BACKGROUND OF T~IE INVENTION
This apparatus relates -to a surgical method and apparatus for making passageways through body tissue and more particularly for making passageways through muscle tissue t~ provide access to underlying tissue for a `surgical operation.
To reach deep structures of the human body, it is necessary to penetrate layers of muscle tissue. With present techniques, this is accomplished by cutting and ¦.
separating layers of muscle tissue. The surgeon uses a scalpel or scissors to make the incision and then opens j :
the lips of the incision with a retractor. He then encounters the vascular net into which he is forced to cut.
Cutting into the vascular net has a number of deleterious consequences; the tissue loses blood; the muscle fibe.rs irrigated by this vascular net no .longer recuperate with .
the same efficiency in the post-operative period, some ..
fibers become fibrotic and others weaken in their function; ~ :
the bleeding phenomenon in-terfers with the objective and ¦~
performance of the surgeon by obscurring the field of blood; and the delicate neuromuscular units are interrupted causing abnormal regeneration, which can become capable of evoking pain. .
SUMMARY OF THE INVENTION .
An object of the presen-t invention is to provide :
a m~thod ana apparatus for penetrating body -tissue wherein there is substantiaily no cutting action on any structure up ~he cellular level o~ tile muscular system, i.e. muscle fibe.rs, nerve fibers, capillaries, connective tissue cells, ¦
etc., reducing bleeding and other deleterious post-operative effects. .~ ~ t 1~)380~3 Another object is to provide a relatively rapicl and simple method for forming precise passageways with less reliance on the skill of the surgeon.
The apparatus of the present invention comprises a tissue penetrating probe, a vibrating device~ and a plurality of tubular kissue separating members adapted to be placed over the penetrating probe. The penetrating probe preferably has a blunt lanceolated end.
In accordance with the present invention a vibrating probe with a blunt end is inserted into body tissue to form a passageway. Subsequen-tly, a tubular tissue separating member, placed over the prohe, is inserted into the previously formed passageway and manipulated so as to separate tissue fibers and enlarge the passageway.
If required, one or more additional separating members having successively larger cross-sections may be used to further enlarge the passageway. The additional larger separating member may be adapted to be used with ::
; the previous probe, or with another larger probe. The 20 ~ separating members may be in the form of a plurality of tubular members of increasing size placed concentrically and slidably over the probe. ~1-: i, - , For the final stages of passageway enlargement, ~ ¦~
one or more frustoconical tubular members may be used. Such a frustoconical member may also be usecl as a~shield to facili-tate access to an underlying region for a subsequent suryical opera-tion~
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BRIFF DESCRIPTION OF THF DRAWINGS
Figure 1 illustrates an embodiment of the I -present invention comprising a tissue penetrating probe, a vibrator, and a tissue separating mernber.
, -~9~ 03 Figure 2 illustrates an additional larger separating member adapted to be interchanged with that shown in figure 1.
Figure 3 illustrates a tissue separating member which includes a gripping device.
Figure 4 illustrates a frustoconical tubular member which may be used in association with the present invention.
DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to figure 1 r the apparatus comprises ', a tissue penetrating probe 1 mounted in a vibrator 2.
The probe 1 comprises an elongated portion having a blunt r preferably lanceolated, end 3. The vibra-ting device 2 may provide axial or lateral vibration of the probe. Slidably and removably disposed over the probe 1 is a tissue separating member 4 comprising a tubular portion with a blunt end 5~
Figure 2 illustrates an additional separating member 6, which has a larger cross-section than the member 4 of figure 1. This larger separating member may be adapted for use with the probe 3 of figure 1, or with another probe having a larger cross-section. Preferablyr a series of such members of various sizes will be provided.
Referring to figure 3~ the separating member 7 may be provided with an adjustable gripping device 8 to facilitate handling. The gripping device 8 comprisès a sleeve element 9 adapted to be slidably inserted over a separating member 7. Pivotally mounted on the sleeve element is a detent 10 adapted to selectively engage one of 1, a series of recesses 11 in the separating member 7.
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~g~ 3 Referring to figure 4, a frustoconical tubular member 12 may be provided to be used as an additional separating device and/or as a shield to facilitate a subsequent operation. A member of conical members of various sizes, or alternatively a single conical device that is adjustable is size may be provided.
In operation, with reference to figure 1, the penetrating probe 1 is mounted in the vibrating device 3 and pressed into the body tissue. If a probe having a lancet shaped end is used, the probe is oriented ~ith the major axis parallel with the tissue fibers. Upon insertion the probe separates or disconnects muscle or other tissue fibers from one another but does not damage the fibers themselves. Only the connective tissue elements are affected which xegenerate readily. The probe is inserted to the depth required, for example, to a bone surface. After the probe has pen~trated the tissue -to the desired depth, the separating membPr 4 is slid down the probe into the tissue. The probe 1 and tissue separating member 4, ~ith or without the use of the vibrating device 2, is manipulated to separate rnuscle fibers and enlarge the passageway.
If it is necessary to enlarge the passageway further, a larger tissue separating member, for example 6 of figure 2, may be used, either in conjunction wlth -the same or a larger probe.
To facili-tate the use of the tissue separating members, a gripping device 8, as shown in f:igure 3, may be used. Depressing the detent 10 allows the separating ~0 member 7 to be adjusted relative to the gripping device 8.
The device 8 may also be used ~or mounting on a stereotaxic r .
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or other supporting device.
When a passageway of the desired size .is obtained, the conical member 12, figure 4, may be inserted :
to provide an unobstructed passageway for a subsequent surgi~al operation, and also may be used to further enlarge the passageway. .
The siæe of the probe to be used will be dete.rmined by the length of tissue fiber one wishes to penetrate. For example, for the gluteal region, in which tissue length is in the order of decimeters, the probe diameter will preferably be in the order of centimeters.
For the erector spinae muscle, which has tissue lengths in the order of centimeters a suitable probe size is in the order of millimeters. For very compact tissue structure, such as the sclera~ the probe s.ize will he in the order of microns.
It appears desirable to have the probes available in a series differing in diameter by a factor of about 2. For example~ a group of probes for separating fibers in the centimeter range would have diameters of 1, 2, 5 and 10 millimeters.
~ The amplitude of oscillation of the probe, which may be axial or lateral, is preferably of the same order ;
as the size of the probe itself.
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