KIT AND DEVICES FOR ORGAN PERFUSION

• US 20150018597A1
• Filed: 03/01/2013
• Published: 01/15/2015
• Est. Priority Date: 03/01/2012
• Status: Abandoned Application

• Current Assignee: Medical Device Works NV
• Original Assignee: Medical Device Works NV
• Inventors: Fierens, Joop, Nackard, Kevin Jason, Marcoux, Eric Thierry Jean, Bartholome, Emmanuel J.
• Application Number:
  US14/381,780
• Publication Number:
  US 20150018597A1
• Time in Patent Office: Days
• US Class Current: 600/4
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61M 1/32 Oxygenators without membranes
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3455 Substitution fluids
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3615 Cleaning blood contaminated by local chemotherapy of a body part temporarily isolated from the blood circuit
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0075 : Valve means
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1018 : Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10183 : Compressible bulbs
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• CPC Class Codes: A61N 5/1002 : Intraluminal radiation therapy

Abstract

The present invention provides a kit for the delivery a therapeutic agent to an organ blood flow and the removal of the excess of said therapeutic agent from said organ blood flow, said kit comprises: (a) the therapeutic agent, (b) a first retrievable medical device (26), for delivering said therapeutic agent into the organ inflow, (c) a second retrievable medical device for isolating the organ outflow vessel and (d) a separation device (25) comprising at least one filter able to separate the therapeutic agent excess from the organ outflow, having an inlet (38) for the organ outflow having a therapeutic agent excess and an outlet (39) for filtered organ outflow.

Claims

1. A kit for the delivery of a therapeutic agent to an organ blood flow and the removal of the excess of said therapeutic agent from said organ blood flow comprising:

a. optionally a therapeutic agent which is a fluid treatment and/or particles comprising a radioactive element, wherein the size of said particles is comprised between 20 and 60 micrometers,

b. a first retrievable medical device, for delivering said therapeutic agent into the organ inflow blood, comprising a catheter and an injection device, said catheter having a proximal end, a distal end and a lumen;

the distal end is in fluid communication with the proximal end via the lumen;

said injection device is suitable to be connected to the proximal end of the catheter,

c. a second retrievable medical device for isolating the organ outflow, having a distal end and a proximal end comprising a catheter suitable for deploying a self-expanding hollow tubular member;

the proximal end of the tubular member is attached to the distal end of the catheter;

said tubular member is configured to expand radially to form a central part flanked by two annular ridges, a distal annular ridge and a proximal annular ridge wherein the central part radially expands to a lesser degree compared to the annular ridges;

said tubular member comprises a liquid-impermeable area disposed with one or more fluid ports for the collection of the organ outflow and two liquid-permeable regions, one distal to the distal annular ridge and one proximal to the proximal annular ridge so forming a passageway between the distal end and the proximal end of the tubular member for the flow the organ blood devoid of therapeutic agent, whereby the liquid-impermeable area is disposed in an area defined by the region flanked by the annular ridges, the distal annular ridge and at least part of the proximal annular ridge isolating the organ outflow containing therapeutic agent excess from the organ blood flow devoid of therapeutic agent, and

d. a separation device comprising at least one filter able to separate the therapeutic agent excess from the organ outflow, having an inlet for the organ outflow having a therapeutic agent excess and an outlet for filtered organ outflow blood,

wherein the separation device is located in the second retrievable medical device, wherein said separation device comprises at least one filter which is positioned at the inner proximal end of the tubular member of the second retrievable medical device.

2. The kit according to claim 1, wherein the tubular member of the second medical device comprises a liquid permeable carrier configured to adopt an essentially cylindrical state when compressed and to self-expand radially to form said tubular member.

3. The kit according to claim 1, wherein the tubular member of the second medical device comprises a liner attached to at least a part of the wall of the tubular member, which provides the liquid impermeable area.

4. The kit according to claim 1, wherein the catheter of the second medical device comprises an inner tube, an outer tube surrounding at least a portion of the length of the inner tube and a pusher means for the deployment of the tubular member;

wherein the distal end of the pusher means is attached to the proximal end of the tubular member.

5. The kit according to claim 4, wherein the inner tube distal end of the catheter of the second medical device is in fluid connection with the liquid-impermeable area of the tubular member and the inner tube proximal end is in fluid connection with the separation device inlet.

6. The kit according to claim 2, wherein the carrier of the second medical device is made of a braided wire mesh.

7. The kit according to claim 1, wherein the separation device comprises at least one filter provided with openings which size is comprised between 15 and 65 micrometers, preferably between 20 and 30 micrometers, more preferably around 25 micrometers.

8. The kit according to claim 1, wherein the separation device comprises at least two filters, a first filter and a second filter.

9. The kit according to claim 1, wherein the openings of the first filter are at least 15% larger than the openings of the second filter through which the blood will flow.

10. The kit according to claim 1, comprising at least one pump suitable to be connected to the proximal end of the second retrievable medical device catheter.

11. The kit according to claim 1, comprising at least one third retrievable medical device for the isolation and/or the perfusion of veins, said third retrievable medical device comprising a lumen, an inflation lumen, a balloon at the distal end (X) of the device and a plurality of outlets, wherein said outlets are positioned at the distal end (X) of the balloon or at the proximal end (Y) of the balloon.

12. The kit according to claim 1, wherein the first retrievable medical device comprises at least one inflatable balloon, wherein said balloon is inflated by flowing therapeutic agent in the lumen of the device and thorough openings provided in said device.

15. Use of the kit as described in claim 1 for the delivery of a therapeutic agent to an organ blood flow and for the removal of the excess of said therapeutic agent from said organ blood flow.

13. A method for the delivery of a therapeutic agent to an organ blood flow and the removal of the excess of said therapeutic agent from said organ blood flow comprising the steps of:

h. introducing a first medical device in the organ inflow vessel,

i. introducing a second medical device in the organ outflow vessel, without obstruction of the systemic blood flow,

j. controlling the infusion and/or the perfusion flow,

k. injecting the therapeutic agent into the organ inflow using the first medical device,

l. collecting the organ outflow having a therapeutic agent excess using the second medical device,

m. circulating the drug loaded perfusate, and

n. separating the therapeutic agent excess from the collected organ outflow using the separation device.

14. The method according to claim 13, further comprising the step of redirecting the filtered blood into the organ blood inflow.