Surgery – Instruments – Sutureless closure
Reexamination Certificate
1999-11-08
2001-08-14
O'Connor, Cary E. (Department: 3732)
Surgery
Instruments
Sutureless closure
C606S142000, C606S151000
Reexamination Certificate
active
06273903
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a stapling device and to an associated surgical staple. More particularly, this invention relates to a device usable with an endoscope and/or in a laparoscopic surgical procedure for performing a stapling operation on a patient's internal body tissues at a surgical site not visible to the unaided eye.
BACKGROUND OF THE INVENTION
Stapling is known in the surgical arts as an alternative to suturing as a method of mechanically fastening cut or torn human tissue as an aid in the healing process. Stapling, or the use of independent rigid or semi-rigid multiple prong penetrating fasteners, enjoys several broad advantages relative to suturing. While suturing in effect results in a customized wound closure, stapling is faster and eliminates tasks requiring direct manipulation of tissue by a doctor or technician. The latter feature is paramount in cases where such manipulation is impractical or impossible, such as in endoscopy or laparoscopy or other minimally invasive surgical techniques. Such techniques characteristically require manipulation and repair of bodily tissues which cannot be directly seen or touched by a physician. Suturing has not proven practicable under these conditions using existing technology. Hence there is a continuing demand for improved methods of fastening for use in minimally invasive surgical techniques, and in particular, improved and various methods of stapling.
In minimally invasive surgery, operating space is at a premium, and in particular, dimensional extension in directions transverse to a longitudinal axis of a laparoscopic or endoscopic device is severely limited. Devices employed in the corresponding surgical tasks, such as endoscopes and laparoscopes generally have one elongate and two limited transverse dimensions: the resulting operational problem is analogous to constructing a model ship through the narrow neck of a bottle. Existing solutions to the problem of delivering a staple through a narrow channel in an endoscopic or laparoscipic procedure include fasteners or clamps which are biased closed, fed to an operating site in a closed configuration and forced open by a stapling tool at a point of use. Upon release by the tool, the fastener clamps intervening tissue. Another solution is to feed a fastener in a distorted closed configuration to the operating site, allow the fastener to open under internal spring forces just prior to application, and force the fastener closed a second time in an undistorted closed configuration, permitting engagement of locking elements to maintain the fastener in a closed configuration.
While endoscopic fastening devices certainly exist, the field is not mature, and a novel fastening assembly employing a parameter set or design choices not universally inferior in result to existing sets of parameters of design choices has a positive probability of proving superior to existing devices in solving some particular surgical problem. In particular, a novel surgical fastening device or assembly, allowing, relative to prior art, either a greater variety of fastener types to be inserted into a patient's body, or insertion at novel orientations relative to a distal tip of a minimally invasive surgical device, has a prima facie utility in the minimally invasive surgical arts.
OBJECTS OF THE INVENTION
An object of the present invention is to provide a surgical staple assembly for use in endoscopic surgical procedures to close openings internal to a patient's body.
Another object of the present invention is to provide an associated staple for use in endoscopic surgical procedures to close openings internal to a patient's body.
Yet a further object of the present invention is provide a surgical staple and related surgical staple assembly which substantially expands the functionality of existing endoscopic surgical staplers in at least one aspect.
These and other objects of the present invention will be apparent from the drawings and descriptions herein.
SUMMARY OF THE INVENTION
A surgical fastener in the form of a staple generally includes two legs which pierce and compress an intervening mass or body of tissue. A tensile force is thereby transferred to an intermediate portion of the staple, or bight, joining the two legs. The staple thereby serves as a bridge, temporarily assuming tensile force or stress which would have been assumed by cut or torn tissue, bring edges or lips of the cut together, in order to promote healing.
Force developed by a staple in compressing or resisting separating forces on intervening material is elastic in origin; i.e., developed by the staple in reaction to strain or deformation from an equilibrium configuration. The equilibrium configuration in turn may be modified in situ, following plastic deformation of a fastener having appropriate cold working properties by a fastening tool, or be preloaded in the form of a spring bias. The latter nomenclature calls attention to a design emphasis on strain in a particular element of a structure, a “spring element,” while regarding a remainder of a structure as essentially rigid.
A staple body as a whole, comprising integral legs and optionally prongs or piercing elements, may be constructed from a material allowing substantial elastic deformation without plastic deformation, such as a spring steel, and thereby enjoy an elastic bias or equilibrium configuration from which substantial elastic deviations may be enjoyed. When an equilibrium configuration is fixed prior to use, and plastic deformation of a staple during a stapling operation is not contemplated, the staple or fastener may also conventionally be called a “clamp.”
Yet another means of altering an equilibrium configuration of a fastener during use, as an alternative to plastic deformation, is the employment of locking elements. Locking elements in effect permit a change in overall equilibrium configuration by the introduction of permanent internal stresses. The distinction between “clamps,” “staples” and other mechanical fasteners which may be envisaged for use in surgical procedures is blurred by invention.
The present invention is directed to a staple in the form of a clamp, or spring-loaded fastener, biased towards a closed use configuration, in which the fastener or staple grasps and compresses a mass of intervening tissue, thereby occluding or closing an intervening tear in the tissue. The invention is also directed to an associated stapler assembly, incorporating at least one staple in a tool adapted for insertion into a patient's body through a narrow channel, such as a biopsy channel of an endoscope or laparoscope, and a mechanism for placement and release of the staple from the staples assembly into the patient's tissue.
In particular, a stapler assembly in accordance with the present invention comprises at least one spring-loaded staple and a stalk, or elongate manipulating member, on which the staple is disposed in an open, prefiring configuration. The staple is spring-biased towards a closed or postfiring configuration. The staple in turn comprises two legs joined to one another and spring biased towards the closed configuration where the legs are adjacent and substantially parallel. The legs may be parts of a single body member having an elastic bight which functions in producing elastic bias, or clamping, forces. Alternatively, a separate spring element may be connected to the legs, which are coupled at a hinge joint. In either case, a pair of prongs or penetrating elements are located at free ends of the legs and are oriented so as to grasp a section of intervening soft tissue as the staple tends towards a closed configuration.
In accordance with another feature of the present invention, eyelets mounted on the legs, or apertures in the leg portions, enable the staple to be mounted on the stalk in a spread open configuration, the stiffness of the stalk being sufficient to maintain the legs in the open, prefiring, configuration, where the legs are substantially aligned, and diametrically opposed. The stalk or
Coleman Henry D.
Coleman Sudol Sapone P.C.
O'Connor Cary E.
Sudol R. Neil
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