Rheolytic thrombectomy catheter and method of using same

• US 5,989,210 A
• Filed: 02/06/1998
• Issued: 11/23/1999
• Est. Priority Date: 02/06/1998
• Status: Expired due to Fees

• Current Assignee: Medrad Incorporated (Bayer AG)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Le, Hieu V., Drasler, William J., Dutcher, Robert G., Setum, Cindy M., Morris, John Edward
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): SADULA, JENNIFER R
• Application Number:
  US09/019,728
• Time in Patent Office: 655 Days
• Field of Search: 604/22, 604/49, 604/52-54, 604/164-165, 604/170, 604/264, 604/280, 604/283, 604/266, 604/267
• US Class Current: 604/22
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself

Abstract

A surgical device and method for removal of tissue, such as thrombus, from a vessel in the body. The device has a first tube with a distal open end and an inward directed stop and a second tube with an outward directed stop for engaging the inward directed stop and thereby regulating the relationship between a retrograde jet and the distal open end. Thrombus is dislodged, entrained, and broken into pieces which are evacuated through the first tube.

Claims

1. A catheter for removing material from a body cavity comprising:

a. an outer assembly including

(1) a first tube having a lumen with an open distal end and an internally located stationary stop partially obstructing said lumen at said open distal end and,

b. an inner assembly including

(1) a second tube insertable into said first tube, said second tube having a high pressure lumen having a distal end, said distal end having an orifice;

(2) a transitional stop fixed to said second tube adjacent to said distal end; and

,

(3) means positioned at said distal end of said second tube and coacting with said distal end of said second tube for directing fluid exiting said orifice toward said open distal end of said first tube, said second tube being movable axially within said first tube such that said transitional stop engages said stationary stop to hold said means in a desired relationship with respect to said open distal end of said first tube.

2. A catheter for removing material from a body vessel or other body cavity comprising:

a. an outer assembly including

(1) an evacuation tube having a proximal end and an open distal end containing a stationary stop and having an evacuation lumen; and

,

b. an inner assembly including

(1) a high pressure tube having a high pressure lumen, said high pressure tube having a proximal end and a distal end, said distal end having one or more orifices through which fluid can exit from said high pressure lumen to be directed toward said open distal end of said evacuation tube;

(2) a transitional stop fixed to said high pressure tube at a position closer to said distal end than to said proximal end; and

,

(3) means positioned at said distal end of said high pressure tube and coacting with said distal end of said high pressure tube to direct fluid toward said open distal end of said evacuation tube.

3. The catheter of claim 2, wherein said means has a distal end and said distal end of said jet cap has a guidewire coil attached thereto to assist in advancement of said outer assembly and said inner assembly together or separately within the body vessel or other body cavity.

4. The catheter of claim 2, wherein said means is configured to create a jet of fluid and to direct it toward said open distal end of said evacuation tube.

5. The catheter of claim 2, wherein said evacuation tube is flexible and can pass over a guidewire through tortuous pathways.

6. A method of removing material from a body vessel or other body cavity comprising the steps of:

a. providing a guidewire and a first catheter having an open distal end and an internally located stationary stop positioned adjacent to the open distal end;

b. advancing the guidewire to a body cavity site containing material to be removed;

c. advancing the first catheter over the guidewire to the body cavity site containing material to be removed to position the distal end at the body cavity site;

d. removing the guidewire from the first catheter;

e. providing a second catheter carrying a means for directing fluid and a transitional stop spaced apart from the means for directing fluid;

f. advancing the second catheter within the first catheter to engage the transitional stop with the stationary stop; and

,

g. providing a high pressure fluid supply to the second catheter so as to cause fluid to emanate therefrom and to impinge upon and dislodge the material to be removed and force it into the open distal end of the first catheter.

7. The method of claim 6, wherein the means for directing fluid carries a distally projecting coil to facilitate further distal advancement of the first catheter and the second catheter together or separately within the body vessel or other body cavity to a further body cavity site containing material to be removed so as to remove additional distally situated material.

8. A catheter combination comprising:

a. a first tube having an open distal end and a lumen extending to the open distal end;

b. a second tube, separable from the first tube, and insertable within the lumen of the first tube, the second tube having a distal end and a lumen extending to the distal end;

c. means connected to the second tube at the distal end of the second tube and coacting with the distal end of the second tube for directing fluid exiting the lumen of the second tube, toward the open distal end of the first tube, said means being capable of passage through the lumen of the first tube and being characterized by the ability to provide a localized region of low pressure associated with a liquid flow directed generally proximally and into the lumen of the first tube through the open distal end of the first tube when located and oriented appropriately relative to the open distal end of the first tube; and

,

d. means for indexing an appropriate positional relationship of said means and the distal end of the second tube relative to the open distal end of the first tube, the means for indexing comprising a transitional stop fixed to the second tube adjacent to the distal end of the second tube.

space="preserve" listing-type="tabular">______________________________________ RHEOLYTIC THROMBECTOMY CATHETER AND METHOD OF USING SAME PARTS LIST ______________________________________ 10 rheolytic thrombectomy catheter 12 outer assembly 14 inner assembly 16 manifold 18 hemostasis nut 20 manifold proximal end 22 Luer connection 23 proximal end (branch) 24 branch 26 Luer fitting 28 distal manifold end 30 strain relief 31 tube 32 first tube or guide catheter 33 guide catheter distal end 33a guide catheter distal end 34 second tube or hypo-tube 34a-n hypo-tube portions 34n last hypo-tube portion 34na last hypo-tube portion 34ne last hypo-tube portion 34nc last hypo-tube portion 34nd last hypo-tube portion 34x U-shaped hypo-tube portion 36 filter housing/high pressure connection assembly 38 hypo-tube proximal end 40 transitional stop 42 hypo-tube distal end 42a hypo-tube distal end 42b hypo-tube distal end 42c hypo-tube distal end 42d hypo-tube distal end 42e hypo-tube distal end 44 jet cap 46 quidewire coil 46a guidewire coil 46b guidewire coil 46c guidewire coil 46d guidewire coil 46e guidewire coil 48 central passage 50 branch passage 52 multi-radius cavity 54 round outer cavity portion 56 round inner cavity portion 58 threaded surface 60 seal 61 distal annular surface 62 body 63 annular surface 64 grasping surface 66 threaded surface 68 passageway 72 filter 74 central bore 76 annular flange 78 tapered proximal tube mouth end 80 distal tube end 82 tapered tube surface 84 threads 86 threads 87 lumen (of

     32) 88 tapered central passage surface 90 body 92 threaded surface 94 tubular cavity 96 fine filter 98 course filter 100 central passage 102 cap 104 central bore 106 lumen (of

     34) 108 body 110 central bore 112a-n guide bars 114a-n angled leading edges 116a-n arced surfaces 117 shoulder-like transition 118 peripheral wall 118a peripheral wall 118b peripheral wall 120 circular end wall 120a circular end wall 120b circular end wall 122 elongated hole 124 arcuate portion 126 arcuate portion 128 jet orifice 130 jet orifice 132 weld 132a weld 132b weld 134 tapered core 134a tapered core 136 orifice 138 orifice 140 central cavity 140a central cavity 140b central cavity 142 weld 142a weld 142b weld 144 jet orifice 146 jet orifice 148 bore 150 stationary stop 152 cylindrical body 153 cap 154 central bore 156 shoulder 158 angled annular surface 160 crimp sleeve 162a-n passages 164 blood vessel 166 thrombotic deposit and lesion 170 saline jet 180 jet cap 182 hole 184 hole 200 jet cap 202 hole 206 jet orifice 210 transitional stop 212 jet cap 214 angled annular surface 216 hole 218 lumen 230 stationary stop 230a-n arcuate stops 234a-n proximal tapered surfaces 236a-n distal tapered surfaces 238 transitional stop 240 jet cap 242 distal tapered surface 244 central bore 246 cylindrical fixture 248 crimp sleeve 250 jet cap ______________________________________