Percutaneous medical probe and flexible guide wire

• US 6,512,958 B1
• Filed: 04/26/2001
• Issued: 01/28/2003
• Est. Priority Date: 04/26/2001
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T., Swoyer, John M.
• Primary Examiner(s): RIVELL, JOHN A
• Application Number:
  US09/846,559
• Time in Patent Office: 642 Days
• Field of Search: 607/116, 607/117, 606/129, 600/373, 600/377, 600/393, 600/585
• US Class Current: 607/117
• 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 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61M 2025/0007 Epidural catheters
• CPC Class Codes: A61M 2025/09066 having a coil without a core possibly combined with a sheath
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A medical instrument for obtaining access to a site within the body directly inserted through the skin or through an incision in the skin to enable introduction of further medical instruments to the percutaneously accessed site or from the percutaneously accessed site to a more remote site in the body. The instrument comprises a combined medical probe and flexible guide wire for introduction of the further elongated diagnostic or surgical or therapy delivery devices over the guide wire and probe. The combined medical probe and flexible guide wire further comprises a stiff tissue penetrating probe having a probe length between a probe proximal end and a probe distal end, the probe length shorter than the elongated medical device length, and a flexible guide wire body having a guide wire length between a guide wire body proximal end and a guide wire body distal end, the guide wire distal end coupled to the probe proximal end, the guide wire length sufficiently long to support the elongated medical device to enable its over-the-wire advancement over the guide wire body and probe.

Claims

1. A combined percutaneous medical probe and guide wire employed to form a percutaneous pathway to a percutaneously accessed site and to enable over-the-wire advancement of an elongated medical device having a device length and device through-lumen to the percutaneously accessed site or into an access pathway accessible from the percutaneously accessed site comprising:

a stiff tissue penetrating probe having a probe length between a probe proximal end and a probe distal end, the probe adapted to be manually grasped and advanced from the skin to the percutaneous access site to provide the percutaneous pathway to the percutaneously accessed site at the probe distal end the probe length shorter than the device length; and

a flexible guide wire body having a guide wire length between a guide wire body proximal end and a guide wire body distal end, the guide wire distal end coupled to the probe proximal end, the guide wire length sufficiently long to support the device length to enable its over-the-wire advancement over the guide wire body and probe.

2. The combined percutaneous medical probe and guide wire of claim 1, further comprising:

an insulating coating overlying the tissue penetrating probe except for a distal exposed electrode area and overlying the guide wire body except for an exposed electrical connector area of the guide wire body; and

conductive means for conducting electrical signals between the distal exposed electrode area and the electrical connector area.

3. The combined percutaneous medical probe and guide wire of claim 2, wherein:

the flexible guide wire body comprises a coiled wire extending between the guide wire body proximal end and the guide wire body distal end forming a coiled wire lumen and an inextensible core wire extending through the coiled wire lumen and affixed to the coiled wire at the guide wire body proximal end and the guide wire body distal end to inhibit stretching of the guide wire body.

4. The combined percutaneous medical probe and guide wire of claim 2, wherein:

the tissue penetrating probe has a probe lumen extending distally from the probe proximal end;

the flexible guide wire body comprises a coiled wire extending between the guide wire body proximal end and the guide wire body distal end forming a coiled wire lumen and an inextensible core wire extending through the coiled wire lumen and affixed to the coiled wire at the guide wire body proximal end and extending into the probe lumen and affixed to the tissue penetrating probe to at least partially attach the guide wire body distal end to the probe proximal end and to inhibit stretching of the guide wire body.

5. The combined percutaneous medical probe and guide wire of claim 4, wherein the core wire extends distally through the probe lumen to the probe distal end.

6. The combined percutaneous medical probe and guide wire of claim 1, wherein:

the flexible guide wire body comprises a coiled wire extending between the guide wire body proximal end and the guide wire body distal end forming a coiled wire lumen and an inextensible core wire extending through the coiled wire lumen and affixed to the coiled wire at the guide wire body proximal end and the guide wire body distal end to inhibit stretching of the guide wire body.

7. The combined percutaneous medical probe and guide wire of claim 1, wherein:

the tissue penetrating probe has a probe lumen extending distally from the probe proximal end;

the flexible guide wire body comprises a coiled wire extending between the guide wire body proximal end and the guide wire body distal end forming a coiled wire lumen and an inextensible core wire extending through the coiled wire lumen and affixed to the coiled wire at the guide wire body proximal end and extending into the probe lumen and affixed to the tissue penetrating probe to at least partially attach the guide wire body distal end to the probe proximal end and to inhibit stretching of the guide wire body.

8. The combined percutaneous medical probe and guide wire of claim 7, wherein the core wire extends distally through the probe lumen to a distal core wire end at the probe distal end.

9. The combined percutaneous medical probe and guide wire of claim 8, wherein the core wire is electrically conductive and further comprising an electrical connector element formed along the flexible guide wire body electrically coupled to the core wire to enable delivery of electrical stimulation pulses through the core wire to the distal core wire end.

10. The combined percutaneous medical probe and guide wire of claim 1, wherein the guide wire length exceeds the device length to enable grasping the guide wire body proximal end upon advancement of the elongated medical device over the guide wire body to align the guide wire body and elongated medical device axially with the tissue penetrating probe to enable advancement of the elongated medical device over the tissue penetrating probe.

11. The combined percutaneous medical probe and guide wire of claim 1, wherein the elongated medical device comprises one of an electrical stimulation lead for stimulating a body organ, nerve or other tissue, a dilator for dilating tissue surrounding the combined percutaneous medical probe and guide wire, a catheter, an introducer, a cannula or a medical tube.

12. The combined percutaneous medical probe and guide wire of claim 1, wherein the elongated medical device comprises a sacral nerve stimulation lead, and the percutaneously accessed site comprises a site accessed through a foramen of the sacrum adjoining a sacral nerve.

13. The combined percutaneous medical probe and guide wire of claim 1, wherein the elongated medical device comprises a dilator comprising the assembly of:

a dilator body having a dilator body diameter, a dilator body length extending between a dilator proximal end and a dilator distal end, and a dilator body lumen extending from the dilator proximal end to the dilator distal end and having a dilator body lumen diameter sized to receive the combined percutaneous medical probe and guide wire therein,

a dilator sheath having a dilator sheath diameter, a dilator sheath length extending between a dilator sheath proximal end and a dilator sheath distal end, and a dilator sheath lumen extending from the dilator sheath proximal end to the dilator sheath distal end and having a dilator sheath lumen diameter sized in operative relation to the dilator body diameter to selectively receive the dilator body therein,

whereby the dilator sheath and dilator body are adapted to be assembled with the dilator body received within the dilator sheath lumen, the dilator body is adapted to be inserted over the combined percutaneous medical probe and guide wire and to be advanced distally over the combined percutaneous medical probe and guide wire through the insertion path to dilate the insertion path to the dilator sheath diameter.

14. A minimally invasive method of inserting an elongated medical device having a device length and device through-lumen percutaneously to a percutaneously accessed site comprising the steps of:

providing a combined percutaneous medical probe and guide wire comprising a stiff tissue penetrating probe having a probe length between a probe proximal end and a probe distal end, the probe length shorter than the elongated medical device length, and a flexible guide wire body having a guide wire length between a guide wire body proximal end and a guide wire body distal end, the guide wire distal end coupled to the probe proximal end, the guide wire length sufficiently long to support the elongated medical device to enable its over-the-wire advancement over the guide wire body and probe;

manually grasping the probe and advancing the probe from the skin to the percutaneously accessed site to provide the percutaneous pathway to the percutaneously accessed site at the probe distal end;

inserting the guide wire body proximal end into the through-lumen of the elongated medical device;

advancing the elongated medical device over the guide wire body;

grasping the guide wire body proximal end upon advancement of the elongated medical device over the guide wire body to align the guide wire body and elongated medical device generally axially with the tissue penetrating probe;

advancing the elongated medical device over the tissue penetrating probe; and

withdrawing the combined percutaneous medical probe and guide wire from the through-lumen of the medical device.

15. The method of claim 14, wherein the elongated medical device comprises one of an electrical stimulation lead for stimulating a body organ, nerve or other tissue, a dilator for dilating tissue surrounding the combined percutaneous medical probe and guide wire, a catheter, an introducer, a cannula or a medical tube.

16. The method of claim 14, wherein the elongated medical device comprises a sacral nerve stimulation lead, and the percutaneously accessed site comprises a site accessed through a foramen of the sacrum adjoining a sacral nerve.

17. A minimally invasive method of inserting an elongated a sacral nerve stimulation lead having a lead body length and lead body through-lumen percutaneously to a percutaneously accessed foramen of the sacrum adjoining a sacral nerve comprising the steps of:

(a) providing a combined percutaneous medical probe and guide wire comprising a stiff tissue penetrating probe having a probe length between a probe proximal end and a probe distal end, the probe length shorter than the elongated medical device length, and a flexible guide wire body having a guide wire length between a guide wire body proximal end and a guide wire body distal end, the guide wire distal end coupled to the probe proximal end, the guide wire length sufficiently long to support the elongated medical device to enable its over-the-wire advancement over the guide wire body and probe;

(b) manually grasping the probe and advancing,the probe from the skin to the percutaneously accessed site to provide the percutaneous pathway to the percutaneously accessed site adjoining a sacral nerve at the probe distal end;

(c) inserting the guide wire body proximal end into the through-lumen of the elongated stimulation lead;

(d) advancing the elongated stimulation lead over the guide wire body;

(e) grasping the guide wire body proximal end upon advancement of the elongated stimulation lead over the guide wire body to align the guide wire body and elongated stimulation lead generally axially with the tissue penetrating probe;

(f) advancing the elongated stimulation lead over the tissue penetrating probe to position lead stimulation electrodes in operative relation to the sacral nerve,

(g) delivering test stimuli to the sacral nerve through the lead stimulation electrodes, and

(h) withdrawing the combined percutaneous medical probe and guide wire from the through-lumen of the stimulation lead.

18. The method of claim 17 further comprising the steps of:

providing a dilator having a dilator through-lumen adapted to receive the combined percutaneous medical probe and guide wire; and

before step (c),

inserting the guide wire body proximal end into the through-lumen of the dilator; and

expanding the percutaneous pathway by advancing the dilator over the combined percutaneous medical probe and guide wire.

19. A surgical instrumentation kit for minimally invasive implantation of a sacral stimulation lead through a foramen of the sacrum in a patient to electrically stimulate a sacral nerve, the sacral stimulation lead of the type having a lead body extending between a lead body proximal end and a lead body distal end, the lead body having a lead body diameter extending from the lead body proximal end and lead body distal end, the lead body further enclosing at least one electrical conductor extending between at least one proximally located electrical connector adapted to be coupled to an electrical stimulation pulse generator and at least one distally located stimulation electrode adapted to apply electrical stimulation to a sacral nerve, the kit comprising:

a combined percutaneous medical probe and guide wire comprising a stiff tissue penetrating probe having a probe length between a probe proximal end and a probe distal end, the probe length shorter than the lead body length, and a flexible guide wire body having a guide wire length between a guide wire body proximal end and a guide wire body distal end, the guide wire distal end coupled to the probe proximal end, the guide wire length sufficiently long to support the elongated lead body to enable its over-the-wire advancement over the guide wire body and probe, the probe distal end capable of penetrating body tissue, the probe adapted to be grasped by a medical clinician with the probe distal end directed toward and inserted through an entry point of the skin or a skin incision posterior to the sacrum and guided along an insertion path into a foramen to locate at least a distal portion of the probe extending alongside a sacral nerve and a proximal portion of the probe extending from the entry point away from the patient'"'"'s skin; and

a dilator body having a dilator body diameter, a dilator body length extending between a dilator proximal end and a dilator distal end, and a dilator body lumen extending from the dilator proximal end to the dilator distal end and having a dilator body lumen diameter sized to receive the combined percutaneous medical probe and guide wire therein,

a dilator sheath having a dilator sheath diameter, a dilator sheath length extending between a dilator sheath proximal end and a dilator sheath distal end, and a dilator sheath lumen extending from the dilator sheath proximal end to the dilator sheath distal end and having a dilator sheath lumen diameter sized in operative relation to the dilator body diameter to selectively receive the dilator body therein,

whereby the dilator sheath and dilator body are adapted to be assembled with the dilator body received within the dilator sheath lumen, the dilator body is adapted to be inserted over the combined percutaneous medical probe and guide wire and to be advanced distally over the combined percutaneous medical probe and guide wire through the insertion path to dilate the insertion path to the dilator sheath diameter.

20. The surgical instrumentation kit of claim 19, wherein the combined percutaneous medical probe and guide wire is adapted to be withdrawn through the dilator body lumen, the dilator body is adapted to be withdrawn through the dilator sheath lumen.