Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
2001-10-05
2004-08-17
Bui, Vy Q. (Department: 3731)
Surgery
Instruments
Cutting, puncturing or piercing
C604S022000
Reexamination Certificate
active
06776787
ABSTRACT:
BACKGROUND
1. Field of Invention
The present invention relates generally to surgical devices. More particularly, the present invention relates to surgical punch devices for the formation of well-defined holes in blood vessel walls (or other internal bodily tissue layers) during the course of a surgical procedure. Still more particularly, the present invention relates to improvements in surgical punch devices that reduce the levels of applied force required to punch out tissue plugs from tissue walls, and that otherwise improve the operational characteristics of the device.
2. Summary of the Prior Art
Surgical punch devices for forming holes through bodily tissue layers during the course of surgical procedures per se are generally well known in the art. Representative examples of some of the various versions of known surgical punch devices are shown in the following United States Patents (the disclosures of which are hereby incorporated by reference into this specification): U.S. Pat. Nos. 4,018,228; 4,216,776; 5,129,913; 5,192,294; 5,403,338; 5,488,958; and 5,827,316.
The basic concept of surgical punch devices is to provide a device including a pair of externally operable, reciprocally interacting, elongate elements for the formation of a hole through an internal tissue layer at an internal surgical site easily and simply during the course of a surgical procedure. The devices heretofore utilized to accomplish this goal typically included an elongate outer sheath having a distally facing sharpened edge, and an elongate plunger-like member disposed within the outer sheath. The plunger-like member was designed for the reciprocating movement of its distal end from a normally extended position relative to the sharpened edge of the outer sheath into the distal portion of the outer sheath in response to external manipulation of an activation mechanism associated with the proximal portions of the outer sheath and the plunger-like member respectively. The plunger-like member also typically included structure designed to receive tissue while its distal end portion was extended out of the distal end of the outer sheath. Further, the plunger-like member was contemplated to fit tightly enough within the outer sheath that received tissue could be caused to be sheared away from the adjoining tissue layer as the plunger-like member was caused to move past the distally facing sharpened edge of, and into, the outer sheath by the external activation mechanism. (Obviously, the relative movement of the outer sheath and the plunger-like member just described also could be considered as the outer sheath moving relative to the plunger-like member, or as the outer sheath and the plunger-like member moving simultaneously in opposite directions relative to each other without changing the basic operational characteristics of the device.)
Various structural modifications also have been provided to this basic surgical punch device in the prior art.
For example, the outer sheath and the plunger-like member have been interconnected with one another in various ways so as to cause them to rotate relative to each other as they are moved from the normal plunger extended position to the plunger retracted position, and vice versa. This modification introduces a slicing component to the cutting out of a section of a tissue layer contemplated by the basic surgical punch concept. The purpose of this modification is to reduce the level of applied force required to remove a cut out tissue portion (plug) from its adjoining tissue layer.
Further, numerous activation mechanisms for causing the desired relative movement between the outer sheath and inner plunger have been proposed with varying degrees of success. In addition, it is common in surgical punch devices to use a separate cutting blade mounted at the distal end of the outer sheath to provide the distally facing cutting edge, instead of simply sharpening the distal end of the outer sheath. Other modifications of the basic surgical punch device are described in the above-referred-to United States Patents and/or will become apparent as the present discussion proceeds.
A typical example of the heretofore known structure and use of surgical punch devices will be better understood with reference to the following brief discussion of the procedures and requirements of coronary by-pass surgery. It is to be understood, however, that this usage context is presented herein by way of illustrative example only, and that surgical punch devices may, and do, find other usage contexts satisfying other specific requirements.
The goal in coronary by-pass procedures is to create an open blood flow passageway around one or more diseased, blocked or partially occluded coronary arteries so as to ensure appropriate blood flow to the heart muscle. Without such blood flow, the heart muscle may be damaged and/or cease to function appropriately. Hence, if the condition is not corrected, the result may be a heart attack or, in extreme cases, death to the patient.
To accomplish the desired by-pass, it is conventional to use a saphenous vein graft to create an alternative pathway for the flow of blood to the heart muscle. Specifically, an opening (i.e., hole) is formed in the wall of the ascending aorta. Thereafter, the proximal end wall of the graft is anastomosed (attached) around the periphery of the opening in a tight, sealing manner (typically by suturing). The distal end of the graft is then affixed in a similar manner to the periphery of a hole formed in the subject artery downstream from the diseased portion, blockage or occlusion.
The formation of the desired openings in the walls of the involved blood vessels (as parenthetically suggested above) must be understood as involving the creation of open holes in the blood vessel walls. The reasons for this are clear to those skilled in the art. It is only by the formation of open holes that an unobstructed flow of blood through the graft can be insured. The creation of slits, cuts, punctures or the like are not satisfactory. This is primarily because internal bodily tissue demonstrates a tendency to close in upon itself after the passage of a knife-like blade or awl-like device through it. Therefore, it is only by the actual removal of tissue from the blood vessel wall that the presence of a continuously open passageway may be assured.
Accordingly, it has become conventional in the art that the formation of the desired openings (holes) through the blood vessel walls involves the creation of “pilot opening”, i.e., a small, slit-like cut or opening through the tissue of the blood vessel wall, often using either a scalpel or scissors. Thereafter, a surgical punch device typically is used to form the desired well-defined hole in the blood vessel wall. This procedure has been found to facilitate the attachment of grafts to blood vessel walls in the desired relationship. It also has been found to aid in the avoidance of complications such as leakage from the attachment site and/or the presence of loose tissue pieces within the hole and/or adjoining blood vessel lumens that could break away and be carried in the bloodstream causing damage or blockages elsewhere within the patient. It also facilitates the removal of punched out tissue from the interior of the patient.
An illustrative version of a conventional surgical punch useful in surgical procedures of the type just summarized is illustratively shown in FIG.
1
. Generally speaking, the surgical punch
2
includes an anvil or other support portion
4
formed and/or located at the distal end
6
of a core member (rod)
8
. The core member
8
in turn is disposed in telescoping, and generally co-axial, engagement within a generally cylindrical member (outer sheath)
10
. Accordingly, the surgical punch may be very much syringe-like in appearance.
Further, while the internal linkage mechanisms inherent in surgical punch devices are different from a common syringe (i.e., distal pushing on the proximal end of the plunger while pulling on finger engagement elements moves the plunger proximally rela
Hamilton Jason LaShun
Moore Douglas W
Phung Trinh D.
Bui Vy Q.
Dechert LLP
Nguyen Victor X
Ryan John W.
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