Mechanical thrombus maceration device

• US 5,569,275 A
• Filed: 02/08/1994
• Issued: 10/29/1996
• Est. Priority Date: 06/11/1991
• Status: Expired due to Term

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: Microvena Corporation
• Inventors: Claude, Timothy, Kotula, Frank
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/193,490
• Time in Patent Office: 994 Days
• Field of Search: 606/159, 606/170, 606/171, 606/180, 604/22
• US Class Current: 606/159
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00553 using a turbine
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

In one embodiment, the present invention provides a mechanical thrombus maceration device which includes a flexible shaft adapted to be guided along a vascular path and rotated within a vascular channel; a rotor affixed to the shaft adjacent the distal end thereof for rotation therewith; drive means for rotating the shaft; and a rotor housing within which the rotor rotates. The rotor housing of this embodiment comprises a generally cylindrical wall substantially surrounding the rotor and having at least one port formed therein, the port or ports being positioned about the housing such that when a fluid (e.g. blood) is ejected through the ports within a vascular channel, the housing will tend to deflect toward one side of the vascular channel to permit the device to be steered during deployment. In another embodiment of the invention, the device includes an elongate, flexible shaft adapted to be guided along a vascular path and which is rotatable within a vascular channel; a plurality of rotors spaced from one another along the shaft and attached to the shaft for rotation therewith; drive means for rotating the shaft; and a rotor housing enclosing at least one of the rotors.

Claims

1. A mechanical thrombus maceration device comprising:

a. an elongate, flexible shaft having proximal and distal ends, the shaft being adapted to be guided along a vascular path and being rotatable within a vascular channel having a vascular wall;

b. a plurality of rotors affixed to the shaft for rotation therewith, the rotors being spaced apart from one another along the shaft;

c. drive means for rapidly rotating the shaft; and

d. a rotor housing enclosing at least one of the rotors and within which said rotor rotates, the housing comprising a generally cylindrical wall substantially surrounding said rotor.

2. The invention of claim 1 wherein said rotors are carried along a distal segment of the shaft and the rotor housing encloses all of the rotors and includes a first discharge port passing through the wall of the housing at a location proximal of the distal-most rotor and an intake port disposed distally of the proximal-most rotor.

3. The invention of claim 1 further comprising a casing about the shaft, wherein a first of the rotors is positioned adjacent a distal end of the device and is adapted to macerate thrombi entrained in fluid in a patient'"'"'s vascular system and to displace a fluid proximally, and a second of the rotors is disposed proximally of the first rotor and is adapted to displace a fluid proximally, the first and second rotors acting together to draw fluid into the device adjacent its distal end and pump at least a portion of that fluid rearwardly through the casing for removal from the patient'"'"'s vascular system.

4. The invention of claim 3 wherein the second rotor is larger than the first rotor and displaces a greater volume of fluid than the first rotor when the shaft is rotated.

5. The invention of claim 4 wherein the casing is generally tubular and has a distal segment, a proximal segment and a tapered segment disposed between the distal and proximal segments, the proximal segment having a larger diameter than the distal segment, the tapered segment tapering relatively gradually from a diameter adjacent its proximal end substantially equal to the diameter of the proximal segment to a diameter adjacent its distal end substantially equal to the diameter of the distal segment.

6. A mechanical thrombus maceration device comprising:

a. an elongate, flexible shaft having proximal and distal ends, the shaft being adapted to be guided along a vascular path and being rotatable within a vascular channel having a vascular wall;

b. a rotor affixed to the shaft adjacent the distal end thereof for rotation therewith;

c. drive means for rapidly rotating the shaft;

d. a rotor housing carried about the rotor and within which the rotor rotates, the housing comprising a generally cylindrical wall substantially surrounding the rotor and having at least one discharge port formed therein for discharging fluid out of the housing when the rotor is rotated, the port being spaced proximally of the rotor; and

e. fluid directing means associated with the discharge port for directing fluid from the discharge port back toward the rotor.

7. The invention of claim 6 wherein the fluid directing means is expandable from a collapsed state for deployment to an expanded position wherein it directs fluid from the discharge port back toward the rotor.

8. The invention of claim 7 wherein the fluid directing means comprises a selectively inflatable balloon positioned adjacent a distal end of the housing.

9. The invention of claim 8 wherein the balloon is sized to engage the wall of the vessel and substantially fill the vessel'"'"'s lumen.

10. The invention of claim 7 wherein the fluid directing means comprises a sheath formed of a flexible elastomeric material attached to the device proximally of the port, the sheath in its collapsed state covering at least a portion of the port and being expanded into its expanded state by fluid discharged through the port.

11. The invention of claim 10 wherein the sheath in its expanded state is generally frustoconical in shape, having a proximal end narrower than a distal end.

12. The invention of claim 6 wherein the fluid directing means comprises a gate carried adjacent the port, the gate being oriented at an angle with respect to the housing when fluid is discharged from the housing through the port to direct discharged fluid distally of the port.

13. The invention of claim 12 wherein the gate is normally biased toward the housing to substantially cover the port, the gate being hingedly attached to the device such that it will pivot outwardly of the housing in response to fluid being discharged from the port.

14. The invention of claim 13 wherein the housing includes a plurality of ports, one gate being positioned adjacent each port.

15. A mechanical thrombus maceration device comprising:

a. an elongate, flexible shaft having proximal and distal ends, the shaft being adapted to be guided along a vascular path and being rotatable within a vascular channel having a vascular wall;

b. a rotor affixed to the shaft adjacent the distal end thereof for rotation therewith;

c. drive means for rapidly rotating the shaft; and

d. a rotor housing carried about the rotor and within which the rotor rotates, the housing comprising a generally cylindrical wall substantially surrounding the rotor and having at least one port formed therein, the surface area of the port or ports being distributed unevenly about the circumference of the housing such that when a fluid is ejected through the ports within a vascular channel, the housing will tend to deflect toward one side of the vascular channel to permit the device to be steered during deployment thereof within a patient'"'"'s vascular system.

16. The invention of claim 15 wherein the housing has only one port formed therein.

17. The invention of claim 15 wherein the housing has first and second ports formed therein, the first port having a greater surface area than the second port.

18. The invention of claim 17 wherein the housing has at least three of said ports formed therein, the ports being substantially equiangularly spaced about the circumference of the housing.