AU2001264958A1 - Surgical instrument with cushioned handle assembly - Google Patents

Description

SURGICAL INSTRUMENT WITH CUSHIONED HANDLE ASSEMBLY

This application claims priority from provisional application serial no. 60/207,012,

filed May 25, 2000, which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Technical Field

The present disclosure relates generally to surgical instrumentation having handle

actuators. More particularly, the present disclosure relates to surgical instrumentation

including a handle actuator for actuating an end effector supported on one end of a

surgical instrument.

2. Background of Related Art

Surgical mstrumentation for applying fasteners, e.g., staples and clips, to tissue

and performing other tasks are well known in the art, and are commonly used to perform

a variety of surgical procedures. Typically, these instruments include an end effector,

e.g., an anvil, and a drive mechanism for actuating the end effector, e.g., driving a staple

(or clip) 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 which includes a

movable actuator, e.g., a pivotable trigger, a slidable knob, a button, a rotatable knob, etc.

The force required for a surgeon to grip the handle assembly and move the actuator to actuate the device varies greatly depending on the type of actuator and on the size and

type of surgical instrument. Such force may be as high as about 50 lbs. or higher and is

generally between about 20 lbs. and about 50 lbs.

Generally, the handle assemblies of surgical instruments are formed from hard

plastic or surgical grade steel, e.g., stainless steel. During certain surgical procedures, a

surgeon may be required to actuate the drive mechanism to actuate the end effector, e.g.,

fire staples or clips, a multiplicity of times causing the surgeon discomfort. Such

repetitive use may eventually lead to bruising of the surgeon's hand and/or repetitive

injury. It is common for blood and other body fluids to 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 the surgical instruments make it

difficult for the surgeon to grip and manipulate the surgical mstruments.

Accordingly, a need exists for a surgical mstrument which can be actuated by a

surgeon multiple times without causing the surgeon discomfort. A need also exists for a

surgical instrument which includes a handle assembly which can be easily gripped and

manipulated by a surgeon diαring a surgical procedure even in the presence of blood and

other bodily fluids.

SUMMARY

In accordance with the present disclosure, a surgical mstrument having an end effector and a handle assembly including an actuator for actuating the end effector is

provided. A cushioned portion is attached to one or more pressure contact regions" of the

handle assembly. The cushioned portion is preferably formed from a material which is

slip-resistant even in the presence of body fluids. In a preferred embodiment, the

cushioned portion is over-molded onto the pressure contact regions of the handle

assembly. Alternately, the cushioned portion can be fastened to the pressure contact

regions of the handle assembly using other fastening techniques, e.g., physical, chemical

or mechanical, mcluding adhesives, screws, welding, etc. In one preferred embodiment

the cushioned grip portion is formed from a thermoplastic elastomer. However, other

slip-resistant, pliant materials may also be used including thermoplastics, elastomers,

synthetics, etc. Slip-resistance can be provided or enhanced by providing the cushioned

portion with a textured or roughened surface finish. By providing a cushioned, slip-

resistant portion on the operator pressure contact regions of the handle assembly, a

surgeon can more easily grasp and manipulate the instrument with less or no discomfort.

BRIEF DESCRIPTION OF THE DRAWINGS

Various preferred embodiments of the presently disclosed surgical instrument are

described herein with reference to the drawings wherein:

FIG. 1 is a side view of one preferred embodiment of a stationary handle portion

of the presently disclosed surgical instrument prior to attachment of the cushioned portion;

FIG. 2 is a side view of the stationary handle portion shown in FIG. 1 with the

cushioned grip portion separated therefrom;

FIG. 3 is a side view of the stationary handle portion shown in FIG. 1 with the

cushioned portion fastened thereto;

FIG. 4 is a perspective view of an end-to-end anastomosis instrument including

cushioned portions positioned on the pressure contact regions of the handle assembly;

FIG. 5 is a perspective view of a gasttointestinal anastomosis mstrument with

cushioned portions positioned on the pressure contact regions of the handle assembly;

and

FIG. 6 is a perspective view of a transverse anastomosis instrument with cushioned

portions positioned on the pressure contact regions of the handle assembly.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed surgical instrument will now be

described in detail with reference to the drawings wherein like reference numerals

designate identical or corresponding elements in each of the several views.

FIGS. 1-3 illustrate the stationary handle portion 10 of a surgical instrument.

Stationary handle portion 10 includes a rigid or substantially rigid body portion 14 and a

pliant or cushioned portion 16. In one preferred embodiment, stationary handle portion 10 is injection molded from a thermoplastic material and cushioned portion 16 is formed

from a thermoplastic 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 flexible

properties and can be injection molded. Alternately, body portion 14 can be formed from

other materials including a variety of surgical grade metals and plastics and portion 14

can be formed from other pliant or elastomeric materials mcluding isoprenes or nitrile or

silicon containing materials, etc.

Cushioned portion 16 is fastened to the pressure contact regions of the handle

assembly. The pressure contact regions include those areas of the handle assembly to

which a surgeon must apply pressure, e.g., hand and or digital, during manipulation and

actuation of the surgical instrument. In a preferred embodiment portion 16 is over-

molded onto body portion 14. Alternately, portion 16 can be secured to body portion 14

using any known suitable physical, chemical or mechanical fastening techniques

including adhesives, interengaging members, screws, welding, bonding, fusing, coating,

dipping, spraying, etc.

The use of a cushioned portion formed from a thermoplastic elastomer or an

elastomeric material on the pressure contact regions of the handle assembly cushions the

impact on a surgeon's hand during operation of the surgical instrument. Preferably, the

material is slip-resistant or is provided with a slip-resistant surface, e.g., roughened, textured, ridged, etc., such that the surface(s) adhere well to the

surgeon, even in the presence of bodily fluids, to improve a surgeon's grip on the surgical

mstrument.

FIG. 4 illustrates a surgical stapler 100 mcluding an end effector for performing

end-to-end anastomosis. Stapler 100 includes a handle assembly including a stationary

handle 112 and a pivotable handle 114. The end effector includes an anvil assembly 116

and a cartridge assembly 118 which houses a circular array of staples. A rotatable knob

120 is supported on the proximal end of stationary handle 112 and is rotatable to move

cartridge assembly 118 in relation to anvil assembly 116 between spaced and

approximated positions. Pivotable handle 118 and stationary handle 112 each include a

cushioned member or layer 122 which is fastened to at least one of the pressure contact

regions of the handle assembly. Actuator knob 120 may also be provided with a

cushioned member in accordance with this disclosure. Preferably, cushioned layer 122

includes an over-molded thermoplastic elastomeric material. Alternately, the use of other

pliant materials and fastening techniques, are envisioned.

FIG. 5 illustrates a surgical stapler 200 for applying linear rows of staples to

tissue. Stapler 200 includes a handle assembly including handles 212 and 214 and an end

effector including an anvil assembly 216 and a cartridge assembly 218. A firing knob

224 is slidable from a proximal position to an advanced position to sequentially eject

staples from the cartridge. Each handle includes a cushioned member or layer 222 formed on pressure contact regions of the handle. The firing knc

portion of cushioning material.

FIG. 6 illustrates a transverse anastomosis instrument 300 for applying linear rows

of staples to tissue. Instrument 300 includes a handle assembly including a stationary

handle 312 and a pivotable handle 314, and an end effector including an anvil assembly

316 and a cartridge assembly 318. Cartridge assembly 318 houses a plurality of rows of

staples. Pivotable handle 314 is movable through an actuation stroke to move cartridge

assembly 318 in relation to anvil assembly 316 between spaced and approximated

positions. Handles 312 and 314 each include a slip-resistant, cushioned member or layer

322 formed thereon. Cushioned layers 322, as discussed above, can be over-molded

about handles 312 and 314 or fastened thereto using any known fastening technique.

The hardness of the cushioning material employed will vary depending on the

particular surgical instrument and its application. The pressure required to actuate a

surgical instrument should be considered when choosing the material for forming the

cushioned portion of the surgical instrument. For example, a softer material may be more

suitable for use with instruments requiring higher actuation pressures. Conversely, a

harder material may be suitable for use in surgical instruments requiring lower actuation

pressures. The durometer of the cushioning material can be from about 10 to about 80,

but is preferably from about 20 to about 50, and more preferably about 40.

Other factors should also be considered prior to selecting the cushioning material. These include whether the instrument is disposable or reusable ar

sterilization or other cleaning processes. If the instrument is reusable, a cushioning

material having heat resistant properties should be used. In the alternative, it is

contemplated that the cushioning member can be removable such that it could be removed

from the surgical mstrument prior to the sterilization and/or cleaning process. For

example, the cushioning member could be provided as a removable member including a

flexible sleeve.

The preferred method of providing surgical instruments with a cushioned portion

to form the surgical instruments of the invention is to over-mold the cushioning material

onto the desired portion(s) of the instrument. More particularly, the preferred method is a

two-step injection molding process wherein, for example, by use of a rotary table, at a

first station the plastic material for forming a rigid handle housing is injected into a mold

in the form of the portion, e.g. the handle housing is injected into a mold in the form of

the portion, e.g. the handle housing of the mstrument to be over-molded. Once the plastic

has cooled sufficiently, the mold is opened, and the table is rotated to move the formed

handle housing to a second station. At the second station, the handle housing is placed in

or is fully or selectively surrounded by a second mold. The cushioning material,

preferably the themoplastic elastomer Versoplex™ OM 1040-X, is injected into the

second mold such that the material is formed on the portion of the handle housing to be cushioned. After the cushioning material has sufficiently cooled

the handle housing, the mold is opened and the finished cushioned handle is removed

from the mold. Conventional over molding equipment, and conventional times

temperatures and procedures can be employed in the two-step injection molding process.

Though the above in-line process is preferred, other in-line or off-line injection over

molding processes, or other forming processes can be employed.

It will be understood that various modifications may be made to the embodiments

disclosed herein. For example, it is envisioned that other pliant or cushion materials may

be used to achieve a cushioning effect similar to that disclosed above. Moreover, the

above described pliant handle portion may be provided on other hand operated trigger

devices such as graspers or cutting instruments. Therefore, the above description should

not be construed as limiting, but merely as exemplifications of preferred embodiments.

Those skilled in the art will envision other modifications within the scope and spirit of the

claims appended hereto.

Claims (19)

WHAT IS CLAIMED IS:

1. A surgical instrument comprising:

a handle assembly including a movable actuator;

a body portion extending distally from the handle; and

a head portion supported on one end of the body portion and including an end

effector;

wherein the movable actuator includes a cushioned portion.

2. A surgical instrument according to Claim 1, wherein the cushioned portion

is formed from a thermoplastic elastomer.

3. A surgical instrument according to Claim 1, wherein the cushioned portion

is formed from an elastomeric material.

4. A surgical instrument according to Claim 1, wherein the cushioned portion

is over-molded onto the movable actuator.

5. A surgical instrument according to Claim 1, wherein the movable actuator

includes a pivotable trigger.

6. A surgical instrument according to Claim 5, wherein the handle assembly

further includes a stationary handle portion.

7. A surgical instrument according to Claim 6, wherein the stationary handle

portion includes a cushioned portion.

8. A surgical instrument according to Claim 7, wherein the end effector includes a pair of jaws.

9. A surgical instrument according to Claim 8, wherein one of the jaws

includes a staple cartridge and the other of the jaws includes an anvil.

10. A surgical instrument according to Claim 9, wherein the jaws are

configured to perform end-to-end anastomoses.

11. A surgical instrument according to Claim 8, wherein the jaws are

configured to perform side-to-side anastomoses.

12. A surgical instrument according to Claim 1, wherein the cushioned

portion is formed from a slip-resistant material.

13. A surgical instrument according to Claim 1, wherein the handle assembly

includes a stationary handle portion, and the cushioned portion is positioned on the

pressure contact regions of the movable actuator and the stationary handle portion.

14. A surgical instrument according to Claim 1, wherein the cushioned portion

is provided with a slip-resistant textured surface.

15. A surgical instrument according to Claim 1, wherein the cushioned portion

is a cushioned grip portion.

16. A process for forming a surgical instrument comprising the steps of:

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 one location on the molded rigid handle housing; and

injection molding a cushioning material on said at least one location on the molded

rigid handle housing.

17. A process as in Claim 16 wherein the step of injection molding a

cushioning material includes injection molding a thermoplastic elastomer on said at least

one location on the molded rigid handle housing.

18. A surgical instrument having a cushioning material formed thereon in

accordance with the process of Claim 16.

19. A process as in Claim 16 wherein the steps of injection molding a rigid

handle housing and injection molding a cushioning material on said handle housing are

performed sequentially using a two shot injection process.