US20060247492A1 - Mitral shield - Google Patents
Mitral shield Download PDFInfo
- Publication number
- US20060247492A1 US20060247492A1 US11/479,681 US47968106A US2006247492A1 US 20060247492 A1 US20060247492 A1 US 20060247492A1 US 47968106 A US47968106 A US 47968106A US 2006247492 A1 US2006247492 A1 US 2006247492A1
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- United States
- Prior art keywords
- valve
- shield according
- sheet
- leaflet
- valve shield
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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- 239000000463 material Substances 0.000 claims abstract description 21
- 238000000034 method Methods 0.000 claims description 11
- 208000012287 Prolapse Diseases 0.000 claims description 9
- 239000007787 solid Substances 0.000 claims description 7
- 239000012620 biological material Substances 0.000 claims description 4
- 206010067171 Regurgitation Diseases 0.000 claims description 2
- 210000004115 mitral valve Anatomy 0.000 description 18
- 206010027727 Mitral valve incompetence Diseases 0.000 description 5
- 230000008901 benefit Effects 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 210000003709 heart valve Anatomy 0.000 description 2
- 241000283690 Bos taurus Species 0.000 description 1
- 229920004934 Dacron® Polymers 0.000 description 1
- 208000005189 Embolism Diseases 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 208000011682 Mitral valve disease Diseases 0.000 description 1
- 208000001435 Thromboembolism Diseases 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 210000001765 aortic valve Anatomy 0.000 description 1
- 238000010009 beating Methods 0.000 description 1
- 230000003412 degenerative effect Effects 0.000 description 1
- 230000010339 dilation Effects 0.000 description 1
- 206010014665 endocarditis Diseases 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 208000005907 mitral valve insufficiency Diseases 0.000 description 1
- RVTZCBVAJQQJTK-UHFFFAOYSA-N oxygen(2-);zirconium(4+) Chemical compound [O-2].[O-2].[Zr+4] RVTZCBVAJQQJTK-UHFFFAOYSA-N 0.000 description 1
- 210000003516 pericardium Anatomy 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 239000005020 polyethylene terephthalate Substances 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 210000003102 pulmonary valve Anatomy 0.000 description 1
- 238000002271 resection Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
- 210000000591 tricuspid valve Anatomy 0.000 description 1
- 239000011800 void material Substances 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
Definitions
- This invention relates to surgical apparatus and methods in general, and more particularly to apparatus and methods for addressing mitral regurgitation.
- Mitral valve repair is the procedure of choice to correct mitral regurgitation of all etiologies. With the use of current surgical techniques, between 70% and 95% of regurgitant mitral valves can be repaired. The advantages of mitral valve repair over mitral valve replacement are well documented. These include better preservation of cardiac function and reduced risk of anticoagulant-related hemorrhage, thromboembolism and endocarditis.
- One object of the present invention is to provide novel apparatus and method for the repair of heart valves so as to increase their efficiency.
- Another object of the present invention is to provide novel apparatus and method for the repair of mitral valves so as to reduce mitral regurgitation.
- Another object of the present invention to provide novel apparatus and method to correct mitral valve regurgitation caused by mitral valve leaflet prolapse or posterior annulus dilation.
- the present invention which comprises a shaped sheet of material affixed to the annulus of the valve and extending over at least one leaflet of the valve so as to assist or replace the closing function of that valve leaflet.
- the device may be used for mitral valve repair or for other valve repair, on a beating heart or on an arrested heart.
- FIG. 1 is a schematic view showing a normal mitral valve in its closed position
- FIG. 2 is a schematic view showing a regurgitant mitral valve in its closed position, with its posterior leaflet in a prolapsed condition;
- FIG. 3 is a schematic view showing a mitral 5 shield affixed to the periphery of the regurgitant mitral valve of FIG. 2 so as to prevent prolapse of the posterior leaflet and thereby ameliorate mitral regurgitation;
- FIG. 4 is a schematic view showing an alternative form of mitral shield formed in accordance with the present invention.
- FIG. 5 is a schematic view showing another alternative form of mitral shield formed in accordance with the present invention.
- FIG. 6 is a schematic view showing still another form of mitral shield also formed in accordance with the present invention.
- FIG. 7 is a schematic view showing yet another form of mitral shield formed in accordance with the present invention.
- FIG. 8 is a schematic view showing another alternative form of mitral shield formed in accordance with the present invention.
- FIG. 9 is a schematic view showing still another alternative form of mitral shield formed in accordance with the present invention.
- FIG. 10 is a schematic view showing yet another alternative form of mitral shield formed in accordance with the present invention.
- FIG. 1 there is shown a normal mitral valve V.
- Mitral valve V is shown in its closed position, with its posterior leaflet PL and its anterior leaflet AL properly engaging one another. Also shown is the valve's posterior annulus PA and its anterior annulus AA.
- a mitral shield 5 is shown affixed to the posterior annulus PA of the valve RV so as to prevent prolapse of the posterior leaflet PL and thereby ameliorate mitral regurgitation.
- mitral shield 5 comprises a shaped sheet of material which is sized to the circumference of the mitral annulus. This sheet may be uniform in thickness or specifically shaped to match the surface of the mitral valve. When affixed to the valve annulus, the sheet will project over a portion of the orifice of the mitral valve. In most cases, the sheet will be oriented over the posterior leaflet PL, such as is shown in FIG. 3 , thereby providing an area of contact for the anterior mitral leaflet AL and reducing or eliminating regurgitation due to leaflet prolapse by the posterior leaflet PL.
- a solid portion of a shield will fill the void and provide a contact surface for the anterior leaflet.
- a mitral shield 105 which is substantially solid.
- a mitral shield 105 which is solid except for pre-formed suture holes 120 .
- a mitral shield 105 which is solid and includes integral fixation staples 125 .
- the native posterior valve leaflet may either be excised or left in situ when the mitral shield 105 is employed.
- FIG. 9 there is shown a wire frame shield 305 for addressing posterior and/or anterior leaflet prolapse only.
- FIG. 10 there is shown a mitral shield 405 combining a solid shield portion and perforations 410 and integral staples 425 around the entire annulus circumference.
- the device described is intended primarily for mitral valve repair, it is also contemplated that the same or substantially similar apparatus and methodology may be used in repairing other cardiac valves, including the tricuspid, pulmonary and aortic valves.
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
A valve shield comprising a shaped sheet of material adapted to be affixed to the annulus of a valve and adapted to extend over at least a portion of at least one leaflet of the valve so as to assist or replace the closing function of that valve leaflet.
Description
- This patent application claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 60/243,234, filed Oct. 25, 2000 by Richard B. Streeter for MITRAL SHIELD, which patent application is hereby incorporated herein by reference.
- This invention relates to surgical apparatus and methods in general, and more particularly to apparatus and methods for addressing mitral regurgitation.
- Mitral valve repair is the procedure of choice to correct mitral regurgitation of all etiologies. With the use of current surgical techniques, between 70% and 95% of regurgitant mitral valves can be repaired. The advantages of mitral valve repair over mitral valve replacement are well documented. These include better preservation of cardiac function and reduced risk of anticoagulant-related hemorrhage, thromboembolism and endocarditis.
- Degenerative mitral valve disease most commonly affects the chordae of the posterior leaflet, causing posterior leaflet prolapse. Traditional repair techniques for such lesions include leaflet resection and annular plication.
- One object of the present invention is to provide novel apparatus and method for the repair of heart valves so as to increase their efficiency.
- Another object of the present invention is to provide novel apparatus and method for the repair of mitral valves so as to reduce mitral regurgitation.
- And another object of the present invention to provide novel apparatus and method to correct mitral valve regurgitation caused by mitral valve leaflet prolapse or posterior annulus dilation.
- These and other objects are addressed by the provision and use of the present invention, which comprises a shaped sheet of material affixed to the annulus of the valve and extending over at least one leaflet of the valve so as to assist or replace the closing function of that valve leaflet. The device may be used for mitral valve repair or for other valve repair, on a beating heart or on an arrested heart.
- These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts and further wherein:
-
FIG. 1 is a schematic view showing a normal mitral valve in its closed position; -
FIG. 2 is a schematic view showing a regurgitant mitral valve in its closed position, with its posterior leaflet in a prolapsed condition; -
FIG. 3 is a schematic view showing a mitral 5 shield affixed to the periphery of the regurgitant mitral valve ofFIG. 2 so as to prevent prolapse of the posterior leaflet and thereby ameliorate mitral regurgitation; -
FIG. 4 is a schematic view showing an alternative form of mitral shield formed in accordance with the present invention; -
FIG. 5 is a schematic view showing another alternative form of mitral shield formed in accordance with the present invention; -
FIG. 6 is a schematic view showing still another form of mitral shield also formed in accordance with the present invention; -
FIG. 7 is a schematic view showing yet another form of mitral shield formed in accordance with the present invention; -
FIG. 8 is a schematic view showing another alternative form of mitral shield formed in accordance with the present invention; -
FIG. 9 is a schematic view showing still another alternative form of mitral shield formed in accordance with the present invention; and -
FIG. 10 is a schematic view showing yet another alternative form of mitral shield formed in accordance with the present invention. - Looking first at
FIG. 1 , there is shown a normal mitral valve V. Mitral valve V is shown in its closed position, with its posterior leaflet PL and its anterior leaflet AL properly engaging one another. Also shown is the valve's posterior annulus PA and its anterior annulus AA. - Looking next at
FIG. 2 , there is shown a regurgitant mitral valve RV. Regurgitant mitral valve RV is shown in its closed position, with posterior leaflet PL in a prolapsed condition and failing to properly engage anterior leaflet AL, thus leaving a regurgitant orifice RO therebetween. - Looking next at
FIG. 3 , amitral shield 5 is shown affixed to the posterior annulus PA of the valve RV so as to prevent prolapse of the posterior leaflet PL and thereby ameliorate mitral regurgitation. - More particularly,
mitral shield 5 comprises a shaped sheet of material which is sized to the circumference of the mitral annulus. This sheet may be uniform in thickness or specifically shaped to match the surface of the mitral valve. When affixed to the valve annulus, the sheet will project over a portion of the orifice of the mitral valve. In most cases, the sheet will be oriented over the posterior leaflet PL, such as is shown inFIG. 3 , thereby providing an area of contact for the anterior mitral leaflet AL and reducing or eliminating regurgitation due to leaflet prolapse by the posterior leaflet PL. - A perforated shield over the affected leaflet will be sufficient to prevent leaflet prolapse while maintaining adequate blood flow. Thus, in
FIG. 1 , a plurality of radiallyelongated perforations 10 are provided inmitral shield 5. Alternatively, circular perforations, such as thecircular perforations 10 provided in themitral shield 5 shown inFIG. 2 , may also be provided. Still other perforation configurations, in both shape and number, will be apparent to those skilled in the art in view of the present disclosure. - The mitral shield may be constructed of biological material (e.g., human or bovine pericardium) or non-biological material (e.g., Dacron, PTFE, a biocompatible plastic, a biocompatible metal such as titanium, nitinol wire, etc). It may also consist of autologous cells grown on a matrix or frame. The sheet may be attached to the annulus using sutures, staples, wire, medical grade adhesives or other means of fixation. Thus, for example, in
FIG. 1 staples 15 are shown attachingshield 5 to the annulus of the valve. - If the posterior annulus is dilated, a solid portion of a shield will fill the void and provide a contact surface for the anterior leaflet. Thus, for example, in
FIG. 5 there is shown amitral shield 105 which is substantially solid. InFIG. 6 , there is shown amitral shield 105 which is solid except forpre-formed suture holes 120. InFIG. 7 there is shown amitral shield 105 which is solid and includesintegral fixation staples 125. - It should be appreciated that the native posterior valve leaflet may either be excised or left in situ when the
mitral shield 105 is employed. - Looking next at
FIG. 8 , there is shown a solidcrescent shield 205 which is configured to correct posterior leaflet flail, and which is also provided with amid-line projection 230 to support the anterior leaflet AL from prolapsing. - In
FIG. 9 , there is shown awire frame shield 305 for addressing posterior and/or anterior leaflet prolapse only. - And in
FIG. 10 , there is shown amitral shield 405 combining a solid shield portion and perforations 410 and integral staples 425 around the entire annulus circumference. - Alternative designs of the same invention allow for correcting one or both leaflets while maintaining adequate blood flow. The shield may also be used in conjunction with other mitral valve repair techniques and devices.
- Although the device described is intended primarily for mitral valve repair, it is also contemplated that the same or substantially similar apparatus and methodology may be used in repairing other cardiac valves, including the tricuspid, pulmonary and aortic valves.
Claims (18)
1. A valve shield comprising a shaped sheet of material adapted to be affixed to the annulus of a valve and adapted to extend over at least a portion of at least one leaflet of the valve so as to assist or replace the closing function of that valve leaflet.
2. A valve shield according to claim 1 wherein the sheet of material is adapted to prevent leaflet prolapse.
3. A valve shield according to claim 2 wherein the sheet of material is crescent shaped.
4. A valve shield according to claim 3 wherein the portion of the sheet of material extending over at least a portion of the at least one leaflet includes at least one opening therein.
5. A valve shield according to claim 3 wherein the portion of the sheet of material extending over at least a portion of the at least one leaflet is substantially solid.
6. A valve shield according to claim 2 wherein the sheet of material is adapted to be fastened to the annulus of the valve with sutures.
7. A valve shield according to claim 6 wherein the sheet of material includes preformed holes for receiving the suture.
8. A valve shield according to claim 2 wherein the sheet of material is adapted to be fastened to the annulus of the valve with staples.
9. A valve shield according to claim 8 wherein the sheet of material includes staples formed integral therewith.
10. A valve shield according to claim 2 wherein the material comprises biological material.
11. A valve shield according to claim 2 wherein the material comprises periocardium.
12. A valve shield according to claim 2 wherein the material comprises non-biological material.
13. A valve shield according to claim 1 wherein the material is round and includes at least one opening therein.
14. A valve shield according to claim 1 wherein the shaped sheet of material comprises a wire frame.
15. A valve shield according to claim 2 wherein the shaped sheet of material comprises a crescent shape with a mid-line projection adapted to support a second leaflet against prolapse.
16. A valve shield according to claim 1 wherein the sheet of material is adapted to extend over at least two leaflets.
17. A valve shield according to claim 16 wherein the sheet of material includes at least one opening therein.
18. A method for reducing regurgitation in a valve having a plurality of leaflets, said method comprising:
providing a valve shield comprising a shaped sheet of material; and
affixing the valve shield to the annulus of the valve so that it extends over at least a portion of at least one leaflet of the valve so as to assist or replace the closing function of that valve leaflet.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US11/479,681 US20060247492A1 (en) | 2000-10-25 | 2006-06-30 | Mitral shield |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US24323400P | 2000-10-25 | 2000-10-25 | |
US10/004,068 US7070618B2 (en) | 2000-10-25 | 2001-10-25 | Mitral shield |
US11/479,681 US20060247492A1 (en) | 2000-10-25 | 2006-06-30 | Mitral shield |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US10/004,068 Continuation US7070618B2 (en) | 2000-10-25 | 2001-10-25 | Mitral shield |
Publications (1)
Publication Number | Publication Date |
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US20060247492A1 true US20060247492A1 (en) | 2006-11-02 |
Family
ID=26672566
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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US10/004,068 Expired - Lifetime US7070618B2 (en) | 2000-10-25 | 2001-10-25 | Mitral shield |
US11/479,681 Abandoned US20060247492A1 (en) | 2000-10-25 | 2006-06-30 | Mitral shield |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/004,068 Expired - Lifetime US7070618B2 (en) | 2000-10-25 | 2001-10-25 | Mitral shield |
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US (2) | US7070618B2 (en) |
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US20050004665A1 (en) * | 2003-07-02 | 2005-01-06 | Lishan Aklog | Annuloplasty rings and methods for repairing cardiac valves |
US20050004668A1 (en) * | 2003-07-02 | 2005-01-06 | Flexcor, Inc. | Annuloplasty rings and methods for repairing cardiac valves |
US20050159810A1 (en) * | 2004-01-15 | 2005-07-21 | Farzan Filsoufi | Devices and methods for repairing cardiac valves |
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US20090132036A1 (en) * | 2007-11-19 | 2009-05-21 | The Cleveland Clinic Foundation | Apparatus and method for treating a regurgitant heart valve |
US20090264995A1 (en) * | 2008-04-16 | 2009-10-22 | Subramanian Valavanur A | Transvalvular intraannular band for valve repair |
US7666224B2 (en) | 2002-11-12 | 2010-02-23 | Edwards Lifesciences Llc | Devices and methods for heart valve treatment |
US7678145B2 (en) | 2002-01-09 | 2010-03-16 | Edwards Lifesciences Llc | Devices and methods for heart valve treatment |
US20100121435A1 (en) * | 2008-04-16 | 2010-05-13 | Cardiovascular Technologies, Llc | Percutaneous transvalvular intrannular band for mitral valve repair |
US20100121437A1 (en) * | 2008-04-16 | 2010-05-13 | Cardiovascular Technologies, Llc | Transvalvular intraannular band and chordae cutting for ischemic and dilated cardiomyopathy |
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