
- the fibrin sheath that forms in response to the introduction of the first catheter may be disrupted on the exchange with the further catheter.
- replacing the catheter 120 with the further catheter enables and/or improves outpatient care.
- the method further comprises closing the distal ureter 250 after step (e).
- the distal ureter 250 is closed by a mechanical obstruction, scissoring agent, application of energy such as RF energy, or combinations thereof.
- the needle 110 has a size of 15 gauge to 25 gauge. In some embodiments, the needle 110 has a size of 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 gauge. In some embodiments, the needle 110 has a size of at least 15, 16, 17, 18, 19, 20, 21, 22, 23, or 24 gauge. In some embodiments, the needle 110 has a size of at most 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 gauge. In some embodiments, at least a portion of a tip of the needle 110 is straight. In some embodiments, at least a portion of a tip of the needle 110 is curved. In some embodiments, the needle 110 is tunneled. In some embodiments, the tunneled needle 110 reduces infections during the procedure. In some embodiments, a distal portion of the needle 110 comprises a plurality of openings to facilitate exchange of fluid therethrough.
- the needle 110, the guidewire 130, the catheter 120 or any combination thereof are formed of metal, plastic, wood, carbon fiber, glass, or any combination thereof.
- a flexural modulus (or stiffness) of the catheter 120 is greater than a flexural modulus of the guidewire 130.
- a flexural modulus (or stiffness) of the catheter 120 is greater than a flexural modulus of the guidewire 130 by about 10 GPa to about 80 GPa.
- a flexural modulus of the catheter 120 is greater than a flexural modulus of the guidewire 130 by about 10, 20, 30, 40, 50, 60, 70, or 80 GPa.
- a flexural modulus of the catheter 120 is greater than a flexural modulus of the guidewire 130 by at least about 10, 20, 30, 40, 50, 60, or 70 GPa. In some embodiments, a flexural modulus of the catheter 120 is greater than a flexural modulus of the guidewire 130 by at most about 20, 30, 40, 50, 60, 70, or about 80 GPa. In some embodiments, the greater rigidity of the catheter 120 enables its passage through and anchoring within the ureter 250. In some embodiments, the lesser rigidity of the guidewire 130 enables it to exit the catheter 120 at an angle of about 45 degrees.
- the catheter 120 is advanced through an anatomic structure or lumen of the subject.
- the anatomic structure or lumen comprises the distal ureter 250 of the subject.
- the anatomic structure or lumen comprises the urethra, the femoral canal, or the inguinal canal of the subject.
- a device for peritoneal dialysis on a subject comprising: a needle configured for insertion into the renal pelvis of the subject; a catheter configured for advancement to the distal ureter of the subject; and a guidewire within the catheter.
- the catheter may be at least in part stiffened and/or braided.
- the catheter has a plurality of lumens such as a guidewire lumen, a drainage lumen, a fluid infusion lumen, and the like.
- the lumens of the catheter may be fluidically isolated from one another. The lumens may end at various ports at different locations of the catheter.
- the needle, the catheter, or both are further configured to: enable ultrasound guidance; inject a fluorographic into the renal pelvis; measure a flow resistance, such as with a pressure (resistance) transducer; or any combination thereof.
- the device further comprises a radio-opaque marker covering at least a portion of the needle, the catheter, or both.
- the needle has a size of 15 gauge to 25 gauge. In some embodiments, at least a portion of a tip of the needle is straight.
- the device further comprises stent coupled to the catheter.
- the stent is expandable (such as selfexpandable), collapsible, removable, or any combination thereof.
- the stent is coupled to a distal end of the catheter.
- the guidewire is configured to advance from within the catheter at an angle of about 25 degrees to about 65 degrees with respect to the catheter. In some embodiments, the guidewire is configured to advance into the true pelvis and/or peritoneum of the subject at an angle of about 25 degrees to about 65 degrees with respect to the peritoneal membrane.
- the catheter is configured to be advanced through an anatomic structure or lumen of the subject.
- the anatomic structure or lumen comprises the distal ureter of the subject.
- the anatomic structure or lumen comprises the urethra, the femoral canal, or the inguinal canal of the subject.
- an assembly for peritoneal dialysis of a subject comprising the herein and one or more of: a floppy tip wire configured to replace the guidewire; a further catheter configured to replace or exchange with the (first) catheter; a mechanical obstruction configured to close the distal ureter; a scissoring agent configured to close the distal ureter; and/or an energy applicator, such as an RF energy applicator, to close the distal ureter.
- the term “about” refers to an amount that is near the stated amount by 10%, 5%, or 1%, including increments therein.
- the term “about” in reference to a percentage refers to an amount that is greater or less the stated percentage by 10%, 5%, or 1%, including increments therein.
- each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.
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Abstract
Provided herein are systems, devices, and methods for performing peritoneal dialysis. A needle is advanced into the renal pelvis of a subject from the back or side of the subject. After confirming the needle is within the renal pelvis of a kidney of the subject, a catheter is advanced from the back or side of the subject over the needle and into the renal pelvis and distal ureter. A guidewire is advanced through the catheter to the distal ureter and then into true pelvis and/or peritoneum. The catheter is advanced over the guidewire and into the true pelvis and/or peritoneum. The guidewire is removed and peritoneal dialysis is performed through the catheter accessing the true pelvis and/or peritoneum.
Description
URETERAL ACCESS PERITONEAL CATHETER
CROSS-REFERENCE
[0001] This PCT application claims priority to U.S. Provisional Patent Application No. 63/124,648, filed Dec. 11, 2020, the contents of which are fully incorporated herein by reference.
BACKGROUND
[0002] The application of chronic peritoneal dialysis (PD) is often performed by a catheter configured for unrestricted inflow and outflow of a dialysate solution, which is circulated through the catheter inside the peritoneal cavity of a patient. As typically used in current practice, catheter malfunctions due to factors such as catheter migration, kinking, fibrin deposition, omental wrapping, obstruction secondary to intraperitoneal adhesions, and the like often reduce the efficacy of dialysis treatments. There are therefore needs for improved peritoneal dialysis catheters and methods of use.
SUMMARY
[0003] Provided herein are methods of performing peritoneal dialysis on a subject. An exemplary method may comprise the steps of advancing a needle into the renal pelvis of the subject; confirming that the needle is within the renal pelvis of the subject; advancing the needle to the ureter of the subject, typically the distal ureter; advancing a guidewire from within the needle to the true pelvis and/or peritoneum of the subject; and advancing the needle over the guidewire and into the true pelvis and/or peritoneum of the subject.
[0004] One aspect provided herein is a method of peritoneal dialysis on a subject. The method may comprise: (a) advancing a needle into the renal pelvis of the subject; (b) confirming that the needle is within the renal pelvis of the subject; (c) advancing a catheter to the distal ureter of the subject; (d) advancing a guidewire from within the catheter to the true pelvis and/or peritoneum of the subject; and (e) advancing the catheter over the guidewire and into the true pelvis and/or peritoneum of the subject.
[0005] In some embodiments, the needle is advanced into the renal pelvis of the subject from the back or side of the subject.
[0006] In some embodiments, confirming that the needle is within the renal pelvis of the subject comprises: using ultrasound guidance; using fluoroscopy; injecting a contrast agent into the renal pelvis; measuring a flow resistance; covering at least a portion of the needle with a radio-opaque marker; or any combination thereof.
[0007] In some embodiments, the method further comprises confirming that the catheter is within the ureter of the subject. In some embodiments, confirming that the catheter is within the distal ureter of the subject comprises: using ultrasound guidance; using fluoroscopy; injecting a contrast agent into the renal pelvis; measuring a flow resistance; performing a pyelography; covering at least a portion of the catheter with a radio-opaque marker; or any combination thereof.
[0008] In some embodiments, the method further comprises confirming that the catheter is within the true pelvis and/or peritoneum of the subject of the subject. In some embodiments, confirming that the catheter is within the true pelvis and/or peritoneum of the subject of the subject comprises: using ultrasound guidance; using fluoroscopy; injecting a contrast agent into the renal pelvis; measuring a flow resistance; performing a pyelography; covering at least a portion of the catheter with a radio-opaque marker; or any combination thereof.
[0009] In some embodiments, the guidewire is advanced from within the catheter and into the true pelvis and/or peritoneum of the subject between the iliac vessel and the bladder of the subject. In some embodiments, the method further comprises expanding a stent in the distal ureter of the subject before step (d). In some embodiments, the method further comprises collapsing the stent. In some embodiments, the method further comprises removing the stent. In some embodiments, the guidewire is advanced from within the catheter at an angle of about 25 degrees to about 65 degrees with respect to the catheter. In some embodiments, the guidewire is advanced into the true pelvis and/or peritoneum of the subject at an angle of about 25 degrees to about 65 degrees with respect to the peritoneal membrane. In some embodiments, the method further comprises replacing the guidewire with floppy tip wire after step (e).
[0010] In some embodiments, the method further comprises exchanging the catheter while disrupting a fibrin sheath after step (e).
[0011] In some embodiments, the method further comprises closing the distal ureter after step (e). In some embodiments, the distal ureter is closed by a mechanical obstruction, scissoring agent, application of energy such as RF energy, or combinations thereof.
[0012] In some embodiments, the needle has a size of 15 gauge to 25 gauge. In some embodiments, at least a portion of a tip of the needle is straight. In some embodiments, at least a portion of a tip of the needle is curved.
[0013] In some embodiments, the catheter is tunneled.
[0014] Another aspect provided herein is a device for peritoneal dialysis on a subject. The device may comprise: a needle configured for insertion into the renal pelvis of the subject; a catheter configured for advancement to the distal ureter of the subject; and a guidewire for translation
within the catheter. In some embodiments, the needle, the catheter, or both are further configured to: enable ultrasound guidance; inject a contrast agent into the renal pelvis; measure a flow resistance; or any combination thereof.
[0015] In some embodiments, the device further comprises a radio-opaque marker covering at least a portion of the needle, the catheter, or both. In some embodiments, the needle has a size of 15 gauge to 25 gauge. In some embodiments, at least a portion of a tip of the needle is straight. In some embodiments, at least a portion of a tip of the needle is curved.
[0016] In some embodiments, the catheter is tunneled.
[0017] In some embodiments, the device further comprises stent coupled to the catheter. In some embodiments, the stent is expandable, collapsible, removable, or any combination thereof. In some embodiments, the stent is coupled to a distal end of the catheter. In some embodiments, the guidewire is configured to advance from within the catheter at an angle of about 25 degrees to about 65 degrees with respect to the catheter. In some embodiments, the guidewire is configured to advance into the true pelvis and/or peritoneum of the subject at an angle of about 25 degrees to about 65 degrees with respect to the peritoneal membrane.
[0018] Another aspect provided herein is an assembly comprising the herein and one or more of: a floppy tip wire configured to replace the guidewire; a further catheter configured to replace or exchange with the (first) catheter; a mechanical obstruction configured to close the distal ureter; a scissoring agent configured to close the distal ureter; and/or an energy applicator, for instance an RF energy applicator, to close the distal ureter. The further catheter may be the catheter to perform the peritoneal dialysis.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The novel features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:
[0020] FIG. 1 shows an illustration of an exemplary method of performing peritoneal dialysis on a subject, in accordance with embodiments described herein; and
[0021] FIG. 2 shows a detailed illustration of an exemplary method of performing peritoneal dialysis on a subject, in accordance with embodiments described herein.
DETAILED DESCRIPTION
[0022] Leaking and other malfunctions associated with migration of current catheters include kinking, fibrin deposition, omental wrapping, obstructions, or any combination thereof. Such malfunctions can cause inadequate dialysis, dialysis insecurity (e.g., uncertainty of where and how next dialysis treatment will occur) and may require a temporary or permanent transition from PD to hemodialysis. Further, current catheters may be dislodged or damaged by the peristaltic movement of the bowel, and are difficult to drain. Such malfunctions can induce pain and missed dialysis treatments.
[0023] As such, provided herein are methods and catheters for performing peritoneal dialysis. In some embodiments, the methods and devices herein employ utilizes an existing anatomic structure or lumen to provide a tunneled abdominal sheath for access to the peritoneum. In some embodiments, the existing anatomic structure or lumen is the ureter, the urethra, the femoral canal, or the inguinal canal. In some embodiments, the methods and devices herein employ insertion of a percutaneous catheter into the peritoneal cavity within the pelvis via an anatomic lumen. In some embodiments, the anatomic lumen is accessed by tunneling through tissue of the subject. In some embodiments, the anatomic structure or lumen is the ureter, the urethra, the femoral canal, and/or the inguinal canal. In some embodiments, the methods herein bypass exposure to peristaltic movement of the bowel by using the tunneled abdominal sheath as conduit to the pelvis. In some embodiments, the anatomic structure or lumen is the ureter, wherein the methods and devices herein access the ureter by cannulating the renal pelvis, advancing a guidewire to the distal ureter, through the ureteral wall, and into the true pelvis and/or peritoneum. In some embodiments, a catheter is advanced over the guidewire into the true pelvis and/or peritoneum. In some embodiments, the catheter is anchored to the ureter via a stent. [0024] In some embodiments, the devices and methods herein are configured for immediate placement, use, and exchange without dialysis disruption. In some embodiments, the devices and methods herein improve exchangeability of a peritoneal dialysis catheter inside of an interventional suite. In some embodiments, the ability of the catheters herein to be reliably located in the true pelvis and/or peritoneum, without kinking, enables its immediate placement. Further the catheters herein are configured to reduce infection and subcutaneous leakage by minimizing exposure in the abdomen. Such reduced exposure prevents the development of adhesions, omental wrapping, fibrin deposition, obstructions, or any combination thereof to ensure regular and adequate dialysis and prevents the need for the subject to temporarily or permanently transfer to hemodialysis. Additionally, the methods and devices herein are secured
within the anatomic structure or lumen to prevent dislodgement and/or damage by the peristaltic movement of the bowel.
Methods of Performing Peritoneal Dialysis on a Subject
[0025] Provided herein, per FIGS. 1-2, is a method of performing peritoneal dialysis on a subject. In some embodiments, the method comprises: (a) advancing an introducer needle 110 into the renal pelvis 210 of the subject; (b) confirming that the needle 110 is within the renal pelvis 210 of the subject; (c) advancing a catheter 120 to the distal ureter 250 of the subject; (d) advancing a guidewire 130 from within the catheter 120 to the true pelvis 230 of the subject; and (e) advancing the catheter 120 over the guidewire 130 and into the true pelvis 230 of the subject. [0026] As shown in FIG. 1, the ureter 250 is a duct through which urine passes from the kidney to the bladder 240 or cloacae. Further, the true pelvis 230 (or lesser pelvis) encloses the peritoneal space between bladder 240 and rectum or uterus.
[0027] In some embodiments, the needle 110 is advanced into the renal pelvis 210 of the subject from the back or the side of the subject. In some embodiments, the needle 110 is advanced into the renal pelvis 210 of the subject from the back or the side of the subject using a drape to maintain sterilization. In some embodiments, the needle 110 is advanced into the renal pelvis 210 of the subject from the back or the side of the subject as the renal vessels are closes to an anterior of the subject. In some embodiments, the guidewire 130 is advanced from within the catheter 120 and into the true pelvis 230 of the subject between the iliac vessel 220 and the bladder 240 of the subject.
[0028] In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the catheter 120 of about 25 degrees to about 65 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the catheter 120 of about 25, 30, 35, 40, 45, 50, 55, 60, or 65 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the catheter 120 of at most about 25, 30, 35, 40, 45, 50, 55, or 60 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the catheter 120 of about 30, 35, 40, 45, 50, 55, 60, or 65 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the peritoneal membrane of about 25 degrees to about 65 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the peritoneal membrane of about 25, 30, 35, 40, 45, 50, 55, 60, or 65 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with
respect to the peritoneal membrane of at most about 25, 30, 35, 40, 45, 50, 55, or 60 degrees. In some embodiments, the guidewire 130 is advanced from within the catheter 120 at an angle with respect to the peritoneal membrane of about 30, 35, 40, 45, 50, 55, 60, or 65 degrees. In some embodiments, a distal tip of the guidewire 130 comprises a micro-puncture. In some embodiments, the micro-puncture punctures the peritoneal membrane.
[0029] In some embodiments, confirming that the needle 110 is within the renal pelvis 210 of the subject comprises: using ultrasound guidance; using fluoroscopy; injecting a contrast agent into the renal pelvis 210; measuring a flow resistance covering at least a portion of the needle 110 with a radio-opaque marker; or any combination thereof. In some embodiments, the method further comprises confirming that the catheter 120 is within the distal ureter 250 of the subject. In some embodiments, confirming that the catheter 120 is within the distal ureter 250 of the subject comprises: using ultrasound guidance; using fluoroscopy; injecting a contrast agent into the renal pelvis 210; measuring a flow resistance performing a pyelography; covering at least a portion of the catheter 120 with a radio-opaque marker; or any combination thereof. In some embodiments, the method further comprises confirming that the catheter 120 is within the true pelvis 230 of the subject of the subject. In some embodiments, confirming that the catheter 120 is within the true pelvis 230 of the subject of the subject comprises: using ultrasound guidance; using fluoroscopy; injecting a contrast agent into the renal pelvis 210; measuring a flow resistance performing a pyelography; covering at least a portion of the catheter 120 with a radioopaque marker; or any combination thereof.
[0030] In some embodiments, ultrasound guidance comprises performing an ultrasound, X-ray, fluoroscopy, or other imaging while injecting the needle 110 or catheter 120, wherein contrast between the needle 110 or catheter 120 and the subject’s organs enables proper placement. In some embodiments, the contrast agent is a fluorographic dye that enhances contrast between the needle 110 or catheter 120 and the subject’s organs under X-ray or fluoroscopy. Alternatively or in combination, the contrast agent is an echogenic agent that enhances contrast between the needle 110 or catheter 120 and the subject’s organs under ultrasound. In some embodiments, the radio-opaque marker is a dye that enables contrast between the needle 110 or catheter 120 and the subject’s organs under radio waves.
[0031] In some embodiments, confirming that the needle 110 is within the renal pelvis 210 ensures proper needle 110 placement, especially if the kidneys are atrophic. In some embodiments, the guidewire 130, the catheter 120, or both has a distal transducer to enable ultrasound guidance. In some embodiments, the flow resistance is measured by an injector.
[0032] In some embodiments, per FIG. 2, the method further comprises expanding a stent 140 in the distal ureter 250 of the subject before step (d). In some embodiments, the stent 140 is expanded by a trocar. In some embodiments, the method further comprises collapsing the stent 140. In some embodiments, the method further comprises removing the stent 140. In some embodiments, the stent 140 is an angioplasty balloon. In some embodiments, advancing the guidewire 130 from within the catheter 120 to the true pelvis 230 of the subject comprises piercing or passing the guidewire 130 through the stent 140. In some embodiments, expanding the stent 140 in the distal ureter 250 of the subject reduces fibrin deposition on the catheter 120 when in the peritoneal cavity.
[0033] In some embodiments, the method further comprises replacing the guidewire 130 with floppy tip wire after step (e). In some embodiments, the floppy tip wire prevents internal damage that the sharp tipped guidewire 130 may induce during use. In some embodiments, the method further comprises replacing the catheter 120 with a further catheter after step (e). The further catheter may be the catheter to perform the peritoneal dialysis. The fibrin sheath that forms in response to the introduction of the first catheter may be disrupted on the exchange with the further catheter. In some embodiments, replacing the catheter 120 with the further catheter enables and/or improves outpatient care. In some embodiments, the method further comprises closing the distal ureter 250 after step (e). In some embodiments, the distal ureter 250 is closed by a mechanical obstruction, scissoring agent, application of energy such as RF energy, or combinations thereof.
[0034] In some embodiments, the needle 110 has a size of 15 gauge to 25 gauge. In some embodiments, the needle 110 has a size of 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 gauge. In some embodiments, the needle 110 has a size of at least 15, 16, 17, 18, 19, 20, 21, 22, 23, or 24 gauge. In some embodiments, the needle 110 has a size of at most 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 gauge. In some embodiments, at least a portion of a tip of the needle 110 is straight. In some embodiments, at least a portion of a tip of the needle 110 is curved. In some embodiments, the needle 110 is tunneled. In some embodiments, the tunneled needle 110 reduces infections during the procedure. In some embodiments, a distal portion of the needle 110 comprises a plurality of openings to facilitate exchange of fluid therethrough.
[0035] In some embodiments, the needle 110, the guidewire 130, the catheter 120 or any combination thereof are formed of metal, plastic, wood, carbon fiber, glass, or any combination thereof. In some embodiments, a flexural modulus (or stiffness) of the catheter 120 is greater than a flexural modulus of the guidewire 130. In some embodiments, a flexural modulus (or stiffness) of the catheter 120 is greater than a flexural modulus of the guidewire 130 by about 10
GPa to about 80 GPa. In some embodiments, a flexural modulus of the catheter 120 is greater than a flexural modulus of the guidewire 130 by about 10, 20, 30, 40, 50, 60, 70, or 80 GPa. In some embodiments, a flexural modulus of the catheter 120 is greater than a flexural modulus of the guidewire 130 by at least about 10, 20, 30, 40, 50, 60, or 70 GPa. In some embodiments, a flexural modulus of the catheter 120 is greater than a flexural modulus of the guidewire 130 by at most about 20, 30, 40, 50, 60, 70, or about 80 GPa. In some embodiments, the greater rigidity of the catheter 120 enables its passage through and anchoring within the ureter 250. In some embodiments, the lesser rigidity of the guidewire 130 enables it to exit the catheter 120 at an angle of about 45 degrees.
[0036] In some embodiments, the catheter 120 is advanced through an anatomic structure or lumen of the subject. In some embodiments, the anatomic structure or lumen comprises the distal ureter 250 of the subject. In some embodiments, the anatomic structure or lumen comprises the urethra, the femoral canal, or the inguinal canal of the subject.
Device for Peritoneal Dialysis on a Subject
[0037] Another aspect provided herein is a device for peritoneal dialysis on a subject, the device comprising: a needle configured for insertion into the renal pelvis of the subject; a catheter configured for advancement to the distal ureter of the subject; and a guidewire within the catheter. The catheter may be at least in part stiffened and/or braided. In some embodiments, the catheter has a plurality of lumens such as a guidewire lumen, a drainage lumen, a fluid infusion lumen, and the like. The lumens of the catheter may be fluidically isolated from one another. The lumens may end at various ports at different locations of the catheter. For example, there may be a proximal drainage port to draw out fluids at the renal pelvis, a first distal port for the guidewire lumen, and/or a second distal port for peritoneal dialysis. In some embodiments, the needle, the catheter, or both are further configured to: enable ultrasound guidance; inject a fluorographic into the renal pelvis; measure a flow resistance, such as with a pressure (resistance) transducer; or any combination thereof. In some embodiments, the device further comprises a radio-opaque marker covering at least a portion of the needle, the catheter, or both. In some embodiments, the needle has a size of 15 gauge to 25 gauge. In some embodiments, at least a portion of a tip of the needle is straight. In some embodiments, at least a portion of a tip of the needle is curved. In some embodiments, the catheter is tunneled. In some embodiments, the device further comprises stent coupled to the catheter. In some embodiments, the stent is expandable (such as selfexpandable), collapsible, removable, or any combination thereof. In some embodiments, the stent is coupled to a distal end of the catheter. In some embodiments, the guidewire is configured
to advance from within the catheter at an angle of about 25 degrees to about 65 degrees with respect to the catheter. In some embodiments, the guidewire is configured to advance into the true pelvis and/or peritoneum of the subject at an angle of about 25 degrees to about 65 degrees with respect to the peritoneal membrane.
[0038] In some embodiments, the catheter is configured to be advanced through an anatomic structure or lumen of the subject. In some embodiments, the anatomic structure or lumen comprises the distal ureter of the subject. In some embodiments, the anatomic structure or lumen comprises the urethra, the femoral canal, or the inguinal canal of the subject.
Assembly for Peritoneal Dialysis of a Subject
[0039] Another aspect provided herein is an assembly for peritoneal dialysis of a subject, the assembly comprising the herein and one or more of: a floppy tip wire configured to replace the guidewire; a further catheter configured to replace or exchange with the (first) catheter; a mechanical obstruction configured to close the distal ureter; a scissoring agent configured to close the distal ureter; and/or an energy applicator, such as an RF energy applicator, to close the distal ureter.
Terms and Definitions
[0040] 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.
[0041] As used herein, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Any reference to “or” herein is intended to encompass “and/or” unless otherwise stated.
[0042] As used herein, the term “about” in some cases refers to an amount that is approximately the stated amount.
[0043] As used herein, the term “about” refers to an amount that is near the stated amount by 10%, 5%, or 1%, including increments therein.
[0044] As used herein, the term “about” in reference to a percentage refers to an amount that is greater or less the stated percentage by 10%, 5%, or 1%, including increments therein.
[0045] As used herein, the phrases “at least one”, “one or more”, and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.
***
[0046] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
Claims
1. A method of peritoneal dialysis on a subject, the method comprising:
(a) advancing a needle into the renal pelvis of the subject;
(b) confirming that the needle is within the renal pelvis of the subject;
(c) advancing a catheter to the distal ureter of the subject;
(d) advancing a guidewire from within the catheter to the true pelvis and/or peritoneum of the subject; and
(e) advancing the catheter over the guidewire and into the true pelvis and/or peritoneum of the subject.
2. The method of any of the preceding claims, wherein the needle is advanced into the renal pelvis of the subject from the back or the side of the subject.
3. The method of any of the preceding claims, wherein confirming that the needle is within the renal pelvis of the subject comprises:
(a) using ultrasound guidance;
(b) using fluoroscopy;
(c) injecting a contrast agent into the renal pelvis;
(d) measuring a flow resistance;
(e) covering at least a portion of the needle with a radio-opaque marker; or
(f) any combination thereof.
4. The method of any of the preceding claims, further comprising confirming that the catheter is within the distal ureter of the subject.
5. The method of claim 4, wherein confirming that the catheter is within the distal ureter of the subject comprises:
(a) using ultrasound guidance;
(b) using fluoroscopy;
(c) injecting a contrast agent into the renal pelvis;
(d) measuring a flow resistance;
(e) performing a pyelography;
(f) covering at least a portion of the catheter with a radio-opaque marker; or
(g) any combination thereof.
6. The method of any of the preceding claims, further comprising confirming that the catheter is within the true pelvis and/or peritoneum of the subject of the subject.
The method of claim 6, wherein confirming that the catheter is within the true pelvis and/or peritoneum of the subject of the subject comprises:
(a) using ultrasound guidance;
(b) using fluoroscopy;
(c) injecting a contrast agent into the renal pelvis;
(d) measuring a flow resistance;
(e) performing a pyelography;
(f) covering at least a portion of the catheter with a radio-opaque marker; or
(g) any combination thereof. The method of any of the preceding claims, wherein, the guidewire is advanced from within the catheter and into the true pelvis and/or peritoneum of the subject between the iliac vessel and the bladder of the subject. The method of any of the preceding claims, further comprising expanding a stent in the distal ureter of the subject before step (d). The method of claim 9, further comprising collapsing the stent. The method of claim 9 or 10, further comprising removing the stent. The method of any of the preceding claims, wherein the guidewire is advanced from within the catheter at an angle of about 25 degrees to about 65 degrees with respect to the catheter. The method of any of the preceding claims, wherein the guidewire is advanced into the true pelvis and/or peritoneum of the subject at an angle of about 25 degrees to about 65 degrees with respect to the peritoneal membrane. The method of any of the preceding claims further comprising replacing the guidewire with floppy tip wire after step (e). The method of any of the preceding claims, further comprising replacing the catheter with a further catheter after step (e). The method of any of the preceding claims, further comprising closing the distal ureter after step (e). The method of claim 16, wherein the distal ureter is closed by a mechanical obstruction, scissoring agent, application of energy, application of RF energy, or combinations thereof. The method of any of the preceding claims, wherein the needle has a size of 15 gauge to 25 gauge. The method of any of the preceding claims, wherein at least a portion of a tip of the needle is straight.
The method of one of claims 1-17, wherein at least a portion of a tip of the needle is curved. The method of any of the preceding claims, wherein the catheter is tunneled. A device for peritoneal dialysis on a subject, the device comprising:
(a) a needle configured for insertion into the renal pelvis of the subject;
(b) a catheter configured for advancement to the distal ureter of the subject; and
(c) a guidewire within the catheter. The device of claim 22, wherein the needle, the catheter, or both are further configured to:
(a) enable ultrasound guidance;
(b) inject a fluorographic into the renal pelvis;
(c) measure a flow resistance; or
(d) any combination thereof. The device of any of claims 22 to 23, further comprising a radio-opaque marker covering at least a portion of the needle, the catheter, or both. The device of any of claims 22 to 24, wherein the needle has a size of 15 gauge to 25 gauge. The device of any of claims 22 to 25, wherein at least a portion of a tip of the needle is straight. The device of any of claims 22 to 26, wherein at least a portion of a tip of the needle is curved. The device of any of claims 22 to 27, wherein the catheter is tunneled. The device of any of claims 22 to 28, further comprising stent coupled to the catheter. The device of claim 29, wherein the stent is expandable, collapsible, removable, or any combination thereof. The device of claim 29 or 30, wherein the stent is coupled to a distal end of the catheter. The device of any of claims 22 to 31, wherein the guidewire is configured to advance from within the catheter at an angle of about 25 degrees to about 65 degrees with respect to the catheter. The device of any of claims 22 to 33, wherein the guidewire is configured to advance into the true pelvis and/or peritoneum of the subject at an angle of about 25 degrees to about 65 degrees with respect to the peritoneal membrane.
An assembly for peritoneal dialysis of a subject, the assembly comprising the device of any one of claims 22 to 33 and one or more of:
(a) a floppy tip wire configured to replace the guidewire;
(b) a further catheter configured to replace the catheter;
(c) a mechanical obstruction configured to close the distal ureter;
(d) a scissoring agent configured to close the distal ureter; or
(e) an energy applicator configured to close the distal ureter. A method of peritoneal dialysis on a subject, the method comprising:
(a) advancing a catheter through an anatomic lumen in the subject;
(b) advancing a guidewire from within the catheter to the true pelvis and/or peritoneum of the subject; and
(c) advancing the catheter over the guidewire and into the true pelvis and/or peritoneum of the subject. The method of claim 35, wherein the anatomic lumen comprises one or more of the distal ureter, the urethra, the femoral canal, or the inguinal canal of the subject. The method of claim 35, wherein the anatomic lumen is in an abdomen of the subject. The method of claim 35, further comprising tunneling through tissue in the subject to access the anatomic lumen.
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US202063124648P | 2020-12-11 | 2020-12-11 | |
US63/124,648 | 2020-12-11 |
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