System and method for introducing multiple medical devices
First Claim
1. A method of introducing multiple medical devices into a work site within a bodily lumen of a patient, comprising the steps of:
- a. advancing both a guiding member and a first elongate medical device, each having a distal end, a distal portion, and a proximal portion, into the work site to perform a first medical operation such that the distal ends of the guiding member and the first elongate medical device are positioned within the work site while maintaining the proximal portions of the guiding member and the first elongate medical device external to the patient, the first elongate medical device engaging the guiding member along a coupling region having a first end and a second end located proximal thereto, the coupling region being located about the distal portion of the first elongate medical device;
b. longitudinally advancing the first elongate medical device relative to the guiding member in a controlled manner until it can be determined that the guiding member has disengaged from the coupling region of the elongate medical device such that the guiding member and the first elongate medical device are uncoupled from one another while remaining within the work site;
c. coupling a third elongate medical device to one of the guiding member and the first elongate medical device; and
d. advancing the third elongate medical device to the work site,wherein the guiding member and the first elongate medical device include an alignment indication system configured for use by the operator to determine when the guiding member and the first elongate medical device have uncoupled from one another within the work site, the alignment indication system comprising a first proximal indicator located about the proximal portion of the guiding member and a second proximal indicator located about the proximal portion of the first elongate medical device, the first and second proximal indicators configured to be spaced relative to one another during the first medical operation to indicate that uncoupling of the guiding member and the first elongate medical device within the work site is at least imminent, the first and second proximal indicators configured to remain external to the patient during the first medical operation; and
wherein the method further comprises the step of visually monitoring the alignment indication system externally of the patient until the first and second proximal indicators are substantially aligned to thereby indicate that uncoupling of the guiding member and the first elongate medical device has occurred within the work site.
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Accused Products
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, permit 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.
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Citations
41 Claims
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1. A method of introducing multiple medical devices into a work site within a bodily lumen of a patient, comprising the steps of:
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a. advancing both a guiding member and a first elongate medical device, each having a distal end, a distal portion, and a proximal portion, into the work site to perform a first medical operation such that the distal ends of the guiding member and the first elongate medical device are positioned within the work site while maintaining the proximal portions of the guiding member and the first elongate medical device external to the patient, the first elongate medical device engaging the guiding member along a coupling region having a first end and a second end located proximal thereto, the coupling region being located about the distal portion of the first elongate medical device; b. longitudinally advancing the first elongate medical device relative to the guiding member in a controlled manner until it can be determined that the guiding member has disengaged from the coupling region of the elongate medical device such that the guiding member and the first elongate medical device are uncoupled from one another while remaining within the work site; c. coupling a third elongate medical device to one of the guiding member and the first elongate medical device; and d. advancing the third elongate medical device to the work site, wherein the guiding member and the first elongate medical device include an alignment indication system configured for use by the operator to determine when the guiding member and the first elongate medical device have uncoupled from one another within the work site, the alignment indication system comprising a first proximal indicator located about the proximal portion of the guiding member and a second proximal indicator located about the proximal portion of the first elongate medical device, the first and second proximal indicators configured to be spaced relative to one another during the first medical operation to indicate that uncoupling of the guiding member and the first elongate medical device within the work site is at least imminent, the first and second proximal indicators configured to remain external to the patient during the first medical operation; and wherein the method further comprises the step of visually monitoring the alignment indication system externally of the patient until the first and second proximal indicators are substantially aligned to thereby indicate that uncoupling of the guiding member and the first elongate medical device has occurred within the work site. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39)
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40. A method of introducing multiple medical devices into a work site within a bodily lumen of a patient, comprising the steps of:
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a. advancing both a wire guide and a first tubular member, each having a distal end, a distal portion, and a proximal portion having a visual indicia disposed thereon, into the work site to perform a first medical operation such that the distal ends of the wire guide and the first elongate medical device are positioned within the work site while maintaining the proximal portions and the visual indicia of the wire guide and the first tubular member external to the patient, the first tubular member including a passageway extending at least partially therethrough, the distal portion thereof comprising a coupling region configured to receive and engage the wire guide therein, the coupling region having a first end and a second end, the second end comprising a side access port traversing a wall of the tubular member; b. longitudinally advancing the first tubular member relative to the wire guide until the operator has determined, by monitoring the position of the visual indicia of the wire guide relative to the visual indicia of the first tubular member, that the distal end of the wire guide has disengaged from the coupling region through the side access port such that the wire guide and the first elongate medical device are uncoupled from one another while remaining within the work site; c. coupling a second tubular member to the wire guide; and d. advancing the second tubular member along the wire guide to the work site.
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41. A method of introducing a medical device into a work site within a bodily lumen of a patient, comprising the steps of:
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a. introducing a wire guide having a distal end into the bodily lumen until the distal end is positioned within a biliary system of the patient; b. advancing a first elongate medical device having a distal end, a passageway, and a side access port over the wire guide and into the biliary system to perform a first medical operation, wherein a substantial portion of the wire guide extends proximally out of passageway via the side access port, the side access port being located about the distal portion of the elongate medical device and communicating with the passageway thereof; c. monitoring indicia located about both the wire guide and the first elongate medical device to determine the position of the distal end of the wire guide relative to the side access port, the indicia being disposed on proximal portions of each of the wire guide and the first elongate member such that the indicia remain external to the patient while the distal ends of the wire guide and the first elongate medical device are disposed within the work site; d. longitudinally withdrawing the wire guide in a proximal direction relative to the first elongate medical device until it can be determined by direct visual observation of the indicia that the wire guide has disengaged from the passageway of the first elongate medical device such that the wire guide and the first elongate medical device are uncoupled while remaining within the work site; e. coupling a third elongate medical device to the wire guide or first elongate medical device via a second coupling region located on one of the first elongate medical device or third elongate medical device; and f. advancing the third elongate medical device to the work site.
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Specification