Claims for Patent: 10,357,601

Summary for Patent: 10,357,601

Title:	Method and apparatus for fibrin sheath disruption
Abstract:	A hemodialysis catheter is disclosed for deploying in an artery or vein, comprising various means for disrupting, mechanically and/or chemo-mechanically, a fibrous sheath forming naturally outside of the catheter; optionally the disrupted fibrin sheath and/or thrombus is captured.
Inventor(s):	Flora; Maurino G. (San Jose, CA), Black; David L. (Cameron, MT), Bagaoisan; Celso J. (Union City, CA), Pai; Suresh Subraya (Los Altos, CA), Florescu; Marius C. (Omaha, NE)
Assignee:	CHRYSALIS MEDICAL, INC. (Sunnyvale, CA) BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA (Lincoln, NE)
Application Number:	15/257,468
Patent Claims:	1. A hemodialysis catheter apparatus operable to disrupt an external fibrin sheath comprising: a tubular apparatus comprising a first portion, extruded second portion and partially extruded third portion, each of the three portions comprising a distal region and a proximal region, wherein the first portion is configured to be external to a patient, and the first portion's distal region is connected to the extruded second portion through a hub, and the second portion's proximal region is configured to be external to a patient, and the second portion's distal region is configured to be internal to the patient, and the proximal region of the partially extruded third portion is connected to the distal region of the second portion; first, second and third channels disposed within the second portion of the tubular apparatus; a first and second lumen, each lumen comprising a proximal, a middle and a distal section, and means for displacement disposed within the third portion of the tubular apparatus wherein the first lumen, at its proximal section, is connected to the first channel and the second lumen, at its proximal section, is connected to the second channel and the means for displacement separates the first lumen from the second lumen and is connected to the third channel wherein the first channel comprises an exit port at a distal end of the first channel and the second channel comprises an entrance port at a distal end of the second channel; a plug located on the distal region of the third portion wherein the distal section of the first lumen and the distal section of the second lumen are separated by and pinned in place by the plug; and a flexible sleeve over-cladding the entirety of the third portion of the tubular apparatus including the first and second lumens wherein the means for displacement is operable to displace only the middle section of the first lumen from only the middle section of the second lumen by more than 3 mm such that at least a portion of an external fibrin sheath is disrupted. 2. The apparatus of claim 1 wherein the means for displacement comprises an actuator at a proximal end of the first portion of tubular apparatus in communication via the third channel with the means for displacement located in the third portion of the tubular apparatus. 3. The catheter of claim 1, wherein the flexible sleeve is substantially a thin, smooth, transparent, flexible medical grade material. 4. The catheter of claim 3 wherein the flexible sleeve comprises a plurality of traversable pores. 5. The catheter of claim 1 further comprising: an expandable fibrin capture element disposed within the first or second lumen and engaged to a catch actuator in the first portion of the tubular apparatus, whereby activation of the catch actuator causes the expandable fibrin capture element to extend out of the first or second lumen and expand into an open state operable for collection of displaced fibrin sheath. 6. A catheter comprising: a tubular apparatus comprising a distal portion and a proximal portion and first, second and third channels, each of the three channels comprising a distal region and a proximal region; and a means for displacement disposed within the distal portion of the tubular apparatus separating the first channel from the second channel and connected to the third channel wherein the first channel is not in contact with the second channel and wherein the first channel connects to a first lumen comprising an exit port at an end of the distal portion and the second channel connects to a second lumen comprising an entrance port at the end of the distal portion; a flexible sleeve over-cladding the entirety of the distal portion of the tubular apparatus wherein the means for displacement is operable to displace a middle portion of the first channel from a middle portion of the second channel by more than 3 mm; and an expandable fibrin capture element comprising surgical mesh or wire disposed within the first or second channel and engaged to a catch actuator in the proximal portion of the tubular apparatus through the first or second channel, whereby activation of the catch actuator causes the expandable fibrin capture element to extend out of the first or second lumen and expand into an open state operable for collection of displaced fibrin sheath. 7. The catheter of claim 6, wherein the flexible sleeve is substantially a thin, smooth, transparent, flexible medical grade material. 8. The catheter of claim 7, wherein the flexible sleeve is further composed of a plurality of traversable pores enabling a controlled release of collagenase, or any sheath disrupting compositions. 9. A method of disrupting fibrin sheath while performing hemodialysis, coronary artery surgery, endoscopic procedures, ureterscopy, laser lithotripsy, or percutaneous nephrolithotomy when a catheter is required, the method comprising the steps of: inserting a catheter comprising a tubular apparatus comprising a first portion, extruded second portion and partially extruded third portion, each of the three portions comprising a distal region and a proximal region, wherein the first portion is configured to be external to a patient, and the first portion's distal region is connected to the extruded second portion through a hub, and the second portion's proximal region is configured to be external to a patient, and the second portion's distal region is configured to be internal to the patient, and the proximal region of the partially extruded third portion is connected to the distal region of the second portion; first, second and third channels disposed within the second portion of the tubular apparatus; a first and second lumen, each lumen comprising a proximal, a middle and a distal section, and means for displacement disposed within the third portion of the tubular apparatus wherein the first lumen, at its proximal section, is connected to the first channel and the second lumen, at its proximal section, is connected to the second channel and the means for displacement separates the first lumen from the second lumen and is connected to the third channel wherein the first channel comprises an exit port at a distal end of the first channel and the second channel comprises an entrance port at a distal end of the first channel; a plug located on the distal region of the third portion wherein the distal section of the first lumen and the distal section of the second lumen are separated by and pinned in place by the plug; and a flexible sleeve over-cladding the entirety of the third portion of the tubular apparatus including the first and second lumens wherein the means for displacement is operable to displace only a middle section of the first lumen from only a middle section of the second lumen by more than 3 mm; displacing the first and second lumens of the catheter by at least 3 mm such that the fibrin sheath is disrupted and detaches from the catheter.

Details for Patent 10,357,601

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2039-08-18