Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-10-20
2002-11-19
Isabella, David J. (Department: 3738)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S116000, C604S165010, C604S167040, C604S167060, C606S185000
Reexamination Certificate
active
06482175
ABSTRACT:
The invention concerns a surgical implement for forming an opening in the skin of a patient, in particular for use in procedures involving the introduction of drainage tubing into body cavities.
BACKGROUND OF THE INVENTION
Surgical drains are routinely inserted into body cavities during certain surgical operations in order to allow fluid communication between the interior and the exterior. To avoid wound complications it is common practice not to route such drains via the primary surgical incision, but instead through a different part of the body wall by way of a smaller secondary incision. Introduction of the surgical drain involves passage of a tube from the body cavity (such as the abdomen or the thorax) through the body wall and, as skin is generally the most resistant tissue to be traversed, the conventional method is to employ an appropriately sharp metal introducer passed from the interior to the exterior, whilst the surgeon's free hand is used to provide counterpressure on the outside of the skin. An example of such an instrument is disclosed in U.S. Pat. No. 4, 716,901. Whilst quick and simple, there are a number of inherent risks with this procedure. Firstly, the introduction of a sharp instrument into a body cavity threatens injury by laceration or perforation to the patient's viscera. Secondly, because of the necessary proximity of the surgeon's hand to the point of exit of the sharp introducer, the surgeon is exposed to a significant risk of self injury, with the result of both physical trauma and, more importantly, ‘drainstick’ injury with the attendant risk of transmission of serious infective disease such as HIV and Hepatitis B.
Once the sharp introducer has passed through the skin the drain, which is conventionally a simple flexible latex tube attached to the rear end of the introducer, is pulled through the body wall opening. The introducer is then cut from the tube and the tube is sutured into place to prevent it being inadvertently pulled out of the body. This is generally done by stitching a suture loop to the skin, and then looping sutures around the tubing for a short distance from the skin exit point.
FIG. 1
illustrates schematically a part of the above-described conventional procedure, with the introducer
10
(attached to drain tubing
11
) in the process of being pushed through the body wall
12
from the interior to the exterior, whilst the fingers
1
, of the surgeon's free hand are shown applying a counterpressure to the tented outer surface of the skin.
DE-A-3919740 and U.S. Pat. No. 5,152,749 disclose devices for inserting a catheter into the bladder in which a hollow sheath element carrying a sharp incision element is introduced into the bladder via the urethra, and the incision element is moved relative to the sheath to cut an opening through the wall of the bladder and through to the exterior. A catheter introducer is then attached to the incision element and the proximal end of incision element is pulled to draw the catheter into the bladder from the exterior.
SUMMARY OF THE INVENTION
The object of the invention is to provide a surgical implement for forming an opening in the skin of a patient which overcomes at least some of the drawbacks of conventional procedures. To this end, the invention provides a surgical implement for forming an opening in the skin of a patient comprising a first body having a distal end for application to one side of the skin and a second body for application to the other side of the skin to co-operate with the first body, the second body having: a sharp skin incision element moveably mounted thereto, a hollow form adapted to receive and locate the distal end of the first body, and means for moving said incision element relative to said second body. According to an alternative aspect of the invention, there is provided a surgical implement for forming an opening in the skin of a patient comprising a first body for application to one side of the skin; a second body having a sharp skin incision element moveably mounted thereto and means for causing movement of said incision element; whereby in use the first body can be applied to one side of the skin to cause tenting of the skin in a direction towards the other side of the skin and the second body can be applied to the other side of the skin to co-operate with the first body via the skin, while protecting the surrounding skin.
Preferably, the distal end of the first body is of blunt form to minimise damage to the one side of the skin. Said first body distal end may be provided with a recess, such that said movement of the incision element carries the element into said recess.
Use of the invention reduces the risk of harm to both the patient and to medical staff in making an incision in the wall of a body cavity, for example when introducing a drain tube to the body cavity. For such an operation, the surgical implement of the invention may include a surgical drain tube attached or attachable to the proximal end of said first body.
In a preferred form, said second body is of a generally tapering form, tapering from a distal portion for contacting the skin to a proximal portion to which said incision element is mounted. An opening may be provided in the proximal portion of said second body, providing access to the hollow interior of the second body, and the incision element may be arranged to travel through said opening between a first position, when it is held outside the opening, and a second position, when it is positioned within the hollow interior of the said second body.
When the surgical implement is to be used in respect of the introduction of a surgical drain, said opening can be dimensioned to allow passage therethrough of said first body.
Preferably, the incision element is supported by at least two wall sections projecting from the exterior of said second body, such that manipulation of said wall sections causes the incision element to travel between said first position and said second position.
The incision element may be arranged to be detachable from said second body on reaching said second position, and to this end a preferred embodiment is provided with an incision element mounted to said second body by way of at least one frangible element which breaks when the incision element is in said second position.
Preferably, the incision element depends from at least two substantially planar wings which are connected to the said wall sections and which, when the incision element is in its first position, are orientated obliquely to the incision element travel direction, such that an urging together of said wall sections will cause the incision element to travel towards said second position.
Said second body may be provided with opposed barb elements, and preferably said barb elements are provided on said wall sections to allow securement of a surgical drain tube passed through said opening in the distal portion of said second body.
Additionally or alternatively, said second body is provided with suture points to assist in its securement to said other side of the skin during surgical procedure.
For drain tube introduction the invention may take the form of a surgical kit comprising at least one surgical implement according to the invention, the kit including a range of said first bodies and a range of said second bodies, the bodies in each range differing from one another in at least one characteristic.
According to a further aspect of the invention, there is provided a method of forming an opening in the skin of a patient. said method comprising:
applying a distal end of a first body to one side of the skin;
applying a second body to the other side of the skin, the second body having a hollow form adapted to receive and locate the distal end of the first body via the skin while protecting the surrounding skin area, the second body having a sharp skin incision element moveably mounted thereto; and
bringing the first and the second body into mutual co-operation respectively on different sides of the skin and moving said incision element to
BTG International Limited
Chattopadhyay Urmi
Isabella David J.
Nixon & Vanderhye
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