Surgical clip applicator device

• US 6,896,684 B2
• Filed: 05/30/2002
• Issued: 05/24/2005
• Est. Priority Date: 06/12/2000
• Status: Expired due to Fees

• Current Assignee: Niti Surgical Solutions Ltd.
• Original Assignee: NITI Medical Technologies Limited
• Inventors: Harari, Boaz, Neeman, Ronen, Lelcuk, Shlomo, Monassevitch, Leonid, Arad, Michael
• Primary Examiner(s): Dawson, Glenn K.
• Assistant Examiner(s): DAVIS, DANIEL J
• Application Number:
  US10/158,673
• Publication Number:
  US 20020177859A1
• Time in Patent Office: 1,090 Days
• Field of Search: 606/139, 606/142, 606/144, 606151-158, 606/174, 606/207, 606/208, 606/210, 606/120
• US Class Current: 606/142
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/128 for applying or removing clamps or clips
• CPC Class Codes: A61B 17/2812 with a single pivotal connection A61B17/29 takes precedence
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1125 Forceps, specially adapted for performing or assisting anastomosis
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/1225 for clipping and cutting in a single operation

Abstract

The present invention, discloses an anastomosis clip applicator device for applying a surgical clip, formed at least partly of a shape memory alloy, to press together adjacent wall portions of adjacent hollow organ portions so as to effect anastomosis therebetween. The applicator device includes: gripping apparatus for gripping a surgical clip, a release mechanism, associated with the gripping apparatus, and tissue cutting apparatus, operatively associated with the gripping apparatus. There is also apparatus for activating the gripping apparatus, the release mechanism and the cutting apparatus, so as to introduce and apply the surgical clip into adjacent hollow organ portions, such that the surgical clip compresses together the adjacent walls of the hollow organ portions, and thereafter causes the cutting apparatus to perforate the adjacent pressed together organ walls to provide patency through the joined portions of the hollow organ.

Claims

1. A method for anastomosing a gastrointestinal tract, which includes the following steps:

(a) gripping a surgical clip which includes;

i) a first length of a wire having a predetermined cross-sectional shape and surface configuration, defining a closed geometrical shape having a central opening;

ii) a second length of a wire having a predetermined cross-sectional shape and surface configuration, defining a closed geometrical shape substantially similar in configuration and magnitude to that of the first length of wire, having a central opening, wherein the first and second lengths of wire fully overlap, when configured in side-by-side registration; and

iii) an intermediate portion located between said first length of wire and said second length of wire, said intermediate portion formed of a shape memory alloy;

b) maintaining at least the intermediate portion of the clip at a temperature below a lower phase transition temperature thereof, whereat the intermediate portion is in a plastic state;

c) moving the first and second lengths of wire into a position of mutual separation;

d) drawing together portions of the gastrointestinal tract, wherein anastomosis is required, so as to bring them into an adjacent, side-by-side position, at least one of the portions being open-ended;

e) surgically sealing the open ends of the portions of the gastrointestinal tract;

f) forming predetermined perforations in adjacent walls of the adjacent portions of gastrointestinal tract and introducing the clip through the punctures, such that the adjacent portions of each wall are disposed between the first and second lengths of wire;

g) retaining the relative adjacent positions of the portions of the gastrointestinal tract and the clip in relation thereto, while raising the temperature of at least the intermediate portion of the clip to a temperature above an upper phase transition temperature, whereat the intermediate portion is in an elastic stat;

thereby causing the first and second lengths of wire to attain side-by-side registration, thereby to apply a compressive force to the walls located therebetween; and

h) perforating the adjacent walls, held within the central openings between the first and second lengths of wire configured in side-by-side registration for creating an initial patency of the gastrointestinal tract.

2. An anastomosis system for applying at least one surgical clip formed at least partly of a shape memory alloy, said system including,

a) at least one surgical clip including:

i) a first length of a wire, having a predetermined cross-sectional shape and surface configuration, defining a closed geometrical shape having a central opening,

ii) a second length of a wire, having a predetermined cross-sectional shape and surface configuration, defining a closed geometrical shape substantially similar in configuration and magnitude to that of said first length of wire, wherein said first and second lengths of wire fully overlap, when disposed in side-by-side registration, and

iii) an intermediate portion located between said first length of wire and said second length of wire, said intermediate portion formed of a shape memory alloy;

wherein, when at a first temperature or higher, said first and second lengths of wire are positioned in a side-by-side closed position and said shape memory alloy is in an elastic state, and further, when at a second temperature or lower, below said first temperature, said shape memory alloy is in a plastic state, thereby enabling said first and second lengths of wire to be moved into and to retain a spaced apart position, and upon heating of said clip to a temperature at least equal to said first temperature, said first and second lengths of wire return to said side-by-side closed position, thereby to apply a compressive force to tissue located therebetween; and

b) an anastomosis clip applicator device for applying the surgical clip to press together adjacent wall portions of adjacent hollow organ portions so as to effect anastomosis between the adjacent organ portions, wherein said applicator device includes;

i) gripping apparatus for gripping the surgical clip, configured to permit positioning of the clip into a pair of adjacent hollow organ portions;

ii) a release mechanism, associated with said gripping apparatus, for selectably releasing said clip from said gripping apparatus when the clip is positioned in a selected position about a pair of organ walls to be anastomosed;

iii) tissue cutting apparatus having a predetermined configuration, operatively associated with said gripping apparatus, selectably operable, after positioning of the clip, to cut through the tissue walls so as to form therethrough a predetermined perforation; and

iv) apparatus for activating said gripping apparatus, said release mechanism and said cutting apparatus, so as to introduce and apply the surgical clip into adjacent hollow organ portions, such that the surgical clip compresses together the adjacent walls of the hollow organ portions, and thereafter causes said cutting apparatus to perforate the adjacent pressed together organ walls.

3. The system according to claim 2 wherein said cutting apparatus includes:

a) a blade element having a predetermined configuration; and

b) a counter element having a predetermined configuration, wherein said blade and counter elements are arranged in mutually opposing registration, and adapted to be closable in mutual mating engagement, thereby to perforate tissue located therebetween.

4. The system according to claim 2, wherein said geometrical shape is substantially a shape selected from the group including:

circular; and

elliptical.

5. The system according to claim 2, wherein said first length of wire and said second length of wire are defined by a continuous coil.

6. The surgical clip according to claim 2, wherein said first length of wire and said second length of wire are two distinct lengths of wire, each defining a closed geometrical shape.

7. The system according to claim 2, wherein at least one of said first length of wire and said second length of wire is formed having a cross-sectional shape substantially as selected from the group including:

a) circular;

b) circular, having planar surfaces formed therein such that, when configured in side-by-side registration, said planar surfaces of said first and second lengths of wire fully overlap thereby to control pressure applied to tissue compressed therebetween; and

c) elliptical, thereby to control pressure applied to tissue compressed between said first and second lengths of wire.

8. The system according to claim 2, at least one overlapping surface of at least one of said first length of wire and said second length of wire is formed having a surface configuration selected from at least one of the group including:

a) a plurality of parallel surface grooves;

b) knurled;

c) a plurality of spikes; and

d) a plurality of studs.

9. The system according to claim 2, wherein said gripping apparatus includes at least one pair of fastener elements for securing said clip to said applicator device.

10. The system according to claim 2, wherein said counter element is a second blade clement.

11. The system according to claim 2, wherein said applicator device includes ejector apparatus for disengaging and ejecting the clip from said gripping apparatus.

12. The system according to claim 2, wherein said applicator device has a proximal end portion and a distal end portion and wherein said gripping apparatus, said blade element and said at least one counter element are formed at said distal end.

13. The system according to claim 12, wherein said distal end portion is detachable from said proximal end portion.