Needle and lead and methods of use

• US 20120209283A1
• Filed: 12/08/2009
• Published: 08/16/2012
• Est. Priority Date: 12/08/2008
• Status: Active Grant

• Current Assignee: Hui Zhu
• Original Assignee: Hui Zhu
• Inventors: Zhu, Hui
• Granted Patent: US 9,522,269 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• 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: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

Example embodiments provide a medical lead adapted for to be steerable during insertion into an animal body. The lead comprises a structure comprised of a tip portion and a body. The tip portion is on a distal end of the structure. The tip portion is flexible in a direction that is substantially parallel to a principle plane. The lead provides structures to change the shape of the tip portion during insertion of the lead into an animal whereby the lead can move in a desired direction. Other example embodiments provide a needle for medical use comprised of: a needle having a shaft and a tip section; an opening in the shaft; a lumen communicating with the opening and a plurality of holes in the tip section. Aspects of the needle have symmetric and asymmetric tip sections and an overlying sheath. Example methods embodiments are provided that use the leads, needles and needle assemblies.

Claims

1. A lead adapted to be steerable during insertion into an animal body, the lead comprising:

a structure that is substantially defined by at least one principal planar surface;

said structure having a proximate end and a distal end;

said structure comprised of a tip portion and a body;

said tip portion on a distal end of said structure;

at least an electrode connected with said structure;

said tip portion is flexible in a direction that is substantially parallel to the principle planar surface whereby the shape of said tip portion is changeable during insertion of the lead into an animal such that the lead can move in a desired direction.

2. The lead of claim 1 which further includes a first means for changing the shape of said tip portion in a direction that is parallel with the principle planar surface during insertion into an animal whereby the lead moves in a desired direction.

3. The lead of claim 1 wherein said tip section has an about V shape with a left side and a right side;

said lead providing a means for changing the shape of the tip by an operator controlled alteration of the length of said left side or right side of said tip section during the insertion of the lead.

4. The lead of claim 1 which further comprises at least one fluid chamber in at least said tip portion and one passage in at least the body;

whereby inflating or deflating the fluid chamber changes the shape of the tip section.

5. The lead of claim 1 which further comprises:

at least two fluid chambers in said tip portion;

at least two passages extending in said body to said tip portion;

said passages in communication with the fluid chambers;

whereby inflating or deflating at least one fluid chamber changes the shape of the tip section.

6. The lead of claim 1 which further comprises:

at least one control wire passing through at least a channel extending from said body to said tip portion;

a distal end of said control wire positioned in said tip portion wherein extending and/or retracting a control wire changes the shape of said tip portion.

7. The lead of claim 1 which further comprises:

a stylet passing through a channel in said body extending from portions of said body to said tip portion;

said stylet having a bent or curved section within said tip section.

35. A combination comprising:

a. the lead of claim 1;

b. a needle; and

c. a sheath having a channel adapted so the needle fits in said channel;

wherein the lead is adapted to be inserted into the animal through the sheath after said sheath'"'"'s placement in the animal using the needle.

8. A lead adapted to be steerable during insertion into an animal body, the lead comprising:

a structure that is defined by at least one principal planar surface;

said structure having a proximate end and a distal end;

said structure comprised of a tip portion and a body;

said tip portion on a distal end of said structure;

at least an electrode connected with said structure;

said tip portion is flexible in a direction that is substantially parallel to the principle planar surface;

at least one fluid chamber in at least in said tip portion wherein the volume of the fluid chamber can be changed to change the shape of the tip section.

9. The lead of claim 8 which further comprises:

at least two fluid chambers in said tip portion;

said tip portion having an about V shape with a blunted tip;

at least two passages extending in said body to said tip portion;

said passages in communication with corresponding fluid chambers;

wherein the volume of the fluid chamber can be changed to change the shape of the tip section so that the blunted tip moves to the left or right only in a direction substantially parallel to the principal planar surface.

10. The lead of claim 8 wherein said body incorporates a plurality of electrodes, and a conductor of a plurality of conductors electrically couples one terminal of a plurality of terminals with at least one electrode of the plurality of electrodes;

said body is substantially defined by two principal opposing planar surfaces;

said tip portion is flexible in a direction that is substantially parallel to a principle plane.

11. The lead of claim 8 which further comprises:

at least one passage extending from the proximate end of said body to said tip portion;

said passage in a medial portion of said body or in a lateral portion of said structure;

at least a tube in communication with said passage.

12. The lead of claim 8 which further comprises:

a first means for differentially expanding and/or contracting said fluid chambers and moving said tip portion in a direction that is substantially parallel to the principle planar surfaces of said body.

13. The lead of claim 8 which further comprises a device for introducing to or withdrawing fluid from the chambers;

said device is in communication with said passage; and

said tip portion is comprised of accordion shaped folds;

at least a portion of said fluid chambers are within said folds;

wherein the folds allow one side of the tip portion to shorten and allow the other side of the tip portion to lengthen.

14. The lead of claim 8 which further includes a tip marker proximate to the distal end;

said tip marker is observable using an imaging technique in an animal body.

15. A lead that is capable of percutaneous insertion, the lead comprising:

a structure having a proximate end and a distal end;

said structure is substantially defined by at least one planar surface;

said structure comprised of a tip portion and a body;

said tip portion on a distal end of said structure;

at least an electrode connected with said body;

said tip portion is flexible in a direction that is substantially parallel to the planar surface;

at least one control wire passing through at least a channel extending from said body to said tip portion; and

a distal end of said control wire positioned in said tip portion wherein extending and/or retracting a control wire changes the shape of said tip portion.

16. The lead of claim 15 wherein said structure is a paddle structure being substantially defined by two principal opposing planar surfaces;

a conductor of the plurality of conductors electrically couples one terminal of the plurality of terminals with at least one electrode of a plurality of electrodes;

one of the two planar surfaces incorporates the plurality of electrodes,

said tip portion is flexible in a direction that is substantially parallel to a principle planar surface of said body;

said tip portion having an about V shape with a blunted tip.

17. The lead of claim 15 wherein said lead further comprises a tip marker in said tip section;

said tip marker has two dimples; and

a bending means for flexing the tip portion in an angle parallel with said planar surfaces by manipulating said control wires; and

said control wires are removably anchored to the tip marker.

18. The lead of claim 15 wherein said lead further comprises two control wires and two channels that extend from said body to said tip portion;

the two control wires pass through the two channels; and

two tubes which communicate with said two channels;

said two control wires pass through said two tubes;

the end away from said channels of said tubes connected with tube handles;

the proximate ends of said control wires are connected with wire handles.

19. The lead of claim 15 wherein said lead further comprises two control wires passing through two channels extending from said body to said tip portion;

a tip marker located in the distal end of said tip portion;

said control wires are detachable from the tip body;

the dimples on said tip marker seat the distal ends of the control wires when either or both control wires are advanced with force through the channels; and

said tip portion is comprised of a flexible material;

said tip portion is more flexible than said body.

20. A percutaneous insertion-capable lead, the lead comprising:

a structure having a proximate end and a distal end;

said structure comprised of a tip portion and a body;

said tip portion on said distal end of said structure;

said structure is a paddle structure being substantially defined by two principal opposing planar surfaces;

a conductor of the plurality of conductors electrically couples one terminal of the plurality of terminals with at least one electrode of the plurality of electrodes;

said tip portion is flexible in a direction that is substantially parallel to the principle planar surfaces of said body; and

a stylet passing through a channel in said body at least extending from portions of said body to said tip portion.

21. The lead of claim 20 wherein said stylet is pre-bent and said tip section is bent in the direction of said stylet;

said stylet is removable from said lead.

22. The lead of claim 20 wherein said tip section has a tapered shape that is not about semicircular shaped.

23. The lead of claim 20 wherein said tip section has an about V shape with a blunted tip;

said stylet is comprised of a metallic material with memory and the tip portion is pre-bent at an angle between about 125 to 155 degrees.

24. The lead of claim 20 wherein said tip section is comprised of accordion shaped folds wherein the folds allow one tip section side to shorten while another tip section side to lengthen;

said tip section has an about V-shape with a blunt termination at the tip and an about symmetrical shape without the stylet inserted.

25. A needle for medical use comprised of:

a needle having a shaft and a tip section;

an opening in said shaft;

a lumen communicating with said opening and a plurality of holes in said tip section.

26. The needle of claim 25 wherein said shaft has a circular horizontal cross section at least near the tip section;

said tip section having a superior face and an inferior face;

the area of said superior face is about 50% of the area of the tip section and the area of said inferior face is about 50% of the area said tip section; and

said tip section has a blunt tip.

27. The needle of claim 25 wherein the holes are in the tip section, not in the junction between the tip section and shaft;

said tip section having a superior face and an inferior face;

more than 50% of the holes are in said superior face and less than 50% of said holes are in said inferior face.

28. The needle of claim 25 wherein said tip portion having a superior face and an inferior face;

more than 50% of the holes are in said superior face and less than 50% of said holes are in said inferior face;

said needle shaft near the tip section has a diameter between about 1 to 6 mm and said holes in tip section have a diameter between about 0.3 to 0.6 mm and said needle tip section has a circular cross sectional area.

29. The needle of claim 25 which further comprises:

said tip section has a non-circular horizontal cross sectional shape;

a front edge in said tip section defined by the intersection of said superior and inferior faces and the intersection of an asymmetric axis;

a plurality of holes in said superior face and on an upper portion of said inferior face adjacent to said front edge.

30. The needle of claim 25 wherein at least a portion of said shaft has a non-circular cross sectional shape;

said tip section has a non-circular horizontal cross sectional shape;

a front edge defined by the intersection of said superior and inferior faces and the intersection of an asymmetric plane;

said asymmetric plane is above a midline plane of said shaft;

said plurality of holes in said superior face and on an upper portion of said inferior face adjacent to said front edge;

a bottom portion of said inferior face not having the holes.

at least one of the plurality of holes interrupts the front edge;

the area of said superior face is less than 50% of the total tip portion area and the area of said inferior face is more than 50% of the total area of said tip portion;

the plurality of holes comprise between 5 and 10 holes in each of the inferior face and superior face;

the holes have a diameter about between 0.5 and 1.5 mm.

31. The needle of claim 25 which further comprises a sheath;

said sheath having a channel from a proximate end opening to a distal opening;

said distal opening having a tapered thin edge;

said sheath and said needle adapted so that said needle fits in said channel and portions of said needle tip extend through said distal opening;

said sheath having a tip opening and an end opening and a sheath lumen communicating between said tip opening and said end opening;

the tip opening is off center opening skewed to the superior side;

the tip opening of the sheath has an inferior aspect that covers a portion of the inferior face of the tip section of the needle; and

the needle and sheath adapted to be used as a percutaneous structure for the insertion of a lead.

32. A method of introducing a lead, solid or fluid in a human;

the method comprising the steps of;

percutaneously accessing a site proximate to a desired placement site though formation of an access passage using a needle and overlying sheath;

said sheath having a sheath lumen;

removing said needle while leaving said sheath in place; and

introducing a solid and/or a fluid thru said sheath into said human or inserting a lead thru said sheath and directing the lead further through a human'"'"'s tissue to the desired placement site.

33. The method of claim 32 which further comprises:

said needle further comprises a needle having a shaft and a tip section;

an opening in said shaft;

a lumen communicating with said opening and a plurality of holes in said tip section.

and

inserting said needle and sheath in said human to access the epidural space and sensing the tip of the needle reaching said epidural space by the loss of resistance technique;

removing said needle;

inserting said lead thru said sheath lumen and directing the lead further through the epidural space to the desired lead placement site; and

removing said sheath.

34. The method of claim 32 wherein said lead further comprises a structure that is substantially defined by at least one principal planar surface;

said structure having a proximate end and a distal end;

said structure comprised of a tip portion and a body;

said tip portion on a distal end of said structure;

at least an electrode connected with said structure;

said tip portion is flexible in a direction that is substantially parallel to the principle planar surface whereby the shape of said tip portion is changeable during insertion of the lead into an animal such that the lead can move in a desired direction.