Minimally invasive revascularization apparatus and methods
First Claim
1. Instrumentation for facilitating penetration of a side wall of a tubular body tissue conduit from the interior lumen of the conduit comprising:
- a tubular structure which is axially insertable into and along the lumen of the conduit and which has an axial portion configured to deflect toward a first portion of the interior surface of the side wall from a second portion of the interior surface of the side wall which is axially spaced from the first portion and on the side of the side wall which is substantially opposite the first portion, the tubular structure having an axially extending interior passageway with an opening to the exterior of the tubular structure adjacent the first portion; and
a laterally flexible, longitudinal, tissue piercing structure configured to pierce a side wall of the tubular body tissue conduit and to project from the side wall through any adjacent tissue outside of the tubular body tissue conduit, wherein said tissue piercing structure is axially insertable into and along the passageway and which is axially reciprocable relative to the tubular structure so that it exits the opening toward the first portion when moved toward the opening;
wherein the axial portion is an axially medial portion of the tubular structure which is configured to arch toward the first portion from the second portion and from a third portion of the interior surface of the side wall which is on the same side of the side wall as the second portion, the second and third portions being axially spaced from the first portion in respective opposite axial directions from the first portion.
4 Assignments
0 Petitions
Accused Products
Abstract
A bypass graft conduit is installed in the circulatory system of a patient using apparatus which facilitates performing most or all of the necessary work intraluminally (i.e., via lumens of the patient'"'"'s circulatory system). A guide structure such as a wire is installed in the patient via circulatory system lumens so that a portion of the guide structure extends along the desired path of the bypass conduit, which bypass conduit path is outside the circulatory system as it exists prior to installation of the bypass graft. The bypass graft is then introduced into the patient along the guide structure and connected at each of its ends to the circulatory system using connectors that form fluid-tight annular openings from the bypass graft lumen into the adjacent circulatory system lumens. The guide structure is then pulled out of the patient.
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Citations
92 Claims
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1. Instrumentation for facilitating penetration of a side wall of a tubular body tissue conduit from the interior lumen of the conduit comprising:
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a tubular structure which is axially insertable into and along the lumen of the conduit and which has an axial portion configured to deflect toward a first portion of the interior surface of the side wall from a second portion of the interior surface of the side wall which is axially spaced from the first portion and on the side of the side wall which is substantially opposite the first portion, the tubular structure having an axially extending interior passageway with an opening to the exterior of the tubular structure adjacent the first portion; and
a laterally flexible, longitudinal, tissue piercing structure configured to pierce a side wall of the tubular body tissue conduit and to project from the side wall through any adjacent tissue outside of the tubular body tissue conduit, wherein said tissue piercing structure is axially insertable into and along the passageway and which is axially reciprocable relative to the tubular structure so that it exits the opening toward the first portion when moved toward the opening;
wherein the axial portion is an axially medial portion of the tubular structure which is configured to arch toward the first portion from the second portion and from a third portion of the interior surface of the side wall which is on the same side of the side wall as the second portion, the second and third portions being axially spaced from the first portion in respective opposite axial directions from the first portion. - View Dependent Claims (2)
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3. Apparatus for use in forming an aperture in a side wall of a tubular body tissue conduit from the interior lumen of the conduit comprising:
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a first tubular structure which is axially insertable into and along the lumen of the conduit and which has a distal portion configured to penetrate and pass through the side wall of the conduit from the interior of the lumen through any adjacent tissue outside of the tubular body tissue conduit;
a longitudinal structure which is axially extendable from the distal portion of the first structure, the longitudinal structure being laterally flexible to a degree that it is substantially unable to penetrate body tissue when unsupported by other structure; and
an annular tissue cutting structure disposed annularly around the first structure and being extendable through the side wall of the conduit to cut through the side wall annularly around the first structure, the tissue cutting structure being guidable by the longitudinal structure which is extendable from the first portion to substantially prevent the tissue cutting structure from cutting additional tissue outside the side wall of the conduit. - View Dependent Claims (4, 5, 6, 7, 8, 9)
a second tubular structure disposed annularly around the tissue cutting structure and extendable into and through an aperture formed in the side wall by the tissue cutting structure.
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8. The apparatus defined in claim 7 further comprising:
an inflatable annular balloon which extends annularly around an outer surface portion of the second structure for restricting axial shifting of the second structure when the balloon is inflated and contacts the side wall.
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9. The apparatus defined in claim 7 further comprising:
first and second inflatable annular balloons which extend annularly around respective first and second, axially spaced, outer surface portions of the second structure for respectively resiliently bearing on annular portions of inner and outer surfaces of the side wall when the second structure is positioned so that the balloons are on respective sides of the side wall and the balloons are inflated.
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10. A method of forming an aperture in a side wall of a tubular body tissue conduit from the interior lumen of the conduit comprising:
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inserting a first tubular structure axially into and along the lumen of the conduit;
causing a distal portion of the first structure to penetrate and pass through the side wall of the conduit from the interior of the lumen through any adjacent tissue outside of the tubular body tissue conduit;
axially extending a longitudinal structure from the distal portion of the first structure, the longitudinal structure being laterally flexible to a degree that it is substantially unable to penetrate body tissue when unsupported by other structure; and
axially extending an annular tissue cutting structure, which is annularly disposed around the first structure, through the side wall of the conduit to cut through the side wall of the conduit annularly around the first structure. - View Dependent Claims (11)
axially extending a second tubular structure, which is annularly disposed around the tissue cutting structure, into and through an aperture formed in the side wall by the tissue cutting structure.
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- 12. An elongated, catheter-like, medical instrument configured for axial insertion into a patient'"'"'s body comprising an elongated shaft having (1) a proximal portion which is laterally flexible in response to external forces applied laterally to the shaft and which is configured to transmit torque along a longitudinal axis of the shaft, and (2) a distal portion which is laterally deflectable by lateral deflection forces transmitted axially along the proximal portion via lateral deflection force transmitting structure included in the proximal portion, the proximal portion being substantially laterally undeflected by lateral deflection forces transmitted by the lateral deflection force transmitting structure, and the shaft have a lumen which extends axially along the proximal and distal portions.
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23. Apparatus for use in penetrating a side wall of a tubular body tissue conduit from the interior lumen of the conduit comprising:
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a longitudinal structure configured for axial insertion into and along the lumen of the conduit and including a first relatively distal portion having a first relatively low lateral stiffness and a second relatively proximal portion having a second relatively high lateral stiffness, wherein gradual transition is provided between the second relatively proximal portion and the first relatively distal portion at the second relatively proximal portion'"'"'s distal end, the first portion having a distal tip which is configured to facilitate penetration of the side wall of the conduit through any adjacent tissue outside of the tubular body tissue conduit. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48)
a radiologic marker on the first portion.
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27. The apparatus defined in claim 26 wherein the radiologic marker comprises radiologic material disposed annularly about the first portion.
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28. The apparatus defined in claim 27 wherein the radiologic material comprises wire wrapped around the first portion.
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29. The apparatus defined in claim 27 wherein the first portion comprises an exterior surface part for providing a substantially smooth exterior surface transition from a location distal of the marker to an exterior surface of the marker.
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30. The apparatus defined in claim 27 wherein the first portion includes a channel extending annularly around the first portion, and wherein the marker comprises an annulus of radiologic material disposed in the channel.
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31. The apparatus defined in claim 23 wherein the first portion includes a longitudinal section which is resiliently biased to deflect laterally when unsupported by other structure.
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32. The apparatus defined in claim 23 wherein the first portion includes a longitudinal section which is laterally bifurcated to reduce its stiffness.
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33. The apparatus defined in claim 32 wherein portions of the longitudinal section on opposite sides of the bifurcation are resiliently biased to spring apart from one another when not confined by other structure.
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34. The apparatus defined in claim 33 wherein the portions of the longitudinal section on opposite sides of the bifurcation form an open loop when they spring apart from one another.
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35. The apparatus defined in claim 33 further comprising:
a hooking structure configured for disposition outside the conduit, and further configured to engage the longitudinal structure by hooking one of the portions of the longitudinal structure on opposite sides of the bifurcation when those portions are separated from one another.
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36. The apparatus defined in claim 23 wherein the distal tip of the first portion is sharply pointed in the distal direction to facilitate penetration of the side wall of the conduit.
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37. The apparatus defined in claim 23 further comprising:
a longitudinal support structure configured for axial insertion into and along the lumen of the conduit substantially parallel to the longitudinal structure, the support structure being configured to laterally support at least a portion of the longitudinal structure while permitting the longitudinal structure to move axially relative to the support structure.
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38. The apparatus defined in claim 37 wherein the support structure is configured to guide the distal tip of the longitudinal structure toward the side wall of the conduit.
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39. The apparatus defined in claim 38 wherein the support structure includes a longitudinal section which is configured to laterally deflect toward the side wall of the conduit to guide the distal tip of the longitudinal structure toward the side wall.
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40. The apparatus defined in claim 39 wherein the longitudinal section of the support structure is resiliently biased to laterally deflect toward the side wall of the conduit.
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41. The apparatus defined in claim 39 wherein the longitudinal section of the support structure is a longitudinal medial section of the support structure.
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42. The apparatus defined in claim 41 wherein the longitudinal section is configured to arch transversely in the lumen of the conduit between opposite portions of the side wall of the conduit.
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43. The apparatus defined in claim 42 wherein the arch has an apex, and wherein the support structure is configured to guide the distal tip of the longitudinal structure toward the side wall of the conduit adjacent the apex.
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44. The apparatus defined in claim 37 further comprising:
a longitudinal guide structure configured for axial insertion into and along the lumen of the conduit, and further configured to guide the support structure into and along the lumen of the conduit substantially parallel to guide structure.
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45. The apparatus defined in claim 44 wherein the support structure is configured for removal of the guide structure after the guide structure has guided the support structure into and along the lumen of the conduit.
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46. The apparatus defined in claim 45 wherein the support structure is configured to substantially conform to alignment of the guide structure during guidance by the support structure.
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47. The apparatus defined in claim 46 wherein a longitudinal section of the first portion of the longitudinal structure is configured to deflect laterally in the lumen of the conduit when the guide structure is removed.
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48. The apparatus defined in claim 45 wherein the support structure is configured to receive the longitudinal structure substantially in place of the guide structure after the guide structure has been removed.
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49. Apparatus for use in medical treatment of a patient'"'"'s tubular body conduit comprising:
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an elongated, laterally flexible but resilient structure having (1) an axially medial portion configured for axial insertion into and along a lumen of the body conduit and also for axial reciprocation through an aperture in a side wall of the body conduit, and (2) an axially distal portion configured for passage along the lumen of the body conduit in either axial direction along that lumen from the aperture;
wherein the distal portion is radially enlarged relative to the medial portion; and
the distal portion is approximately ball-shaped.
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50. A method of positioning an elongated, laterally flexible but resilient structure relative to a body conduit in a patient comprising:
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initially positioning the structure relative to the body conduit so that an axially distal portion of the structure extends axially along the lumen inside a first length of the conduit that extends axially in a first direction from an aperture in a side wall of the conduit, and so that a proximal portion of the structure extends out through the aperture and axially along a path that extends back along the outside of the first length of the conduit;
pulling the proximal portion in the proximal direction until the amount of the distal portion that remains inside the first length of the conduit is too short to be guided by the first length of the conduit and therefore resiliently shifts into the lumen inside a second length of the conduit that extends axially in a second direction from the aperture; and
pushing the proximal portion in the distal direction to cause the distal portion to extend farther along the lumen inside the second length of the conduit.
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51. Apparatus for inserting a tubular graft into a side wall of a tubular body tissue conduit from outside the conduit comprising:
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a hollow tubular shaft structure configured to receive a longitudinal guide structure axially along a lumen inside the shaft structure so that the shaft structure and the guide structure can slide axially relative to one another; and
a substantially conical tip structure disposed on an axial end portion of the shaft structure substantially concentrically with the shaft structure so that an apex of the conical tip structure points axially away from the shaft structure, an axial continuation of the lumen inside the shaft structure extending through the tip structure and out at the apex so that the guide structure can extend through the axial continuation and can slide axially relative to the axial continuation, the shaft structure being configured to receive the graft annularly around the shaft structure, and the tip structure including an annular recess which extends substantially annularly around the shaft structure, the recess being open in a direction that points away from the apex, and the recess having a radially outer side wall that is radially spaced from the shaft structure by an amount sufficient to allow an annular axial end portion of the graft to be received in the recess with the outer side wall radially outside the portion of the graft that is thus received in the recess;
wherein the shaft structure is connected to the tip structure so that the shaft structure can be used to push the tip structure in the direction of its apex.
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52. Apparatus for inserting a tubular graft into a side wall of a tubular body tissue conduit from outside the conduit comprising:
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a hollow tubular shaft structure configured to receive a longitudinal guide structure axially along a lumen inside the shaft structure so that the shaft structure and the guide structure can slide axially relative to one another;
a substantially conical tip structure disposed on an axial end portion of the shaft structure substantially concentrically with the shaft structure so that an apex of the conical tip structure points axially away from the shaft structure, an axial continuation of the lumen inside the shaft structure extending through the tip structure and out at the apex so that the guide structure can extend through the axial continuation and can slide axially relative to the axial continuation, the shaft structure being configured to receive the graft annularly around the shaft structure, and the tip structure including an annular recess which extends substantially annularly around the shaft structure, the recess being open in a direction that points away from the apex, and the recess having a radially outer side wall that is radially spaced from the shaft structure by an amount sufficient to allow an annular axial end portion of the graft to be received in the recess with the outer side wall radially outside the portion of the graft that is thus received in the recess; and
a radially expandable structure disposed substantially annularly around the shaft structure inside a graft around the shaft structure, wherein the expandable structure is movable along the shaft structure.
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53. Apparatus for inserting a tubular graft into a side wall of a tubular body tissue conduit from outside the conduit comprising:
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a hollow tubular shaft structure configured to receive a longitudinal guide structure axially along a lumen inside the shaft structure so that the shaft structure and the guide structure can slide axially relative to one another;
a substantially conical tip structure disposed on an axial end portion of the shaft structure substantially concentrically with the shaft structure so that an apex of the conical tip structure points axially away from the shaft structure, an axial continuation of the lumen inside the shaft structure extending through the tip structure and out at the apex so that the guide structure can extend through the axial continuation and can slide axially relative to the axial continuation, the shaft structure being configured to receive the graft annularly around the shaft structure, and the tip structure including an annular recess which extends substantially annularly around the shaft structure, the recess being open in a direction that points away from the apex, and the recess having a radially outer side wall that is radially spaced from the shaft structure by an amount sufficient to allow an annular axial end portion of the graft to be received in the recess with the outer side wall radially outside the portion of the graft that is thus received in the recess; and
a radially expandable structure disposed substantially annularly around the shaft structure inside a graft around the shaft structure, wherein the graft is movable along the shaft structure.
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54. Apparatus for adding a tubular graft conduit to a patient'"'"'s existing circulatory system between first and second points on the circulatory system that are spaced from one another by a space in the patient comprising:
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a first longitudinal shaft structure configured to emerge axially from inside the circulatory system at the second point and to move axially through the space to the first point, the first shaft structure having a distal tip structure which is configured to penetrate the circulatory system at the first point and to pass substantially coaxially inside the circulatory system adjacent the first point;
a graft conduit disposed substantially coaxially around the first shaft structure proximal of the distal tip structure, the graft conduit having a first annular connector on its first end adjacent the distal tip structure and a second annular connector on its second end remote from the distal tip structure, the first connector being initially circumferentially small enough to at least partly follow the distal tip structure into the circulatory system adjacent the first point substantially coaxially with the circulatory system at that point;
a first connector deployment structure disposed adjacent to the first connector and configured to selectively circumferentially enlarge the first connector to cause the first connector to secure the first end of the graft conduit to the circulatory system substantially coaxially in the circulatory system adjacent the first point; and
a second connector deployment structure disposed adjacent to the second connector and configured to cause the second connector to connect the second end of the graft conduit to the circulatory system at the second point. - View Dependent Claims (55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70)
first, second, and third substantially concentric tubes for respectively maintaining the first and second arrays and the main body in an initially relatively small circumference, each of the tubes being axially movable to selectively release the first and second arrays and the main body for resilient circumferential enlargement.
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66. The apparatus defined in claim 54 wherein the second connector deployment structure is still further configured to selectively pull the second connector in a direction away from the first point toward the second point.
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67. The apparatus defined in claim 54 wherein the first and second connector deployment structures are movable relative to one another axially along the first shaft structure, and wherein the apparatus further comprises:
a lock structure for selectively locking the first and second connector deployment structures axially relatively one another.
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68. The apparatus defined in claim 67 wherein the lock structure is operable with the first and second connector deployment structures having any of a plurality of different axial spacings.
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69. The apparatus defined in claim 54 further comprising:
a guide structure configured to extend through the space between the first and second points and to guide the first shaft structure from the second point to the first point.
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70. The apparatus defined in claim 69 wherein the first shaft structure is further configured for disposition annularly around the guide structure and for sliding axially along the guide structure.
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71. The method of attaching a tubular graft to a patient'"'"'s existing tubular body conduit at a predetermined point along the length of that conduit comprising:
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the lumen introducing a longitudinal structure axially into the lumen of the conduit so that the longitudinal structure initially passes along the lumen to reach the predetermined point from a first direction along the conduit and passes out through the side wall of the conduit through any adjacent tissue outside of the tubular body tissue conduit at the predetermined point;
re-routing at least a portion of the longitudinal structure inside the lumen so that that portion extends from the predetermined point in a second direction along the conduit, the second direction being substantially opposite to the first direction;
using the longitudinal structure to guide the graft to the predetermined point from outside the conduit; and
securing the graft to the conduit adjacent the predetermined point. - View Dependent Claims (72, 73, 74, 75, 76, 77, 78, 79, 80)
removing the longitudinal structure from the patient.
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73. The method defined in claim 71 wherein the using comprises:
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disposing the graft annularly around a part of the longitudinal structure which passes out through the side wall of the conduit; and
shifting the graft axially along that part of the longitudinal structure toward the predetermined point.
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74. The method defined in claim 71 wherein the securing comprises:
forming an anastomotic connection between the conduit and the graft so that the patient'"'"'s body fluid can flow between the lumen of the conduit and the interior of the graft.
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75. The method defined in claim 74 wherein the securing comprises:
deploying a mechanical connector to secure the graft to the conduit adjacent the predetermined point.
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76. The method defined in claim 71 further comprising:
passing a part of the longitudinal structure which passes out through the side wall of the conduit at the predetermined point back into a portion of the patient'"'"'s conduit system at a predetermined location which is spaced along the conduit system from the predetermined point, the longitudinal structure then passing along the interior of the conduit system until it exits from the patient at a remote location.
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77. The method defined in claim 76 wherein the using comprises:
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disposing the graft annularly around the longitudinal structure outside the patient adjacent the remote location; and
shifting the graft axially along the longitudinally structure so that it successively enters the patient at the remote location, travels along the interior of the conduit system toward the predetermined location, emerges from the conduit system at the predetermined location, and extends from the predetermined location to the first location.
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78. The method defined in claim 77 further comprising:
attaching the graft to the conduit system at the predetermined location.
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79. The method defined in claim 78 wherein the attaching comprises:
forming an anastomotic connection between the conduit system and the graft so that the patient'"'"'s body fluid can flow between the interior of the conduit system and the interior of the graft.
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80. The method defined in claim 79 wherein the attaching comprises:
deploying a mechanical connector to secure the graft to the conduit adjacent the predetermined location.
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81. Apparatus for attaching a tubular graft graft to a patient'"'"'5 existing tubular body conduit at a predetermined point along the length of that conduit comprising:
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a longitudinal structure configured for axial introduction to the lumen of the conduit so that the longitudinal structure initially passes along the lumen to the predetermined point from a first direction along the conduit and passes through the side wall of the conduit at the predetermined point through any adjacent tissue outside of the tubular body tissue conduit, the longitudinal structure being further configured for re-routing of at least a portion of that structure inside the lumen so t at that portion extends from the predetermined point in a second direction along the conduit, the second direction being opposite to the first direction; and
a graft delivery structure configured to convey the graft axially along the longitudinal structure from outside the conduit into engagement with the conduit at the predetermined point. - View Dependent Claims (82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92)
a connector deploying structure configured to deploy a connector for securing the graft to the conduit adjacent the predetermined point.
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84. The apparatus defined in claim 83 further comprising:
a substantially annular connector configured for deployment by the connector deploying structure substantially concentric with an axial end portion of the graft.
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85. The apparatus defined in claim 84 wherein the connector is further configured to produce a substantially annular connection between the conduit and the graft when deployed by the connector deploying structure.
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86. The apparatus defined in claim 84 wherein the connector deploying structure and the connector are further configured for conveyance toward the conduit along the longitudinal structure from outside the conduit.
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87. The apparatus defined in claim 81 wherein a part of the longitudinal structure that passes out through the side wall of the conduit at the predetermined point is configured to pass back into a portion of the patient'"'"'s conduit system at a predetermined location which is spaced along the conduit system from the predetermined point, that part of the longitudinal structure being further configured to pass along the interior of the conduit system until it exits from the patient at a remote location.
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88. The apparatus defined in claim 87 wherein the graft delivery structure is further configured to convey the graft axially along the longitudinal structure from outside the patient adjacent the remote location, into the patient at the remote location, along the interior of the conduit system toward the predetermined location, and at least partly out of the conduit system at the predetermined location.
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89. The apparatus defined in claim 88 further comprising:
a connecter deploying structure configured to deploy a connector for securing the graft to the conduit system at the predetermined location.
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90. The apparatus defined in claim 89 further comprising:
a substantially annular connector configured for deployment by the connector deploying structure substantially concentric with an axial end portion of the graft.
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91. The apparatus defined in claim 90 wherein the connector is further configured to produce a substantially annular connection between the conduit system and the graft when deployed by the connector deploying structure.
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92. The apparatus defined in claim 90 wherein the connector deploying structure and the connector are further configured for conveyance toward the predetermined location along the longitudinal structure from outside the patient adjacent the remote location.
Specification