Device and method for less forceful tissue puncture

• US 10,219,832 B2
• Filed: 10/24/2014
• Issued: 03/05/2019
• Est. Priority Date: 06/29/2007
• Status: Active Grant

• Current Assignee: Actuated Medical, Inc.
• Original Assignee: Actuated Medical, Inc.
• Inventors: Bagwell, Roger B., Clement, Ryan S., Meehan, Andrew J., Scruggs, Casey A., Sheehan, Ryan M., Mulvihill, Maureen L.
• Primary Examiner(s): Towa, Rene
• Application Number:
  US14/522,681
• Publication Number:
  US 20150073357A1
• Time in Patent Office: 1,593 Days
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3476 Powered trocars, e.g. electrosurgical cutting, lasers, powered knives
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/32007 with suction or vacuum means
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence

Abstract

A device for penetrating tissue is provided that has a driving actuator with a body and motor shaft that is reciprocated. A coupler is attached to the motor shaft, and a key engages the driving actuator and coupler and limits rotational motion of the motor shaft and permits linear motion of the motor shaft. A penetrating member is carried by the coupler, and linear motion of the motor shaft is translated to the penetrating member to linearly reciprocate the penetrating member.

Claims

1. A device for penetrating tissue, comprising:

a driving actuator that has a body and a motor shaft, wherein the motor shaft is reciprocated;

a penetrating member coupled to said motor shaft, wherein reciprocation of the motor shaft is translated to the penetrating member to reciprocate the penetrating member; and

a controller in electrical communication with the driving actuator and configured to send signals to the driving actuator to reciprocate the motor shaft according to a preselected operating frequency based on tissue type to be penetrated, wherein said preselected operating frequency is sufficient to offset at least a portion of damping of oscillatory displacement amplitude resulting from a resonant frequency shift from air to said tissue type upon insertion of said penetrating member into said tissue type, wherein the preselected operating frequency is selected from the group consisting of;

(i) the resonance frequency of the penetrating member in said tissue type;

(ii) a frequency higher than a resonant frequency of said penetrating member in air;

(iii) in the range of ⅓

to ½

octave higher than the resonant frequency of said penetrating member in air; and

(iv) in the range of 95-150 Hz.

2. The device as set forth in claim 1, wherein the controller is configured to perform at least one of the following:

maintaining the preselected operating frequency during penetration of tissue;

maintaining a current amplitude to the driving actuator during penetration of tissue;

increasing a current amplitude to the driving actuator during penetration of tissue.

3. The device as set forth in claim 1, further comprising a keyed coupler that is attached to the motor shaft, wherein the penetrating member is carried by the keyed coupler, wherein the keyed coupler has a key;

wherein the body of the driving actuator is an exterior handpiece body that defines a keyway, wherein the key is disposed within the keyway, and wherein the key prevents rotational motion of the motor shaft during reciprocation of the motor shaft.

4. The device as set forth in claim 1, wherein the driving actuator has a first magnet array and a second magnet array, and wherein the driving actuator has a first centering magnet and a second centering magnet, wherein the first and second magnet arrays are located between the first and second centering magnets, wherein the first centering magnet and the first magnet array repel one another, and wherein the second centering magnet and the second magnet array repel one another, wherein alternating current is applied to the first and second magnet arrays to cause the first and second magnet arrays to reciprocate, wherein the reciprocation of the first and second magnet arrays is translated to the motor shaft.

5. The device as set forth in claim 1, wherein the preselected operating frequency is the resonance frequency of the penetrating member in tissue.

6. A device as set forth in claim 1, further comprising a coupler attached to the motor shaft for removably affixing a penetrating member to the motor shaft, wherein linear motion of the motor shaft is translated to the penetrating member to linearly reciprocate the penetrating member, said coupler having a key integral to and extending outwardly from the coupler and engaging the driving actuator, limiting rotational motion and permitting linear motion of the motor shaft.

7. The device as set forth in claim 6, wherein the body of the driving actuator is an exterior handpiece body that defines a keyway, wherein the key is disposed within the keyway, wherein the key prevents rotational motion of the motor shaft, and wherein the penetrating member has a beveled end.

8. The device as set forth in claim 6, further comprising:

a coupling sled selectively attachable to the body of the driving actuator and configured to move relative to the body of the driving actuator during reciprocation of the motor shaft;

a safety IV device that is releasably attachable to the coupling sled and configured to move relative to the body of the driving actuator during reciprocation of the motor shaft, wherein the penetrating member is carried by the safety IV device so as to be carried by the coupler; and

an IV catheter located on the penetrating member, wherein the N catheter is removable from the penetrating member, and wherein the penetrating member is retractable into the safety IV device after removal of the IV catheter from the penetrating member.

9. The device as set forth in claim 6, further comprising:

a syringe clip carried by the coupler, wherein the penetrating member is carried by the syringe dip so as to be carried by the coupler;

a handpiece dip attached to the body of the driving actuator, wherein the body of the driving actuator is an exterior handpiece body, wherein the handpiece dip has a moveable portion that is movable relative to the body of the driving actuator;

a syringe carried by the handpiece dip so as to be side mounted to the body of the driving actuator;

a plunger that is in communication with the moveable portion of the handpiece dip, wherein movement of the moveable portion of the handpiece clip causes movement of the plunger relative to the syringe.

10. The device as set forth in claim 9, wherein the movable portion of the handpiece dip has a drive gear and a guide shaft, wherein the drive gear is rotatable and is in gearing communication with a rack of the guide shaft, wherein rotation of the drive gear causes linear movement of the guide shaft;

further comprising a guide shaft coupling that is attached to the guide shaft and to the plunger, wherein the plunger is in communication with the guide shaft by way of the guide shaft coupling such that linear movement of the guide shaft causes linear movement of the plunger.

11. The device as set forth in claim 9, wherein the moveable portion has a switch that is actuated by a finger or thumb of a user, wherein the switch is located adjacent the exterior handpiece body of the driving actuator.

12. The device as set forth in claim 6, wherein the driving actuator has a first magnet array and a second magnet array, wherein the first magnet array is located proximal to the second magnet array, wherein the driving actuator has a first centering magnet located proximal to both the first and second magnet arrays, wherein the first centering magnet and the first magnet array repel one another, wherein the driving actuator has a second centering magnet that is located distal to the first centering magnet and the first and second magnet arrays, wherein the second centering magnet and the second magnet array repel one another, wherein alternating current is applied to the first and second magnet arrays by a coil of the driving actuator to cause the first and second magnet arrays to reciprocate, wherein the reciprocation of the first and second magnet arrays is translated to the motor shaft.

13. The device as set forth in claim 12, wherein the driving actuator has a voice coil through which the alternating current is applied to the first and second magnet arrays, wherein the driving actuator has a first end cap that is located proximal to the first centering magnet, wherein the driving actuator has a second end cap that is located distal to the second centering magnet, wherein the driving actuator has a pole piece that is located between the first and second magnet arrays, wherein the motor shaft extends through the first end cap, the first centering magnet, the first magnet array, the pole piece, the second magnet array, the second centering magnet, and the second end cap.

14. The device as set forth in claim 6, wherein the penetrating member has a hub, wherein the hub has an attachment selected from the group consisting of a LUER lock attachment and a slip tip attachment;

and wherein the coupler is configured to be reversibly attachable to a LUER lock attachment and a slip tip attachment, wherein the hub is attached to the coupler such that the attachment is received by the coupler.

15. The device as set forth in claim 1, wherein the body of the driving actuator is an exterior handpiece body, and wherein the penetrating member has an inner lumen, and further comprising:

a syringe coupling bracket that is releasably attached to the exterior handpiece body;

a syringe body that is releasably attached to the syringe coupling bracket, when an axis of the syringe body is not coaxial with an axis of the penetrating member; and

a plunger that moves relative to the syringe body, wherein fluid in the syringe body is dispensed from the syringe body through a side port and into the inner lumen of the penetrating member.

16. The device as set forth in claim 1, further comprising:

a coupling sled that engages the body of the driving actuator and is configured to move relative to the body of the driving actuator during reciprocation of the motor shaft;

a safety IV device that is releasably attachable to the coupling sled and configured to move relative to the body of the driving actuator during reciprocation of the motor shaft, wherein the penetrating member is carried by the safety IV device; and

an IV catheter located on the penetrating member, wherein the IV catheter is removable from the penetrating member, and wherein the penetrating member Is retractable into the safety IV device after removal of the IV catheter from the penetrating member.

17. The device as set forth in claim 1, further comprising a keyed coupler that is attached to the motor shaft, wherein the penetrating member is carried by the keyed coupler, wherein the keyed coupler has a key;

wherein the body of the driving actuator is an exterior handpiece body that defines a keyway, wherein the key is disposed within the keyway, and wherein the key prevents rotational motion of the motor shaft during reciprocation of the motor shaft.

18. The device as set forth in claim 1, wherein said preselected operating frequency is a frequency higher than a resonant frequency of said penetrating member in air.

19. The device as set forth in claim 1, wherein said preselected operating frequency is in the range of ⅓

to ½

octave higher than the resonant frequency of said penetrating member in air.

20. The device as set forth in claim 1, wherein said preselected operating frequency is in the range of 95-150 Hz.

21. The device as set forth in claim 1, wherein:

the driving actuator has a first magnet array and a second magnet array, and wherein the driving actuator has a first centering magnet and a second centering magnet, wherein the first and second magnet arrays are located between the first and second centering magnets, wherein the first centering magnet and the first magnet array repel one another, and wherein the second centering magnet and the second magnet array repel one another, wherein alternating current is applied to the first and second magnet arrays to cause the first and second magnet arrays to reciprocate, wherein the reciprocation of the first and second magnet arrays is translated to the motor shaft.

22. The device as set forth in claim 1, wherein said preselected operating frequency Is an initial operating frequency and said controller is configured to send signals to the driving actuator to reciprocate the motor shaft according to a technique selected from the group consisting of:

(a) driving the motor shaft at said preselected operating frequency when penetrating tissue;

(b) driving the motor shaft at the said preselected operating frequency and providing a constant current amplitude to the driving actuator when penetrating tissue;

(c) driving the motor shaft at the said preselected operating frequency and increasing said current amplitude when penetrating tissue; and

(d) driving the motor shaft by increasing said current amplitude and a subsequent operating frequency that differs from said preselected operating frequency when penetrating tissue.

23. The device as set forth in claim 22, further comprising a displacement sensor configured to monitor oscillatory displacement amplitude during reciprocation of said penetrating member, wherein a feedback loop is employed and configured to use Input from the displacement sensor to optimize performance of the device by adjusting a property of the device selected from the group consisting of:

the initial operating frequency of the driving actuator such that the subsequent operating frequency is closer to resonance frequency of said penetrating member in tissue than the initial operating frequency;

current amplitude supplied to the driving actuator during load when penetrating tissue; and

a combination of the initial operating frequency and current amplitude supplied to the driving actuator.

24. A device for penetrating tissue, comprising:

a driving actuator having;

(i) an exterior handpiece body;

(ii) a motor shaft configured to be reciprocated;

(iii) a first magnet array and a second magnet array, the first magnet array located proximal to the second magnet array;

(iv) a first centering magnet located proximal to both the first and second magnet arrays, the first centering magnet and the first magnet array configured to repel one another;

(v) a second centering magnet located distal to the first centering magnet and the first and second magnet arrays, the second centering magnet and the second magnet array configured to repel one another; and

(vi) a coil;

the first and second magnet arrays configured to receive alternating current from the coil of the driving actuator, reciprocate, and translate the reciprocation to the motor shaft;

a penetrating member having an inner lumen and a penetrating axis defined along its length, the penetrating member removably affixed to the motor shaft and receiving reciprocation from the motor shaft;

a coupler attached to the motor shaft, the coupler removably affixing the penetrating member to the motor shaft and configured to translate linear motion from the motor shaft to the penetrating member, the coupler having a key integral to and extending outwardly therefrom, the key engaging the driving actuator, limiting rotational motion and permitting linear motion to the motor shaft;

a controller in electrical communication with the driving actuator and configured to send signals to the driving actuator to reciprocate the motor shaft according to a preselected operating frequency based on the tissue type to be penetrated, the preselected operating frequency being sufficient to offset at least a portion of damping of oscillatory displacement amplitude resulting from a resonant frequency shift from air to tissue upon insertion of the penetrating member into the tissue type;

a syringe coupling bracket configured to releasably attach to the exterior handpiece body;

a syringe body having a syringe axis defined along its length, the syringe body configured to releasably attach to the syringe coupling bracket, the syringe axis being spaced apart form the penetrating axis; and

a plunger configured to move relative to the syringe body, wherein fluid in the syringe body is dispensed through a side port into the inner lumen of the penetrating member.

25. The device as set forth in claim 24, wherein the exterior handpiece body defines a keyway, wherein the key is disposed within the keyway, wherein the key prevents rotational motion of the motor shaft, and wherein the penetrating member has a beveled end.

26. The device as set forth in claim 24, wherein said preselected operating frequency is an initial operating frequency and said controller is configured to send signals to the driving actuator to reciprocate the motor shaft according to a technique selected from the group consisting of:

(a) driving the motor shaft at said preselected operating frequency when penetrating tissue;

(b) driving the motor shaft at the said preselected operating frequency and providing a constant current amplitude to the driving actuator when penetrating tissue;

(c) driving the motor shaft at the said preselected operating frequency and increasing said current amplitude when penetrating tissue; and

(d) driving the motor shaft by increasing said current amplitude and a subsequent operating frequency that differs from said preselected operating frequency when penetrating tissue.

27. The device as set forth in claim 26, further comprising a displacement sensor configured to monitor oscillatory displacement amplitude during reciprocation of said penetrating member, wherein a feedback loop is employed and configured to use input from the displacement sensor to optimize performance of the device by adjusting a property of the device selected from the group consisting of:

the initial operating frequency of the driving actuator such that the subsequent operating frequency is closer to resonance frequency of said penetrating member in tissue than the initial operating frequency;

current amplitude supplied to the driving actuator during load when penetrating tissue; and

a combination of the initial operating frequency and current amplitude supplied to the driving actuator.

28. The device as set forth in claim 24, wherein the penetrating member has a hub, wherein the hub has an attachment selected from the group consisting of a LUER lock attachment and a slip tip attachment;

and wherein the coupler is configured to be reversibly attachable to a LUER lock attachment and a slip tip attachment, wherein the hub is attached to the coupler such that the attachment is received by the coupler.

29. The device as set forth in claim 24, wherein the controller is configured to perform at least one of the following:

maintaining the preselected operating frequency during penetration of tissue;

maintaining a current amplitude to the driving actuator during penetration of tissue;

increasing a current amplitude to the drying actuator during penetration of tissue.

30. The device as set forth in claim 24, wherein the preselected operating frequency is selected from the group consisting of:

(i) the resonance frequency of the penetrating member in tissue;

(ii) a frequency higher than a resonant frequency of said penetrating member in air;

(iii) in the range of ⅓

to ½

octave higher than the resonant frequency of said penetrating member in air; and

(iv) in the range of 95-150 Hz.

31. The device as set forth in claim 24, wherein the driving actuator has a voice coil through which the alternating current is applied to the first and second magnet arrays, wherein the driving actuator has a first end cap that is located proximal to the first centering magnet, wherein the driving actuator has a second end cap that is located distal to the second centering magnet, wherein the driving actuator has a pole piece that is located between the first and second magnet arrays, wherein the motor shaft extends through the first end cap, the first centering magnet, the first magnet array, the pole piece, the second magnet array, the second centering magnet, and the second end cap.

32. The device as set forth in claim 24, further comprising:

a coupling sled selectively attachable to the body of the driving actuator and configured to move relative to the body of the driving actuator during reciprocation of the motor shaft;

a safety IV device that is releasably attachable to the coupling sled and configured to move relative to the body of the driving actuator during reciprocation of the motor shaft, wherein the penetrating member is carried by the safety IV device so as to be carried by the coupler; and

an IV catheter located on the penetrating member, wherein the IV catheter is removable from the penetrating member, and wherein the penetrating member is retractable into the safety IV device after removal of the IV catheter from the penetrating member.

33. The device as set forth in claim 24, further comprising:

a syringe clip carried by the coupler, wherein the penetrating member is carried by the syringe clip so as to be carried by the coupler;

a handpiece clip attached to the exterior handpiece body, wherein the handpiece clip has a moveable portion that is movable relative to the body of the driving actuator;

a syringe carried by the handpiece clip so as to be side mounted to the body of the driving actuator;

wherein the plunger is in communication with the moveable portion of the handpiece clip and movement of the moveable portion of the handpiece clip causes movement of the plunger relative to the syringe.

34. The device as set forth in claim 33, wherein the moveable portion of the handpiece clip has a drive gear and a guide shaft, wherein the drive gear is rotatable and is in gearing communication with a rack of the guide shaft, wherein rotation of the drive gear causes linear movement of the guide shaft;

further comprising a guide shaft coupling that is attached to the guide shaft and to the plunger, wherein the plunger is in communication with the guide shaft by way of the guide shaft coupling such that linear movement of the guide shaft causes linear movement of the plunger.

35. The device as set forth in claim 33, wherein the moveable portion has a switch that is actuated by a finger or thumb of a user, wherein the switch is located adjacent the exterior handpiece body of the driving actuator.