MEDICAL DELIVERY SYSTEM AND METHOD FOR DELIVERY OF A MEDICALLY USEFUL PAYLOAD
The present disclosure concerns a delivery system for delivering a medically useful payload through the vasculature to a site of interest in the patient's body. The medically useful payload may be a therapeutic device, such as a stent, and it may be a diagnostic tool, such as an imaging device. Owing to its structural attributes, the presently-inventive delivery system is well suited for carrying medical payload to and through vessel curvature and to branched regions (i.e., bifurcations) in same. Also, the device is well-suited to traveling through a vessel over a guiding element, such as a guidewire, which itself exhibits curvature.
1 . A device for carrying a medically useful payload positioned upon the device to a location of interest relative to a non-linear path in a body lumen, comprising:
an elongate intralumenal member having proximal and distal end portions, and sized and dimensioned to travel to a location of interest in a body lumen; and
an orienting member positioned along the distal end portion of the elongate intralumenal member, the orienting member exhibiting a curved shape and being configured to rotate in response to the non-linear path.
2 . The device of claim 1 wherein the orienting member is configured to seek a position of lower resistance as it rotates in response to the non-linear path.
3 . The device of claim 1 wherein the curved shape of the orienting member is configured prior to being introduced into the body.
4 . The device of claim 3 wherein the orienting member comprises a pre-shaped element.
5 . The device of claim 4 wherein the pre-shaped element is the payload.
6 . The device of claim 4 wherein the pre-shaped element is a biasing element.
7 . The device of claim 6 wherein the biasing element is a shaped biasing wire.
8 . The device of claim 6 wherein the biasing element is a shaped ribbon.
9 . The device of claim 6 wherein the biasing element is a shaped extrusion.
10 . The device of claim 6 wherein the biasing element is an integral part of the elongate intralumenal member.
11 . The device of claim 3 wherein the orienting member comprises a shapeable element.
12 . The device of claim 11 wherein the shapeable element is the payload.
13 . The device of claim 11 wherein the shapeable element is a plastically deformable element.
14 . The device of claim 11 wherein the plastically deformable element is a wire.
15 . The device of claim 11 wherein the plastically deformable element is a ribbon.
16 . The device of claim 9 wherein the plastically deformable element is an integral part of the elongate intralumenal member.
17 . The device of claim 3 wherein the orienting member comprises an active component capable of creating a curved shape.
18 . The device of claim 17 wherein the active component comprises a hydraulically controlled element.
19 . The device of claim 18 wherein the hydraulically controlled element includes at least one pressure chamber that is configured to induce a shape change in the orienting member corresponding to changes in pressure.
20 . The device of claim 19 wherein the hydraulically controlled element includes an incompressible fluid.
21 . The device of claim 19 wherein the hydraulically controlled element includes a compressible fluid.
22 . The device of claim 17 wherein the active component comprises a mechanically controlled element that is configured to induce a shape change in the orienting member through the application of relative motion or force.
23 . The device of claim 22 wherein the mechanically controlled element includes a pull wire.
24 . The device of claim 22 wherein the mechanically controlled element includes a deflectable tube.
25 . The device of claim 22 wherein the mechanically controlled element includes a deflectable guidewire.
26 . The device of claim 17 wherein the active component comprises an electrically controlled element that is configured to induce a shape change in the orienting member corresponding to a change in electrical potential or current.
27 . The device of claim 26 wherein the electrically controlled element includes a piezoelectric element.
28 . The device of claim 26 wherein the electrically controlled element includes a bimetallic strip with a least one resistive heating element.
29 . The device of claim 26 wherein the electrically controlled element includes a conductive polymer that exhibits shape memory effects under the influence of electric potential.
30 . The device of claim 26 wherein the electrically controlled element includes an electromechanical actuator.
31 . The device of claim 17 wherein the active component comprises a magnetically controlled element that is configured to induce a shape change in the orienting member corresponding to a change in magnetic field.
32 . The device of claim 31 wherein the magnetic field is an external magnetic field.
33 . The device of claim 31 wherein the magnetic field is an internal magnetic field.
34 . The device of claim 31 wherein the magnetically controlled element includes a magnetostriction element.
35 . The device of claim 34 wherein the magnetostriction element comprises Terfenol.
36 . The device of claim 17 wherein the active component comprises a chemically controlled element that is configured to induce a shape change in the orienting member corresponding to a change in local chemistry.
37 . The device of claim 36 wherein the change in local chemistry is caused by a chemical reaction.
38 . The device of claim 37 wherein the chemical reaction causes swelling of the active component.
39 . The device of claim 37 wherein the chemical reaction causes a shape change of the active component.
40 . The device of claim 39 wherein the change is local chemistry is caused by a change in chemical concentration.
41 . The device of claim 37 wherein the change in chemical concentration causes swelling of the active component.
42 . The device of claim 37 wherein the change in chemical concentration causes a shape change of the active component.
43 . The device of claim 17 wherein the active component comprises a thermally controlled element that is configured to induce a shape change in the orienting member corresponding to a change in temperature.
44 . The device of claim 43 wherein the thermally controlled element includes regions having different coefficients of thermal expansion.
45 . The device of claim 43 wherein the thermally controlled element comprises nitinol.
46 . The device of claim 17 wherein the active component comprises a thermally controlled element that changes material phase corresponding to changes in temperature.
47 . The device of claim 1 wherein the orienting element's curved shape is assumed subsequent to introduction into the body.
48 . The device of claim 47 wherein the orienting member comprises an active component capable of creating a curved shape.
49 . The device of claim 48 wherein the active component comprises a hydraulically controlled element.
50 . The device of claim 49 wherein the hydraulically controlled element includes at least one pressure chamber that changes shape corresponding to changes in pressure.
51 . The device of claim 50 wherein the hydraulically controlled element includes at least one pressure chamber that changes shape corresponding to changes in chamber pressure.
52 . The device of claim 51 wherein the hydraulically controlled element includes a compressible fluid.
53 . The device of claim 48 wherein the active component comprises a mechanically controlled element that changes shape through the application of relative motion or force.
54 . The device of claim 53 wherein the mechanically controlled element includes a pull wire.
55 . The device of claim 53 wherein the mechanically controlled element includes a deflectable tube.
56 . The device of claim 53 wherein the mechanically controlled element includes a deflectable guidewire.
57 . The device of claim 48 wherein the active component comprises an electrically controlled element that changes shape corresponding to a change in electrical potential or current.
58 . The device of claim 57 wherein the electrically controlled element includes a piezoelectric transducer.
59 . The device of claim 57 wherein the electrically controlled element includes a bimetallic strip.
60 . The device of claim 57 wherein the electrically controlled element includes a resistive element.
61 . The device of claim 57 wherein the electrically controlled element includes an electromechanical actuator.
62 . The device of claim 48 wherein the active component comprises a magnetically controlled element that changes shape corresponding to a change in magnetic field.
63 . The device of claim 62 wherein the magnetic field is an external magnetic field.
64 . The device of claim 62 wherein the magnetic field is an internal magnetic field.
65 . The device of claim 62 wherein the magnetically controlled element includes a magnetostriction element.
66 . The device of claim 65 wherein the magnetostriction element comprises Terfenol.
67 . The device of claim 48 wherein the active component comprises a chemically controlled element that changes shape corresponding to a change in local chemistry.
68 . The device of claim 67 wherein the change is local chemistry is caused by a chemical reaction.
69 . The device of claim 68 wherein the chemical reaction causes swelling of the active component.
70 . The device of claim 68 wherein the chemical reaction causes a change in stiffness of the active component.
71 . The device of claim 70 wherein the change is local chemistry is caused by a change in chemical concentration.
72 . The device of claim 68 wherein the change in chemical concentration causes swelling of the active component.
73 . The device of claim 70 wherein the change in chemical concentration causes a change in stiffness of the active component.
74 . The device of claim 48 wherein the active component comprises a thermally controlled element that changes shape corresponding to a change in temperature.
75 . The device of claim 74 wherein the thermally controlled element includes regions having different coefficients of thermal expansion.
76 . The device of claim 48 wherein the active component comprises a thermally controlled element that changes mechanical properties corresponding to changes in temperature.
77 . The device of claim 48 wherein the active component comprises a thermally controlled element that changes material phase corresponding to changes in temperature.
78 . The device of claim 1 wherein the payload is selected from the group consisting of a diagnostic tool, ultrasound transducer (IVUS), pressure transducer, infrared sensor, and endoscope lens.
79 . The device of claim 1 wherein the payload is selected from the group consisting of a therapeutic device, a stent, an atherectomy device, brachytherapy source, herniated or focal bump balloon, injection needle, laser, and thermal cauterization device.
80 . In combination, the device of claim 1 positioned over a wire member having a length, wherein the wire member has a bendable section at a preselected location along the wire member length.
81 . The device of claim 1 wherein the orienting member is a tube having a plastically deformable material embedded on or within the tube walls in preselected regions to impart curvature in the orienting member.
82 . The device of claim 1 wherein the curved shape of the orienting member is effected by the manual placement or displacement of a shaped member within the orienting member.
83 . In combination, the device of claim 82 positioned over a wire member having a length, wherein the wire member has a bendable section at a preselected location along the wire member length.
84 . A device for carrying a medical implant, optionally, a stent, to a bifurcated vessel of a patient, comprising:
a guidewire entry port,
an intralumenal element sized and dimensioned to travel to the bifurcated vessel, the intralumenal element having proximal and a distal end portions;
a lumen positioned within the intralumenal element in communication with the guidewire port;
a guidewire exit port;
a guidewire passing into the guidewire entry port and out of the guidewire exit port and extending distally beyond the device;
a orienting element positioned on the distal end of the intralumenal element, wherein the orienting member exhibits a curved shape and being configured to rotate relative to the bifurcated vessel;
a medical implant positioned over the intralumenal element or a portion of the orienting member, wherein the rotation of the orienting member orients the medical implant towards the target location for deployment at the site of bifurcation.
85 . A method for orienting a payload carried by a elongate intralumenal member to a location of interest relative to a non-linear path in a body lumen, the intralumenal member having proximal and distal end portions and an orienting member positioned along the distal end portion, comprising:
determining the anatomy of the non-linear path in the body lumen;
imparting a curvature to the orienting member that approximately corresponds to the anatomy of the non-linear path in the body lumen, the curvature being positioned relative to the payload to orient the payload in a desired position;
advancing the intralumenal member such that the curvature of the orienting member aligns with the curvature of the non-linear path in the body lumen, orienting the payload into the desired position.
86 . The method of claim 85 wherein the step of determining the anatomy of the non-linear path in the body lumen comprises:
intraluminally advancing guidewire through the non-linear path in the body lumen; and
observing the curvature taken by the guidewire.
87 . The method of claim 86 wherein the step of observing the curvature taken by the guidewire comprises visualizing the guidewire using fluoroscopic imaging equipment.
88 . A method of performing a medical procedure on a patient comprising the steps of:
inserting the device of claim 1 in a conduit within a patient;
moving the device to a site of diagnosis or therapy;
permitting the device to orient into position within the conduit;
deploying a payload to effect the diagnosis or therapy; and
removing the device from the patient.