Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Combined with surgical tool
Reexamination Certificate
1999-12-21
2001-05-15
Winakur, Eric F. (Department: 3736)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Combined with surgical tool
C606S108000, C606S001000, C294S019200, C294S024000, C623S002220
Reexamination Certificate
active
06231601
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method of using a multi-purpose surgical implement handle and particularly to a method of surgery including bending a multi-purpose adjustable surgical implement handle having regions of varying bending strength.
BACKGROUND OF THE INVENTION
Surgical patients today often desire operations be performed with the least amount of intrusion into the body. Such minimally invasive procedures usually provide speedier recovery for the patient with less pain and bodily trauma, thereby reducing the medical costs and the overall disruption to the life of the patient. A minimally invasive approach also usually results in a smaller incision and, therefore, less scarring, which is an aesthetic advantage attractive to most patients.
The use of a minimally invasive approach, however, introduces new complexities to surgery thus placing a greater burden on the operating surgeon. Most notably, minimally invasive approaches drastically reduce the size of the surgical field available to the surgeon for the manipulation of tissue and for the introduction of necessary surgical instruments, such as cutting devices, clamps, prosthetic holders, and so on.
The aforesaid complexities are especially acute in connection with heart surgery. Unlike common heart surgeries performed using a full medial sternotomy, minimally invasive heart surgery offers a surgical field that may be only as large as a resected intercostal space or a transversely cut and retracted sternum. Consequently, the introduction of tools, such as prosthetic sizing elements, valve holders, annuloplasty ring holders, and other such devices, becomes a great deal more complicated.
The majority of instruments currently available to surgeons for performing minimally invasive surgeries are devices designed for use in far less restrictive surgical fields. That is, the existing instruments have characteristics which are not conducive for use in restrictive surgical fields. For example, in heart surgery, the majority of implements available to hold or retain various heart devices or tools (e.g., heart valves and annuloplasty rings) in a minimally invasive procedure either are too short to enable easy introduction of prostheses to the target site and/or have shafts which lack the necessary malleability or flexibility to enable proper orientation of the prostheses at the distal end of the shaft. Indeed, there are a number of conventional handles with shafts that require and end load of 25 pounds (lbs.) or more to bend the shaft. Furthermore, many of the existing devices have only one application, e.g., a handle for a valve-sizing template or a handle for holding a prosthetic valve, thus requiring the introduction of multiple tools into the surgical field. Examples of such prior art devices are disclosed in U.S. Pat. Nos. 4,679,556 to Lubock et al.; 5,531,785 to Love et al.; 5,360,014 to Sauter et al.; 5,403,305 to Sauter et al.; 5,476,510 to Eberhardt et al.; 5,489,296 to Love et al.; and 5,560,487 to Starr.
SUMMARY OF THE INVENTION
It is therefore an object of the present invention to overcome the shortcomings of the prior art by providing a multi-purpose surgical implement handle that is especially useful in minimally invasive surgical procedures.
It is a further object of the present invention to provide a surgical implement handle that has sufficient length to enable a surgeon to easily place a heart device at a target site.
It is a further object of the present invention to provide a surgical implement handle with a malleable portion that is sufficiently flexible to enable suitable orientation of the heart device for insertion in a minimally invasive procedure.
It is a further object of the present invention to provide a surgical implement handle that has multiple uses.
It is a further object of the present invention to provide a surgical implement handle that reduces the complexities of minimally invasive procedures.
It is a further object of the present invention to provide a surgical implement handle that is cost effective to produce.
These and other objects not specifically enumerated above are believed to be accomplished by a surgical implement handle according to the present invention wherein the handle includes a distal end and a proximal end. The handle has a gripping section located toward the proximal end and an attachment section located toward the distal end. The handle includes a malleable section interposed between the gripping section and the attachment section. The malleable section is sufficiently flexible to enable formation of a bend by a human user at substantially any discrete location along substantially the length of the malleable section.
The present invention thus provides a method of surgery including providing a handle having a gripping section disposed on a proximal end thereof, an attaching section disposed on a distal end thereof, and a bendable adjusting section disposed between the gripping and attaching sections. The bendable adjusting section includes a main portion and an increased-adjustability portion which is more bendable than the main portion. The method includes the steps of: mounting an implement to the attaching section of the handle; bending the bendable adjusting section of the handle; and inserting the implement into a surgical field.
According to another aspect of the invention, a shape-adjustable handle includes a gripping section disposed on a proximal end thereof, an attaching section disposed on a distal end thereof, and an adjusting section disposed between the gripping and attaching sections. The adjusting section is bendable so that the attaching section is positionable with respect to the gripping section. The attachment section may include a securing mechanism for engaging, either releasably or permanently, with a surgical implement. The adjusting section may include a main portion and an increased-adjustability portion which may be more easily bent than the main portion. For example, a surgeon may hold the gripping section in one hand and the attaching section in the other hand and may position a thumb at a discrete location along the increased-adjustability portion. The surgeon may then urge either the attaching section or the gripping section about the thumb to form a bend in the increased-adjustability section.
To be more bendable than the main portion, the increased-adjustability portion may have a smaller diameter than the main portion. Alternatively, the increased-adjustability portion may be made from material which is more malleable (or less stiff) than material from which the main portion is made. In one embodiment in which the adjusting section is tubular in cross section, the increased-adjustability portion may have a smaller wall thickness than that of the main portion. As the adjusting section is made from material which is malleable and pliable, the adjusting section is sufficiently supple to bend repeatedly without breaking or causing substantially material fatigue. The capacity of the shape-adjustable handle for adaptive change allows the handle to be readjusted to various positions during surgical procedures.
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Bartholomew Ross
Jackman Jerry
Li Jane
Myers Keith
Packham Victor
Cumberbatch Guy L.
Edwards Lifesciences Corporation
Natnithithadha Navin
Winakur Eric F.
LandOfFree
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