Devices, systems and methods for creating sutureless on-demand vascular anastomoses and hollow organ communication channels
First Claim
1. A catheterless, piercing introducer assembly suitable for the introduction and sutureless juncture of a prepared communication channel to the interior space of an anatomic body part within a living subject, said introducer comprising:
- a perforator instrument comprised of (i) at least one elongated supporting shaft of predetermined overall dimensions and axial configuration (ii) a handle attached at one end to said supporting shaft; and
(iii) a perforating headpiece integrally joined to the other end of said supporting shaft, said perforating headpiece comprising a perforating tip, a penetrating body, and a base aspect; and
communication channel controlling means disposed adjacent to said perforating headpiece on said supporting shaft of said perforator instrument.
0 Assignments
0 Petitions
Accused Products
Abstract
The present invention provides devices, systems, assemblies, and methods intended for the introduction and sutureless juncture of a prepared communication channel to the interior spatial volume of a blood vessel or a hollow organ within a living subject. The introducer assembly and system is functional and suitable as a complete substitute and replacement for conventionally used apparatus and methods for performing vascular bypass graft surgery in order to overcome an obstruction in a major artery or vein in-vivo. The introducer assembly and system is also most appropriate for use in providing penetration and juncture of a tubular conduit for use as an access duct in order to drain materials from or introduce fluids into the interior spatial volume of a hollow organ in-vivo.
156 Citations
29 Claims
-
1. A catheterless, piercing introducer assembly suitable for the introduction and sutureless juncture of a prepared communication channel to the interior space of an anatomic body part within a living subject, said introducer comprising:
-
a perforator instrument comprised of (i) at least one elongated supporting shaft of predetermined overall dimensions and axial configuration (ii) a handle attached at one end to said supporting shaft; and
(iii) a perforating headpiece integrally joined to the other end of said supporting shaft, said perforating headpiece comprising a perforating tip, a penetrating body, and a base aspect; and
communication channel controlling means disposed adjacent to said perforating headpiece on said supporting shaft of said perforator instrument. - View Dependent Claims (4, 5, 6, 7, 8, 10, 11, 12)
-
-
2. A catheterless, piercing introducer assembly suitable for the introduction and sutureless juncture of a prepared communication channel to the interior space of an anatomic body part within a living subject, said introducer assembly comprising:
-
a perforator instrument comprised of (i) at least one elongated supporting shaft of predetermined overall dimensions and axial configuration (ii) a handle attached at one end to said supporting shaft; and
(iii) a perforating headpiece integrally joined to the other end of said supporting shaft, said perforating headpiece comprising a perforating tip, a penetrating body, and a base aspect;
channel controlling means disposed adjacent to said perforating headpiece on said supporting shaft of said perforator instrument;
a volumetric shaft having two open ends and at least one sidewall of determinable dimensions, said sheath being (1) sized at one open end for on-demand placement adjacent to and aligned closure with said perforating headpiece of said perforator instrument, (2) substantially annular in configuration over its axial length, and (3) adapted for protective positioning around and volumetric spatial envelopment of at least a portion of said supporting shaft extending from said perforating headpiece of said perforator instrument, said sheath providing a protective covering for said enveloped spatial volume then surrounding said supporting shaft; and
holding means attachable to and detachable from said volumetric sheath and said supporting shaft of said perforator instrument for holding said volumetric sheath and the enveloped spatial volume at a set position around said supporting shaft of said perforator instrument. - View Dependent Claims (9, 13, 14, 15)
-
-
3. A catheterless, piercing introducer assembly suitable for the introduction and sutureless juncture of a prepared communication channel to the interior space of an anatomic body part within a living subject, said introducer assembly comprising:
-
a perforator instrument comprised of (i) at least one elongated supporting shaft of predetermined overall dimensions and axial configuration, (ii) a handle attached at one end to said supporting shaft, and (iii) a perforating headpiece integrally joined to the other end of said supporting shaft, said perforating headpiece comprising a perforating tip, a penetrating body, and a base aspects communication channel controlling means disposed adjacent to said perforating headpiece on said supporting shaft of said perforator instrument;
a volumetric sheath having two open ends and at least one sidewall of determinable dimensions, said sheath being (1) sized at one open end for on-demand placement adjacent to and aligned closure with said perforating headpiece of said perforator instrument, (2) substantially annular in configuration over its axial length, and (3) adapted for protective positioning around and volumetric spatial envelopment of at least a portion of said supporting shaft extending from said perforating headpiece of said perforator instrument, said sheath providing a protective covering for said enveloped spatial volume then surrounding said supporting shaft;
position holding means attachable to and detachable from said volumetric sheath and said supporting shaft of said perforator instrument for holding said volumetric sheath and the enveloped spatial volume at a set position around said supporting shaft of said perforator instrument; and
a prepared communication channel comprising a linking connector including at least a first portion of determined dimensions and configuration which is deformable on-demand, said first portion of said linking connector being suitable for passage through an aperture and deformation within the interior space of an anatomic body part whereby said deformation serves to secure said communication channel to the interior of the anatomic body part and places said secured communication channel in fluid flow communication with the interior space of the anatomic body part, and a second portion of determined dimensions and configuration which is permanently joined to a tubular conduit such that said joining retains and secures the tubular conduit for fluid flow communication; and
a tubular conduit of fixed dimensions and configuration having two open ends and at least one internal lumen, said tubular conduit being permanently joined at one open end to said linking connector. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
-
-
26. A perforator instrument suitable for the introduction and sutureless juncture of a prepared communication channel to the interior space of an anatomic body part within a living subject, said introducer perforator instrument comprising:
-
(i) at least one elongated supporting shaft of predetermined overall dimension and axial configuration (ii) a handle attached at one end to said supporting shaft; and
(iii) a perforating headpiece integrally joined to the other end of said supporting shaft, said perforating headpiece comprising a perforating tip, a penetrating body, and a base aspect.
-
-
27. A volumetric sheath suitable for use within a catheterless, piercing introducer assembly for the introduction and sutureless juncture of a prepared connecting conduit apparatus to the interior space of an anatomic body part within a living subject, said volumetric sheath comprising:
-
a shell covering having two open ends and at least one sidewall of determinable dimensions, said shell covering being (1) sized at one open end for on-demand placement adjacent to and aligned closure with an introducer instrument;
(2) substantially annular in configuration over its axial length; and
(3) adapted for protective positioning around and volumetric spatial envelopment of at least a portion of a perforator instrument, wherein said volumetric sheath provides a protective covering for said enveloped spatial volume of the perforator instrument.
-
-
28. A method for introduction and sutureless juncture of a prepared communicating channel to the interior space of an anatomic body part within a living subject, said method comprising the steps of:
-
obtaining an introducer assembly comprised of a perforator instrument including (i) at least one elongated supporting shaft of predetermined overall dimensions and axial configuration;
(ii) a controlling handle attached at one end to said supporting shaft; and
(iii) a perforating headpiece integrally joined to the other end of said supporting shaft, said perforating headpiece comprising a perforating tip, a penetrating body, and a base aspect; and
communication channel controlling means disposed adjacent to said perforating headpiece on said supporting shaft;
preparing a communicating channel comprising a linking connector including at least a first portion of determined dimensions and configuration which is permanently deformable on-demand, said first portion of said linking connector being suitable for passage through an aperture and deformation within the interior space of an anatomic body part whereby said deformation serves to secure said communicating channel to the interior of the anatomic body part and places said secured communicating channel in fluid flow communication with the interior space of the anatomic body part, and a second portion of determined dimensions and configuration which is permanently joined to a tubular conduit such that said joining retains and secures the tubular conduit for fluid flow communication; and
a tubular conduit of fixed dimensions and configuration having two open ends and at least one internal lumen, said tubular conduit being permanently joined at one open end to said linking connector;
positioning said prepared communicating channel around said supporting shaft of said perforator;
introducing said positioned communicating channel using said introducer assembly to the interior space of an anatomic body part within a living subject such that said first portion of said linking connector of said positioned communicating channel becomes deformed and secures said joined tubular conduit to the interior space of the anatomic body part for fluid flow communication.
-
-
29. A method for introduction and sutureless juncture of a prepared communicating channel to the interior space of an anatomic body part within a living subject, said method comprising the steps of:
-
obtaining an introducer assembly comprised of a perforator instrument including (i) at least one elongated supporting shaft of predetrined overall dimensions and axial configuration;
(ii) a controlling handle attached at one end to said supporting shaft; and
(iii) a perforating headpiece integrally joined to the other end of said supporting shaft, said perforating headpiece comprising a perforating tip, a penetrating body, and a base aspect;
a volumetric sheath having two open ends and at least one sidewall of determinable dimensions, said sheath being (1) sized at one open end for on-demand placement adjacent to and aligned closure with said perforating headpiece of said perforator instrument, (2) substantially annular in configuration over its axial length, and (3) adapted for protective positioning around and volumetric spatial envelopment of at least a portion of said supporting shaft extending from said perforating headpiece of said perforator instrument, said sheath providing a protective covering for said enveloped spatial volume then surrounding said supporting shaft;
position holding, means attachable to and detachable from said volumetric sheath and said supporting shaft of said perforator instrument for holding said volumetric sheath and the enveloped spatial volume at a set position around said supporting shaft of said perforator instrument; and
a prepared communicating channel comprising a linking connector including at least a first portion of determined dimensions and configuration which is deformable on-demand, said first portion of said linking connector being suitable for passage through an aperture and deformation within the interior space of an anatomic body part whereby said deformation serves to secure said communication channel to the interior of the anatomic body part and places said secured communication channel in fluid flow communication with the interior space of the anatomic body part, and a second portion of determined dimensions and configuration which is permanently joined to the sidewall of a tubular conduit such that said joining retains and secures the tubular conduit for fluid flow communication; and
a tubular conduit of fixed dimensions and configuration having two open ends and at least one internal lumen, said tubular conduit being permanently joined at one open end to said linking connector;
positioning said prepared communicating channel around said supporting shaft of said perforator instrument such that said volumetric sheath envelops and protects said positioned communicating channel; and
introducing said positioned communicating channel using said introducer assembly to the interior space of an anatomic body part within a living subject such that said portion of said linking connector of said positioned communicating channel becomes deformed and secures said joined tubular conduit to the interior space of the anatomic body part for fluid flow communication.
-
Specification