Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
1999-12-14
2001-08-21
Jackson, Gary (Department: 3731)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
C606S143000, C606S104000, C606S219000
Reexamination Certificate
active
06277130
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a novel surgical fastener with an electrical discharge-based delivery system that allows for precise control of the momentum imparted to the fastener for penetration into or through tissue, for example into dense periosteal tissue or through captured tissue layers.
BACKGROUND OF THE INVENTION
In various orthopedic and general surgeries, it often is necessary to use penetrating-type implantable fasteners to secure tissue, cartilage, ligaments, sutures, mesh or other artifacts to perisoteum or other dense anatomic structures. A common procedure is the repair of a torn meniscus in which it is desirable to re-attach overlying portions of a torn meniscus to adjacent or underlying meniscus portions. One class of fastening device known in the art may be compared to a staple gun which uses a spring mechanism to drive a fastener distally from the device working end into the anatomic structure, or a reciprocating hammer to repeated drive the fastener. Also, various types deformable fasteners are used in surgeries to attach 1
st
and 2
nd
tissue layers, such as a biocompatible implantable staple. Such commercially available fastening instruments typically are designed to mechanically deform the malleable leg portions of a wire-form staple by holding a portion of the staple while bending leg portions as the staple is ejected from the distal working end of the instrument. A related type of fastener system captures tissue and drives a deformable fastener by means of a hammer mechanism into an anvil portion, as in an Endo-GIA or circular anastomosis stapler. The fastening instruments of all the types described above are mechanically complex and require many moving parts which results in relatively expensive instruments (e.g., from $100 to $300). Typically, such instruments must be disposable and thus add measurably to the costs of a surgery and cause financial burdens on the health care system.
Besides being expensive, the typical commercially available stapling systems suffer from several other disadvantages. First, a spring-driven mechanical fastener is propelled outwardly and into bone, periosteum, etc., with only a predetermined amount of force that in turn develops a particular rate of staple penetration. The rate may be too slow for the densest anatomic structure, often requiring repeated firings of staples until staple's depth of penetration is adequate. This may lead to time-consuming retrieval and removal of mis-fired staples. Also, the rate of staple penetration may be too fast for less dense anatomic structures leading to collateral tissue damage upon staple firing. When hammer-and-anvil type fastening mechanisms is employed, the thickness of captured tissue may vary widely. Such a system that develops a staple-driving force from a squeeze-type handgrip may not provide the operator adequate control over the power needed to propel the fastener through tissue layers. If the tissues are poorly fastened, for example in an intestinal anastomosis, the fastened site may leak and result in serious complications. Many tissue fastening procedures offer only a single opportunity to develop a secure or leak-proof seal. Another disadvantage of prior art fastener systems is that they cannot be scaled down in size to 2.0 to 5.0 mm. (or smaller) introducers for microsurgeries due to the mechanical complexity and moving parts of the device. Many of the above-described disadvantages relate to the unsophisticated means of delivering mechanical driving forces to the fastener—typically (i) a spring-load mechanism in the introducer or (ii) squeeze grips in a handle that mechanically translate driving forces to the fastener through a moving push-rod.
What is needed is: (1) a surgical fastener system that allows for precise control of the rate at which the fastener penetrates tissue; (2) a surgical fastener system that has very few moving thus making it inexpensive to manufacture; and (3) a surgical fastener that can be miniaturized and delivered from a substantially small introducer (e.g., 1.0 mm. to 3.0 mm. in diameter or cross-section). Besides, the above listed requirements, it would be desirable if the fastener system were suited for disposable introducers or non-disposable introducers.
SUMMARY OF THE INVENTION
The subjects and objects of this disclosure relate to novel surgical fastener systems that are adapted for developing penetrating forces based on the release of energy from an electrical discharge in a fluid captured in a chamber adjacent to a head portion of the fastener. The fastener typically is used for orthopedic procedures to attach tissue to periosteum etc., but may be also be used fasten tissue layers with a hammer-and-anvil type tissue-capturing and fastening system.
More in particular, the system comprises a first fastener component (or fastener body) that is configured with penetrating legs and a second fastener component (or driving component) that comprises a captured fluid volume just proximal to the head of the fastener body. In a typical embodiment, the fastener body and the captured fluid volume are sealably carried in an introducer working end having an elongate interior chamber with an open distal termination. The interior chamber portion containing the captured fluid volume carries 1
st
and 2
nd
electrode terminations that are connected to a remote high intensity electrical energy source. Upon actuation of a switch mechanism, an electrical discharge is induced between the 1
st
and 2
nd
electrodes to cause an intense thermal effect within the captured fluid volume to generate an explosive bubble (cf. such energy density also has been described as causing a cavitation bubble. The expansion pressures caused by the bubble formation thus will cause distal driving forces against the head of the fastener body to propel the fastener outwardly from the introducer and into or through the targeted structure. The driving force applied to the fastener head can be easily controlled by altering the power level of the electrical discharge. Moreover, the rate of fastener penetration can be further controlled by (i) adjusting the dimensions of the interior chamber and volume of captured fluid; and (ii) the dimensions between the 1
st
and 2
nd
electrodes. After firing a fastener with the electrical discharge, the only byproducts of the energy deposition in the fluid (e.g., sterile water) is water vapor which is compatible with the interior of the patient's body.
In general, the present invention is adapted to quickly and efficiently drive surgical fasteners in orthopedic procedures and other surgeries.
The present invention advantageously provides an introducer member that needs no moving mechanical parts for driving a fastener body.
The present invention advantageously provides a fastener system that utilizes electrical discharge (electrothermally generated) forces to drive a fastener body.
The present invention advantageously provides a fastener system that provides an electrical power controller for precisely varying the driving forces applied to a fastener body.
The present invention advantageously provides a fastener for micro-surgical procedures in which a fastener body can be scaled down to extremely small dimensions, e.g., 0.50 mm. to 1.0 mm. in diameter or cross-section.
The present invention advantageously provides an introducer portion that may be (i) highly elongate such as in a catheter, and/or (ii) deflectable or articulatable without detracting from the potential energy that may be applied to drive a fastener body from the distal working end of such an introducer.
The present invention advantageously provides a surgical fastener that may be constructed with relatively fragile bioabsorbable leg portions that may driven into dense structures by selectively high levels of momentum offered by the electrical discharge aspect of invention, wherein such relatively fragile bioabsorbable leg portions could not be driven by pounding with a prior art hammer-type delivery mechanism.
The present invention provides a fastene
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