Implant delivery system

• US 6,447,522 B2
• Filed: 06/18/2001
• Issued: 09/10/2002
• Est. Priority Date: 09/30/1998
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Parascandola, Michael, Gambale, Richard A., Ahern, John E.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US09/883,658
• Publication Number:
  US 20010037117A1
• Time in Patent Office: 449 Days
• Field of Search: 606/108, 606/107, 606/191, 606/194, 606/195, 606/196, 606/220, 606/185, 623/1.11, 623/1.23, 623/1.22, 623/1.31, 623/1.36
• US Class Current: 606/108
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like

Abstract

The present invention provides an implant delivery system for placing interior defining implants in the human body. The devices comprise elongate shafts and a mechanism at the distal end of the shaft for engaging and retaining the implant in place on the shaft during delivery through the vessels and insertion of the distal end of the shaft into tissue. Some embodiments of the devices are configured to have a plurality of implants and configured to deliver the implants sequentially to a plurality of locations. One embodiment employs a flexible outer tube at its distal end that compresses and crinkles to a larger diameter upon being compressed lengthwise to engage the inside surface of the implant. Another embodiment utilizes a tubular delivery shaft having a circular cross section with segments of oval shaped cross sections which serve to engage the inside of implant located on the shaft. A cam slidable within the shaft engages the oval areas, deforming them to a circular shape which permits the implants to be released. Another embodiment provides delivery force by pressurizing fluid filling the shaft lumen to move a plunger at the distal end of the shaft which carries the implant to be delivered. A feature of the invention provides for monitoring of the depth to which an implant is delivered within tissue by monitoring pressure changes experienced near the distal tip of the shaft. Another feature of the delivery devices provides for drug delivery at the implant site by compressing a drug filled bladder by the expansion of an adjoining bladder. Also disclosed is the use of an electromagnetic guidance system to accurately navigate the delivery devices to the implant delivery sites.

Claims

1. An implant delivery device comprising:

a tubular shaft having a lumen and proximal and distal ends;

a plunger having a proximal side and a distal side configured to hold an implant and the plunger being in slidable and fluid tight engagement with the lumen at the distal end of the shaft such that pressurization of fluid contained with in the lumen causes the plunger to move in a distal direction.

2. An implant delivery device as defined in claim 1 further comprising:

a pullwire joined to the distal end of the tube and extending proximally through the proximal end and arranged such that placing the wire in tension causes the distal end of the shaft to be deflected away from the axis defined by the shaft.

3. An implant delivery device as defined in claim 1 further comprising:

a source of pressurized fluid in fluid communication with the proximal end of the shaft.

4. A method of delivering an implant comprising:

providing a tubular shaft having a lumen and proximal and distal ends;

a plunger having a proximal side and a distal side configured to hold an implant and the plunger being in slidable and fluid tight engagement with the lumen at the distal end of the shaft;

placing an implant on the distal side of the plunger;

navigating the distal end tubular shaft and implant through a patient'"'"'s vasculature to an implantation site;

connecting the proximal end of the shaft to a source of fluid to be pressurized;

filling the lumen with fluid and pressurizing the fluid to cause distal movement of the plunger to drive the implant into the intended implantation site.

5. An implant delivery device comprising:

an outer delivery shaft having a lumen;

an inner shaft having a lumen;

a first bladder with perfusion ports sealed around the shaft, defining an interior with a volume and containing a therapeutic substance within the interior and;

a second bladder sealed around the shaft in close proximity to the first bladder and in fluid communication with the lumen.

6. An implant delivery device as defined in claim 5 wherein the second bladder is laterally displaced form the first bladder a minimal distance such that inflation of the second bladder causes significant contact with the first bladder so that deformation of the first bladder occurs.

7. An implant as defined in claim 5 wherein the second bladder is located within the interior of the first bladder such that inflation of the second bladder causes expulsion of the therapeutic substance through the perfusion ports.

8. A method of delivering an implant and a therapeutic substance to a treatment site within a patient comprising:

providing a shaft having a lumen, proximal and distal ends;

an inner tube within the shaft lumen having a lumen and a first bladder having a volume and perfusion ports and containing a therapeutic substance and a second bladder in fluid communication with the tube lumen;

an implant releasably attached to the distal end of the shaft;

navigating the shaft, tube and implant to the implantation site within a patient;

releasing the implant at the implantation site;

inflating the second bladder to reduce the volume of the first bladder and cause expulsion of the therapeutic substance in the area of the released implant.

9. A delivery system for implanting a device in tissue in a patient comprising:

a shaft having proximal and distal ends and means for temporarily restraining an implant at the distal end;

a depth monitor mechanism having a sensor at the distal end of the shaft and indicator means joined to the proximal end of the shaft.

10. A delivery system for implanting a device in tissue in a patient as defined in claim 9 wherein the depth monitor operates by sensing pressure at the distal end of the shaft.

11. A delivery system for implanting a device in tissue in a patient as defined in claim 10 further comprising

a plurality of sensors spaced longitudinally along the shaft adjacent the distal end.

12. A method of monitoring the placement depth of an implant delivery device within tissue comprising:

providing an implant delivery device having proximal and distal ends and a plurality pressure sensors each, with independent output, longitudinally spaced and placed at known distances along the shaft;

advancing the distal end shaft into tissue;

observing which sensors record a pressure change in conjunction with the known placement of the sensors on the shaft to determine the position of the shaft.

13. An implant delivery system for placing a device in a patient comprising:

a shaft having proximal and distal ends;

a mechanism for releasably retaining an implant at the distal end of the shaft;

a navigation system having components internal and external to the patient including sensors mounted on the shaft.

14. A catheter for accessing the left ventricle of the heart to promote revascularization of the myocardium by mechanical means comprising:

an implant configured to promote revascularization of myocardial tissue;

a shaft having proximal and distal ends;

a mechanism for releasably retaining the implant at the distal end of the shaft;

a navigation system having components internal and external to the patient including sensors mounted on the shaft.