Surgery – Specula – Retractor
Reexamination Certificate
2001-04-10
2003-04-15
Calvert, John J. (Department: 3765)
Surgery
Specula
Retractor
C606S139000
Reexamination Certificate
active
06547725
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of surgical apparatus and more specifically, to a suture and associated anchoring mechanism for applying tissue retraction during surgery.
BACKGROUND OF THE INVENTION
Generally, surgery requires an incision through a patient's skin, underlying muscle and tissue to expose the underlying body organ or anatomical tissue which is in need of the particular surgical intervention. In certain types of surgery such as cardiac surgery for instance, the patient's bone structure may also be incised and retracted. This is the case with a midline sternotomy incision which incises the patient's sternum and retracts the ribcage, or in situations where bone structure is spread apart without incision thereof as with an intercostal thoracotomy incision in which two adjacent patient ribs are spread apart in order to expose the underlying body organ, namely the patient's heart.
To obtain and maintain a surgical window or opening onto the underlying body organ or tissue in relation to which the surgical intervention will take place, abdominal or thoracic surgical retractors are used subsequent to the initial incision to spread the incised body tissue. Surgical retractors exist in many sizes and shapes and have been present since the dawn of surgery. Most known retractors have an elongate rack bar and two retracting arms, namely a fixed retracting arm and a movable retracting arm. Both arms typically extend in a direction normal to the rack bar. The movable arm can be displaced along the rack bar, and relative to the fixed arm, by using a crank to activate a pinion mechanism which engages teeth on the rack bar. Two blades are provided, usually disposed below the retractor arm and extending into the surgical incision, to interface with the patient's skin and tissue and to apply the retraction that creates the surgical window by relative movement and an ensuing spacing apart of the two retractor arms. The retractor blades may also engage with the patient's bone structure during surgery that requires access to tissue or organs contained within the patient's thorax. This is the case with coronary artery bypass graft (CABG) surgery, where the patient's skin and incised sternum are engaged with the blades of a surgical retractor known as a sternum or sternal retractor. The basic surgical approach and surgical retractor design for creating a surgical window onto the underlying tissue and organs requiring the surgical intervention, whereby the two or more spreader members or retractor arms are moved apart to retract engaged tissue, have remained relatively unchanged since the first introduction of retractors to surgery, regardless of the type, size and shape of the surgical retractor. The surgeon may at times place a sterile drape, cloth, or other type of packing between the patient's incised body tissue and the interfacing blades or other portion of the surgical retractor.
Once the surgical window is created, the surgeon often times will retract other internal body tissue which becomes accessible through the surgical window, with a flexible wire-like filament having a tissue-piercing member on one end of the wire-like filament, such as a suture line with integral needle on one end of the suture line. The suture line with the integral tissue piercing needle at one end will be referred to herein as the “traditional suture” or simply the “suture”.
A standard technique for retraction of coronary tissue during cardiac surgery has been the use of sutures, including traction sutures and stay sutures. These sutures are well known in the field of cardiac surgery and are available in a variety of needle configurations, suture length and diameter thicknesses. The sutures are generally available in kit form in disposable sterilized packets containing a needle and a length of filament.
Internal body tissue may be retracted for a number of reasons during surgery, namely:
a) to improve access to the target body organ or target organ tissue requiring the surgical intervention; this may be accomplished by displacing or retracting surrounding internal body tissue that may obstruct, restrict or impede surgical access, as for instance when retracting fatty tissue;
b) to maintain access to the inside of an organ cavity or body vessel subsequent to an incision of the organ or vessel; this may be accomplished by retracting incised portions of organ tissue or vessel tissue, as for instance when retracting incised portions of the aorta to maintain access to the aortic valve;
c) to position or orient at least a portion of the body organ; this may be accomplished through retraction of surrounding tissue which is anatomically attached to the body organ or through retraction of the body organ directly.
Tissue retraction is typically achieved by piercing the body organ or body tissue with a needle at the end of a suture line, threading a length of suture line through the pierced body tissue, and pulling simultaneously on both resulting lengths of the suture line; that is, the length between the pierced tissue and the free end of the suture line, and the length between the pierced tissue and the needle-bearing end of the suture line. Retraction loads are imposed on the body tissue or body organ at the location where the needle pierces and penetrates through the tissue or the organ.
In most surgical procedures, retraction is maintained by securing the above mentioned two lengths of the suture line by accomplishing one of the following techniques:
a) tying the free end and needle-bearing end of the suture line to each other through another part of the patient's anatomy, preferably remote to the location of body tissue where the surgical intervention will take place;
b) simultaneously clamping these two lengths of suture line to other body tissue or to the sterile cloth or packing inserted between the surgical retractor and the patient's incised tissue creating the surgical window;
c) clamping these two lengths to the surgical retractor with a surgical clamp or tying the free end and the needle-bearing end of these two lengths to each other and to a portion of the surgical retractor;
d) clamping these two lengths with a surgical clamp and wedging the tip or at least a portion of the surgical clamp between the retractor and the patient's body or between the retractor and the sterile cloth or packing placed along the surgical incision and trapped between the retractor blades and patient's body.
The current methods described above of maintaining tissue retraction may, in some instances:
a) be time consuming, since securing of the retraction load through the manual tying of the suture line lengths is a multi-step threading and knotting procedure,
b) be cumbersome due to poor access during the manual tie down of the suture line lengths, especially in surgical interventions when the surgical window is small;
c) not be conducive to readjustment of the magnitude of the desired tensile retraction load on the organ or body tissue, or on the direction of said load relative to the organ or body tissue without having to untie and retie suture line lengths or without having to cut the existing suture line having the undesired retraction load and replacing it with a new suture that must again pierce the organ or body tissue and be secured by way of one of the methods listed above;
d) compromise the ergonomics of and the surgeon's access into the surgical window, especially when a surgical clamp is used to secure the two lengths of the suture line to the perimeter of the surgical window or to a portion of the surgical retractor used to create the surgical window, all the more when multiple suture lines need to be secured to achieve the desired organ or body tissue retraction;
e) hinder or restrict the readjustment of the surgical window opening through the opening or closing of the surgical retractor, if the lengths of the suture line are tied to the rack bar of the surgical retractor, or hinder the deployment or readjus
Cartier Raymond
Paolitto Anthony
Valentini Valerio
Calvert John J.
Coroneo Inc.
Hoey Alissa L.
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