Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2002-06-07
2004-03-30
Philogene, Pedro (Department: 3732)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S026000
Reexamination Certificate
active
06712795
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a surgical procedure which requires incision through the outer tissues of the body and to apparatus for implementing such procedure.
BACKGROUND OF THE INVENTION
There are several distinct invasive surgical procedures requiring incisions through the outer tissues of the body.
The most traditional approach, known as open surgery usually involves an incision of at least 10-12 inches, often as much as 14 inches, and is favored for providing a relatively large opening for direct visibility of the underlying tissue, easy access for surgical instruments and a surgeon fingers (palpability). A retractor having blades extending in side by side relation into the incision and movable apart to spread edges of the incised tissue is often used to increase the field of operation.
Disadvantages of the open procedure include a relatively long healing time significant bleeding and patient trauma. Nevertheless, open surgery remains by far the most widely used surgical approach.
In an attempt to obviate the above disadvantages, a minimally invasive procedure know as laparoscopy was developed. In laparoscopy, a ring of several, (usually four), small incisions, each of typically ¾ inch are made through outer tissue, such as the abdominal wall and tubes of various stick-like instruments (trocars), incorporating endoscopes/cameras, illuminating devices and insufflation cannula, are inserted therein. The abdominal wall is raised away from underlying tissue by the insufflation pressure, exposing the underlying tissue for access and visibility so that the entire operation can be performed on camera using the inserted instruments.
However, approximately 15-20% of laparoscopic procedures, must be reversed to open surgery for various reasons, such as discovery of extensive disease, or camera blocking events such as excessive bleeding, which can be difficult to locate and staunch in a closed environment, or leakage of other body fluids. Such reversals can be traumatic, requiring the steps of withdrawal of the trocars with loss of insulation pressure, radical extension of one or more of the incisions and fitting a retractor into the newly extended incision, all of which must be carried out with a high degree of urgency under pressure and are undesirably time consuming, with significant additional loss of blood often resulting in significantly greater patient risk than if the traditional approach of open surgery had been adopted initially.
Notwithstanding, the apparent advantages of minimal invasion, it is believed that laparoscopy is used in only approximately 15% of all invasive surgical procedures, most commonly for removal of the gall bladder (for which the procedure was originally devised).
A third ,most recent, approach to invasive surgery described and claimed in my U.S. Pat. No. 6,224,545, issued May 1, 2001, the disclosure of which is incorporated herein by reference, utilizes a special mini-retractor which permits surgery through an outer incision, i.e., outer operating window, much smaller than that required by the traditional open surgery approach, while providing a field of operation within the patient's body, i.e., inner operating window, which is much larger than the outer operating window and, in such respect, provides much of the access advantage of the traditional approach of open surgery.
Such mini-retractor, (trademark ‘DirecTrac’), comprises a pair of blades having proximal ends and distal ends inserted through the incision into the body, the proximal ends being pivotally mounted in side by side relation on a frame both for translational movement apart to expand the outer operating window and for swiveling movement to spread (fan) the distal ends within the body thereby to expand the inner operating window.
As a result of the ability to spread the distal end of the blades an inner operating window (access) of as much as 7-10 inches can be obtained from an incision of only 2-4 inches, which is much smaller than that required for open surgery, while the requirement for insufflation is obviated. In addition, angulation or tilting the device in opposite directions may further increase the transient field of view to as much as much as possibly 14-20 inches creating a relatively open environment as compared with conventional laparoscopy. Notwithstanding, this procedure remains a different and distinct approach from laparoscopy.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a surgical procedure which enjoys most of the advantages of a conventional laparoscopic procedure in requiring only a relatively small increase in initial incision size, but which ameliorates disadvantages associated with of reversal of the conventional laparoscopic procedure in avoiding a need for open surgery and associated delays, blood loss and trauma.
The invention utilizes a mini-applicator similar to the type described above but having blades with narrower sidewalls, permitting the access incision or outer operating window to be as small as 1-1.5 inches.
According to one aspect, the invention provides the steps of: making a small incision of 1-1.5 inches in length in the abdominal wall; providing a mini-retractor with blades having adjacent trocar engaging sidewalls of arcuate cross-section conforming with an outer profile of a tube of a trocar; inserting the blades in closed together, substantially parallel relation, into the incision into the abdominal cavity; moving the blades a small distance apart and inserting a tube of a trocar axially between the blade sidewalls into the abdominal cavity and closing the blades together to embrace the cylindrical tube of the trocar in a sealing fit thereby mounting the trocar in the cavity; and, performing a laparoscopic procedure.
If reversal of the laparoscopic procedure is needed it is only necessary to relax the blades, permitting axial withdrawal of the trocar from the mini-retractor and to swivel (pivot or swing) the distal ends of the blades apart to enlarge the inner operating window.
Although the sealing fit between the blades and the tube of the trocar and surrounding tissue should usually be sufficient to maintain pneumoperitoneum pressure by insufflation, an auxiliary abdominal wall elevator may be employed. For example, the abdominal wall elevator described in U.S. Pat. No. 5,573,495 to Adler may be inserted through another trocar, to reduce the pneumoperitoneum pressure required for adequate access inside the abdominal cavity.
Thus, the procedure of the invention often obviates the need to greatly enlarge the incision and the manipulative steps otherwise required to seat a retractor in an enlarged incision, saving valuable time, blood loss and trauma.
An abdominal elevator and flexible arm positioner comprising a stand normally clamped to the operating table and supporting a flexible positioning arm with a clamping head which can be clamped to the min-retractor can also be used to maintained the mini-retractor elevated when the trocar is removed. Preferably, the abdominal wall elevator and positioner is clamped to the mini-retractor as soon as practicable after the trocar has been clamped in the mini-applicator so that the min-retractor is in place, ready for use to maintained elevation of the abdominal wall in the event of reversal involving removal of the trocar and, in consequence, loss of pneuomoperitoneum pressure.
Preferably, when the trocar tube is clamped between the blades of the mini-applicator, small, instrument access gaps are defined between the proximal ends of the blades on respective opposite sides of the trocar tube at the location of entry, exposing surface portions of skin at opposite edges of the incision to enable a surgeon to increase the length of the incision with the mini-retractor still in place by simply inserting scalpel or other suitable instrument into the gaps. The proximal ends of the blades are then moved apart to spread apart the edges of the enlarged incision to the fullest extend and therefore increase the outer operating window.
An enlargement of
Bonderer David A
Philogene Pedro
Usher Robert W. J.
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