US20080109074A1 - Method for Making a Bicuspid Pulmonary Heart Valve - Google Patents
Method for Making a Bicuspid Pulmonary Heart Valve Download PDFInfo
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- US20080109074A1 US20080109074A1 US12/013,904 US1390408A US2008109074A1 US 20080109074 A1 US20080109074 A1 US 20080109074A1 US 1390408 A US1390408 A US 1390408A US 2008109074 A1 US2008109074 A1 US 2008109074A1
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- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
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- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2415—Manufacturing methods
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Biomedical Technology (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (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)
- Manufacturing & Machinery (AREA)
- Prostheses (AREA)
Abstract
A heart valve constructed from a synthetic resin that is designed to be surgically implanted in the right ventricular outflow tract of the heart comprising a plurality of flexible members, and an orifice.
Description
- This application is a continuation of prior application Ser. No. 11/041,603, filed Jan. 24, 2005, which claims the benefit of U.S. Provisional Application No. 60/538,870, filed Jan. 23, 2004, the entire contents of which are incorporated herein by reference.
- This invention relates generally to a tubular heart valve having a plurality of flexible members that are open when at rest, but capable of collapsing to prevent reverse flow, and more particularly to a pulmonary heart valve comprising a bicuspid configuration, and made from a safe, relatively inexpensive, effective, and durable material, such as a fluoropolymer like PTFE sold under trademarks such as Teflon® and GORE-TEX®, or other synthetic resin suitable for use in biologic applications. The present invention provides a safe, relatively inexpensive, easily-constructed, effective and durable option for patients in need of right ventricular outflow tract reconstruction.
- Many patients who have had surgical reconstruction of the right ventricular outflow tract come back to the doctor in need of reoperative surgical reconstruction of the right ventricular outflow tract (RVOT). Typically there is a history of previously operated tetralogy of Fallot (TOF) or pulmonary stenosis (PS). Tetralogy of Fallot is a heart problem that is characterized by four defects in the heart: 1) ventricular septal defect (VSD), which is a hole between the two bottom chambers of the heart; 2) pulmonary stenosis, or a narrowing at or slightly below the pulmonary valve; 3) positioning of the aorta over the ventricular septal defect; and 4) the right ventricle being unusually muscular.
- The predominant physiologic abnormality is pulmonary insufficiency (PI), but varying degrees of RVOT obstruction may also be present. It is generally believed that patients tolerate PI reasonably well. In some, however, the long term effects of PI and subsequent right ventricle (RV) enlargement and dysfunction result in poor exercise tolerance and increased incidence of arrhythmias. Numerous surgical options are available for these patients; however, the optimal timing and specific valve used for reconstruction remain uncertain. Less than ideal experience with heterograft RVOT reconstruction stimulated interest into alternative materials and techniques. Favorable experimental and clinical experience with reconstruction using PTFE monocusp valves spurred an interest to consider a new method of reconstruction with this material.
- Increasingly, over the last several years, concerns regarding post-operative pulmonary insufficiency or insufficiency/stenosis have emerged. The previous adage that pulmonary insufficiency after valvectomy and/or transanular patching during repair of TOF was well-tolerated is now being questioned. Recent studies with more refined methods of evaluation utilizing echocardiogram or magnetic resonance imaging (MRI), as well as exercise testing, clearly show there is a relationship between pulmonary insufficiency and volume overload that results in right ventricular enlargement and dysfunction. Symptoms resulting from physical exertion are late and usually follow these objective changes in ventricular dysfunction and size. Additionally, life threatening ventricular arrhythmias seem to be associated with the more severe cases of pulmonary insufficiency and ventricular changes.
- There is good evidence that RV enlargement and dysfunction is reversible following pulmonary valve replacement (PVR). However, recent evidence shows that there is a lack of significant recovery of RV indices following PVR in adults with long-standing pulmonary insufficiency. Therefore, the timing of PVR is of major importance in the overall maintenance of ventricular function and optimal long-term outcomes. Additionally, a program of aggressive PVR in conjunction with intraoperative cryoblation is effective in reducing both the size of the heart chamber and the potential for lethal arrhythmias in TOF patients with severe pulmonary insufficiency. It is also useful in decreasing the QRS duration, wherein “QRS” is a complex of waves on an echocardiogram that represent the time it takes for the ventricles to depolarize—the normal length of time being between 40 milliseconds and 160 milliseconds. In general, indications for PVR are evolving but currently include patients with moderate-severe PI/PS and 1) exertional symptoms, class II or greater, 2) RV systolic dysfunction and/or enlargement, 3) decreased exercise tolerance, and 4) ventricular arrhythmias and/or QRS duration greater than 160 milliseconds.
- There is considerable debate as to what type of valve or reconstruction is optimal for the pulmonary position. A vast array of materials and methods have been utilized. Recent studies support the use of homografts, replacement valves from human donors, as well as stented and unstented heterograft valves, valves from non-human donors (pig valves are commonly used). However, despite definite early patient improvement, all reports for use of biologic valves show a significant incidence of recurrent valvar insufficiency and/or obstruction. A recent study of thirty-six patients utilizing homografts and heterografts for PVR noted that nine out of the thirty-four patients that were followed-up developed moderate to severe PI, and seventeen out of thirty-four developed significant obstruction within 80 months follow-up. Similarly, within 4.9 years, the incidence of homograft insufficiency was 50% mild, and 28% moderate-severe. Recent evidence suggests an immunologic basis for this early graft failure pattern.
- In light of the above, it was thought that a non-immunologic, non-degenerating, and relatively durable material, such as PTFE, and a different method of insertion of the valve would provide more optimal results. Experience from 3-17 years utilizing a PTFE monocusp for RVOT reconstruction suggests reasonable long-term durability and freedom from degeneration. A larger study of 158 patients using a PTFE monocusp for RVOT reconstruction, with follow-up from 6 months to 8 years, demonstrated no stenosis, calcification, or embolization. There was, however, significant development of pulmonary insufficiency graded as moderate to severe by 35 months in this monocusp study.
- The prior art discloses many types of heart valves, such in U.S. Pat. No. 5,344,442 issued to Deac, which discloses a cardiac valve designed to replace defective mitral valves in a patient's heart that comprises a plurality of flexible trapezoidal membranes each joined to another trapezoidal membrane to form a frustoconical annular body. Also, U.S. Pat. No. 4,340,977 issued to Brownlee, et al. for a catenary mitral valve replacement, which includes a mitral valve comprising a stent with a circular base and two upstanding, diametrically opposed struts that separate a pair of diametrically opposed arcuately shaped depressed reliefs. U.S. Pat. No. 5,500,015 issued to Deac for a cardiac valve comprising a plurality of membranes; U.S. Pat. No. 4,790,844 issued to Ovil, for a cardiac valve with an annular body having a bishop's miter shape with a cylindrical end and a pair of diametrically opposed triangular flap portions extending therefrom, and when the valve is inserted, the mitered end is free and the cylindrical end is attached to heart tissue; U.S. Patent Application Publication No. US2003/0181974 A1, filed by Xie, et al. for a bioprosthesis and method for suturelessly making same, which discloses a diamond-shaped frame to which a membrane is attached and wherein the frame is folded on itself and a slit cut into the folded side to allow fluid to flow through it; U.S. Pat. No. 6,682,559 B2, issued to Myers, et al. for a prosthetic heart valve that discloses a valve that includes a plurality of leaflets that are sewn together creating an annular structure which is then sutured into the heart; U.S. Patent Application Publication No. US2003/0163195 A1, filed by Quijano, et al. for a stentless atrioventricular heart valve fabricated from a singular flat membrane, which discloses attaching a membrane to a circumferential valve ring wherein the ring is sutured into an atrioventricular junction of a patient's heart.
- The present invention is generally directed to a method of making a heart valve.
- In aspects of the present invention, the method comprises forming a sheet of flexible synthetic resin having an elliptical shape having a minor axis, the sheet including an incision along the minor axis and an outer edge region having no frame structure, wherein the sheet is sufficiently flexible to allow the sheet to bend along the minor axis to form a valve in which the incision is movable between open and closed positions.
- In other aspects of the invention, the method comprises forming an elliptical sheet from a flexible synthetic resin, the elliptical sheet including an incision along the minor axis of the elliptical sheet, and bending the elliptical sheet along the incision to form a valve in which the incision is movable between open and closed positions, the valve including an outer edge region having no frame structure.
- A particularly preferred embodiment of the invention of this apparatus will be described in detail below in connection with the drawings in which:
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FIG. 1 is a flat sheet of PTFE material from which the a preferred embodiment will be crafted; -
FIG. 2 is an ellipse that has been cut out from the flat sheet; -
FIG. 3 is the ellipse, shown folded in half, with the fold defining one end; -
FIG. 4 is a top elevation a preferred embodiment being sized with a sizing tool; -
FIG. 5 is a side view of a preferred embodiment being sized with a sizing tool; -
FIG. 6 shows a horizontal view of the preferred embodiment; -
FIG. 7 shows a longitudinal view of the preferred embodiment; -
FIG. 8 depicts the incision in the right ventricular outflow tract into which the preferred embodiment will be inserted; -
FIG. 9 depicts the preferred embodiment being sewn into place; -
FIG. 10 depicts the preferred embodiment being sewn into place; -
FIG. 11 shows the actual placement of the preferred embodiment into a heart while the valve is in the open position; -
FIG. 12 shows the actual placement of the preferred embodiment into a heart while the valve is in the generally closed position; -
FIG. 13 is an illustration of the human heart, showing a dashed line where the incision into the right ventricular outflow tract is to be made; -
FIG. 14 is an illustration of the human heart into which the preferred embodiment is being sewn. - A particularly preferred embodiment of the present invention is illustrated in the drawings.
- The preferred embodiment of the present invention comprises a heart valve that is constructed from a synthetic, non-degradable, durable, safe, material, such as a fluoropolymer like PTFE, GORE-TEX®, Teflon®, or other synthetic resin suitable for use in biologic applications, and a method for making and inserting the heart valve.
- The preferred embodiment of the present invention is shown in
FIGS. 6 and 7 , and comprises a generallytubular element 42 with a first 26 and a second 30 end, wherein thefirst end 26 comprises a generallycircular orifice 34 defined by at least two opposingfree edges second end 30 comprises a plurality offlexible members 28. Twoflexible members 28 are shown in the figures. Further, theorifice 34 can occupy either of two positions, one being flat and generally closed (FIG. 12 ), the second being generally circular and open (FIG. 11 ). The predetermined length of the two opposingfree edges orifice 34 can be about 1.5 times thediameter 60 of a patient's rightventricular outflow tract 50. - The present invention also encompasses a method of making the heart valve, shown in
FIGS. 8-15 , which comprises the steps of making anincision 58 into the rightventricular outflow tract 50 and measuring thediameter 60 of the right ventricular outflow tract. Then, from a flat sheet of synthetic resin 10 (FIG. 1 ), which may be a synthetic, non-degradable, durable, safe, material, such as a fluoropolymer like PTFE, GORE-TEX®, Teflon®, or other synthetic resin suitable for use in biologic applications, an ellipse 22 (FIG. 2 ), with aminor axis 48 and a major 46 axis, is cut. Theminor axis 48 has a predetermined length and is defined by first 52 and second 54 edges, wherein the predetermined length should measure about 1.5 times thediameter 60 of the patient's rightventricular outflow tract 50, and be defined by twoperipheral edges 62. - The
ellipse 22 is then incised along theminor axis 48, such that theincision 16 extends along theminor axis 48, starting at about 2 mm from thefirst edge 52, and ending at about 2 mm from thesecond edge 54. Theellipse 22 is then folded in half on itself (FIG. 3 ) along theminor axis 48 such that theincision 16 may be formed (FIGS. 4-5 ) into a generally circular orifice 34 (FIG. 6-7 ) of a predetermined size. - The invention also contemplates the insertion (
FIGS. 8-14 ) of the heart valve into a patient's right ventricular outflow tract, comprising the steps of making anincision 58 in the rightventricular outflow tract 50 and attaching each of theflexible members 28, conveniently viasutures 66, to the anterior and posterior walls of theinfundibular septum 70 of the rightventricular outflow tract 50, such that theflexible members 28 are generally parallel to each other, and such that a generally tubular configuration is maintained (FIG. 11 ). - When inserted into the patient's right ventricular outflow tract, the generally tubular configuration enables the incision to extend across the right ventricular outflow tract, such that the
incision 16 can be formed into the generallycircular orifice 34 when blood is flowing through the RVOT, and such that theincision 16 can close into the generally flat and closed position to prevent backflow as the blood flow ceases or slightly reverses as patient's heart beats. Thus, the heart valve has a generally one-way valve function. Theflexible members 28 hold the heart valve in position, as they are sutured to the walls of theinfundibular septum 70, and prevent it from becoming dislodged in use. - While the foregoing describes particularly a preferred embodiment of the method and apparatus of this invention, it is to be understood that this embodiment is illustrative only of the principles of this invention and is not to be considered limitative thereof. Because numerous variations and modification of the apparatus and method of this invention will readily occur to those skilled in the art, the scope of this invention is to be limited solely by the claims appended hereto.
- While several particular forms of the invention have been illustrated and described, it will also be apparent that various modifications can be made without departing from the scope of the invention. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.
Claims (5)
1. A method of making an implantable valve, the method comprising:
forming a sheet of flexible synthetic resin having an elliptical shape having a minor axis, the sheet including an incision along the minor axis and an outer edge region having no frame structure;
wherein the sheet is sufficiently flexible to allow the sheet to bend along the minor axis to form a valve in which the incision is movable between open and closed positions.
2. The method of claim 1 , further comprising suturing the outer edge region to an anatomical site.
3. The method of claim 1 , further comprising suturing the outer edge region to the anterior and posterior wall of the infundibular septum of the right ventricular outflow tract of a patient.
4. The method of claim 3 , wherein the length of the incision or the minor axis is equal to about 1.5 times the diameter of the right ventricular outflow tract.
5. A method of forming an implantable valve, the method comprising:
forming an elliptical sheet from a flexible synthetic resin, the elliptical sheet including an incision along the minor axis of the elliptical sheet; and
bending the elliptical sheet along the minor axis to form a valve in which the incision is movable between open and closed positions, the valve including an outer edge region having no frame structure.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/013,904 US20080109074A1 (en) | 2004-01-23 | 2008-01-14 | Method for Making a Bicuspid Pulmonary Heart Valve |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US53887004P | 2004-01-23 | 2004-01-23 | |
US11/041,603 US7320705B2 (en) | 2004-01-23 | 2005-01-24 | Bicuspid pulmonary heart valve and method for making same |
US12/013,904 US20080109074A1 (en) | 2004-01-23 | 2008-01-14 | Method for Making a Bicuspid Pulmonary Heart Valve |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US11/041,603 Continuation US7320705B2 (en) | 2004-01-23 | 2005-01-24 | Bicuspid pulmonary heart valve and method for making same |
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US20080109074A1 true US20080109074A1 (en) | 2008-05-08 |
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US11/041,603 Active - Reinstated 2025-03-08 US7320705B2 (en) | 2004-01-23 | 2005-01-24 | Bicuspid pulmonary heart valve and method for making same |
US12/013,904 Abandoned US20080109074A1 (en) | 2004-01-23 | 2008-01-14 | Method for Making a Bicuspid Pulmonary Heart Valve |
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US11/041,603 Active - Reinstated 2025-03-08 US7320705B2 (en) | 2004-01-23 | 2005-01-24 | Bicuspid pulmonary heart valve and method for making same |
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US8303647B2 (en) * | 2005-03-03 | 2012-11-06 | Cook Medical Technologies Llc | Medical valve leaflet structures with peripheral region receptive to tissue ingrowth |
US8470022B2 (en) * | 2005-08-31 | 2013-06-25 | Cook Biotech Incorporated | Implantable valve |
-
2005
- 2005-01-24 US US11/041,603 patent/US7320705B2/en active Active - Reinstated
-
2008
- 2008-01-14 US US12/013,904 patent/US20080109074A1/en not_active Abandoned
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20010039450A1 (en) * | 1999-06-02 | 2001-11-08 | Dusan Pavcnik | Implantable vascular device |
US7163556B2 (en) * | 2002-03-21 | 2007-01-16 | Providence Health System - Oregon | Bioprosthesis and method for suturelessly making same |
US20060235511A1 (en) * | 2004-02-09 | 2006-10-19 | Cook Incorporated | Woven implantable device |
Also Published As
Publication number | Publication date |
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US7320705B2 (en) | 2008-01-22 |
US20060167542A1 (en) | 2006-07-27 |
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