US20070293724A1
Active / In Force
US
⏱️ 0.6 years remaining
Visualization apparatus for transseptal access
Assignee: Intuitive Surgical Operations Inc
•
Filing: 2007-06-14
•
Granted: —
•
Expires: 2027-06-14
Abstract
Abstract Visualization apparatus and methods for transseptal access are described herein where intravascular access across a septal wall is facilitated via devices which provide for direct visual viewing of tissue area. Such a system may include a deployment catheter and an attached imaging hood deployable into an expanded configuration. In use, the imaging hood is placed against or adjacent to the tissue to be imaged in a body lumen that is normally filled with an opaque bodily fluid such as blood. A translucent or transparent fluid can be pumped into the imaging hood until the fluid displaces any blood leaving a clear region of tissue to be imaged via an imaging element in the deployment catheter. Any number of therapeutic tools or a guidewire can be passed through the catheter and into the imaging hood for crossing the septal wall and passing the guidewire or instruments therethrough.
Inventors
- 👤 Vahid Saadat
- 👤 Amir Abolfathi
- 👤 Chris Rothe
- 👤 Kevin Van Bladel
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 12:45
CPC Classifications
A; A61; A61B; A61B1/00; A61B1/00064; A61B1/00071; A61B1/0008; A61B1/00089; A61B1/00082; A61B1/00085; A61B1/005; A61B1/012; A61B1/015; A61B1/018; A61B1/04; A61B1/313; A61B1/3137; A61B5/00; A61B5/02; A61B5/02007; A61B8/00; A61B8/12; A61B8/44; A61B8/4444; A61B8/4472
Claims Analysis
Total Claims: 93
Claim 1
Independent Claim
94 words
1 . A tissue imaging and treatment system, comprising: a deployment catheter defining at least one lumen therethrough; a barrier or membrane projecting distally from the deployment catheter and defining an open area therein, wherein the open area is in fluid communication with the at least one lumen; a visualization element disposed within or along the barrier or membrane for visualizing tissue adjacent to the open area; and a piercing instrument translatable through the barrier or membrane and beyond the open area for piercing into or through the tissue adjacent to the open area.
Claim 2
Dependent Claim
94 words
1 . A tissue imaging and treatment system, comprising: a deployment catheter defining at least one lumen therethrough; a barrier or membrane projecting distally from the deployment catheter and defining an open area therein, wherein the open area is in fluid communication with the at least one lumen; a visualization element disposed within or along the barrier or membrane for visualizing tissue adjacent to the open area; and a piercing instrument translatable through the barrier or membrane and beyond the open area for piercing into or through the tissue adjacent to the open area.
Claim 3
Dependent Claim
19 words
2 . The system of claim 1 further comprising a delivery catheter through which the deployment catheter is deliverable.
Claim 4
Dependent Claim
13 words
3 . The system of claim 1 wherein the deployment catheter is steerable.
Claim 5
Dependent Claim
19 words
4 . The system of claim 3 wherein the deployment catheter is steered via pulling at least one wire.
Claim 6
Dependent Claim
16 words
5 . The system of claim 3 wherein the deployment catheter is steered via computer control.
Claim 7
Dependent Claim
18 words
6 . The system of claim 1 wherein the barrier or membrane is comprised of a compliant material.
Claim 8
Dependent Claim
22 words
7 . The system of claim 1 wherein the barrier or membrane defines a contact edge for placement against a tissue surface.
Claim 9
Dependent Claim
27 words
8 . The system of claim 1 wherein the barrier or membrane is adapted to be reconfigured from a low-profile delivery configuration to an expanded deployed configuration.
Claim 10
Dependent Claim
21 words
9 . The system of claim 8 wherein the barrier or membrane is adapted to self-expand into the expanded deployed configuration.
Claim 11
Dependent Claim
23 words
10 . The system of claim 8 wherein the barrier or membrane comprises one or more support struts along the barrier or membrane.
Claim 12
Dependent Claim
15 words
11 . The system of claim 1 wherein the barrier or membrane is conically shaped.
Claim 13
Dependent Claim
22 words
12 . The system of claim 1 wherein the visualization element comprises at least one optical fiber, CCD imager, or CMOS imager.
Claim 14
Dependent Claim
21 words
13 . The system of claim 1 wherein the visualization element is disposed within a distal end of the deployment catheter.
Claim 15
Dependent Claim
23 words
14 . The system of claim 1 wherein the visualization element is articulatable off-axis relative to a longitudinal axis of the deployment catheter.
Claim 16
Dependent Claim
19 words
15 . The system of claim 1 further comprising a fluid reservoir fluidly coupled to the barrier or membrane.
Claim 17
Dependent Claim
18 words
16 . The system of claim 15 wherein the fluid reservoir comprises a syringe or pressurized fluid bag.
Claim 18
Dependent Claim
17 words
17 . The system of claim 15 wherein the fluid comprises saline, plasma, water, or perfluorinated liquid.
Claim 19
Dependent Claim
26 words
18 . The system of claim 1 wherein the piercing instrument comprises a flexible shaft having a needle tip upon a distal end of the shaft.
Claim 20
Dependent Claim
20 words
19 . The system of claim 1 wherein the piercing instrument comprises a flexible shaft having a tapered distal end.
Claim 21
Dependent Claim
15 words
20 . The system of claim 1 wherein the piercing instrument defines a lumen therethrough.
Claim 22
Dependent Claim
19 words
21 . The system of claim 20 further comprising a guidewire which is advanceable through the piercing instrument lumen.
Claim 23
Dependent Claim
27 words
22 . The system of claim 1 wherein the piercing instrument further comprises a tissue engager proximal to or at a distal end of the piercing instrument.
Claim 24
Dependent Claim
14 words
23 . The system of claim 22 wherein the tissue engager comprises helical threading.
Claim 25
Dependent Claim
28 words
24 . The system of claim 1 wherein the piercing instrument comprises a Veres-type piercing needle having a retractable blunt tip positioned through a lumen of the needle.
Claim 26
Dependent Claim
28 words
25 . The system of claim 1 further comprising a tissue engager translatable through the barrier or membrane and beyond the open area adjacent to the piercing instrument.
Claim 27
Dependent Claim
20 words
26 . The system of claim 25 wherein the tissue engager comprises a helical engager disposed upon a flexible shaft.
Claim 28
Dependent Claim
15 words
27 . The system of claim 25 wherein the tissue engager defines a lumen therethrough.
Claim 29
Dependent Claim
14 words
28 . The system of claim 25 wherein the tissue engager comprises a grasper.
Claim 30
Dependent Claim
27 words
29 . The system of claim 1 further comprising an inflatable balloon which is expandable within or distal to the open area of the barrier or membrane.
Claim 31
Dependent Claim
25 words
30 . The system of claim 29 wherein the inflatable balloon comprises a transparent membrane through which the visualization element can image the adjacent tissue.
Claim 32
Dependent Claim
19 words
31 . The system of claim 1 further comprising an introducer sheath through which the deployment catheter is advanceable.
Claim 33
Dependent Claim
33 words
32 . The system of claim 31 wherein a distal portion of the introducer sheath is curved or pre-bent such that the distal portion is angled relative a longitudinal axis of the sheath.
Claim 34
Dependent Claim
35 words
33 . The system of claim 1 wherein the barrier or membrane further comprises at least one transparent distal membrane disposed upon the distal end of the barrier or membrane and over the open area.
Claim 35
Dependent Claim
20 words
34 . The system of claim 33 wherein the distal membrane defines an aperture positioned coaxially with the deployment catheter.
Claim 36
Dependent Claim
18 words
35 . The system of claim 34 wherein the aperture has a diameter of at least 1 mm.
Claim 37
Dependent Claim
16 words
36 . The system of claim 33 wherein the distal membrane defines a plurality of apertures.
Claim 38
Dependent Claim
38 words
37 . The system of claim 36 wherein the plurality of apertures are adapted to adjust from a first diameter to a second diameter which is smaller than the first diameter upon increased pressure within the distal membrane.
Claim 39
Dependent Claim
19 words
38 . The system of claim 33 wherein the distal membrane defines a plurality of slits over its surface
Claim 40
Dependent Claim
19 words
39 . The system of claim 1 wherein the barrier or membrane defines a guidewire lumen along its surface.
Claim 41
Dependent Claim
24 words
40 . The system of claim 1 wherein the deployment catheter defines a guidewire lumen along its surface proximal to the barrier or membrane.
Claim 42
Dependent Claim
37 words
41 . The system of claim 1 wherein the piercing instrument defines at least one visual indicator along its outer surface to provide a direct indication of instrument position relative to the adjacent tissue when pierced therein.
Claim 43
Dependent Claim
23 words
42 . The system of claim 41 wherein the at least one visual indicator comprises a plurality of colors signifying relative instrument position.
Claim 44
Dependent Claim
90 words
43 . A method for intravascularly accessing a body lumen, comprising: positioning an open area of a barrier or membrane projecting distally from a deployment catheter against or adjacent to a region of tissue to be imaged; pumping a translucent fluid into the barrier or membrane via the deployment catheter such that an opaque fluid is displaced from the barrier or membrane; visualizing the region of tissue through the translucent fluid; and piercing into or through the region of tissue to access a body lumen beyond the region of tissue.
Claim 45
Dependent Claim
90 words
43 . A method for intravascularly accessing a body lumen, comprising: positioning an open area of a barrier or membrane projecting distally from a deployment catheter against or adjacent to a region of tissue to be imaged; pumping a translucent fluid into the barrier or membrane via the deployment catheter such that an opaque fluid is displaced from the barrier or membrane; visualizing the region of tissue through the translucent fluid; and piercing into or through the region of tissue to access a body lumen beyond the region of tissue.
Claim 46
Dependent Claim
32 words
44 . The method of claim 43 wherein positioning an open area of a barrier or membrane comprises advancing the barrier or membrane intravascularly into a right atrial chamber of a heart.
Claim 47
Dependent Claim
33 words
45 . The method of claim 43 wherein positioning an open area of a barrier or membrane comprises deploying the barrier or membrane from a low-profile delivery configuration into an expanded deployed configuration.
Claim 48
Dependent Claim
30 words
46 . The method of claim 43 wherein positioning an open area of a barrier or membrane comprises stabilizing a position of the barrier or membrane relative to the tissue.
Claim 49
Dependent Claim
36 words
47 . The method of claim 43 further comprising positioning an introducer sheath into a right atrial chamber and advancing the barrier or membrane therethrough prior to positioning an open area of a barrier or membrane.
Claim 50
Dependent Claim
33 words
48 . The method of claim 47 wherein positioning an introducer sheath comprises positioning a sheath having a curved or pre-bent distal portion angled towards a septal wall into the right atrial chamber.
Claim 51
Dependent Claim
34 words
49 . The method of claim 47 wherein positioning an introducer sheath comprises positioning a sheath having a curved or pre-bent distal portion angled away from a septal wall into the right atrial chamber.
Claim 52
Dependent Claim
27 words
50 . The method of claim 43 wherein positioning an open area of a barrier or membrane comprises steering the deployment catheter to the region of tissue.
Claim 53
Dependent Claim
31 words
51 . The method of claim 43 wherein positioning an open area of a barrier or membrane comprises positioning the barrier or membrane against or adjacent to an atrial septal wall.
Claim 54
Dependent Claim
18 words
52 . The method of claim 51 further comprising visualizing a first location along the atrial septal wall.
Claim 55
Dependent Claim
23 words
53 . The method of claim 52 further comprising moving the barrier or membrane along the atrial septal wall while visualizing the tissue.
Claim 56
Dependent Claim
21 words
54 . The method of claim 53 further comprising obtaining visual confirmation of a suitable location along the atrial septal wall.
Claim 57
Dependent Claim
32 words
55 . The method of claim 43 wherein pumping a translucent fluid comprises pumping the translucent fluid into the barrier or membrane through a fluid delivery lumen defined through the deployment catheter.
Claim 58
Dependent Claim
35 words
56 . The method of claim 43 wherein pumping a translucent fluid comprises pumping saline, plasma, water, or perfluorinated liquid into the barrier or membrane such that blood is displaced from the barrier or membrane.
Claim 59
Dependent Claim
32 words
57 . The method of claim 43 further comprising expanding an inflatable balloon within or distal to the open area prior and visualizing the tissue therethrough prior to pumping a translucent fluid.
Claim 60
Dependent Claim
41 words
58 . The method of claim 43 wherein pumping a translucent fluid comprises partially retaining the fluid within the open area via at least one transparent distal membrane disposed at least partially over a distal end of the barrier or membrane.
Claim 61
Dependent Claim
28 words
59 . The method of claim 58 wherein partially retaining the fluid comprises allowing the fluid to leak through at least one aperture defined through the distal membrane.
Claim 62
Dependent Claim
43 words
60 . The method of claim 43 wherein visualizing the region of tissue comprises moving an imaging element from a distal position exterior to the barrier or membrane to a proximal position within or along an interior surface of the barrier or membrane.
Claim 63
Dependent Claim
33 words
61 . The method of claim 43 wherein visualizing the region of tissue comprises viewing the tissue via an imaging element positioned off-axis relative to a longitudinal axis of the barrier or membrane.
Claim 64
Dependent Claim
32 words
62 . The method of claim 43 further comprising temporarily stabilizing the region of tissue relative to the barrier or membrane via a tissue engagement instrument advanced through the barrier or membrane.
Claim 65
Dependent Claim
34 words
63 . The method of claim 43 further comprising drawing a portion of the tissue into the open area of the barrier or membrane prior to piercing into or through the region of tissue.
Claim 66
Dependent Claim
29 words
64 . The method of claim 43 further comprising passing a guidewire through a lumen defined through a piercing instrument into the body lumen beyond the region of tissue.
Claim 67
Dependent Claim
34 words
65 . The method of claim 64 further comprising removing the piercing instrument and barrier or membrane from the region of tissue such that the guidewire is left within the tissue and body lumen.
Claim 68
Dependent Claim
124 words
66 . A method for intravascularly accessing a body lumen, comprising: positioning an open area of a barrier or membrane projecting distally from a deployment catheter against or adjacent to a region of tissue to be imaged; pumping a translucent fluid into the barrier or membrane via the deployment catheter such that an opaque fluid is displaced from the barrier or membrane; visualizing the region of tissue through the translucent fluid; piercing into or through the region of tissue to access a body lumen beyond the region of tissue; and, monitoring a visualization field within the open area of the barrier or membrane for presence of opaque fluid seepage therewithin as indicative of excess distortion of the region of tissue by a piercing instrument.
Claim 69
Dependent Claim
124 words
66 . A method for intravascularly accessing a body lumen, comprising: positioning an open area of a barrier or membrane projecting distally from a deployment catheter against or adjacent to a region of tissue to be imaged; pumping a translucent fluid into the barrier or membrane via the deployment catheter such that an opaque fluid is displaced from the barrier or membrane; visualizing the region of tissue through the translucent fluid; piercing into or through the region of tissue to access a body lumen beyond the region of tissue; and, monitoring a visualization field within the open area of the barrier or membrane for presence of opaque fluid seepage therewithin as indicative of excess distortion of the region of tissue by a piercing instrument.
Claim 70
Dependent Claim
41 words
67 . The method of claim 66 wherein pumping a translucent fluid comprises partially retaining the fluid within the open area via at least one transparent distal membrane disposed at least partially over a distal end of the barrier or membrane.
Claim 71
Dependent Claim
34 words
68 . The method of claim 66 further comprising drawing a portion of the tissue into the open area of the barrier or membrane prior to piercing into or through the region of tissue.
Claim 72
Dependent Claim
33 words
69 . The method of claim 66 wherein monitoring a visualization field comprises determining whether a color change of the translucent fluid occurs within the open field by dilution the opaque fluid therein.
Claim 73
Dependent Claim
38 words
70 . The method of claim 66 wherein opaque fluid seepage within the open area of the barrier or membrane is indicative of a seal between the barrier or membrane and the underlying region of tissue being broken.
Claim 74
Dependent Claim
118 words
71 . A tissue imaging and treatment system for imaging a surface of a tissue within a heart, the heart having a chamber, the chamber including a tissue surface and containing blood, the system comprising: a catheter body having a lumen; a visualization element disposed adjacent the catheter body, the visualization element having a field of view; a translucent fluid source in fluid communication with the lumen; and a barrier or membrane extendable from the catheter body to localize, between the visualization element and the field of view, displacement of blood by translucent fluid that flows from the lumen; a piercing instrument translatable through the displaced blood for piercing into the tissue surface within the field of view.
Claim 75
Dependent Claim
118 words
71 . A tissue imaging and treatment system for imaging a surface of a tissue within a heart, the heart having a chamber, the chamber including a tissue surface and containing blood, the system comprising: a catheter body having a lumen; a visualization element disposed adjacent the catheter body, the visualization element having a field of view; a translucent fluid source in fluid communication with the lumen; and a barrier or membrane extendable from the catheter body to localize, between the visualization element and the field of view, displacement of blood by translucent fluid that flows from the lumen; a piercing instrument translatable through the displaced blood for piercing into the tissue surface within the field of view.
Claim 76
Dependent Claim
63 words
72 . The system of claim 71 wherein the membrane or barrier is disposed about an open area between the visualization element and the field of view, the fluid source configured to inject translucent fluid so as to displace the blood from the open area sufficiently to allow optical imaging of the tissue surface though the open area while the heart is beating.
Claim 77
Dependent Claim
34 words
73 . The system of claim 72 wherein the membrane is expandable from a low-profile delivery configuration to an expanded configuration to encompass an imaged tissue surface larger than a cross-section of the catheter.
Claim 78
Dependent Claim
23 words
74 . The system of claim 73 further comprises a frame supporting the membrane outside of the open area in the expanded configuration.
Claim 79
Dependent Claim
25 words
75 . The system of claim 74 wherein the frame comprises a shape memory alloy, and wherein the visualization element is supported by the frame.
Claim 80
Dependent Claim
60 words
76 . The system of claim 71 wherein the barrier or membrane comprises a hood, the barrier or membrane having a contact edge surrounding an aperture adjacent the field of view so that, during use, translucent fluid from the lumen is released into the chamber of the heart through the aperture, wherein the piercing instrument is translatable through the aperture.
Claim 81
Dependent Claim
52 words
77 . The system of claim 71 wherein the membrane comprises a balloon, the piercing instrument oriented to pass through the membrane of the balloon at a membrane penetration site so that, during use, translucent fluid from the lumen is released into the chamber of the heart through the membrane penetration site.
Claim 82
Dependent Claim
41 words
78 . The system of claim 71 wherein the barrier or membrane has an inner surface and an outer surface, a volume disposed within the inner surface being greater than a volume disposed between the inner surface and the outer surface.
Claim 83
Dependent Claim
62 words
79 . The system of claim 71 wherein the catheter body is included in a steerable catheter, the steerable catheter having an elongate proximal portion and an articulable section adjacent the barrier, the steerable section comprising a plurality of links and steerable from a proximal end of the proximal portion so as to impose a smooth axial curvature on the catheter body.
Claim 84
Dependent Claim
53 words
80 . The system of claim 71 wherein the catheter body has a working lumen slidably receiving the piercing instrument, a lumen for receiving a steering element to laterally deflect the catheter body, a translucent fluid flow lumen, and an image conduit for transmitting images of the tissue surface from the visualization element.
Claim 85
Dependent Claim
42 words
81 . The system of claim 71 further comprising an intracardiac introducer sheath having a lumen for receiving, from outside the patient body, the catheter body, visualization element, and barrier, the sheath lumen configured to extend into the chamber of the heart.
Claim 86
Dependent Claim
19 words
82 . The system of claim 71 wherein the piercing instrument comprising a trans-septal needle or trans-septal access sheath.
Claim 87
Dependent Claim
84 words
83 . A method for accessing a left atrium of a heart via a septum of the heart, the method comprising: introducing a fluid into a right atrium of the heart; confining the fluid, during beating of the heart, so that blood is displaced sufficiently to allow visualization through the fluid of a surface region of the septum; under guidance of the visualization of the surface region through the fluid, piercing through a safe trans-septal access site within the surface region of the septum.
Claim 88
Dependent Claim
84 words
83 . A method for accessing a left atrium of a heart via a septum of the heart, the method comprising: introducing a fluid into a right atrium of the heart; confining the fluid, during beating of the heart, so that blood is displaced sufficiently to allow visualization through the fluid of a surface region of the septum; under guidance of the visualization of the surface region through the fluid, piercing through a safe trans-septal access site within the surface region of the septum.
Claim 89
Dependent Claim
79 words
84 . The method of claim 83 wherein the fluid comprises a translucent fluid, and further comprising: introducing a barrier or membrane into the right atrium; expanding the barrier or membrane within the right atrium, wherein the fluid is confined by the expanded barrier or membrane adjacent the surface region of the septum; and moving the confined fluid from a first portion of the septum to a second portion of the septum to identify the safe trans-septal access site.
Claim 90
Dependent Claim
37 words
85 . The method of claim 84 further comprising optically identifying, from along the septum, two or three member selected from a group comprising a limbus of a fossa ovalis, the fossa ovalis, and/or a coronary sinus.
Claim 91
Dependent Claim
28 words
86 . The method of claim 84 further comprising penetrating through the septum at the fossa ovalis while visualizing a surface of the fossa ovalis through the fluid.
Claim 92
Dependent Claim
29 words
87 . The method of claim 83 further comprising optically imaging tenting of the surface of the septum through the fluid while advancing a piercing instrument into the septum.
Claim 93
Dependent Claim
27 words
88 . The method of claim 83 further comprising deflecting a catheter body away from the septum and curving the catheter body back toward the surface region.
References Cited (Backward Citations)
No citation records indexed.
USPTO Annuity & Maintenance Windows
Maintenance schedule is calculated for granted US utility patents.