Surgery – Instruments – Blunt dissectors
Utility Patent
1999-10-26
2001-01-02
Buiz, Michael (Department: 3731)
Surgery
Instruments
Blunt dissectors
C606S192000, C604S096010
Utility Patent
active
06168608
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to an apparatus and method for developing an anatomic space for laparoscopic procedures, and more particularly to an apparatus and method for providing laparoscopic visualization during tunneling to a desired anatomic space as well as during subsequent balloon inflation to develop the desired space.
BACKGROUND
A number of surgical devices may be used to develop a surgical space within a body. For example, blunt dissectors or soft-tipped dissectors may be utilized to create a dissected space which is parallel to the plane in which the dissectors are introduced into the body.
More recently, surgical devices including an inflatable balloon have been used to develop an anatomic space. Such devices typically include an elongate shaft or obturator for tunneling into the body with the balloon attached to it. The balloon is generally collapsed initially, for example by gathering the balloon about the shaft, and is secured to the shaft by a tubular sheath or cover. The tunneling shaft with the deflated balloon thereon is introduced into the body and directed to a desired location. Once the desired location is reached, the balloon is deployed by inflation to develop the anatomic space, generally causing dissection along a natural plane within the tissue structures.
The balloon generally comprises two similarly shaped panels that are heat sealed, sonic welded or otherwise substantially fused together along their outer edges, creating a substantially fluid tight seam around the balloon. Although the material comprising the balloon panels is generally flexible, the material may become stiff and/or abrasive along the seam. During tunneling or when the balloon is deployed, an external seam may move along the tissues in the anatomic space being developed, potentially causing tissue trauma, particularly in sensitive tissues, and/or resulting in undesired bleeding in the space.
More particularly, in relation to laparoscopic procedures, surgical devices have been developed that permit visualization during tunneling as well as during development of the anatomic space. Such devices typically include a tunneling shaft, an inflatable balloon, and a laparoscope. The tunneling shaft comprises a substantially rigid tubular member having open proximal and distal ends, defining a passage adapted to receive a laparoscope therein. The balloon is generally formed from substantially transparent material, thereby allowing observation through the balloon wall. The distal end of the tunneling shaft may be inserted through a proximal end of the balloon into the interior of the balloon. Similar to other tunneling devices, the balloon is initially collapsed around the tunneling shaft and may be covered by a sheath.
The distal end of the tunneling shaft generally includes a lip partially obstructing the open distal end. The lip may be formed by providing a rounded tip on the distal end of the shaft and cutting away an angled section of the tip, for example at a forty five degree angle. The lip prevents a laparoscope inserted into the tunneling shaft from extending beyond the distal end of the shaft.
During tunneling, a laparoscope inserted into the tunneling shaft may be positioned for focus and used to observe the progress of the device, the transparent balloon wall allowing observation through the open distal end of the tunneling shaft. Once the desired location is reached, the balloon is inflated. During inflation, the distal end of the tunneling shaft and laparoscope may be moved around within the balloon to view the space being developed, to observe tissue dissection, and to identify tissue structures.
One problem with such devices is that the lip on the tunneling shaft may result in a sharp distal edge. This sharp edge may contribute to tissue trauma when the tunneling shaft is introduced into a body, and/or when the tunneling shaft is moved to observe the anatomic space being developed. The sharp edge may also damage or puncture the balloon, possibly requiring removal and replacement of the device.
In addition, the lip may substantially obstruct the field of view of the laparoscope. Although the tunneling shaft often comprises substantially transparent material in order to transmit light, distortion through the walls may impair peripheral visualization. Thus, the most effective field of view through the laparoscope is generally through the open distal end of the tunneling shaft. Because the lip partially blocks the distal end, however, the lip often obstructs the axial field of view. For this reason, such devices often employ an angled rather than a straight laparoscope, providing visualization at an angle out the open distal end, rather than in an axial direction. Thus, to fully view the tissues being dissected, the tunneling shaft may have to be rotated axially, which may be disfavored in some procedures.
Accordingly, there is a need for an apparatus and method for developing an anatomic space which provides improved visualization during tunneling and subsequent space development.
In addition, there is a need for a laparoscopic apparatus and method for developing an anatomic space which substantially minimizes tissue trauma during tunneling and development of the space, thereby reducing bleeding that may obscure the field.
SUMMARY OF THE INVENTION
The present invention is directed to an apparatus and method for observing tissue dissection while tunneling to a desired location within a body and for developing an anatomic space at the desired location. Generally, the apparatus includes a tunneling member and an inflatable balloon. The tunneling member comprises a substantially rigid tubular shaft having proximal and distal ends, having a passage extending between the ends, and having an opening in the proximal end to receive a conventional laparoscope. The proximal end of the shaft may include a handle thereon for directing the shaft during a procedure.
The distal end is generally truncated and includes an integrally formed lip. Preferably, the lip has a substantially rounded, blunt distal edge, adapted to minimize tissue trauma. In addition, the lip preferably is “U” shaped, partially defining an opening adjacent the axis of the shaft having a recessed center in the opening, to enhance visualization and minimize obstruction of the field of view through the distal end.
The balloon generally comprises a substantially flexible, and preferably non-elastomeric, material having an inflatable space therein, defining a predetermined shape capable of assuming collapsed and inflated conditions. Preferably, the balloon has a substantially circular or elliptical shape, except for a bulge or extension in a distal portion of the balloon.
The balloon generally comprises two panels of material that are fused or welded together around their periphery, creating a substantially fluid tight seam that defines the inflatable space of the balloon and provides substantially flexible outer edges for the balloon. Preferably, flexible outer edges are provided by fusing or welding the panels on their periphery, such as by heat sealing or sonic welding, to create a seam, turning the panels inside out, thereby creating an inverted seam which extends slightly into the inflatable space in the balloon and a reentrant outer profile at the seam on the balloon. Alternatively, the seam may be welded and set in by a predetermined margin from the outer edges of the panels. The balloon may also be selectively strengthened, by attaching or welding reinforcing panels to the walls of the balloon, such as in the distal portion of the balloon.
The balloon generally includes a proximal sleeve or neck having a sealable opening therein, preferably having a handle with a bore therethrough that communicates with the inflatable space within the balloon. The distal end of the tunneling member may be directed into the inflatable space of the balloon through the bore in the handle, seals in the handle providing a substantially fluid tight seal. Alternatively, the neck may be sealably attached dire
Echeverry Jan M.
Fernandez Luis M.
Jervis James E.
Robinson Janine C.
Tanaka Shigeru
Buiz Michael
General Surgical Innovations Inc.
Lewis William W.
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