Endoscopic device and method of assembly
An endoscopic device including an elongate member having opposite ends, and a clevis attached to one end of the opposite ends. The clevis includes a barrel having at least one slot longitudinally extending completely through the barrel. The device includes a pair of jaws mounted on the clevis for pivotal movement. Each of the jaws has an end opposite the elongate member. The device includes an actuator member operatively connected to the pair of jaws for moving the jaws between a closed position in which the end of the corresponding jaw is positioned adjacent the other jaw and an open position in which an end of the jaw is spaced from the other jaw.
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The present invention generally relates to endoscopic instruments, and more particularly to biopsy forceps and other endoscopic end effectors.
Endoscopic biopsy forceps are a medical instrument used in combination with an endoscope for removing tissue samples from inside a patient's body for analysis. These instruments typically include an elongate flexible member having a biopsy jaw assembly mounted on one end. The jaw assembly includes a clevis holding pivotally mounted jaws adapted for removing tissue for analysis. An actuator comprising an actuator handle and an actuator member extending from the handle to the pivoting jaws of the jaw assembly moves the jaws between an open position in which the ends of the jaws are spaced and a closed position in which the ends of the jaws contact each other to obtain the tissue sample. In addition to biopsy forceps, some aspects of the present invention relate to other types of endoscopic end effectors such as a flexible grasper, a dissector, or scissors.
Biopsy forceps frequently have teeth along the mating edges of the jaws to improve grasping of the tissue. As will be appreciated by those skilled in the art, the teeth extending along each side of the jaw and those extending across the end of the jaw interact differently with the tissue. In the past, these differences in interaction have not been taken into account when selecting tooth profiles for the different portions of the jaw. A fundamental function of biopsy forceps is to pinch tissue in order to tear a sample free. The teeth, particularly those at the end of the jaw, are believed to have a significant impact on sample depth and weight.
Many conventional jaws have been made so that each jaw in the assembly has a different configuration. When a single jaw assembly uses two different jaw configurations, the different jaws must be manufactured, stored and handled during assembly. This situation results in manufacturing inefficiency and a cost increase. In addition, many conventional jaws are cast or molded. Jaws designed to be manufactured using other less expensive processes have the potential for reducing overall assembly cost.
Because the jaw assembly includes a clevis, certain obstacles are presented during assembly. If the clevis and axle pin are inseparably assembled before the jaws are installed, the arms of the clevis must be spread when the jaws are being assembled with the clevis. If the clevis and axle pin are separate, the jaws must be inserted between the clevis arms and aligned with the axle pin. Either process has a potential for increasing assembly cost. Still further, connecting the actuator members to the jaw assembly is difficult to achieve using conventional devises because the clevis blocks clear access to these components.
Once assembled, the jaw assembly has portions (e.g., distal portions) that are susceptible to higher stresses and wear. In order to optimize the jaw, some portions of the jaw can be thicker or made from different materials. Although producing a jaw cup by stamping has economic advantages, conventional jaw assemblies have been unable to take advantage of a stamped jaw cup while having thicker portions or portions made from different materials.
During use, a large jaw size is desired to obtain a large tissue sample. However, when the forceps are being pushed into position, a small jaw size is desirable so that the forceps can travel through smaller radius turns. Using conventional jaw shapes, the jaw size is limited by turning radius.
Among the problems common to known biopsy forceps and end effectors generally is that these instruments are very long and flexible, making packaging, storage and handling difficult. The instruments are frequently coiled when packaged. When the packaging is opened, the instruments can spontaneously uncoil, become unmanageable, potentially falling on the floor, and becoming contaminated or being damaged. Thus, there is a need for a feature that retains these types of instruments in a coiled configuration when unpackaged.
SUMMARY OF THE INVENTIONBriefly, the present invention includes an endoscopic device comprising an elongate member having opposite ends, and a clevis attached to one end of the opposite ends. The clevis includes a barrel having at least one slot longitudinally extending completely through the barrel. Further, the device includes a pair of jaws mounted on the clevis for pivotal movement. Each of the jaws has an end opposite the elongate member. In addition, the device comprises an actuator member operatively connected to the pair of jaws for moving the jaws between a closed position in which the end of the corresponding jaw is positioned adjacent the other jaw and an open position in which an end of the jaw is spaced from the other jaw.
In yet another aspect, the invention includes a method of assembling an endoscopic device including a clevis, a pair of opposing jaws, a pivot member and an actuator member. The method comprises positioning the clevis in a fixture, positioning the jaws between arms of the clevis, and installing the pivot member through the clevis and the jaws. The method further includes adjusting a distance between the arms of the clevis to provide a predetermined stack gap, and connecting the actuator member to the jaws.
The invention also includes an elongate surgical instrument comprising an elongate member having opposite ends and a generally uniform outer diameter, and a clevis attached to one end of the opposite ends. The clevis includes a barrel having an inner diameter conforming to the outer diameter of the elongate member. The instrument also includes a jaw assembly mounted on the clevis for pivotal movement, and an actuator member operatively connected to the jaw assembly for moving the jaw assembly between a closed position and an open position.
In addition, the invention includes a method of assembling an endoscopic device including a clevis, an end effector, a pivot member and an actuator member. The method comprises positioning the clevis in a fixture, positioning the end effector in the clevis, and installing the pivot member through a hole in the clevis and a hole in the end effector. The method further comprises biasing the pivot member to a side of the hole in the clevis, and joining the pivot member to the side of the clevis hole.
Other features of the present invention will be in part apparent and in part pointed out hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 21A-E illustrate a sequence of movements used to prepare the instrument for packaging using one method.
Corresponding reference characters indicate corresponding parts throughout the several views of the drawings.
Detailed Description of the Preferred Embodiment Referring now to the drawings and in particular to
As illustrated in
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As shown in
Likewise, although the outer cover 92 may be made of other materials without departing from the scope of the present invention, in one embodiment the outer cover is made from polyolefin. Although the inner lumen 94 may be made of other materials without departing from the scope of the present invention, in one embodiment the inner lumen is made from high density polyethylene. Although the coil 90 may have other dimensions without departing from the scope of the present invention, in one embodiment the coil has an overall length of between about 220 centimeters and about 260 centimeters, an outer diameter of between about 0.070 inch and about 0.080 inch, and an inner diameter of between about 0.035 inch and about 0.040 inch. The coil 90 is made from wire stock having a diameter of between about 0.015 inch and about 0.020 inch. Further, although the outer cover 92 may have other outer diameters without departing from the scope of the present invention, in one embodiment the outer cover has an outer diameter of between about 0.085 inch and about 0.92 inch. Although the inner lumen 94 may have other inner diameters without departing from the scope of the present invention, in one embodiment the inner lumen has an inner diameter of between about 0.020 inch and about 0.035 inch. As the elongate member 32 is generally conventional, it will not be described in further detail.
As further illustrated in
Using one assembly method, the clevis 100 is positioned in a fixture (not shown). The jaws 42 and the needle 110 are positioned between the arms 102 of the clevis 100 and the axle pin 106 is inserted through the holes in the clevis, jaws and needle. The axle pin 106 is biased toward one side of the holes in the clevis 100 and joined to the clevis using a conventional method such as welding, swaging or riveting.
As illustrated in
The jaw 42 also includes an outer face 136 positioned to abut the clevis 100 when assembled in the biopsy forceps 30. The side walls 122 have a common tooth profile and the end 124 wall has a tooth profile different from the side wall tooth profile. Although the jaw 42 maybe formed in other ways, in one embodiment, each jaw is stamped from sheet metal and formed to shape. Although the jaws 42 may be made of other materials without departing from the scope of the present invention, in one embodiment the jaws are made from 17-7 PH stainless steel. In one particular embodiment, the hinge extension 130 includes a folded portion forming the inner face 134 extending along the median plane and the outer face 136 positioned to abut the clevis 100 when assembled in the biopsy forceps 30. Although hinge extension 130 may be folded in other ways without departing from the scope of the present invention, in one embodiment the extension is folded along a substantially straight fold extending parallel to a longitudinal axis of the jaw. Each jaw 42 also includes a control arm 140 for pivoting the respective jaw about the axle pin 106. Although the control arm 140 may have other configurations, in one embodiment the control arm is integrally formed as part of the hinge extension 130. The control arm 140 includes an actuation hole or opening 142 for receiving the actuator member 46. In one embodiment, each cup 120 includes an opening 144 allowing the respective cup to drain.
An alternative embodiment of the clevis is generally designated by the reference number 200 in
Both of the devises described above are assembled using a similar method. A first clevis half is positioned in a fixture (not shown). The jaws are positioned on the first clevis half and if a central needle is used it is positioned between the jaws. A second clevis half is positioned on the jaw assembly. The stacked components are squeezed together by the fixture and then the fixture is relaxed so that a total accumulated stack gap between the components is within a tolerance selected to assure proper operation of the jaws. Although other accumulated gaps may be used without departing from the scope of the present invention, in one embodiment the accumulated gap is between about 0.0005 inch and about 0.003 inch. After the stack gap is adjusted, a pivot member or pivot pin is inserted through the components and fastened in place. The actuator member may be connected to the jaws at a convenient time during the assembly.
A third alternative embodiment is generally designated by the reference number 230 in
The clevises described above having joined halves are assembled similarly to the previously described method except that the first and second clevis halves are simultaneously positioned on the fixture and the jaws and needle are inserted between the arms of the clevis during assembly rather than stacked in sequence. Other aspects of the assembly method are identical and will not be described in further detail.
The instrument described above may be wound in a conventional manner prior to packaging. One method of preparing the instrument for packaging is particularly advantageous because it reduces the likelihood of the instrument becoming tangled and/or springing apart so it is damaged to contaminated. The effector assembly is fastened to the to the fastener on the handle to form a first loop as illustrated in
When introducing elements of the present invention or the preferred embodiment(s) thereof, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of the elements. The terms “comprising”, “including” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements.
As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.
Claims
1. An endoscopic device comprising:
- an elongate member having opposite ends;
- a clevis attached to one end of said opposite ends, said clevis including a barrel having at least one slot longitudinally extending completely through the barrel;
- a pair of jaws mounted on the clevis for pivotal movement, each of said jaws having an end opposite the elongate member; and
- an actuator member operatively connected to said pair of jaws for moving the jaws between a closed position in which the end of the corresponding jaw is positioned adjacent said other jaw and an open position in which an end of the jaw is spaced from the other jaw.
2. An endoscopic device as set forth in claim 1 wherein the barrel of the clevis has at least two slots longitudinally extending completely through the barrel so the barrel comprises at least two separate pieces.
3. An endoscopic device as set forth in claim 1 wherein the barrel of the clevis has two slots longitudinally extending completely through the barrel so the barrel comprises two separate pieces.
4. An endoscopic device as set forth in claim 3 wherein at least one barrel piece includes a protrusion and the other barrel piece includes a recess sized and positioned for receiving the protrusion to align the barrel pieces.
5. An endoscopic device as set forth in claim 4 wherein the barrel piece protrusion comprises a rectangular tab.
6. An endoscopic device as set forth in claim 5 wherein the barrel piece recess comprises a rectangular notch sized and positioned for receiving the rectangular tab.
7. An endoscopic device as set forth in claim 4 wherein the barrel piece recess comprises a rectangular notch.
8. An endoscopic device as set forth in claim 3 wherein at least one barrel piece includes a protrusion and the other barrel piece includes a recess sized and positioned for receiving the protrusion to align the barrel pieces.
9. An endoscopic device as set forth in claim 3 wherein at least one barrel piece includes an alignment feature that aligns the barrel pieces
10. A method of assembling an endoscopic device including a clevis, a pair of opposing jaws, a pivot member and an actuator member, said method comprising:
- positioning the clevis in a fixture;
- positioning the jaws between arms of the clevis;
- installing the pivot member through the clevis and the jaws;
- adjusting a distance between the arms of the clevis to provide a predetermined stack gap; and
- connecting the actuator member to the jaws.
11. A method of assembling forceps as set forth in claim 10 wherein the distance between the arms of the clevis is adjusted to provide a stack gap of between about 0.0005 inch and about 0.003 inch.
12. A method of assembling forceps as set forth in claim 10 wherein the clevis is formed in two halves and a first of said two halves is positioned in the fixture and the jaws are stacked on the first of said halves before a second of said halves is stacked on the jaws to position the jaws between arms of the clevis.
13. An elongate surgical instrument comprising:
- an elongate member having opposite ends and a generally uniform outer diameter;
- a clevis attached to one end of said opposite ends, said clevis including a barrel having an inner diameter conforming to the outer diameter of the elongate member;
- a jaw assembly mounted on the clevis for pivotal movement; and
- an actuator member operatively connected to said jaw assembly for moving the jaw assembly between a closed position and an open position.
14. An instrument as set forth in claim 13 wherein the elongate member comprises a coil having a maximum outer diameter between about 0.070 inch and about 0.080 inch and a compressive preload between about 1 pound and about 1.5 pounds.
15. A method of assembling an endoscopic device including a clevis, an end effector, a pivot member and an actuator member, said method comprising:
- positioning the clevis in a fixture;
- positioning the end effector in the clevis;
- installing the pivot member through a hole in the clevis and a hole in the end effector;
- biasing the pivot member to a side of the hole in the clevis; and
- joining the pivot member to the side of the clevis hole.
Type: Application
Filed: Apr 14, 2006
Publication Date: Oct 18, 2007
Applicant:
Inventors: Patrick Weizman (Liberty Township, OH), John Measamer (Cincinnati, OH), Stephen Evans (West Chester, OH), Deborah Allan (Cincinnati, OH), Michael Sherrill (Batavia, OH), Richard Schwemberger (Cincinnati, OH)
Application Number: 11/404,796
International Classification: A61B 17/00 (20060101);