SCREENING DEVICE AND LEAD DELIVERY SYSTEM

• US 20080177362A1
• Filed: 03/29/2007
• Published: 07/24/2008
• Est. Priority Date: 01/18/2007
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Phillips, William C., Forsberg, John W.
• Application Number:
  US11/693,328
• Publication Number:
  US 20080177362A1
• Time in Patent Office: Days
• US Class Current: 607/115
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Hand-held electrical signal generator screening device include a signal generator. The hand-held devices have incorporated stylets or are capable of receiving a stylet while a stylet is inserted into the lead. The devices allow for movement of the lead and verification of suitable placement of the lead via application of an electrical signal by one user.

Claims

1. A handheld electrical signal generator screening device comprising:

a housing,

electronics disposed in the housing, the electronics capable of generating an electrical signal and controlling a parameter of the electrical signal;

a control element disposed on the housing and being operably coupled to the electronics to provide input regarding the parameter of the electrical signal; and

a contact operably coupled to the electronics;

wherein the housing comprises a connector region configured to engage at least a portion of a medical lead and at least a portion of a handle of a stylet while the stylet is inserted into the lead, and

wherein at least a portion of the contact is positioned such that the contact electrically couples the electronics to the lead when the portion of the lead is engaged by the connector region.

2. The device of claim 1, wherein the connector region comprises a lead recess configured to receive the portion of the lead and wherein the portion of the contact is located in the lead recess.

3. The device of claim 1, wherein the connector comprises a handle recess configured to receive the portion of the stylet handle.

4. The device of claim 1, wherein the device comprises a plurality of contacts, wherein at least a portion of each of the plurality of contacts such that each contact is capable of electrically coupling the electronics to the lead when the portion of the lead is engaged by the connector region.

5. The device of claim 4, further comprising an indicator disposed on the housing, the indicator capable of indicating to which of the plurality of contacts an electrical signal is being applied.

6. The device of claim 5, wherein the plurality of contacts are spaced apart and wherein the indicator comprises a plurality of indicator elements, wherein each indicator element corresponds to one of the plurality of contacts and wherein each indicator element is configured to indicate whether an electrical signal is being applied to the corresponding contact.

7. The device of claim 6, wherein the plurality of indicator elements are spaced apart in a manner substantially similar to the spacing of the contacts.

8. The device of claim 6, wherein the contacts are longitudinally spaced apart in a substantially linear manner and wherein the plurality of indicator elements are longitudinally spaced apart in a substantially linear manner in substantially the opposite direction as the corresponding contacts.

9. The device of claim 6, wherein the indicator elements comprise light emitting elements.

10. The device of claim 9, wherein the light emitting elements are configured to emit more intense light as the amplitude of the electrical signal being applied to the corresponding contact is increased.

11. The device of claim 9, wherein the light emitting elements are configured to emit light of a first color if the corresponding contact is receiving an electrical signal having a positive polarity and to emit light of a second color if the corresponding contact is receiving an electrical signal having a negative polarity.

12. The device of claim 5, wherein the indicator is operably coupled to the contact.

13. The device of claim 5, wherein the indicator is operably coupled to the electronics.

14. The device of claim 1, wherein the control element comprises an actuatable mechanism.

15. The device of claim 1, further comprising an input element operably coupled to the electronics.

16. The device of claim 15, wherein the electronics are capable of receiving input information from the input element regarding patient response to the stimulation signal and using the information to optimize parameters associated with the signal for treating a disease state of the patient.

17. The device of claim 4, wherein the control element is configured to allow a user to select one or more of the plurality of contacts to receive an electrical signal.

18. The device of claim 1, wherein the control element is configured to allow a user to vary amplitude, polarity, pulse width, or frequency of the electrical signal.

19. The device of claim 1, further comprising an impedance check element operably coupled to the electronics, wherein the impedance check element allows the user to check the impedance of the lead coupled to the contact.

20. The device of claim 1, wherein the electronics are capable of controlling a plurality of parameters of the electrical signal and wherein the device comprises a plurality of control elements each configured to allow a user to control one or more of the plurality of parameters of the electrical generator.

21. The device of claim 1, wherein the electronics comprise a memory capable of storing input from the lead, device, or a user of the device.

22. The device of claim 1, further comprising a data output module configured to transfer stored information from the memory of the handheld device to a second device.

23. A handheld electrical signal generator screening device comprising:

a housing,

a signal generator contained within the housing;

a control unit contained within the housing and operably coupled to the signal generator, the control unit capable of controlling a parameter of an electrical signal generated by the signal generator;

a first control element disposed on the housing and being operably coupled to the control unit to provide input to the control unit regarding the parameter of the electrical signal;

a contact operably coupled to the signal generator;

a stylet having a distal end and a proximal end, the distal end protruding from the housing and configured to be inserted into a medical lead;

wherein the housing comprises a connector region configured to engage at least a portion of a medical lead while the stylet is inserted into the lead, and

wherein at least a portion of the contact is positioned such that the contact electrically couples the signal generator to the lead when the portion of the lead is engaged in the connector region.

24. The device of claim 23, further comprising an acutatable steering mechanism operably coupled to the stylet and capable of causing bending at least a portion of the distal end of the stylet when the mechanism is actuated.

25. A method comprising:

inserting a stylet coupled to a hand-held electrical signal generator screening device into a lumen of a lead;

securing a portion of the lead to the hand-held electrical signal generator screening device such that contacts of the screening device are electrically coupled to the contacts of the lead, the contacts of the lead being electrically coupled to electrodes of the lead;

steering the lead, with the assistance of the stylet, within a patient such that the lead electrodes are positioned at a target location in the patient;

activating a control element disposed on the screening device to cause the screening device to apply an electrical signal to the patient via one or more of the electrodes;

wherein the method is carried out by a single user within a sterile field during.

26. The method of claim 25, further comprising determining whether a condition of the patient has improved to a predetermined value as a result of the application of the electrical signal.