Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – With means to attach graft to natural blood vessel
Reexamination Certificate
1998-09-14
2001-03-06
Milano, Michael J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
With means to attach graft to natural blood vessel
C606S151000, C604S008000
Reexamination Certificate
active
06197050
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention pertains to an implant for passing blood flow directly between a chamber of the heart and a coronary vessel. More particularly, this invention pertains to such an implant with an enhanced design for avoiding damage to a vessel.
2. Description of the Prior Art
Commonly assigned U.S. Pat. No. 5,755,682 and PCT International Publication No. WO 98/06356 teach an implant for defining a blood flow pathway directly from a chamber of the heart to a lumen of a coronary vessel. An embodiment disclosed in the aforementioned patent and application teaches an L-shaped implant. The implant is a conduit having one leg sized to be received within a lumen of a coronary artery and a second leg sized to pass through the myocardium and extend into the left ventricle of the heart. As disclosed in the above-referenced patent and application, the conduit remains open for blood flow to pass through the conduit during both systole and diastole. The conduit penetrates into the left ventricle in order to prevent tissue growth and occlusions over an opening of the conduit.
Commonly assigned and co-pending U.S. patent application Ser. No. 08/944,313 filed Oct. 6, 1997, now U.S. Pat. No. 5,984,956, entitled “Transmyocardial Implant”, and filed in the name of inventors Katherine S. Tweden, Guy P. Vanney and Thomas L. Odland, teaches an implant such as that shown in the aforementioned '356 application and '682 patent with an enhanced fixation structure. The enhanced fixation structure includes a fabric surrounding at least a portion of the conduit to facilitate tissue growth on the exterior of the implant.
Implants such as those shown in the aforementioned patent and applications include a portion to be placed within a coronary vessel and a portion to be placed within the myocardium. When placing a portion of the implant in the coronary vessel, the vessel is incised a length sufficient to insert the implant. When placed within the coronary vessel, the implant discharges flow axially into the vessel.
When placing an implant, a portion of the coronary artery is dissected. The dissected portion is incised and the vessel portion of the implant is inserted into the lumen. A stay suture secures the artery to the implant. The stay suture is placed around the artery and vessel portion a distanced spaced from the open end of the vessel portion.
In a preferred embodiment, the implant is rigid. An artery is flexible. A pulsing and alternating flow of blood through the rigid implant and flexible vessel can result in relative movement between the implant and vessel. As a result of such movement, a rubbing action may occur with the implant causing cellular damage to the vessel. Such damage may proliferate resulting in a fibrotic response which grows to block the implant or artery.
SUMMARY OF THE INVENTION
According to a preferred embodiment of the present invention, a transmyocardial implant is disclosed for establishing a blood flow path through a myocardium between a heart chamber and a lumen of a coronary vessel residing on an exterior of the heart. The implant includes a hollow conduit having a first portion and a second portion. The first portion is received within the lumen. The first portion has an axial dimension aligned with an axis of the vessel. The second portion is sized to extend from the vessel through the myocardium into the heart chamber. The conduit has open first and second ends on axial ends of respective ones of the first and second portions to define a blood flow pathway within an interior of the conduit between the first and second ends. A collar surrounds an exterior of the artery overlying the first portion at the first open end.
REFERENCES:
patent: Re. 35253 (1996-05-01), Worley et al.
patent: 3620218 (1971-11-01), Schmitt
patent: 3726279 (1973-04-01), Barefoot et al.
patent: 5330490 (1994-07-01), Wilk et al.
patent: 5399352 (1995-03-01), Hanson
patent: 5509902 (1996-04-01), Ravlerson
patent: 5578075 (1996-11-01), Dayton
patent: 5653755 (1997-08-01), Ledergerber
patent: 5755682 (1998-05-01), Knudson et al.
patent: 5836534 (1998-11-01), Bohmler
patent: 5984956 (1999-11-01), Twedwn et al.
patent: WO 98/06356 (1998-02-01), None
Werker, P. et al., “Review of Facilitated Approaches to Vascular Anastomosis Surgery”,Ann Thorac Surg, 63:S122-S127 (1997).
Eno Robert A.
Knudson Mark B.
Tweden Katherine S.
Vanney Guy P.
Heartstent Corporation
Merchant & Gould P.C.
Milano Michael J.
Pellegrino Brian E
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