System and method for introducing a prosthesis

• US 20050070821A1
• Filed: 07/29/2004
• Published: 03/31/2005
• Est. Priority Date: 07/31/2003
• Status: Abandoned Application

• Current Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Deal, Stephen E., Skerven, Gregory J., Waller, David F., Clark, Victor D. Jr.
• Application Number:
  US10/902,492
• Publication Number:
  US 20050070821A1
• Time in Patent Office: Days
• US Class Current: 600/585
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/041 Bile ducts
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A method and apparatus for introducing a first elongate medical device and short wire guide that are coupled together into a work site and remotely disconnecting them within the work site such that a secondary device comprising a catheter member can be introduced over the wire guide to the work site, and/or a second wire guide can be introduced to the work site via a passageway of the primary access device. A system of indicia, such as radiopaque or viewable markers, permits the operator to monitor the relative alignment of the devices within the work site to determine when uncoupling has occurred. In one example of the method, a wire guide and primary access device (e.g., a sphincterotome) is coupled to the wire guide and introduced via a duodenoscope into the biliary system. After performing a first medical operation, the devices are uncoupled with the wire guide being left within the biliary system such that a secondary access device, such as a balloon, biopsy device, stent delivery catheter, dilator, etc., can be introduced to perform a second medical operation without a traditional over-the-wire exchange being required. In another example of the method, a prosthesis, such as a valve or stent, is placed within the work site coupled to a wire guide which is remotely disconnected within the work site and a secondary device, such as a dilation balloon or second prosthesis, is introduced into the work site after the first delivery system is removed.

Claims

1. An apparatus for delivering a prosthesis into a work site within a bodily lumen of a patient comprising:

an elongate inner member comprising a shaft extending between a distal end and a proximal end, a lumen extending through at least a portion of the shaft, a distal opening in communication with the lumen and disposed near the distal end of the shaft, a proximal opening in communication with the lumen and disposed a substantial distance from the proximal end of the shaft and a relatively shorter distance from the distal end of the shaft;

an elongate outer member slidably disposed over the shaft of the elongate inner member, the elongate outer member including a distal end portion having a distal end; and

a wire guide removably disposed through the lumen of the elongate inner member,

wherein the prosthesis is disposed over the shaft of the elongate inner member and is engaged by the distal end of the elongate outer member; and

wherein the prosthesis is prevented from being removed from the elongate inner member when the wire guide is disposed through the lumen of the elongate inner member, and is permitted to be removed from the elongate inner member when the wire guide is not disposed through the lumen of the elongate inner member.

2. The apparatus of claim 1, wherein the wire guide engages the prosthesis when the wire guide is disposed through the lumen of the elongate inner member.

3. The apparatus of claim 2, wherein a proximal end of the prosthesis abuts the distal end of the elongate outer member and a distal end of the prosthesis abuts the wire guide when the wire guide is disposed through the lumen of the elongate inner member.

4. The apparatus of claim 1, wherein the proximal opening in the elongate inner member comprises a port through a wall of the shaft that is located distal of the distal end of the elongate outer member when the wire guide is disposed through the lumen of the elongate inner member.

5. The apparatus of claim 4, wherein a proximal end of the prosthesis abuts the distal end of the elongate outer member and a distal end of the prosthesis abuts the wire guide when the wire guide is disposed through the lumen of the elongate inner member, the prosthesis abutting a portion of the wire guide extending out from the lumen and through the port in the wall of the shaft.

6. The apparatus of claim 1, wherein the wire guide does not extend through the elongate outer member when the wire guide is disposed through the lumen of the elongate inner member.

7. The apparatus of claim 1, wherein the prosthesis comprises a non-expanding stent.

8. The apparatus of claim 7, wherein the non-expanding stent comprises a plurality of anchor flaps projecting from an exterior surface thereof, the anchor flaps configured to engage an interior surface of the bodily lumen of the patient.

9. The apparatus of claim 7, wherein the non-expanding stent comprises a proximal end that abuts the distal end of the elongate outer member.

10. The apparatus of claim 1, wherein the prosthesis comprises a self-expanding stent.

11. The apparatus of claim 10, wherein the self-expanding stent is expandable from a contracted delivery configuration to an expanded delivered configuration, the self-expanding stent being maintained in the contracted delivery configuration by being disposed within the elongate outer member, the self-expanding stent being allowed to expand to the expanded delivered configuration when not disposed within the elongate outer member.

12. A method for delivering a non-expanding prosthesis into a work site within a bodily lumen of a patient comprising the steps of:

a) providing a wire guide;

b) providing a delivery catheter comprising an elongate inner member and an elongate outer member, the elongate inner member having a shaft and a wire guide lumen extending between a distal opening and a proximal opening, the distal opening being located near a distal end of the shaft, the proximal opening being located a substantial distance from a proximal end of the shaft, the elongate outer member being slidably disposed over the shaft of the elongate inner member;

c) positioning a distal end of the wire guide within the work site;

d) positioning the prosthesis on the delivery catheter by placing the prosthesis over the elongate inner member so as to abut against a distal end of the elongate outer member;

e) inserting a proximal end of the wire guide through the distal opening, the lumen, and the proximal opening of the elongate inner member, the wire guide engaging the prosthesis so as to secure the prosthesis to the delivery catheter;

f) passing the delivery catheter over the wire guide in a distal direction until the prosthesis is within the work site; and

g) moving the prosthesis in a proximal direction by retrieving the delivery catheter along the wire guide in a proximal direction, the wire guide preventing the prosthesis from separating from the delivery catheter.

13. The method of claim 12, wherein step g) comprises the step of retrieving the prosthesis from the work site and removing the stent from the patient.

14. The method of claim 12, wherein step g) comprises the step of re-positioning the prosthesis within the work site of the patient.

15. The method of claim 14, further comprising the following steps:

h) uncoupling the wire guide from the delivery catheter by moving the wire guide in a proximal direction relative to the elongate inner member until distal end of the wire guide has been retracted from the lumen of the elongate inner member; and

i) delivering the prosthesis within the work site by moving the elongate inner member in a proximal direction relative to the elongate outer member until the prosthesis has been pushed off the distal end of the elongate inner member.

16. The method of claim 12, wherein step e) comprises the step of abutting a distal end of the prosthesis against a portion of the wire guide exiting outwardly from the proximal opening of the elongate inner member.

17. A method for delivering a plurality of non-expanding prosthesis into a work site within a bodily lumen of a patient comprising the steps of:

a) providing a wire guide;

b) providing a delivery catheter comprising an elongate inner member and an elongate outer member, the elongate inner member having a shaft and a wire guide lumen extending between a distal opening and a proximal opening, the distal opening being located near a distal end of the shaft, the proximal opening being located a substantial distance from a proximal end of the shaft, the elongate outer member being slidably disposed over the shaft of the elongate inner member;

c) positioning a distal end of the wire guide within the work site;

d) positioning a first prosthesis on the delivery catheter by placing the prosthesis over the elongate inner member so as to abut against a distal end of the elongate outer member;

e) inserting a proximal end of the wire guide through the distal opening, the lumen, and the proximal opening of the elongate inner member;

f) passing the delivery catheter over the wire guide in a distal direction until the first prosthesis is within the work site;

g) uncoupling the wire guide from the delivery catheter by moving the wire guide in a proximal direction relative to the elongate inner member until distal end of the wire guide has been retracted from the lumen of the elongate inner member;

h) maintaining the distal end of the wire guide within the work site, the wire guide being disposed in a side-by-side configuration with the first prosthesis;

i) delivering the first prosthesis within the work site by moving the elongate inner member in a proximal direction relative to the elongate outer member until the first prosthesis has been pushed off the distal end of the elongate inner member;

j) removing the delivery catheter from the patient;

k) positioning a second prosthesis on the delivery catheter by placing the prosthesis over the elongate inner member so as to abut against a distal end of the elongate outer member;

l) re-inserting the proximal end of the wire guide through the distal opening, the lumen, and the proximal opening of the elongate inner member;

m) passing the delivery catheter over the wire guide in a distal direction until the second prosthesis is within the work site;

n) uncoupling the wire guide from the delivery catheter by moving the wire guide in a proximal direction relative to the elongate inner member until distal end of the wire guide has been retracted from the lumen of the elongate inner member; and

o) delivering the second prosthesis within the work site by moving the elongate inner member in a proximal direction relative to the elongate outer member until the second prosthesis has been pushed off the distal end of the elongate inner member.

18. The method of claim 17, wherein step o) comprises the step of positioning the second prosthesis in a side-by-side configuration with the first prosthesis.

19. The method of claim 17, wherein step f) further comprises the step of moving the prosthesis in a proximal direction by retrieving the delivery catheter along the wire guide in a proximal direction, the prosthesis being engaged by the wire guide so as to prevent the prosthesis from separating from the delivery catheter during proximal movement of the delivery catheter.