DE20121643U1 - Surgical instrument, includes handle assembly having movable actuator, body portion, and head portion - Google Patents

Abstract

A surgical instrument comprises a handle (112, 114) assembly including a movable actuator, a body portion extending from the handle, and head portion on one end of the body portion. The body portion includes an end effector. The movable actuator includes a cushioned portion (122). An independent claim is also included for a process for forming a surgical instrument, comprising injection molding a rigid handle housing; placing the molded rigid handle housing adjacent an injection molding fixture configured to form a cushioning material at least a location on the molded rigid handle housing; and injection molding a cushioning material on the molded rigid handle housing.

Description

96 194 t3/h

UNITED STATES SURGICAL,

a division of TYCO HEALTHCARE GROUP LP Norwalk, USA

Surgical instrument with padded handle BACKGROUND OF THE INVENTION

1. Technical area

The present disclosure generally relates to surgical instrumentation having actuating elements in the form of handles. In particular, the present disclosure relates to a surgical instrument comprising an actuating element on a handle element for actuating an end effector held at one end of the surgical instrument.

2. Description of the state of the art

Surgical instruments or instruments for attaching closures, e.g. staples and clips, to tissue and for performing other tasks are state of the art

known and are in widespread use. A wide variety of surgical procedures are performed using these instruments. Typically, these instrumentations comprise an end effector, e.g., an anvil, and a drive mechanism for actuating the end effector, e.g., for driving a staple (or clips) or a plurality of staples through tissue and into contact with the anvil to deform the staples. The drive mechanism is actuated by a handle assembly comprising a movable actuating member, e.g., a rotatable trigger member, a slidable knob, a button, a knob, etc. The force required by the surgeon to grasp the handle assembly and move the actuating member to actuate the device varies widely, and is dependent upon the type of actuating member and the size and type of surgical instrument. Such a force may be up to about 50 pounds or more, and generally ranges from about 20 pounds to about 50 pounds.

Generally, the handles of surgical instruments are formed of hard plastic or surgical grade steel, such as stainless steel. During some surgical procedures, the surgeon may be required to operate the drive mechanism multiple times to actuate the action member, such as to fire staples or clips, which may be cumbersome for the surgeon. Such repetitive use may eventually result in bruising of the surgeon's hand and/or repetitive injury. Blood and other body fluids typically collect on the surgeon's gloves and on the instruments used by the surgeon during the surgical procedure.

The presence of these fluids on the surgeon's gloves or hands and on the surgical instruments makes it difficult for the surgeon to grasp and handle the surgical instruments.

Accordingly, there is a need for a surgical instrument that can be manipulated repeatedly by the surgeon without causing discomfort to the surgeon. There is also a need for a surgical instrument that includes a handle that can be easily grasped and manipulated by the surgeon during the surgical procedure, even when blood and other body fluids are present.

SUMMARY

According to the present disclosure, a surgical instrument is provided having an operating element and a handle assembly comprising an actuating element for actuating the operating element. A padded portion is attached to one or more pressure contact areas of the handle assembly. The padded portion is preferably made of a material that is non-slip even in the presence of body fluids. In a preferred embodiment, the padded portion is over-molded over the pressure contact areas of the handle assembly. Alternatively, the padded portion may be attached to the pressure contact areas of the handle assembly using other attachment methods, e.g., physical, chemical, or mechanical methods, including adhesives, screws, welding, etc. In a preferred embodiment, the padded handle portion is made of a thermoplastic elastomer. Other non-slip,

however, pliable materials may also be used, including thermoplastic materials, elastomers, synthetic materials, etc. Slip resistance may be provided or enhanced by providing the padded portion with a textured or roughened surface layer. By providing a padded, non-slip portion on the operator's pressure contact areas of the handle assembly, a surgeon can easily grasp and manipulate the instrument with less or no discomfort.

BRIEF DESCRIPTION OF THE DRAWINGS

Various preferred embodiments of the surgical instrument disclosed herein are described with reference to the drawings, wherein

Fig. 1 is a side view of a preferred embodiment of a stationary handle portion of the surgical instrument disclosed herein prior to attachment of the padded portion;

Fig. 2 is a side view of the stationary handle portion shown in Fig. 1, with the padded handle portion shown separated therefrom;

Fig. 3 is a side view of the stationary handle portion shown in Fig. 1 with the padded portion attached thereto;

Fig. 4 is a perspective view of an end-to-end anastomosis instrument comprising padded sections mounted on the

pressure contact areas of the handle device;

Fig. 5 is a perspective view of a gastrointestinal anastomosis instrument with padded sections disposed on the pressure contact areas of the handle assembly; and

Fig. 6 is a perspective view of a transverse anastomosis instrument with padded sections disposed on the pressure contact areas of the handle assembly.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Preferred embodiments of the surgical instrument disclosed herein will now be described in detail with reference to the drawings, wherein like reference numerals indicate identical or corresponding elements in each of the views.

Figures 1-3 illustrate the stationary handle portion of a surgical instrument. The stationary handle portion 10 includes a solid or substantially solid body portion 14 and a pliable or cushioned portion 16. In a preferred embodiment, the stationary handle portion 10 is injection molded from a thermoplastic material and the cushioned portion 16 is made from a thermoplastic material or thermoplastic elastomer blend, e.g., Versaflex™ or Santaprene™. A preferred thermoplastic elastomer is OM1040-X Versaflex™. A thermoplastic elastomer is a thermoplastic material that has rubber-like or elastic properties.

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and which can be injection molded. Alternatively, the body portion 14 can be made from other materials including a variety of surgical grade metals and plastics materials, and the portion 14 can be made from other flexible or elastomeric materials including isoprenes or nitriles or silicon-containing materials, etc.

The padded portion 16 is attached to the pressure contact areas of the handle assembly. The pressure contact areas include those areas of the handle assembly to which a surgeon must apply pressure, e.g., manually and/or digitally, during handling and manipulation of the surgical instrument. In a preferred embodiment, the portion 16 is molded over the body portion 14. Alternatively, the portion 16 may be attached to the body portion 14 using any known suitable physical, chemical or mechanical attachment method, including adhesives, interlocking elements, screws, welding, bonding, fusing, coating, dipping, spraying, etc.

The use of a cushioned portion made of a thermoplastic elastomer or an elastomeric material on the pressure contact areas of the handle means cushions the impact on the surgeon's hand during manipulation of the surgical instrument. Preferably, the material is designed to be non-slip, or is provided with a non-slip surface, e.g. roughened, textured, corrugated, etc., such that the surface(s) adhere well to the gloves worn by the surgeon, even in the presence of body fluids, to improve the surgeon's grip on the surgical instrument.

Fig. 4 illustrates a surgical stapling device 100 that includes an operating member for performing an end-to-end anastomosis. The stapling device 100 includes a handle assembly including a stationary handle and a rotary handle 114. The operating member includes an anvil assembly 116 and a cartridge assembly 118 containing a circular array of staples. A rotary knob 120 is provided at the proximal end of the stationary handle 112 and is rotatably configured to move the cartridge assembly 118 between a spaced apart and an approached position with respect to the anvil assembly. Both the rotary handle 118 and the stationary handle 112 include a padded member or layer 122 attached to at least one of the pressure contact areas of the handle assembly. The actuating knob 120 may also be provided with a padded member in accordance with this disclosure. Preferably, the cushioned layer 122 comprises a thermoplastic elastomer material molded thereover. Alternatively, other flexible materials and attachment methods may be used.

Fig. 5 illustrates a surgical stapler 200 for applying linear rows of staples to tissue. The stapler 100 includes a handle assembly including handles 212 and 214, and an operative member including an anvil assembly 216 and a cartridge assembly 218. A firing button 224 is slidable from a proximal position to an advanced position to eject the staples from the cartridge one at a time. Each handle includes a padded member or layer 222 formed on the pressure contact areas of the handle. The firing button 224 may also include a portion of padded material.

6 illustrates a transverse anastomosis instrument 300 for applying linear rows of staples to tissue. The instrument 300 includes a handle assembly including a stationary handle 312 and a rotatable handle 314, and an operating member including an anvil assembly 316 and a cartridge assembly 318. The cartridge assembly 318 contains a plurality of rows of staples. The rotatable handle 314 is movable via an actuating stroke to move the cartridge assembly 318 between a spaced apart and an approached position with respect to the anvil assembly 316. Each of the handles 312 and 314 includes a non-slip, padded member or layer 322 formed thereon. The padded layers 322, as described above, may be molded over the handles 312 and 314 or attached thereto using known attachment techniques.

The hardness of the cushioning material employed will depend on the particular surgical instrument and its application. The pressure required to actuate the surgical instrument should be considered when selecting the material to form the cushioned portion of the surgical instrument. For example, a softer material may be more suitable for use with instruments that require higher actuation pressures. Conversely, a harder material may be more suitable for use with surgical instruments that require lower actuation pressures. The durometer of the cushioning material may range from about 10 to about 80, but is preferably about 20 to about 50, and more preferably about 40.

Other factors should also be considered before selecting the upholstery material. These include

such as whether the instrument is intended for single use only or is intended to be reusable, and whether the instrument is intended to be subjected to a sterilization process or other cleaning process. If the instrument is reusable, a heat-resistant padding material should be used. Alternatively, it is contemplated that the padding material may be removable such that it can be removed from the surgical instrument prior to sterilization and/or cleaning. For example, the padded element may be provided as a removable element including a resilient sleeve.

The preferred method of providing surgical instruments with a padded portion to form the surgical instruments of the present invention comprises molding or overmolding the cushioning material onto the desired portion(s) of the instrument. In particular, the preferred method is an injection molding process comprising two steps wherein, e.g., using a rotary table, the plastic material for forming the solid handle housing is poured at a first station into a mold having the shape of the portion, e.g., the handle housing of the instrument to be overmolded. Once the plastic has cooled sufficiently, the mold is opened and the table is rotated to advance the molded handle housing to a second station. At this second station, the handle housing is placed in a second mold, or is completely or selectively surrounded by the second mold. The cushioning material, preferably the thermoplastic elastomer Versoplex™ OM 1040-X, is poured into the second mold so that the material is formed on the portion of the handle housing to be padded. After the cushioning material has cooled sufficiently and is bonded or fused to the handle housing, the mold is opened and

the finished cushioned handle is removed from the mold. Conventional injection molding equipment and conventional times, temperatures and processes can be used in the two-step injection molding process. Although the above in-line process is preferred, other in-line or off-line injection molding processes or other manufacturing processes can be used.

It will be apparent that various modifications may be made to the embodiments described herein, for example it is contemplated that other flexible or cushioning materials may be used to achieve a cushioning effect similar to that described above. Moreover, the flexible handle portion described above may be provided on other manually operable release devices, such as pliers or cutting instruments. Therefore, the above description should not be construed as limiting, but merely as an example of the preferred embodiments. Other modifications within the scope of the appended claims will be apparent to those skilled in the art.

Claims (7)

1. A surgical instrument ( 100 ) for applying surgical staples to tissue, comprising:
a handle device comprising a stationary handle portion ( 112 ) and a movable actuating element ( 114 );
a body portion extending distally from the handle assembly;
a head portion supported at one end of the body portion and comprising an operative member configured to perform a surgical operation and comprising a first jaw having an anvil ( 116 ) and a second jaw having a magazine means ( 118 ) containing at least one staple, and
a padded, non-slip portion ( 122 ) on pressure contact areas of both the movable actuator and the stationary handle portion to absorb the force exerted on the movable actuator upon actuation of the actuator by both the palm and fingers of a hand. 2. Surgical instrument according to claim 1, wherein the padded portion is made of an elastomer, preferably a thermoplastic elastomer. 3. A surgical instrument according to claim 1 or 2, wherein the padded portion is molded over the movable actuating element. 4. Surgical instrument according to one of claims 1 to 3, wherein the movable actuating element comprises a rotatable trigger element ( 114 ). 5. A surgical instrument according to any one of claims 1 to 4, wherein the jaws are configured for end-to-end anastomosis. 6. A surgical instrument according to any one of claims 1 to 4, wherein the jaws are configured for side-to-side anastomosis. 7. Surgical instrument according to one of claims 1 to 6, wherein the padded portion is provided with a non-slip surface roughened by corrugations or the like, so as to improve the slip resistance of the padded portion.