WO2008021437A2 - Infrared side imaging of cardiovascular structures and indwelling medical devices - Google Patents
Infrared side imaging of cardiovascular structures and indwelling medical devices Download PDFInfo
- Publication number
- WO2008021437A2 WO2008021437A2 PCT/US2007/018145 US2007018145W WO2008021437A2 WO 2008021437 A2 WO2008021437 A2 WO 2008021437A2 US 2007018145 W US2007018145 W US 2007018145W WO 2008021437 A2 WO2008021437 A2 WO 2008021437A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- catheter
- prism
- mirror
- viewing
- light
- Prior art date
Links
- 238000003384 imaging method Methods 0.000 title claims description 14
- 230000002526 effect on cardiovascular system Effects 0.000 title abstract description 5
- 210000003748 coronary sinus Anatomy 0.000 description 16
- 210000003709 heart valve Anatomy 0.000 description 8
- 230000002792 vascular Effects 0.000 description 7
- 238000000034 method Methods 0.000 description 6
- 230000000747 cardiac effect Effects 0.000 description 4
- 238000002399 angioplasty Methods 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 210000002216 heart Anatomy 0.000 description 3
- 230000000250 revascularization Effects 0.000 description 3
- 238000007790 scraping Methods 0.000 description 3
- 210000001367 artery Anatomy 0.000 description 2
- 230000002238 attenuated effect Effects 0.000 description 2
- 230000001010 compromised effect Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- 206010070693 Vascular dissection Diseases 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000001746 atrial effect Effects 0.000 description 1
- 230000002308 calcification Effects 0.000 description 1
- 210000005242 cardiac chamber Anatomy 0.000 description 1
- 210000000748 cardiovascular system Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 210000004351 coronary vessel Anatomy 0.000 description 1
- 238000001804 debridement Methods 0.000 description 1
- 210000003743 erythrocyte Anatomy 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 230000004313 glare Effects 0.000 description 1
- 230000010247 heart contraction Effects 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 238000003331 infrared imaging Methods 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000007505 plaque formation Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 208000037803 restenosis Diseases 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
- A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
- A61B5/0086—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters using infrared radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0033—Features or image-related aspects of imaging apparatus classified in A61B5/00, e.g. for MRI, optical tomography or impedance tomography apparatus; arrangements of imaging apparatus in a room
- A61B5/004—Features or image-related aspects of imaging apparatus classified in A61B5/00, e.g. for MRI, optical tomography or impedance tomography apparatus; arrangements of imaging apparatus in a room adapted for image acquisition of a particular organ or body part
- A61B5/0044—Features or image-related aspects of imaging apparatus classified in A61B5/00, e.g. for MRI, optical tomography or impedance tomography apparatus; arrangements of imaging apparatus in a room adapted for image acquisition of a particular organ or body part for the heart
Abstract
Disclosed is a infrared imager which views out of the side of the catheter at various angles depending on the application. This is accomplished by placing a prism or mirror near or at the distal end of the catheter to direct the light in an angular direction. The mirror/prism the catheter can be rotated to view the full 360 deg. angle of the cardiovascular structure. Alternatively, the prism/mirror itself could be rotated by manipulating a wire on the proximal end of the catheter which is connected to the prism or mirror internal in the catheter. In a similar manner, the prism/mirror angle could also be changed by manipulation of the proximal end of the wire.
Description
Description of Invention Prior Art
Previously disclosed in US Patent 6,178,346 is an infrared imager which views cardiovascular structures and indwelling medical devices in the forward direction centered on the axis of the catheter. While this approach has been used successfully with visible light endoscopes, the turbulence of catheters in the cardiovascular system and the absorptive nature of infrared light result in considerable motion artifact and diminution of contrast at the periphery of the image.
An infrared endoscope placed in the heart will experience "whip" caused by the vigorous heart contraction. This is exacerbated by the imaging element being placed on the end of the catheter as disclosed in US Patent 6,178,346, where the whip is greatest. Catheter motion results in image instability and sometimes image smearing making it difficult to recognize cardiovascular structures. Active movement of the catheter also adds to image instability in the heart.
Unlike a visible light endoscope, infrared images are governed by the absorptive nature of infrared light. Light is attenuated in the wavelength region 1550-1800 nm by exp(4*distance in cm). At the image periphery, less light is generated and this light is attenuated significantly resulting in insufficient contrast at the image periphery as compared to the image center. This occurs since the auto-gain function adjusts to the highest signal amplitude available which is at the center of the image. The periphery, which is at a lower intensity appears with less contrast
In the heart, catheters tend to be scraped along the chamber walls. In this orientation a forward- vie wing catheter is imaging parallel to the surface of the chamber rather than imaging the chamber wall directly. For example, when viewing the coronary sinus (CS), a forward-viewing catheter needs to be perpendicular to the CS to view the CS in the center of the image where the contrast is greatest. In this position, the catheter experiences significant whip making recognition of the CS difficult.
In the vascular tree, a forward-viewing infrared catheter is viewing down the lumen of the vein/artery and the vascular wall is only visible at the image periphery where contrast is the least. To view the wall in the center of the image with a forward- viewing infrared catheter, the catheter would need to be articulated which is dangerous because of the possibility of vascular dissection or dislodging the plaque which is attempted to be imaged. In a similar manner, viewing indwelling medical devices such as a stent is greatly compromised by a forward-viewing infrared catheter. In this case the stent would only appear on the image periphery and observation of such things as stent apposition to the vascular wall or the presence of flaps the stent boundary would be significantly compromised.
Viewing heart valves is also difficult with a forward-viewing infrared catheter. When a forward-viewing infrared catheter is placed perpendicular to the heart valve, the whip is considerable coupled with the difficulty of centering the catheter and viewing the leaflets and. the valve annulus in the presence of such motion. This limits the therapeutic possibilities available despite imaging the heart valve. More desirable would be a catheter which is stable with respect to the annulus or leaflets of the heart valve. In that setting, annulus reduction and leaflet repair could be much more easily accomplished.
Invention Summary
Disclosed is a novel infrared imager which views out of the side of the catheter at various angles depending on the application. This is accomplished by placing a prism or mirror near or at the distal end of the catheter to direct the light in an angular direction. The mirror/prism The catheter can be rotated to view the full 360 deg. angle of the cardiovascular structure. Alternatively, the prism/mirror itself could be rotated by manipulating a wire on the proximal end of the catheter which is connected to the prism or mirror internal in the catheter. In a similar manner, the prism/mirror angle could also be changed by manipulation of the proximal end of the wire.
For vascular imaging, viewing at approximately a 90 deg relative to the catheter axis would be desirable since the vessel wall would be in the center of the image, resulting in stable high-contrast images of the vascular wall. Indwelling medical devices, such as stents, would be viewed directly in the image center and apposition to the vessel wall and the presence of flaps could be readily identified. In the case of heart valves, viewing at an oblique angle (e.g. 100-150 deg) relative to the catheter axis would be desirable since this would permit stable viewing of the annulus and leaflets with the distal end of the catheter placed through the valve to increase stability.
Figures
1. A schematic drawing of the side imager showing light directed at a 90 deg angle through a mirror at the distal end
2. The side imager incorporated in a glare-reducing hood with the light emanating from the oval inside the catheter hood
3. The catheter with a side imager shown scraping across the RA septum to image the CS
4. The catheter with a side imager inside a vessel to image the vessel walls at a 90 deg angle
5. The catheter with a side imager inside a heart valve with the distal end through the heart valve to image the annulus at an oblique angle greater than 90 deg.
6. The catheter with a side imager inside a sheath which permits the catheter to be easily rotated within the sheath to permit 360 deg angle viewing
7. The catheter with a side imager where the prism/mirror is connected to a wire which exits the catheter proximal end and can be rotated to rotate the prism/mirror or change the prism/mirror angle .
Detailed Embodiments
This device operates with the infrared imaging system as described in US Patent 6,178,346. The imaging system has been modified through the use of a prism/mirror which directs both illumination and returned reflected light at various angles to permit viewing on the side of the catheter. Figure 1 shows the schematic drawing of the concept. The catheter body (1) contains a prism or mirror (3) which directs the
incoming light (2) in an angular direction (4) out of the side of the catheter. While the angle is shown at 90 deg in Fig 1, the prism/mirror could be angled to direct the light in a range of angles from acute to oblique.
Figure 2 shows a catheter (1) with a hood (5) designed to spread the light over a broader surface area as discussed in US Patent 6,178,346. The hood is a hemispheric dome which is transparent to infrared light. The hood spreads the light into a greater surface area thereby reducing glare caused from scattering by the red blood cells. In US Patent 6, 178,346, the light is transmitted through the front of the hood where it reflects off a cardiac structure and the reflected light enters an imaging bundle positioned along the catheter axis. As such, the catheter images in the forward direction centered on the catheter axis. Unlike US Patent 6,178,346, the catheter shown in figure 2 has a prism/mirror (3) inside the hood which directs the light out of the side of the hood in an elliptical or circular pattern (6) out of the hood. As the outgoing light is reflected of a cardiac structure the returned light enters the hood and reflects off the prism/mirror to enter the imaging bundle and register an image.
The advantages of this approach in imaging cardiac structures is that when a physician is scraping along a cardiac chamber wall, instead of imaging tangential to the wall, it is imaging the wall directly in the image center where contrast is greatest. Figure 3 shows a catheter (1) scraping along right atrial septal wall (8) where the CS (7) is located. With a conventional forward-viewing catheter, the CS would only appear as a "sliver" on the image periphery and its recognition in question. This catheter, however, incorporates a prism (3) which directs the light at an angle out of the side of the hood. The physician would rotate the catheter so that tissue features appeared in the image, and then scrape along the septal wall until the CS appeared near the image center. The prism could direct the light at 90 deg which would create the greatest contrast image of the CS, or an oblique angle could be used to image the CS prior to arriving directly over it. This approach is more suited to cannulating the CS. As the CS appeared, the catheter could be articulated to permit entry into the CS. Alternatively, the catheter could have a fixed small curve on the distal end, curving
toward the side-viewing window. As the CS is imaged, the fixed-curve would naturally direct the catheter into the CS.
Figure 4 shows the catheter (1) inside a vein/artery (8) such as a coronary artery. In coronary revascularization procedures, devices are slid over a guidewire, which is placed first across the lesion. In this application, the side- viewing catheter (1) is slid over an indwelling guidewire (9) to view the vascular wall. The entire circumference of the vascular wall can be imaged by rotating the catheter (1) over the guidewire (9). Rotation could be done manually by the physiican turning the catheter (1) over the guidewire (9) or it could be connected to rotational drive mechanism to automate the rotation.
The benefit to arterial revascularization procedures would not only include viewing plaque directly but also in assessing the deployment of a stent. Once the guidewire (9) was placed through the plaque region (15), the side-viewing catheter could be inserted over the guidewire and advanced and rotated until the plaque (15) was imaged. Incoming light (2) is redirected by the prism/mirror (3) to direct the light in an angular direction (4) to observe the plaque region. Plaque imaging is useful, since it provides information about the nature (calcified or gelatinous) and the extent of the plaque formation. This information would suggest the optimal revascularization strategy (atherectomy or angioplasty) as well as stent length. After viewing the plaque, the side-viewing catheter is removed and replaced with an angioplasty catheter with a stent oVer the distal end.
Following application of the stent, the side- viewing catheter could again be inserted over the guidewire to evaluate stent placement. The catheter could be advanced and rotated to view the entire circumference of the stent, permitting the evaluation of the stent apposition to the arterial wall. Gaps in the stent-arterial wall are a nidas point for stent restenosis, particularly with drug eluting stents, since the drug would not be applied to the arterial wall in gap regions. If the stent appostion is insufficient, the
angioplasty catheter could be reapplied with greater pressure to improve stent appostion.
In addition, the proximal and distal ends of the stent could be evaluated to see if the stent length is sufficient to encompass all of the plaque information. Also the presence of flaps could be assessed at the stent boundaries. Either of these conditions is correctable by employing another stent to extend the stented region.
Figure 5 shows the side-viewing catheter (1) inserted into a heart valve (9). In this application, the side-viewing catheter now has the incoming light (2) directed by the prism/mirror into an oblique angle (4). This side- viewing catheter has a long distal end which can be placed through the valve to stabilize the catheter. In this application, the physician inserts the distal end of the catheter through the valve and then rotates the catheter to view the entire valve annulus. By advancing/retracting the catheter, individual leaflets could be centered in the infrared image. Valve therapy such as annuloplasty or calcification debridement could be accomplished by employing such a catheter in a dual-lumen sheath with one lumen dedicated for the insertion of tools to perform the procedure. Also a suturing tool could be employed to stitch two leaflets together to provide a percutaneous "butterfly" procedure.
In all the applications, tøiere are several methods of rotating the side- viewing catheter. Figures 6 and 7 show two methods of rotating the catheter to provide 360 deg coverage of a cardiac structure. Figure 6 depicts the catheter (1) inside a lubricious sheath (12). Rotation is accomplished by having the physician manually rotate the catheter within the sheath. Figure 7 shows an internally rotatable system, where a. wire (10) extends down the catheter and is connected to the prism/mirror (3). When the physician rotates the proximal end of the wire (11), it creates a one-to-one rotation of the prism/mirror. In this configuration the 360 deg rotation is accomplished without physically rotating the catheter. This has the advantage of not having catheter rotation displace the catheter position. In a similar manner, the wire could be connected to the prism to instead of rotate the prism/mirror (3), alter its angle. In this
approach, rotating or retracting the proximal end of the wire (11) changes the prism/mirror angle. Ultimate flexibility would be achieved with a system where rotation rotates the prism and retraction/advancement alters the prism/mirror angle.
Claims
1. An imaging catheter having an axis comprising an infrared light source for generating infrared light proximate a distal end of the catheter and means for directing the infrared light at an angle relative to the catheter axis.
2. The device of claim 1 wherein the means for directing include a mirror or a prism.
3. The device of claim 1 wherein the angle is approximately 90 degrees.
4. The device of claim 1 wherein the catheter is capable of being rotated such that it can image 360 degrees.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US83752406P | 2006-08-14 | 2006-08-14 | |
| US60/837,524 | 2006-08-14 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2008021437A2 true WO2008021437A2 (en) | 2008-02-21 |
| WO2008021437A3 WO2008021437A3 (en) | 2008-06-12 |
Family
ID=39082732
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2007/018145 WO2008021437A2 (en) | 2006-08-14 | 2007-08-14 | Infrared side imaging of cardiovascular structures and indwelling medical devices |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2008021437A2 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2485638A2 (en) * | 2009-10-07 | 2012-08-15 | The Board of Regents of The University of Texas System | Pressure-sensing medical devices, systems and methods, and methods of forming medical devices |
| US10315013B2 (en) | 2001-07-13 | 2019-06-11 | Endophys Holdings, Llc | Sheath with sensing capabilities |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6654630B2 (en) * | 2001-05-31 | 2003-11-25 | Infraredx, Inc. | Apparatus and method for the optical imaging of tissue samples |
-
2007
- 2007-08-14 WO PCT/US2007/018145 patent/WO2008021437A2/en active Application Filing
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6654630B2 (en) * | 2001-05-31 | 2003-11-25 | Infraredx, Inc. | Apparatus and method for the optical imaging of tissue samples |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10315013B2 (en) | 2001-07-13 | 2019-06-11 | Endophys Holdings, Llc | Sheath with sensing capabilities |
| US10716921B2 (en) | 2001-07-13 | 2020-07-21 | Endophys Holdings, Llc | Methods of using a dual-lumen sheath in intraluminal procedures |
| EP2485638A2 (en) * | 2009-10-07 | 2012-08-15 | The Board of Regents of The University of Texas System | Pressure-sensing medical devices, systems and methods, and methods of forming medical devices |
| EP2485638A4 (en) * | 2009-10-07 | 2013-04-10 | Univ Texas | Pressure-sensing medical devices, systems and methods, and methods of forming medical devices |
| US9597480B2 (en) | 2009-10-07 | 2017-03-21 | Endophys Holding, LLC | Intraluminal devices and systems |
| US9913959B2 (en) | 2009-10-07 | 2018-03-13 | Endophys Holdings, Llc | Device configured for real-time pressure sensing |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2008021437A3 (en) | 2008-06-12 |
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