Semi-rigid compressive clamp for use in sternotomy, and forceps for its application

• US 6,969,391 B1
• Filed: 04/18/2000
• Issued: 11/29/2005
• Est. Priority Date: 04/21/1999
• Status: Expired due to Term

• Current Assignee: Praesidia S.r.l.
• Original Assignee: Romolo Igino Gazzani
• Inventors: Gazzani, Romolo Igino
• Primary Examiner(s): Philogene, Pedro
• Assistant Examiner(s): STOKES, CANDICE CAPRI
• Application Number:
  US09/959,104
• Time in Patent Office: 2,051 Days
• Field of Search: 606/75, 606/60, 606/61, 606/62, 606/63, 606/64, 606/72, 606/74, 606/151
• US Class Current: 606/75
• CPC Class Codes: A61B 17/823 for the sternum
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: Y10S 606/911 Memory material

Abstract

A clamp designed for use in the heart-surgery field for osteosynthesis following on sternotomy has a roughly C-shaped configuration with a core (11) terminating at opposite ends with hooks (12) set opposite to one another. In the centre, the said core (11) extends vertically according to a plane which is substantially perpendicular to the one on which the end hooks (12) lie, with a loop (13) which is elastically compliant. The said clamp is made of a so-called “shape-memory” metallic alloy, i.e., an alloy which is malleable at a low temperature and which re-acquires its original form at body temperature, exerting a semi-rigid compression on the ends or edges of the bones requiring synthesis.

Claims

1. A clamp for osteosynthesis following a sternotomy said clamp having a C-shaped configuration, two opposite ends and a core (11) which is terminated by said opposite ends, said opposite ends having hooks (12), including terminal ends said core (11) consisting of only a single loop (13) which is elastically compliant and is centered on said C-shaped clamp, said clamp being made of a memory retaining metallic alloy, wherein said clamp is designed for use in the field of heart-surgery for osteosynthesis following a sternotomy, said loop (13) being extended vertically to a first plane which is substantially perpendicular to a second plane in which all of said end hooks (12) lie, said end hooks being adapted to exert a force against each other when placed in position over a sternotomy wherein said clamp before application is maintained in a malleable condition at a low temperature, and after application re-acquires said clamp'"'"'s original form as the temperature of said clamp increases towards body temperature, thereby exerting a semi rigid compression on ends or edges of bones requiring synthesis.

2. A clamp according to claim 1, wherein said shape-memory metallic alloy is a nickel and titanium alloy that is malleable at temperature from about 0°

C. to about 5°

C. and reacquires initial shape at about 37°

C.

3. A medical device comprising a combination of forceps and said clamp (10) as defined in claim 1, wherein said forceps comprise two levers (23, 22) hinged together at an intermediate point (23), said levers being provided with respective opposed jaws (25, 26) between which said clamp (10) may be inserted, said jaws (25, 26) being provided with means for divaricating said loop (13) of said clamp (10) in the closing position of said forceps.

4. The medical device according to claim 3, wherein said forceps further comprise said divaricating means consisting of a seat for said clamp (10) in said jaw (25) and of a wedge-shaped section in said jaw (26) which is designed to wedge into said loop (13) so as to divaricate said clamp (10) when said forceps are closed.

5. The medical device according to claim 4, wherein said forceps further comprise said jaw (25) comprising a fret-shaped cross section defining a C-shaped seat (27) from which opposite flanges (28) extend, said seat being designed to house said clamp (10) with said core (13) bearing upon said flanges (28).

6. The medical device according to claim 5, wherein said forceps further comprise said seat (27) comprising a recess or “

cradle”

(29) for receiving said loop (13), whilst the wedge-shaped section of said jaw (26) has a groove (29′

) for opening said loop.

7. A method for clamping an osteosynthesis following a sternotomy, said method comprising applying to the edges of a sternotomy a clamp, said clamp having a C-shaped configuration, two opposite ends and a core (11) which is terminated by said opposite ends, said opposite ends having hooks (12), said core (11) comprising a loop (13) which is elastically compliant and is centered on said C-shaped clamp, said clamp being made of a memory retaining metallic alloy, wherein said clamp is designed for use in the field of heart-surgery for osteosynthesis following a sternotomy, said loop (13) being extended vertically to a plane which is substantially perpendicular to a plane in which said end hooks (12) lie, said end hooks (12) having terminal portions which oppose one another, said end hooks being adapted to exert a force against each other when placed in position over a sternotomy, wherein said clamp before application is maintained in a malleable condition at a low temperature, and after application re-acquires said clamp'"'"'s original form as the temperature of said clamp increases towards body temperature, thereby exerting a semi rigid compression on ends or edges of a sternotomy.