Medical fluid delivery system

• US 20040147963A1
• Filed: 01/08/2004
• Published: 07/29/2004
• Est. Priority Date: 10/02/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sommer, John L., Coles, James A. Jr., Sigg, Daniel C.
• Granted Patent: US 7,274,966 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0095 being one or more needles protruding from the distal tip and which are not used for injection nor for electro-stimulation, e.g. for fixation purposes
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• 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 1/0575 with drug delivery
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

A medical fluid delivery system includes an implantable medical lead including a fixation element adapted to secure the lead to a tissue site and a fluid delivery device including a tissue piercing distal tip; the device is adapted to pass through a proximal port, a lumen and a distal port of the lead. The system further includes means for adjusting a position of the device distal tip with respect to the lead distal port.

Claims

1. A medical fluid delivery system, comprising:

an implantable medical lead including a proximal port, a distal port, a lumen extending between the proximal port and the distal port and a distal fixation element adapted to secure the lead to a tissue site such that the distal port is in proximity to the tissue site;

a fluid delivery device including a tissue piercing distal tip, the device adapted to pass through the lead proximal port, through the lead lumen and through the lead distal port; and

means for adjusting a position of the device distal tip with respect to the lead distal port.

2. The system of claim 1, wherein the means for adjusting the position of the device distal tip comprises a threaded interface formed between the fluid delivery device and the lead lumen.

3. The system of claim 2, wherein the threaded interface is positioned in proximity to the lead distal port.

4. The system of claim 1, further comprising a locking mechanism adapted to adapted to hold the fluid delivery device in a stable position within the lead lumen and including a lead-clamping portion and a fluid delivery device-clamping portion.

5. The system of claim 4, wherein the means for adjusting the position of the device distal tip comprises a threaded interface formed between the lead-clamping portion and the device-clamping portion of the locking mechanism.

6. The system of claim 4, wherein:

the implantable medical lead further includes a proximal connector pin formed about the proximal port; and

the locking mechanism is affixed to the connector pin via a set-screw.

7. The system of claim 6, wherein the set-screw forms an electrical coupling between an electrical probe and the connector pin.

8. The system of claim 4, wherein the device-clamping portion of the locking mechanism includes a chuck mechanism for engaging the device.

9. The system of claim 1, wherein the means for adjusting the position of the device distal tip further comprises a stop limiting a maximum distance between the device distal tip and the lead distal port.

10. The system of claim 1, wherein the means for adjusting the position of the device distal tip further comprises a fluid delivery device position indicator.

11. The system of claim 1, wherein the fluid delivery device further includes a pre-formed curve in proximity to the device distal tip such that the distal tip is directed away from the fixation element after passing beyond the distal port of the lead.

12. The system of claim 11, wherein the device is formed of a material comprising a shape memory alloy.

13. The system of claim 11, wherein the device is formed from a material comprising a super-elastic material.

14. The system of claim 1, wherein the fluid delivery device further includes a lubricious outer layer.

15. The system of claim 1, wherein:

the implantable medical lead further includes a coiled conductor forming a portion of the lumen;

the device distal tip includes a beveled end; and

the coiled conductor includes a one or more filars having a pitch adapted to prevent the beveled end of the distal tip from catching in the coil as the device passes through the lumen.

16. The system of claim 1, wherein:

the implantable medical lead further includes a proximal connector pin formed about the proximal port and an elongated conductor electrically coupling the connector pin to the fixation element;

the fluid delivery device further includes a proximal end and a conductive element extending between the proximal end and the device distal tip; and

the means for adjusting the position of the device distal tip comprises an impedance monitor coupled to the connector pin of the lead and the proximal end of the device, the impedance monitor adapted to measure an electrical impedance change between the distal tip of the device and the fixation element when the bolus of fluid is injected through the device.

17. The system of claim 1, wherein:

the fluid delivery device further includes a proximal end; and

the means for adjusting the position of the device distal tip comprises a pressure monitor coupled to the proximal end of the device and adapted to measure a pressure change when the bolus of fluid is injected through the device.

18. The system of claim 1, wherein:

the fluid delivery device further includes a distal portion, electromagnetic receiver coils wound around the distal portion and a pair of insulated conductors coupled to the receiver coils and adapted to deliver a magnetically induced current from the coils to a signal converter; and

the means for adjusting the position of the device distal tip comprises an electromagnetic imaging or mapping system including the signal converter.

19. A method for adjusting a position of a fluid delivery device distal tip to access a tissue site, the method comprising the steps of:

passing the fluid delivery device through a lumen of an implantable lead such that the distal tip of the device passes out from a distal port of the lead, which is positioned in proximity to the tissue site; and

monitoring a position of the device tip with respect to the tissue site via an injection of a bolus of fluid through the device.

20. The method of claim 19, wherein the bolus of fluid comprises a conductive solution and the step of monitoring further comprises measuring an impedance change between the device tip and a fixation mechanism, which is coupled to the lead in proximity to the distal port, when the bolus of fluid is injected.

21. The method of claim 19, wherein the step of monitoring further comprises measuring a pressure change through the device when the bolus of fluid is injected.

22. The method of claim 19, wherein the bolus of fluid comprises a radiopaque contrast agent and the step of monitoring further comprises observing a dispersion of the contrast agent out the device tip via fluoroscopy.

23. The method of claim 19, further comprising the step of moving the device through the lead lumen by means of a threaded interface.

24. The method of claim 19, further comprising locking the device in a desired position within the lead lumen.