WO1999042168A2 - Methode de traitement par rayonnement electromagnetique intravasculaire - Google Patents
Methode de traitement par rayonnement electromagnetique intravasculaire Download PDFInfo
- Publication number
- WO1999042168A2 WO1999042168A2 PCT/US1999/003947 US9903947W WO9942168A2 WO 1999042168 A2 WO1999042168 A2 WO 1999042168A2 US 9903947 W US9903947 W US 9903947W WO 9942168 A2 WO9942168 A2 WO 9942168A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- vessel
- electromagnetic radiation
- blood
- blood vessel
- optical fiber
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract description 50
- 230000005670 electromagnetic radiation Effects 0.000 title claims abstract description 32
- 238000011282 treatment Methods 0.000 title description 6
- 210000004204 blood vessel Anatomy 0.000 claims abstract description 44
- 230000005855 radiation Effects 0.000 claims abstract description 33
- 239000013307 optical fiber Substances 0.000 claims abstract description 28
- 230000023555 blood coagulation Effects 0.000 claims abstract description 11
- 230000001678 irradiating effect Effects 0.000 claims abstract description 11
- 230000003595 spectral effect Effects 0.000 claims abstract description 9
- 238000009792 diffusion process Methods 0.000 claims description 12
- 210000003462 vein Anatomy 0.000 claims description 10
- 230000017531 blood circulation Effects 0.000 claims description 7
- 206010002329 Aneurysm Diseases 0.000 claims description 6
- 206010047141 Vasodilatation Diseases 0.000 claims description 6
- 206010003226 Arteriovenous fistula Diseases 0.000 claims description 5
- 208000009443 Vascular Malformations Diseases 0.000 claims description 5
- 230000000903 blocking effect Effects 0.000 claims description 3
- 230000001681 protective effect Effects 0.000 claims description 3
- 239000000126 substance Substances 0.000 claims description 3
- 239000000835 fiber Substances 0.000 description 13
- 238000010438 heat treatment Methods 0.000 description 13
- 239000008280 blood Substances 0.000 description 8
- 210000004369 blood Anatomy 0.000 description 8
- 238000003384 imaging method Methods 0.000 description 5
- 208000007536 Thrombosis Diseases 0.000 description 4
- 210000001367 artery Anatomy 0.000 description 2
- 230000001427 coherent effect Effects 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 208000035475 disorder Diseases 0.000 description 2
- 230000002045 lasting effect Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 1
- 208000006787 Port-Wine Stain Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 238000002583 angiography Methods 0.000 description 1
- 230000001112 coagulating effect Effects 0.000 description 1
- 230000015271 coagulation Effects 0.000 description 1
- 238000005345 coagulation Methods 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 238000005553 drilling Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000003550 marker Substances 0.000 description 1
- -1 polyethylene Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 229910052761 rare earth metal Inorganic materials 0.000 description 1
- 150000002910 rare earth metals Chemical class 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 210000003752 saphenous vein Anatomy 0.000 description 1
- 230000000451 tissue damage Effects 0.000 description 1
- 231100000827 tissue damage Toxicity 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 230000025033 vasoconstriction Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N5/0601—Apparatus for use inside the body
Definitions
- the present invention relates generally to the art of therapeutic electromagnetic treatments. More particularly, the present invention relates to a method of intravascular electromagnetic radiation treatment.
- the method of the present invention serves for effecting blood coagulation within and/or shrinkage of blood vessels, such as veins, arteries and valves, in conditions such as, but not limited to, dilated veins, aneurysms, vascular malformations and arteriovenous fistulas, which are, as so far, treated surgically.
- electromagnetic radiation It is known in the prior art to use electromagnetic radiation in medical applications for therapeutic uses. External application of electromagnetic radiation is most effective in treating external and surficial conditions, such as, but not limited to, skin blood vessel disorders (e.g., port wine stains, etc.).
- skin blood vessel disorders e.g., port wine stains, etc.
- shrinking or coagulating blood vessels There are known medical conditions in which shrinking or coagulating blood vessels is required.
- shrinking refers to narrowing or occluding. These conditions include, for example, dilated veins, aneurysms, vascular malformations and arteriovenous fistulas.
- Shrinking blood vessels is currently effected by surgical techniques such as ligation or ligation followed by stripping. Ligation is effected by making a small incision above the vein and ligation of the vein through this incision using, for example, a string. Stripping is effected by transmitting a wire in a vein and thereby stripping its inside. Being surgical, these methods suffer disadvantages as compared with minimal invasive methods. Additional disadvantages include longer recovery time and, in many cases, ugly cosmetic appearance.
- U.S. Pat. Nos. 5,100,429; 5,330,490; and 5,620,439 teach minimal invasive laser techniques and systems for removing obstructions formed within blood vessels. These systems utilize catheters and optical fibers which bring in laser radiation having energy sufficient for drilling a hole in the obstruction, thereby removing the obstruction.
- U.S. Pat. No. 4,735,201 to O'Reilly teaches a method for blocking blood vessels which employs a metallic tip insertable into a treated blood vessel, which is heated by electromagnetic radiation arriving via an optical fiber, and is left in the vessel to block blood flow therein.
- a method for effecting blood coagulation within, and/or shrinkage of, blood vessels such as veins, arteries and valves.
- a method of narrowing or occluding a blood vessel comprising the steps of (a) obtaining an apparatus including (i) a radiation source for generating electromagnetic radiation output falling within a spectral range; and (ii) at least one optical fiber having a proximal end and a distal end, the proximal end of the optical fiber being optically coupled to the radiation source; (b) inserting the distal end into the blood vessel; and (c) internally irradiating the blood vessel with the electromagnetic radiation in an energy sufficient for causing blood coagulation within or wall shrinkage of the vessel.
- the spectral range is between 0.6 ⁇ m and 2.5 ⁇ m.
- the radiation source is a laser.
- the laser is a Nd:YAG laser operating at 1.064 ⁇ m or 1.32 ⁇ m.
- the laser is a Diode laser operating in the 0.6-2.5 ⁇ m spectral range.
- the radiation source is a multiband source.
- the multiband source is an arc lamp.
- the at least one optical fiber includes a distal diffusion region close to its distal end, such that the electromagnetic radiation dissipates through the diffusion region.
- the electromagnetic radiation dissipates through the distal end of the optical fiber.
- the apparatus further includes a catheter forming a protective sheath around a central lumen, the at least one optical fiber is mounted within the central lumen, whereas the step of inserting the distal end into the blood vessel is effected by inserting the catheter into the blood vessel.
- an inflatable balloon is mounted over the catheter, whereas the method further comprising the step of (d) prior to the step of internally irradiating the blood vessel with the electromagnetic radiation, inflating the balloon for blocking blood flow through the vessel, such that the electromagnetic radiation impinges on the walls of the vessel, thereby causing shrinkage of the vessel.
- the blood vessel is a neck of an incompetent valve of a dilated vein, and the shrinkage is performed until the competence of the valve is restored.
- the catheter is made of a substance which is substantially transparent to the electromagnetic radiation.
- internally irradiating the blood vessel with the electromagnetic radiation is effected in a plurality of locations along the vessel.
- the method further comprising the step of (d) withdrawing the at least one optical fiber from the vessel.
- the step of internally irradiating the blood vessel with the electromagnetic radiation is effected by pulses of irradiation.
- the blood vessel is involved in a condition selected from the group consisting of, dilated veins, aneurysms, vascular malformations and arteriovenous fistulas.
- the present invention successfully addresses the shortcomings of the presently known configurations by providing a minimal invasive method for electromagnetically treating blood vessels which are otherwise treated surgically.
- FIG. 1 is a schematic depiction of an apparatus for effecting the method according to the present invention, the apparatus includes a radiation source optically coupled to a single optical fiber;
- FIG. 2 is a schematic depiction of a distal end of a fiber for effecting the method according to the present invention, the fiber is supplemented with a distal diffusion region;
- FIG. 3 is a schematic depiction of an apparatus for effecting the method according to the present invention, the apparatus includes a radiation source optically coupled to a single optical fiber which is protected by a catheter supplemented with an inflating balloon.
- the present invention is of a method of electromagnetically treating blood vessels, which can be used for occluding or narrowing the vessels.
- the present invention can be used for treating conditions, such as, but not limited to, dilated veins, aneurysms, vascular malformations and arteriovenous fistulas, which are, as so far, treated surgically.
- a method of narrowing or occluding a blood vessel includes the following steps.
- Figures 1-3 provide schematic depictions of few embodiments of suitable apparatuses.
- the apparatus which is generally referred to hereinbelow as apparatus 10, includes a radiation source 12.
- Radiation source 12 serves for generating electromagnetic radiation output which falls within a desired spectral range, say within the range of 0.6 ⁇ m and
- radiation source 12 generates coherent radiation.
- radiation source 12 is a laser device 14, which is easily capable of generating coherent radiation having high energy.
- laser device 14 is a Nd:YAG laser operating at 1.064 ⁇ m or at 1.32 ⁇ m.
- laser device 14 is a Diode laser operating at the 0.8 - 1.0 ⁇ m spectral range.
- radiation source 12 is a multiband radiation source, such as, but not limited to, an arc lamp 16. These radiation sources are well known in the art and therefore require no further description herein.
- apparatus 10 further includes at least one
- optical fiber 18 has a proximal end 20 and a distal end 22. Proximal end 20 of optical fiber 18 is optically coupled to radiation source 12. Coupling an optical fiber or a bundle thereof to a radiation source is well known in the art and requires no further description herein. According to a preferred embodiment of the present invention, and as specifically shown in Figure 2, optical fiber 18 includes a distal diffusion region 24 located close to its distal end 22, such that, as indicated by arrows 26, the electromagnetic radiation laterally dissipates through diffusion region 24, as well as longitudinally from distal end 22, as indicated by arrows 28. Providing a diffusion region in an optical fiber is a well known technology which requires no further description herein.
- a fiber including a diffusion region in its distal end is distributed by Rare Earth Medical Inc., West Yarmouth, MA, USA. For some applications, it may be desirous to optically block distal end 22 and thereby restrict all of the radiation to leave fiber 18 via diffusion region 24. In other applications, light diffusion may be limiting. In these cases a simple optical fiber is employed, wherein all of the radiation leaves the fiber longitudinally through distal end 22.
- distal end 22 is inserted into the blood vessel and appropriately located at a region of the vessel to be narrowed or occluded.
- Appropriately locating end 22 within the vessel is preferably effected by an imaging method capable of imaging both the vessel and the fiber/catheter or a part thereof. Suitable imaging methods are, for example, ultrasound and X- ray imaging.
- a metallic marker 36 is preferably included close to, or at, end 22 of fiber 18.
- appropriately locating end 22 within the vessel is effected by a co-aligned visible laser providing a guiding light beam (e.g., guiding red light), which is visible through the tissue (e.g., skin, vessel's walls) of the patient.
- the blood vessel is internally irradiated with the electromagnetic radiation in an energy sufficient for causing blood coagulation within, or wall shrinkage of, the vessel.
- Using a single fiber 18 is advantageous when narrow (e.g., about 1-3 mm in diameter) vessels are treated.
- apparatus 10 further includes a catheter 30 forming a protective sheath 32 around a central lumen 34.
- Optical fiber 18 is mounted within central lumen 34.
- Distal end 22 of optical fiber 18 preferably protrudes from catheter 30.
- the step of inserting distal end 22 into the blood vessel is effected by inserting catheter 30 into the blood vessel. Inserting catheters into blood vessels is a well established medical procedure.
- catheter 30 is made of a substance which is substantially transparent to the electromagnetic radiation (e.g., transparent polyethylene).
- This procedure is preferably executed a in a plurality of locations, say 3 -5 successive locations along the vessel, to ensure complete, prolonged and safe blockage of the vessel.
- Rapid heating is required for immediate coagulation and blockage of the vessel, so as to avoid migrating thromboses. Rapid heating can be effected by short high-energy laser pulses, each lasting a millisecond and up to a second.
- an inflatable balloon 36 (shown inflated in Figure 3) is mounted over catheter 30.
- the method further includes a step in which balloon 36 is inflated and thereby blocks blood flow through the vessel, such that the electromagnetic radiation impinges on the walls of the vessel, thereby causing the walls to collapse which results in shrinkage (i.e., narrowing or full blockage) of the vessel.
- Inflatable balloon including catheters are well known in the art and are conventionally used for angiography.
- slow heating is sufficient. Slow heating can be effected by long medium-energy laser pulses, or continuous low-energy laser pulse lasting from 5 seconds to five minutes.
- This embodiment of the invention is highly suitable for narrowing blood vessels. For example, narrowing a neck of an incompetent valve of a dilated vein, whereas shrinkage is performed as described until the competence_of the valve is restored.
- end 22 of fiber 18 is positioned intravascularly within the neck of the point which is to be narrowed or occluded and laser energy is transmitted in a short and intense pulse through optical fiber 18 to heat the blood and/or the vessel's walls and thereby to narrow or occlude (e.g., shrink or thrombose) the vessel.
- the radiation is pulsative.
- Radiation sources for generating pulsative radiation are well known in the art.
- the radiation continuous.
- the vessel is internally irradiated in an energy and for a period of time sufficient either to narrow or to totally occlude the vessel.
- the fiber/catheter is withdrawn from the vessel. If a balloon is employed, it is first deflated and the treated tissue is allowed to set for some time, after which catheter 30 is withdrawn from the vessel. The following lists few considerations for wavelength selection.
- the first criterion in this respect is that the radiation will be homogeneously absorbed by the walls of the vessel.
- Medium absorption is preferred for this purpose, such that it will not penetrate too deep into the vessel's tissue and further such that it will not be completely absorbed by the inner superficial layer of the vessel.
- a second criterion is that the radiation will penetrate through the remaining blood to the vessel walls (for the slow heating mode).
- the rapid heating mode blood coagulation
- the same wavelength is suitable since it will coagulate the blood more uniformly.
- the slow heating mode wall shrinkage
- the power applied is a function of the illuminated area, which depends upon the fiber tip geometry. It should be set in such a way that it will heat the vessel wall to between about 70-
- the energy should be applied slowly in such a way that it will heat the vessel wall to between 70-80 °C.
- This steady state heating should be applied until the vessel shrinks to a desired diameter. This time is typically between 5 seconds to 5 minutes, depending on the specific application.
- the energy should be applied fast enough to create blood coagulation and thrombosis. This time is between milliseconds to several seconds.
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Pathology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Laser Surgery Devices (AREA)
- Radiation-Therapy Devices (AREA)
Abstract
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU33092/99A AU3309299A (en) | 1998-02-24 | 1999-02-24 | Method of intravascular electromagnetic radiation treatment |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US3084198A | 1998-02-24 | 1998-02-24 | |
US09/030,841 | 1998-02-24 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO1999042168A2 true WO1999042168A2 (fr) | 1999-08-26 |
WO1999042168A3 WO1999042168A3 (fr) | 1999-10-14 |
Family
ID=21856322
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1999/003947 WO1999042168A2 (fr) | 1998-02-24 | 1999-02-24 | Methode de traitement par rayonnement electromagnetique intravasculaire |
Country Status (2)
Country | Link |
---|---|
AU (1) | AU3309299A (fr) |
WO (1) | WO1999042168A2 (fr) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20110282334A1 (en) * | 2010-05-11 | 2011-11-17 | Ceramoptec Industries Inc. | Device and method for fistula treatment |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5226430A (en) * | 1984-10-24 | 1993-07-13 | The Beth Israel Hospital | Method for angioplasty |
US5741246A (en) * | 1996-04-15 | 1998-04-21 | Prescott; Marvin A. | Method and apparatus for laser balloon angioplasty treatment of medical conditions |
US5620438A (en) * | 1995-04-20 | 1997-04-15 | Angiomedics Ii Incorporated | Method and apparatus for treating vascular tissue following angioplasty to minimize restenosis |
-
1999
- 1999-02-24 WO PCT/US1999/003947 patent/WO1999042168A2/fr active Application Filing
- 1999-02-24 AU AU33092/99A patent/AU3309299A/en not_active Abandoned
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20110282334A1 (en) * | 2010-05-11 | 2011-11-17 | Ceramoptec Industries Inc. | Device and method for fistula treatment |
Also Published As
Publication number | Publication date |
---|---|
AU3309299A (en) | 1999-09-06 |
WO1999042168A3 (fr) | 1999-10-14 |
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