CA1176802A - Heart valve protector - Google Patents

Heart valve protector

Info

Publication number
CA1176802A
CA1176802A CA000408100A CA408100A CA1176802A CA 1176802 A CA1176802 A CA 1176802A CA 000408100 A CA000408100 A CA 000408100A CA 408100 A CA408100 A CA 408100A CA 1176802 A CA1176802 A CA 1176802A
Authority
CA
Canada
Prior art keywords
valve
band
strip
suture
protective band
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.)
Expired
Application number
CA000408100A
Other languages
French (fr)
Inventor
Jonathan J. Rosen
George M. Acosta
Christopher J. Bowman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Extracorporeal Medical Specialties Inc
Original Assignee
Extracorporeal Medical Specialties Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Extracorporeal Medical Specialties Inc filed Critical Extracorporeal Medical Specialties Inc
Application granted granted Critical
Publication of CA1176802A publication Critical patent/CA1176802A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2409Support rings therefor, e.g. for connecting valves to tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0095Packages or dispensers for prostheses or other implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0059Additional features; Implant or prostheses properties not otherwise provided for temporary
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/90Stent for heart valve

Abstract

HEART VALVE PROTECTOR

ABSTRACT

A plastic band is secured around the outside of a prosthetic heart valve adjacent the sewing cushion to protect the valve leaflet material against inadvertent needle punctures and tears while sutures are being placed through the sewing cushion. The band is held in place by a single retention suture which passes through the band and sewing cushion of the valve and extends across the valve orifice. The protector is especially desirable for use with pericardial tissue valves having the tissue mounted on the outside of the valve stent where the tissue is particularly exposed and susceptible to needle damage.

Description

( ~76~30Z

~EART VALVE PROTECTOR
-BACKGROUND OF INVENTION

Field of the Invention This invention relates to prosthetic heart valves and, more particularly, to an apparatus and method for protect-ing valve cusp material against inadvertent needle punc-ture or tear during the implantation of the valve in thepatient.

Description of Prior Art Prosthetic tissue heart valves constructed of autologous or hemologous fascia lata, dura matter or heterologous pericardium are described in U. S. Patent Nos. 4,084,268 and 4,172,295. Typically, such valves are constructed by securing the tissue around the outside of a valve stent or framework having a circular base at one end and three axially-extending commissure posts interconnected by valleys at the other end. The tissue is supported at three points by the stent posts while the tissue interme-diate the stent posts extends through the valleys and into the center of the stent to form three valve cusps.

The valve stent also includes a sewing cushion around the circular base portion as illustrated in the above-re~erenced patents. The sewing cushion provides a means - 30 for attaching the valve to the patient by suturing through the sewing cushion. In one method of implanting the valve, a plurality of sutures are placed through the sewing cushion and the mounting site in the patient using an interrupted mattress stitch while holding the valve several inches away from the mounting site. When all the ~768~Z

sutures are in place, the valve is guided down the suture lines into the mounting position and the sutures are tied off.

In the case of valves constructed of pericardium or other natural tissues, the tissue is positioned outside the stent as illustrated in the above-referenced patents. The tissue is thusly exposed and subject to needle damage as the mounting sutures are placed through the sewing ring.
Since the operating area is cramped and vision may be limited, especially in the case of mitral valve replace-ment where the cusps of the valve are directed away from the surgeon and shielded from view by the sewing ring, great care must be taken when passing the mounting sutures through the sewing ring to avoid accidentally piercing or tearing the valve tissue. Because of the delicate nature of the tissue, a single needle hole can seriously compro-mise the long-term performance and durability of the valve.
It is accordingly an object of the present invention to provide a method and device for protecting the cusp material of a prosthetic heart valve against needle damage during the installation procedure. It is a further object ~5 of the present invention to provide a protective device which is easily removed from the heart valve after all the mounting sutures are in place. These and other objects of the present invention will be apparent from the ensuing description and claims.
Summary of the Invention Pericardial and other prosthetic tissue heart valves susceptible to needle damage during installation are protected from such damage by uroviding a protective band to surround and cover the valve tissue VC~ ~^5 ~768(~;~

immediately adjacent the sewing cushion. The protector may consist of a strip of plastic material which is formed into a cylinder and secured to the valve by a single retention suture. The suture is attached to the protec-S tive band at each end and at one or more points betweenthe ends, traversing the valve by passing through the sewing ring and across the valve orifice.

The retention suture traversing the orifice of the valve 0 i5 highly visible and assures that the valve will not be inadvertently be installed with the protector in place.
Once all the mounting sutures have been positioned through the sewing ring, the protector is removed by cutting the retention suture in the area of the valve orifice and pulling it free of the valve and pro-ective band. Once the retention suture has been removed, the protector is readily withdrawn from between the mounting sutures.

To facilitate suturing through the protector, the plastic strip is provided with a plurality of dimples and/or channels having a thin base-thickness at its ends and midpoint. ~ultiple rows of dimples or channels across the width of the strip are provided at either end to permit the length of the strip to be adjusted to the circumfer-ence of the valve by cutting off excess strip material.

Description of Drawings Figure 1 is a plan view of a protective band.
30Figure 2 is a cross-sectional view of the protective band through line 2-2 of Figure 1.

Figure 3 is a cross-sectional view of the protective band through line 3-3 of Figure 1.

VC~-5 1~7~8~Z

Figure 4 is a view in perspective of a mitral valve with the protective band in position.

Figure 5 is a partial view showing the suture placement at a point between the ends of the protective band.

Figure 6 is a partial view showing the suture placement at the ends of the protective band.

Description Referring now to Figure 1 there is i~lustrated at 10 a side plan view of a protective band of the present invention comprising a strip of plastic sheet material, suitably polypropylene, having a length corresponding to the ou~side circul~ference of the prosthetic tissue heart valve. The width of the strip is preferably at least about 0.25 inches, and the thickness is about 0.02 inches.
On one side at each end of the band are located suture guide means in the form of a double row of circular depressions 11 centrally disposed about the major axis of said strip and extending inward from the ends in a spaced relationship over a distance of at least about 0.5 inches.
Between the ends of the band and aligned with one row of circular depressions are elongated depressions 12 which are preferably about 0.25 inches long. Each depression has a base thickness of less than about 0.01 inches as illustrated in Figures 2 and 3 which are cross-sectional views at lines 2-2 and 3-3 respectively of Figure 1.
The protective band is affixed to the heart valve as illustrated in Figure 4 which is a view in perspective of a mitral heart valve with the protective band in place.
Referring to Figure 4, retention suture 20 passes through both ends of the protective band and through the sewing vcRr ."S

~1768(~Z

ring 16 of the valve and across the valve orifice. The intermediate portion of the band, hidden from view in Figure 4, is secured at two points by the suture as illustrated in Figure 5, the suture passing through the thin-base portion of elongated depressions 12 and thence returning through the sewing cushion. At the ends of the protective band, the suture passes through the outer most circular depressions in a figure X as illustrated in Figure 6. The suture is always placed through the outermost row of depressions at the end of the protective band, and multiple depressions are provided to enable the band to be shortened if necessary to fit smaller size valves by cutting off appropriate end sections at one or both ends of the protective strip.
The circular and elongated depressions in the band facili-tate the suture attachment of the band to the valve since the thin areas in the base of the depressions are easily pierced by a surgical needle.
The preferred material for band construction is polypro-pylene which is soft and flexible, easily molded and easily stitched. Other suitable materials include poly-ethylene, nylon, polyvinylchloride and other nontoxic polymeric compositions which possess the desirable combination of physical properties.

The protective band is intended primarily for use on heart valves constructed of natural or synthetic sheet materials such as pericardium, fascia lata, dura matter or polyur-ethane, and where the construction of the valve places the sheet material on the outside of the valve stent where it is particularly exposed and susceptible to needle damage.
The band may, of course, also be used in conjunction with porcine heart valve~ where, although the valve tissue is contained within th~ confines of the stent, the needles of VCR-~

-6- 1~768~Z
the mounting sutures may catch in the fabric of the stent cover and interfere with suture placement.

When attaching the protective band to the valve, the ends of the band are butted together and secured with a double armed suture. The band is then positioned on the valve and both ends of the suture passed through the sewing ring and over the valve annulus. One end of the suture pro-ceeds through the sewing ring and intermediate depressions 12 as illustrated in Figure 4. The two ends of the suture are finally tied so the knot is located over the valve orifice.

The protective band is removed by cutting one strand of the retention suture at a point over the valve orifice.
When an interrupted mattress stitch is used for a valve installation, the band is not removed until all the sutures have been placed through the sewing ring. When a continuous or semicontinuous suturing technique is used to sew the valve directly in place, the band is removed before the valve is positioned for suturing.

While the foregoing description has been directed to a preferred embodiment of the protective band of the present invention, it will be appreciated that certain variations thereof which are functionally equivalent are also included within the scope of the invention. For example, the circular depressions illustrated in the Figures as suture guide means may be converted to openings extending through the band, and the suture threaded through these openings rather than being sewn through the band material.
In another alternative embodiment, the double row of circular depressions at the ends of the strip may be replaced by a plurality of single, elongated depressions extending across the width of the band, or by a pair of elongated channels extending lengthwise along either side VC~-~5 ~l76saz of the central axis of the band. A singular elongated depression 12 located at the midpoint of the protective strip may also be used rather than the pair of depressions as illustrated in Figure 1. These and other variations will be apparent to those skilled in the art in view of the disclosure contained herein.

C~;

Claims (18)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:-
1. In a prosthetic heart valve comprising a cylindrical stent, sheet material overlying the stent and extending inwardly to form a closure within the confines of said stent, and a sewing cushion encircling the stent at one end thereof, the improvement comprising a removable protective band circumscribing the stent and overlying the sheet material immediately adjacent said sewing cushion.
2. The valve of Claim 1 wherein said protective band is secured to said valve by means of a single retention suture passing through the band and sewing cushion and traversing the orifice of the valve.
3. The valve of Claim 1 wherein the band is fabricated of a polymeric material.
4. The valve of Claim 3 wherein said protective band is molded of polypropylene.
5. The valve of Claim 2 wherein said protective band includes depressions at locations where the suture is passed through the band.
6. The valve of Claim 2 wherein said band includes openings at locations where the suture is passed through the band.
7. The valve of Claim 2 wherein the protective band comprises an elongated strip formed into a cylinder with the ends secured by said retention suture.
8. The valve of Claim 1 wherein said protective band is at least about 0.25 inches wide.
9. The valve of Claim 1 wherein said sheet material is a natural tissue material.
10. The valve of Claim 8 wherein said natural tissue material is selected from the group consisting of pericardium, fascia lata and dura matter.
11. The valve of Claim 1 wherein said sheet material is polyurethane.
12. A protective band adapted to circumscribe a prosthetic heart valve constructed of natural or synthetic sheet material and comprising a flat, elongated strip having a length corresponding to the circumference of said valve a width of at least about 0.25 inches, said band having a plurality of suture guide means at each end thereof and at least one suture guide means intermediate said ends.
13. A protective band of Claim 12 wherein said strip is fabricated of a nontoxic polymeric material.
14. The protective band of Claim 13 wherein said protective band is molded of polypropylene.
15. The protective band of Claim 12 wherein said suture guide means comprise openings through said strip.
16. The protective band of Claim 12 wherein said suture guide means comprise depressions in one surface of said strip.
17. The protective band of Claim 16 wherein the thickness of said strip is about 0.02 inches, and the thickness at the base of said depressions is less than about 0.01 inches.
18. The protective strip of Claim 12 wherein said strip includes a double row of suture guide means centrally disposed about the major axis of said strip at each end thereof and a pair of elongated suture guide means aligned with one of said rows and equidistantly spaced between the ends of said strip.
CA000408100A 1981-07-28 1982-07-26 Heart valve protector Expired CA1176802A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US287,606 1981-07-28
US06/287,606 US4364126A (en) 1981-07-28 1981-07-28 Heart valve with removable cusp protector band

Publications (1)

Publication Number Publication Date
CA1176802A true CA1176802A (en) 1984-10-30

Family

ID=23103624

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000408100A Expired CA1176802A (en) 1981-07-28 1982-07-26 Heart valve protector

Country Status (10)

Country Link
US (1) US4364126A (en)
JP (1) JPS5827556A (en)
BR (1) BR8204387A (en)
CA (1) CA1176802A (en)
CH (1) CH657039A5 (en)
DE (1) DE3227829A1 (en)
ES (1) ES278712Y (en)
FR (1) FR2510396B1 (en)
GB (1) GB2102545B (en)
NL (1) NL8202900A (en)

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US3755823A (en) * 1971-04-23 1973-09-04 Hancock Laboratories Inc Flexible stent for heart valve
CA1069652A (en) * 1976-01-09 1980-01-15 Alain F. Carpentier Supported bioprosthetic heart valve with compliant orifice ring
US4084268A (en) * 1976-04-22 1978-04-18 Shiley Laboratories, Incorporated Prosthetic tissue heart valve
US4172295A (en) * 1978-01-27 1979-10-30 Shiley Scientific, Inc. Tri-cuspid three-tissue prosthetic heart valve
US4222126A (en) * 1978-12-14 1980-09-16 The United States Of America As Represented By The Secretary Of The Department Of Health, Education & Welfare Unitized three leaflet heart valve
US4211325A (en) * 1979-06-07 1980-07-08 Hancock Laboratories, Inc. Heart valve holder

Also Published As

Publication number Publication date
CH657039A5 (en) 1986-08-15
ES278712Y (en) 1985-04-16
DE3227829A1 (en) 1983-02-17
US4364126A (en) 1982-12-21
FR2510396B1 (en) 1986-05-09
GB2102545B (en) 1985-01-09
FR2510396A1 (en) 1983-02-04
BR8204387A (en) 1983-07-19
NL8202900A (en) 1983-02-16
GB2102545A (en) 1983-02-02
JPS5827556A (en) 1983-02-18
ES278712U (en) 1984-10-16

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