WO2008021436A2 - Infrared endoscope for branch selection and cannulation with guidewire - Google Patents
Infrared endoscope for branch selection and cannulation with guidewire Download PDFInfo
- Publication number
- WO2008021436A2 WO2008021436A2 PCT/US2007/018144 US2007018144W WO2008021436A2 WO 2008021436 A2 WO2008021436 A2 WO 2008021436A2 US 2007018144 W US2007018144 W US 2007018144W WO 2008021436 A2 WO2008021436 A2 WO 2008021436A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- catheter
- sheath
- curve
- branch
- guidewire
- Prior art date
Links
- 210000003748 coronary sinus Anatomy 0.000 claims abstract description 37
- 238000003331 infrared imaging Methods 0.000 abstract description 3
- 210000003462 vein Anatomy 0.000 description 21
- 238000002347 injection Methods 0.000 description 11
- 239000007924 injection Substances 0.000 description 11
- 238000000034 method Methods 0.000 description 11
- 210000005166 vasculature Anatomy 0.000 description 6
- 230000000747 cardiac effect Effects 0.000 description 5
- 210000005240 left ventricle Anatomy 0.000 description 5
- 230000003907 kidney function Effects 0.000 description 4
- 210000005245 right atrium Anatomy 0.000 description 4
- 230000002861 ventricular Effects 0.000 description 4
- 230000004048 modification Effects 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 208000001647 Renal Insufficiency Diseases 0.000 description 2
- 238000012790 confirmation Methods 0.000 description 2
- 238000001802 infusion Methods 0.000 description 2
- 201000006370 kidney failure Diseases 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- 208000033988 Device pacing issue Diseases 0.000 description 1
- 102100026827 Protein associated with UVRAG as autophagy enhancer Human genes 0.000 description 1
- 101710102978 Protein associated with UVRAG as autophagy enhancer Proteins 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000002594 fluoroscopy Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 210000003709 heart valve Anatomy 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 210000003492 pulmonary vein Anatomy 0.000 description 1
- 238000007790 scraping Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 210000001631 vena cava inferior Anatomy 0.000 description 1
- 210000002620 vena cava superior Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
-
- 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
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6852—Catheters
- A61B5/6855—Catheters with a distal curved tip
Definitions
- a cardiac structure of great importance in the field of biventricular pacing is the coronary sinus (CS) and its branches.
- CS coronary sinus
- a catheter is inserted into the CS and routed through sub-branches into a branch which is in close proximity to the lateral wall of the left ventricle.
- a pacing lead is inserted into the appropriate sub-branch and connected to a biventricular pacemaker to pace the left ventricle. This procedure is guided by fluoroscopy.
- a variety of sub-branch selection techniques have been developed based on a combination of tactical feel and fluoroscopic information.
- the cannulation device is removed and radioopaque dye is injected into the CS vasculature and the branches deduced from the fluoroscopic image of the dye injection. Since the CS vasculature is a vein, the dye flows back into the right atrium following injection. Once deduced, a guidewire is inserted and navigated through the CS vasculature.
- US Patent 6,178,346, discloses an infrared viewing system for the imaging of cardiac structures. Not discussed in this patent is its role in cannulating CS branches based on the infrared image.
- the infrared catheter showing an approximate 90 deg bend with a guidewire channel and protruding guidewire.
- the branch vein has now been seen on the infrared image and the guidewire has been extended into the branch vein.
- the infrared catheter is tracked over the guidewire to enter the branch vein.
- the sheath is advanced over the catheter so that the sheath and catheter now both reside in the branch vein.
- Figure 4 shows the basic cannulation mechanism of the sheath-catheter.
- Figure 4A shows the sheath (5)-catheter (1) traveling down the great cardiac vein (6) where a branch (7) is present ahead of the infrared catheter (1).
- Figure 4B shows the infrared catheter (1) extended out of the sheath (5) in an opposite direction from the branch vein (7). The infrared catheter (1) is then rotated inside of the sheath until the branch appears on the infrared image.
- Figure 4C shows the infrared catheter (1) pointing in the direction of the branch vein (7).
- Figure 5 A shows the guidewire (3)extended through the guidewire port (4) to cannulate the branch vein (7).
- the infrared catheter (1) is then tracked over the guidewire (3) to enter the branch vein (7).
- Figure 5C shows the sheath (5) tracked over the guidewire (3) so that both sheath (5)and infrared catheter (1) now reside in the branch vein (7).
- Subsequent branch veins are then navigated in the same manner until the infrared catheter resides in the branch vein appropriate for left ventricular pacing. At this point the infrared catheter is removed and a left ventricular pacing lead is placed over the guidewire and tracked to the final branch vein. Once pacing thresholds are established, the guidewire is removed and the sheath slit so that only the pacing lead resides in the candidate branch vein.
- the left ventricular pacing lead is then connected to a biventricular pacer.
- the advantage of this technique is that the CS vasculature can be navigated with minimal or no dye infusion. Preferably one dye infusion is made upon entry to the CS so that a global view of the CS vasculature can be obtained. This provides a "roadmap" of where the branch points can be found. Navigation of the CS vascular tree is then accomplished using only infrared imaging to find the branch points.
- This technique is useful for finding any orifice in the heart such as the CS, inferior vena cava, superior vena cava, pulmonary veins or heart valves.
- FIG. 6A the infrared catheter (1) is extended out of th sheath (5), with the CS (9) ahead of the sheath-catheter. The infrared catheter (1) is rotated until tissue features appear on the infrared image.
- Figure 6B shows the infrared catheter (1) in near proximity to the CS (9). The infrared image of the CS appears and the guidewire (3) is extended into the CS (9).
- Figure 6C shows the infrared catheter (1) tracked over the guidewire (3) into the CS. The sheath (5) can then be extended over the infrared catheter (1) so that sheath (5) and infrared catheter (1) now reside in the CS. At this point branch selection can begin as described above.
Abstract
To accomplish coronary sinus sub-branch selection, an infrared imaging catheter has a distal end wherein a small curve is formed over the last centimeter of the distal end. The curve is at about a 60-120 degree angle. The curve permits the catheter to be torqued within the guiding sheath to image the CS sub-branch. When the catheter is completely in the sheath, the curve is absent since the spring constant of the curve is not great enough to curve inside the sheath. The curve only appears as the catheter is advanced out of the sheath. The further advancement out of the sheath results in a greater angle of the catheter. Moreover, the catheter may have a guidewire channel exiting the distal end of the catheter. This permits a guidewire to be inserted into the visualized sub-branch. Once inserted, the catheter is advanced over the guidewire into the observed branch.
Description
Infrared Endoscope for Branch Selection and Cannulation with Guidewire Description of Invention Prior Art
A cardiac structure of great importance in the field of biventricular pacing is the coronary sinus (CS) and its branches. To gain access to the left ventricle, a catheter is inserted into the CS and routed through sub-branches into a branch which is in close proximity to the lateral wall of the left ventricle. Once this sub-branch has been cannulated with a guidewire or sheath, a pacing lead in inserted into the appropriate sub-branch and connected to a biventricular pacemaker to pace the left ventricle. This procedure is guided by fluoroscopy.
A variety of sub-branch selection techniques have been developed based on a combination of tactical feel and fluoroscopic information. Once the CS has been cannulated with a cannulation device inside of a sheath, the cannulation device is removed and radioopaque dye is injected into the CS vasculature and the branches deduced from the fluoroscopic image of the dye injection. Since the CS vasculature is a vein, the dye flows back into the right atrium following injection. Once deduced, a guidewire is inserted and navigated through the CS vasculature.
A consequence of this dye injection technique, only the larger branches tend to contain enough dye to appear on the fluoroscopic image. Moreover, sub-branches are often at oblique angles relative to the main branch (great cardiac vein) and sometimes have valves which inhibit the uptake of the dye. The effect of these two factors is that many branches which exist and may led to the left ventricle are not apparent in the dye injection procedure.
An additional consequence of the dye injection technique is that the radio-opaque dye in toxic and can affect kidney function. Generally, dye injections are limited to < 100 cc since greater amounts can endanger kidney function depending on the patient's tolerance for the dye. Even in healthy kidneys, dye injections of > 500 cc can result in renal failure. The concern over renal function discourages physicians from
injecting too much dye. Patients already in renal failure often need to have their CS vasculatures cannulted without any dye injection whatsoever.
The combination of limited dye injection and the dye returning retrograde to the right atrium make the elucidation of the CS branches an arduous task. Sometimes, in about 10-15% of the cases, no acceptable CS branch is found and the patient is referred to surgery to have the left ventricular lead attached directly to the left ventricle. Invention Summary
US Patent 6,178,346, discloses an infrared viewing system for the imaging of cardiac structures. Not discussed in this patent is its role in cannulating CS branches based on the infrared image.
Observing the infrared image in CS sub-branch selction , rather than the subset determined from dye injection. The infrared image of the sub-branch is superior to the dye injection technique since small branches as well as branches covered by valves can be visualized. Furthermore, no dye is used in the process and therefore the technique does not compromise renal function.
To accomplish CS sub-branch selection, a catheter unlike those depicted in US Patent 6,178,346, has been developed. The catheter has two modifications from those devices shown in US Patent 6,178,346.
The first modification is that at distal end of the catheter, a small curve is formed over the last centimeter of the distal end. The curve is at about a 60-120 deg angle. The curve permits the catheter to be torqued within the guiding sheath to image the CS sub-branch. When the catheter is completely in the sheath, the curve is absent since the spring constant of the curve is not great enough to curve inside the sheath. The curve only appears as the catheter is advanced out of the sheath. The further advancement out of the sheath results in a greater angle of the catheter.
The second modification is a guidewire channel exiting the distal end of the catheter. This permits a guidewire to be inserted into the visualized sub-branch. Once inserted, the catheter is advanced over the guidewire into the observed branch.
This technique is useful for CS cannulation as well, since the CS is the first branch selection inside the right atrium. To cannulate the CS, the catheter would be dragged along the septal wall with the catheter extended out of the sheath so that it forms an angle from 45-90 deg. As the infrared image of the CS appears, the guidewire is then inserted into the CS and the catheter is then tracked over the guidewire to enter the CS as well. Figures
1. The infrared catheter showing an approximate 90 deg bend with a guidewire channel and protruding guidewire.
2. The infrared catheter inside of a sheath which straightens the catheter
3. (A) The infrared catheter exiting partially from the sheath and starting to show its a small curvature. (B) The infrared catheter pushed further out of the sheath to reveal its natural 90 deg confirmation
4. (A) the infrared catheter and sheath shown traveling down the great cardiac vein and about to encounter a branch vein. (B) the infrared catheter is extended out o fthe sheath pointing in an opposite direction from the branch vein. (C) The infrared catheter has been rotated 180 deg inside of the sheath in the direction of the branch vein.
5. The branch vein has now been seen on the infrared image and the guidewire has been extended into the branch vein. (B) the infrared catheter is tracked over the guidewire to enter the branch vein. (C) The sheath is advanced over the catheter so that the sheath and catheter now both reside in the branch vein.
6. Shows the infrared catheter and sheath scraping across the septal wall to find the CS In Figure 6 A, the infrared catheter and sheath are scraped along the septal wall of the right atrium. In Figure 6B, The catheter is very close to the CS and the guidewire is extended. In Fig 6C, the infrared catheter is tracked ofer the guidewire residing in the CS.
Detailed Embodiments
The infrared imaging functions as described in US Patent 6,178,346, Figure 1 shows the infrared catheter (1) in its natural confirmation with an approximate 90 deg bend with a small spring constant. The spring constant is selected so that the catheter places minimal stress on the vascular wall and straightens when it is placed inside of a sheath. The hood (2) contains a guidewire channel (4) where a guidewire (3) protrudes out of the channel. Figure 2 shows the infrared catheter (1) inside of a sheath (5). The sheath has sufficient stiffness relative to the spring constant of the curved portion of the infrared catheter, so that it straightens the infrared catheter (1).
Figure 4 shows the basic cannulation mechanism of the sheath-catheter. Figure 4A shows the sheath (5)-catheter (1) traveling down the great cardiac vein (6) where a branch (7) is present ahead of the infrared catheter (1). Figure 4B shows the infrared catheter (1) extended out of the sheath (5) in an opposite direction from the branch vein (7). The infrared catheter (1) is then rotated inside of the sheath until the branch appears on the infrared image. Figure 4C shows the infrared catheter (1) pointing in the direction of the branch vein (7). Now that the branch vein appears in the infrared image, Figure 5 A shows the guidewire (3)extended through the guidewire port (4) to cannulate the branch vein (7). As shown in Figure 5B, the infrared catheter (1) is then tracked over the guidewire (3) to enter the branch vein (7). Figure 5C shows the sheath (5) tracked over the guidewire (3) so that both sheath (5)and infrared catheter (1) now reside in the branch vein (7). Subsequent branch veins are then navigated in the same manner until the infrared catheter resides in the branch vein appropriate for left ventricular pacing. At this point the infrared catheter is removed and a left ventricular pacing lead is placed over the guidewire and tracked to the final branch vein. Once pacing thresholds are established, the guidewire is removed and the sheath slit so that only the pacing lead resides in the candidate branch vein. The left ventricular pacing lead is then connected to a biventricular pacer.
The advantage of this technique is that the CS vasculature can be navigated with minimal or no dye infusion. Preferably one dye infusion is made upon entry to the CS so that a global view of the CS vasculature can be obtained. This provides a "roadmap" of where the branch points can be found. Navigation of the CS vascular tree is then accomplished using only infrared imaging to find the branch points.
This technique is useful for finding any orifice in the heart such as the CS, inferior vena cava, superior vena cava, pulmonary veins or heart valves.
Finding the CS is shown in Figure 6. In figure 6A the infrared catheter (1) is extended out of th sheath (5), with the CS (9) ahead of the sheath-catheter. The infrared catheter (1) is rotated until tissue features appear on the infrared image. Figure 6B shows the infrared catheter (1) in near proximity to the CS (9). The infrared image of the CS appears and the guidewire (3) is extended into the CS (9). Figure 6C shows the infrared catheter (1) tracked over the guidewire (3) into the CS. The sheath (5) can then be extended over the infrared catheter (1) so that sheath (5) and infrared catheter (1) now reside in the CS. At this point branch selection can begin as described above.
Claims
1. A catheter comprising a distal end wherein a curve is formed over the last centimeter of the distal end, the curve being at about a 60-120 degree angle relative to the catheter angle, the curve permitting the catheter to be torqued within the guiding sheath to image a coronary sinus sub-branch; and wherein the catheter is completely in a catheter sheath, the curve is absent since a spring constant of the curve is not great enough to curve inside the sheath; and further comprising a guidewire channel exiting the distal end of the cathether.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US83752506P | 2006-08-14 | 2006-08-14 | |
| US60/837,525 | 2006-08-14 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2008021436A2 true WO2008021436A2 (en) | 2008-02-21 |
| WO2008021436A3 WO2008021436A3 (en) | 2008-11-20 |
Family
ID=39082731
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2007/018144 WO2008021436A2 (en) | 2006-08-14 | 2007-08-14 | Infrared endoscope for branch selection and cannulation with guidewire |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2008021436A2 (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050038412A1 (en) * | 1999-09-24 | 2005-02-17 | Omnisonics Medical Technologies, Inc. | Apparatus and method for using a steerable catheter device |
-
2007
- 2007-08-14 WO PCT/US2007/018144 patent/WO2008021436A2/en active Application Filing
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050038412A1 (en) * | 1999-09-24 | 2005-02-17 | Omnisonics Medical Technologies, Inc. | Apparatus and method for using a steerable catheter device |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2008021436A3 (en) | 2008-11-20 |
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