Tissue penetrating device and methods for using same

• US 20010053888A1
• Filed: 01/09/2001
• Published: 12/20/2001
• Est. Priority Date: 03/02/1998
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences Limited (Teleflex Incorporated)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Athanasiou, Kyriacos A., Lanctot, Dan R., Constantinides, George
• Granted Patent: US 6,527,778 B2
• Time in Patent Office: Days
• US Class Current: 604/154
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61M 2005/3289 with rotation of the needle, e.g. to ease penetration
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

The present invention involves a device for tissue, especially hard tissue, penetration device which incorporated a novel paddle-shaped needle for low friction rotatory penetration of hard tissue and a controlled delivery or extraction system for transfer of material from to device into a tissue site or transfer of material from the tissue site to the device. The delivery system or extraction system includes at least on solenoid or other similar device.

Claims

1. A device comprising:

a. a fluid reservoir;

b. a tissue penetrator or needle detachably engaging a first end of the reservoir;

c. a plunger associated with the reservoir at its second end and designed to slidingly engage an interior surface of the reservoir;

d. a solenoid having a shaft detachably engaging a top of the plunger for moving the plunger within the reservoir at a controlled rate for controlled delivery of material into or extraction of bio-material out of a tissue site;

e. a power supply and associated circuitry for supplying electrical power to the solenoid;

f. a switch for starting and stopping the device; and

g. a housing surrounding the reservoir, the plunger, the solenoid and the power supply.

2. The device of

claim 1

, further comprising:

h. a disposable, biased retractable protector having a septum at its distal for protecting a tip of the penetrator and adapted to engage a portion of an interior surface of the housing at its proximal end.

3. The device of

claim 1

, further comprising:

i. a second solenoid for controlling needle penetration speed and depth; and

j. a second switch for starting and stopping the second solenoid.

4. The device of

claim 1

, further comprising:

i. a motor for rotating the solenoid, the plunger, the reservoir and the needle during tissue site penetration;

j. a motor/solenoid coupler assembly including a coupler, a bushing and a bearing for transferring the rotational energy of the motor to the solenoid, plunger, reservoir and needle; and

k. a relay circuit for automatically stopping the motor after tissue penetration after a change in motor torque and starting the solenoid.

5. The device of

claim 1

, wherein the needle including a tip having two cutting surface and two non-cutting surfaces.

6. The device of

claim 5

, wherein the needle tip is of a parallelogram shape and the cutting surfaces are opposed and the non-cutting surfaces are opposed.

7. The device of

claim 6

, wherein the cutting surfaces are associated with short sides of the parallelogram and wherein the parallelogram has an acute angle less than 90°

and greater than 0°

.

19. A method comprising the steps of:

a. placing a device of

claim 1

in contact with a skin of an animal above a tissue site to be penetrated;

b. penetrating the tissue site with the needle of the device; and

c. transferring material from the reservoir of the device into the tissue site.

20. A method comprising the steps of:

a. placing a device of

claim 1

in contact with a skin of an animal above a tissue site to be penetrated;

b. penetrating the tissue site with the needle of the device; and

c. transferring material from the tissue site into the reservoir of the device.

8. A device comprising:

a. needle/solenoid assembly including;

i. a fluid reservoir;

ii. a tissue penetrator or needle detachably engaging a first end of the reservoir;

iii. a plunger associated with the reservoir at its second end and designed to slidingly engage an interior surface of the reservoir;

iv. a solenoid having a shaft detachably engaging a top of the plunger for moving the plunger within the reservoir at a controlled rate for controlled delivery of material into or extraction of bio-material out of a tissue site;

b. a motor for rotating the needle/solenoid assembly during tissue site penetration;

c. a motor/solenoid coupler assembly including a coupler, a bushing and a bearing for transferring the rotational energy from the motor to the needle/solenoid assembly;

d. a power supply for supplying electrical power to the solenoid;

e. a relay circuit for stopping the motor after tissue penetration after a change in motor torque and starting the solenoid;

f. a switch for starting and stopping the device;

g. a housing surrounding the motor, motor/solenoid coupler and the needle/solenoid assembly; and

h. a biased retractable protector having a septum at its distal for protecting a tip of the penetrator and adapted to engage a portion of an interior surface of the housing at its proximal end.

9. The device of

claim 8

, wherein the needle including two cutting surface and two non-cutting surfaces.

10. The device of

claim 9

, wherein the needle is of a parallelogram shape and the cutting surfaces are opposed and the non-cutting surfaces are opposed.

11. The device of

claim 10

, wherein the cutting surfaces are associated with short sides of the parallelogram and wherein the parallelogram has an acute angle less than 90°

and greater than 0°

.

17. The method of

claim 11

, wherein the acute angle is between about 80°

and about 60°

.

12. A needle comprising at least two cutting surface and at least two non-cutting surfaces.

13. The device of

claim 12

, wherein the needle is of a parallelogram shape and the cutting surfaces are opposed and the non-cutting surfaces of opposed.

14. The device of

claim 13

, wherein the cutting surfaces are associated with short sides of the parallelogram and wherein the parallelogram has an acute angle less than 90°

and greater than 0°

.

15. The device of

claim 14

, wherein the acute angle is between about 80°

and about 10°

.

16. The method of

claim 15

, wherein the acute angle is between about 80°

and about 50°

.

18. The method of

claim 14

, wherein the acute angle is about 70°

.