Instrument introducer

Instrument introducers are disclosed which facilitate the insertion of a surgical instrument into a cavity or a body of a patient. In one embodiment, the instrument introducer includes a hollow elongate cylindrical body including a distal end portion terminating in a distal edge and a proximal end portion, the cylindrical body defining a central longitudinal axis, and an elastomeric cap secured to the distal end portion of the cylindrical body, the cap including a distal end wall having an outer terminal edge and an annular side wall depending from the outer terminal edge thereof. The distal end wall includes an aperture formed therein, wherein a center of the aperture is coaxially aligned with the central longitudinal axis.

BACKGROUND

1. Technical Field

The present disclosure relates to instrument introducers or protective sleeves and method of using the same, and more particularly, to novel protective sheaths configured to facilitate the introduction of surgical instruments into a cavity or a body opening of a patient.

2. Background of Related Art

Surgical instruments configured for remote use inside the body of a patient typically define a central longitudinal axis including a distal end portion and a proximal end portion. The distal end portion of the surgical instrument can include configurations which have either blunt or rounded faces and/or in certain instances include sharper subassemblies including electrosurgical or mechanical blades for cutting as well as fasteners for securing tissue portions. Typically, the distal end portions and, in particular, the distal end surfaces of these surgical instruments are such that irritation or trauma may be caused to the tissue surrounding the opening of the body through which the instrument is to be inserted. As a result of the mechanical complexity of these surgical instruments, the distal end portions of these instruments have been provided with a shell or cover that may partially or fully enclose the distal end portion of the surgical instrument.

For example, presently, various intra-anal surgical instruments, such as intraluminal anastomotic surgical staplers, require insertion into the colon or intestine through the anus. In certain embodiments, these surgical staplers have staple anvil portions removably mounted to a distal end thereof. Generally, the surgical stapler is inserted with the anvil portion attached, however, certain surgical procedures require that the surgical stapler is inserted into the colon or intestine through the anus with anvil portion removed.

Typically, in instances where the surgical stapler is to be inserted into the colon or intestine of the patient with the anvil portion mounted to a distal end thereof, the anvil portion is tapered inward toward the tip and formed to have an atraumatic end, thus facilitating the insertion of the distal end of the surgical instrument into the colon or intestine of the patient. However, in instances where the surgical stapler is to be inserted into the colon or intestine without the anvil portion mounted to a distal end thereof, the substantially squared or non-taped distal end of the surgical instrument may cause irritation and trauma to the surrounding tissue.

Thus, a need exists for a instrument introducer in the form of a sheath, which instrument introducer facilitates the passage of the surgical instrument into the body of the patient and that can be either adapted to be removably mounted on a distal end of the surgical instrument or be used as a separate device adapted to be positioned at least partially into the body of the patient (i.e., into the anus) and wherein the surgical instrument is subsequently positioned into the instrument introducer to facilitate insertion of the surgical instrument into the body of the patient.

SUMMARY

The present disclosure relates to instrument introducers configured to facilitate the introduction of surgical instruments into a cavity or a body opening of a patient. In one aspect of the present disclosure, the instrument introducer includes a tubular body portion defining a lumen therethrough, the tubular body portion having a proximal end and a distal end and a distal end portion secured to the distal end of the tubular body portion, the distal end portion including a distal end wall configured and adapted to facilitate passage of a surgical instrument therethrough.

It is contemplated that the distal end portion includes an annular side wall depending from an outer terminal edge thereof. Preferably, the distal end portion is made from an elastomeric material. The distal end wall of the distal end portion includes an aperture formed therein, wherein the aperture is preferably coaxially aligned with a central longitudinal axis of the tubular body portion.

In one embodiment the distal end portion is secured to the distal end of the tubular body portion such that the annular side wall at least partially overlaps the distal end of the tubular body portion. In another embodiment the distal end portion is secured to the distal end of the tubular body portion such that the annular side wall completely overlaps the distal end of the tubular body portion. In yet another embodiment a proximal terminal edge of the annular side wall of the distal end portion is secured to a distal terminal edge of the distal end of the tubular body. The distal end portion is secured to the distal end of the tubular body by fusing, overmolding, gluing and/or bonding.

The tubular body portion is preferably fabricated from polypropylene. In one embodiment, the instrument introducer includes a flange extending radially outward from the proximal end of the tubular body portion.

It is envisioned that the distal end wall of the distal end portion is provided with a region of weakened strength. The region of weakened strength includes score lines, perforations, webbing and/or reduced thickness. It is further envisioned that the distal end wall of the distal end portion is shaped to define a pocket.

In another aspect of the present disclosure the instrument introducer includes a hollow elongate cylindrical body including a distal end portion terminating in a distal edge and a proximal end portion, the cylindrical body defining a central longitudinal axis, and an elastomeric cap secured to the distal end portion of the cylindrical body, the cap including a distal end wall having an outer terminal edge and an annular side wall depending from the outer terminal edge thereof. The distal end wall includes an aperture formed therein, wherein a center of the aperture is coaxially aligned with the central longitudinal axis. It is envisioned that the cylindrical body is configured and adapted to receive a surgical instrument therethrough.

In one embodiment, the instrument introducer further includes a flange extending radially outward from a proximal terminal edge of the proximal end portion of the cylindrical body.

In one embodiment it is envisioned that the cap is secured to the distal end of the cylindrical body such that the distal end wall of the cap is spaced a distance from the distal terminal edge of the cylindrical body. In another embodiment it is envisioned that the cap is secured to the distal end of the cylindrical body such that a proximal terminal edge of the annular side wall is secured to the distal terminal edge of the cylindrical body.

It is contemplated that the distal end wall of the cap is shaped to define a pocket and wherein the aperture is formed in the pocket.

The present disclosure also discloses methods of introducing a surgical instrument into a cavity or a body opening of a patient. One method includes the step of providing an instrument introducer, wherein the instrument introducer includes a hollow tubular body having a distal end portion and a proximal end portion defining a lumen therebetween, and a resilient cap secured to the distal end of the tubular body, the cap having an aperture formed therein. The method further includes the steps of inserting the distal end of the instrument introducer into the cavity or body opening of the patient, inserting a surgical instrument into the lumen of the tubular body of the instrument introducer through a proximal end of the tubular body, and advancing the surgical instrument through the lumen of the tubular body of the instrument introducer until a distal end of the surgical instrument projects out through the aperture of the cap, wherein the cap creates a seal around the perimeter of the surgical instrument extending therefrom.

In another aspect of the method, a distal end of a surgical instrument is first inserted into a proximal end of the tubular body of the instrument introducer, the distal end of the surgical instrument, having the instrument introducer placed thereon, is then inserted into the cavity or body opening of the patient, the surgical instrument is then advanced through the instrument introducer until the distal end of the surgical instrument projects out through the aperture of the cap.

Accordingly, it is an object of the present disclosure to provide a surgical instrument introducer which facilitates the insertion of a distal end of the surgical instrument into a cavity or a body opening of a patient.

It a further object of the present disclosure to provide an instrument introducer which reduces the potential for irritation and/or trauma as a result of the insertion of the surgical instrument into the cavity or body opening of the patient if the surgical instrument were to be inserted into the cavity or body opening of the patient without the instrument introducer operatively coupled thereto.

The presently disclosed instrument introducer, together with attendant advantages, will be more clearly illustrated below by the description of the drawings and the detailed description of the preferred embodiments.

Other objects and features of the present disclosure will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

While the device according to the present disclosure is especially suitable for introducing a distal end portion of a surgical instrument into body cavities, such as, for example, anal orifices, the external urethral opening or the mouth of a patient, for performing, for example, hemorrhoidal or end-to-end anastomotic applications, it is envisioned that the device according to the present disclosure can be used in connection with other surgical instruments for performing any number of other endoscopic or laparoscopic surgical procedures. For example, it is believed that the device disclosed herein may find use in other procedures in which blunt ended surgical instruments are introduced into the bodies of patients.

In the drawings and in the description which follows, the term “proximal”, as is traditional will refer to the end of the surgical device or instrument of the present disclosure which is closest to the operator, while the term “distal” will refer to the end of the device or instrument which is furthest from the operator.

Referring now in specific detail to the drawings, in which like reference numerals identify similar or identical elements,FIGS. 1,1A,1B and1C illustrate a surgical instrument introducer generally designated with the reference numeral10. Surgical instrument introducer10is in the form of a sheath, drape, sock, sleeve, covering, casing, condom, etc. Accordingly, as used herein, instrument introducer10can embody any one of these terms.

As will be further described below, instrument introducer10is configured and adapted to be either removably mounted on a distal end portion of a surgical instrument (e.g., anastomotic stapler) prior to insertion of the surgical instrument into an orifice of the body or for initial placement into the orifice of the body and for subsequent insertion of the distal end portion of the surgical instrument therein. Preferably, instrument introducer10has a shape which facilitates its entry into the orifice of the body and which is also compatible with the distal end portion of the surgical instrument. It is contemplated that instrument introducer10functions as a protective sheath or sleeve to cap the distal end of and to facilitate the entry of the distal end portion of the surgical instrument into the orifice of the body. In addition, instrument introducer10can act as an insulative barrier and/or an isolating barrier between the surgical instrument and the body of the patient.

In a preferred embodiment, introducer10has two principle sections, namely, a hollow tubular section12and a distal end portion14affixed adjacent to a distal edge12a(seeFIG. 1A) of tubular section12. It is contemplated that instrument introducer10may be constructed from a tubular section12and a distal end portion14made from different materials which are in turn joined together, or introducer10may be monolithically formed in which case tubular section12and distal end portion14are made from a single material specifically selected depending upon its desired application.

Hollow tubular section12includes an annular wall16defining a lumen18therethrough, which lumen18defines a central longitudinal axis “A”. Preferably, annular wall16has an inner diameter sized to receive a distal end portion of the surgical instrument. It is envisioned that tubular section12can vary in length depending on the surgical instrument that is going to be inserted into the orifice of the body through lumen18and depending on the particular surgical application in which instrument introducer10is going to be used. Preferably, tubular section12will vary in length from about two inches to about eight inches.

Tubular section12is preferably fabricated from a suitable moldable plastic material with sufficient pliability to provide for controlled deflection and sufficient stiffness to retain shape during insertion and use. Tubular section12is preferably fabricated from polypropylene or like acceptable medical grade material capable of sterilization.

In a preferred embodiment, distal end portion14is in the form of a cap having a preferably circular distal end wall20and an annular side wall22depending substantially orthogonally from an outer terminal edge24of end wall20. End wall20bounds a circular through-hole26formed therein, wherein a central axis of through-hole26is substantially co-axial with central longitudinal axis “A” of lumen18. While the central axis of through-hole26has been described as being co-axial with longitudinal axis “A”, it is envisioned that through-hole26need not be concentric with lumen18or that end wall20can define additional holes having varying alignments and directional orientations for the passage of portions of a surgical instrument therethrough.

Distal end portion14of instrument introducer10, and preferably at least distal end wall20of distal end portion14, is fabricated from a flexible/pliable/stretchable material, preferably a thermoformable material, more preferably, an extrudable or injection moldable material, and most preferably an elastomer or elastomeric material. Distal end portion14is configured and adapted for receiving the distal end of the surgical instrument therein, and for deforming and yielding about the distal end of the surgical instrument during the advancement of the distal end of the surgical instrument through lumen18of tubular section12and against an inner surface of distal end wall20of distal end portion14.

In an alternative embodiment, it is contemplated that through-hole26can be partially or fully closed, or distal end wall20can be weakened by score lines26A (seeFIG. 2A), thinned (seeFIG. 2B), provided with perforations or webbed portions (not shown) which define the bounds of through-hole26. In still a further embodiment, through-hole26can be a slit formed in end wall20of distal end portion14. In this embodiment, through-hole26of distal end portion14is subsequently opened or created by the operator of the surgical instrument and/or instrument introducer10or by the application of an axial force to the inner surface of distal end wall20upon advancement of the distal end of the surgical instrument through lumen18of instrument introducer10and against the weakened distal end wall20.

Turning back toFIGS. 1-1Cand, in particular toFIG. 1B, preferably, annular side wall22of distal end portion14has an inner diameter which is substantially equal to the outer diameter of tubular section12. As such, distal end portion14is snuggly fitted over the distal end portion of tubular section12. Accordingly, distal end portion14is restricted or prevented from sliding off of distal edge12aof tubular section12, thereby reducing the susceptibility of distal end portion14from separating from tubular section12.

As seen inFIG. 1B, distal end portion14is preferably secured at “B” about the distal end of tubular section12. It is contemplated that distal end portion14is secured about the distal end of tubular section12by fusion, a two shot, overmold, gluing, or other bonding processes known by those skilled in the art. Further, in the present embodiment, the entire length of annular side wall22of distal end portion14is preferably in contact with and subsequently bonded to the distal end of tubular section12.

It is envisioned that when instrument introducer10is adapted to be initially coupled to or to be removably coupled on the distal end portion of the surgical instrument, instrument introducer10can be coupled thereto using, for example, mechanical lugs, directly overmolding the material, suitable adhesives, mechanical friction enhancing surface finishes, or heat shrinking.

In another preferred embodiment, as seen inFIGS. 1 and 1A, tubular section12includes a structure having one or more radially outwardly extending portions such as tabs or more preferably such as a continuous flange28(represented as dashed lines inFIGS. 1 and 1A) integral with or connected to a proximal edge29of tubular section12. In one aspect of the disclosure, flange28functions to limit the depth of entry of instrument introducer10into the body of the patient. Flange28can advantageously provide a surface suitable for the positioning of adhesives or tapes, e.g., such as those sold under the trademark Steri-strip, to fix or secure instrument introducer10and potentially the surgical instrument relative to the patient and to limit the depth of penetration of instrument introducer10and/or the distal end of the surgical instrument into the body of the patient. While it is envisioned that flange28is to be used when instrument introducer10is employed as a stand alone device that is unconnected to a surgical instrument, it is envisioned that an instrument introducer10having a flange28can also be employed when instrument introducer10is connected to the surgical instrument prior to insertion of instrument introducer10into the cavity or body opening of the patient.

While distal end portion14of instrument introducer10is preferably a flexible/pliable/stretchable material adapted to accommodate the distal end portion of a surgical instrument, alternative embodiments are envisioned where distal end portion14utilizes predisposed or formed folds or combinations of folds which flex and/or stretch and have a shape suitable for penetration and passage of the tip, head, assembly, subassembly or end effector of the surgical instrument. In a further alternative embodiment, distal end portion14can be fabricated from a radially expandable mesh such that distal end portion14is expandable to accommodate the distal end portion of the surgical instrument.

While two different materials have been described herein with reference to respective tubular section12and distal end portion14, it is envisioned that a single elastomer or combinations of elastomers and flexible/stretchable materials of different durometers, having suitable characteristics, may be used to fabricate instrument introducer10. For example, distal end wall20can have a durometer that renders it more flexible than annular side wall22thereby permitting the distal end portion of a surgical instrument to more easily pass through through-hole26of distal end portion14.

Turning now toFIGS. 3 and 3A, an alternative embodiment of an instrument introducer10is illustrated. As shown inFIGS. 3 and 3A, instrument introducer10includes a distal end portion14in which the distal end wall thereof defines a pocket30. Pocket30extends distally or proximally from distal end wall20and is defined by having a diameter which is less than the diameter of annular side wall22. In addition, pocket30is provided with through-hole26centrally formed therein. Preferably, the diameter of pocket30substantially corresponds to a diameter of a distal end of a surgical instrument “S” which has a relatively smaller diameter than the inner diameter of annular wall16of tubular section12. Accordingly, when relatively smaller diameter surgical instrument “S” is received within instrument introducer10, the distal end of smaller diameter surgical instrument “S” is snuggly received within pocket30. As smaller diameter surgical instrument “S” is advanced distally through instrument introducer10, pocket30stretches/flexes distally and through-hole26stretches/flexes radially outward to a diameter sufficient to accommodate the passage of smaller diameter surgical instrument “S” therethrough.

Turning now toFIGS. 4 and 4A, a relatively larger diameter surgical instrument “L”, having an outer diameter slightly smaller than the inner diameter of annular wall16of tubular section12, is shown inserted into instrument introducer10. As larger diameter surgical instrument “L” is advanced distally through instrument introducer10, pocket30stretches/flexes to conform to the shape of the distal end of the larger diameter surgical instrument “L”. As larger diameter surgical instrument “L” is further advanced through instrument introducer10, through-hole26stretches/flexes radially outward to a diameter sufficient to accommodate the passage of the larger diameter surgical instrument “L” therethrough.

As seen inFIG. 5, distal end portion14, including through-hole26, can have sufficient elasticity to accommodate the passage of a head “H” of either smaller or larger diameter surgical instrument “S” or “L” through through-hole26, and is suitably biased in each instance to return to the first unstretched state after passage of head “H” therethrough. Instrument introducer10is configured to stretch/flex in order to accommodate the passage of head “H” of smaller or larger surgical instrument “S” or “L” therethrough as head “H” is passes proximally and distally across through-hole26.

Turning now toFIGS. 6 and 7, alternative embodiments of instrument introducer10are disclosed. As seen inFIGS. 6 and 7, it is envisioned that distal end wall20of distal end portion14is spaced a distance “Y” from a distal edge12aof tubular section12. In the embodiment shown inFIG. 6, the internal surface of annular side wall22of distal end portion14is in contact with the outer surface of a distal end of annular wall16of tubular section12such that distal end wall20is spaced a distance “Y” from distal edge12aof tubular section12. In addition, annular side wall22of distal end portion14overlaps the distal end of annular wall16of tubular section12by an amount “Y1”. As described above, preferably, the inner surface of annular wall22of distal end portion14is fused, bonded, etc, at “B”, to the outer surface of annular wall16of tubular section12.

In the embodiment shown inFIG. 7, it is envisioned that a proximal edge33of annular side wall22of distal end portion14is fused, bonded, etc., at “B”, to distal edge12aof tubular section12. In this manner, the entire length of annular wall22of distal end portion14extends from tubular section12.

Operation of instrument introducer10will now be described with reference toFIGS. 1-5. In a preferred method of use, instrument introducer10is initially positioned on a distal end portion of a surgical instrument. As the distal end portion of the surgical instrument, with instrument introducer10positioned thereon, is inserted and/or introduced into a cavity or body opening of a patient (e.g., the anus), the flexible/stretchable distal end wall20of distal end portion14of instrument introducer10is flexed/stretched in an axial direction as a result of the side walls of the cavity or body opening of the patient creating a resistance to the advancement of instrument introducer10and the continued distal advancement of the surgical instrument through lumen18of instrument introducer10. As the surgical instrument is further advanced distally, the distal end portion of the surgical instrument at least partially deforms and/or stretches distal end portion14of instrument introducer10and deforms and/or stretches through-hole26, radially enlarging it, to a diameter sufficient to accommodate the passage of head “H” of the surgical instrument through instrument introducer10and, if need be, to accommodate the passage of the distal end portion of the surgical instrument (not shown).

In an alternative method of use, instrument introducer10is initially placed within the cavity or body opening of the patient such that distal end portion14of instrument introducer10is retained therein. With instrument introducer10in place, the distal end of a surgical instrument is inserted within lumen18of instrument introducer10and advanced until the distal end of the surgical instrument contacts the inner surface of distal end wall20of distal end portion14of instrument introducer10. Similar to the method described above, as the surgical instrument is further advanced distally within instrument introducer10, the distal end portion of the surgical instrument begins to partially deform and/or stretch distal end portion14of instrument introducer10and to deform and/or stretch hole26and radially enlarge it to a diameter sufficient to accommodate the passage of head “H” of the surgical instrument through instrument introducer10and, if need be, to accommodate the passage of the distal end portion of the surgical instrument (not shown).

In either method, it is understood by those skilled in the art that flange28will limit the depth of penetration of instrument introducer10into the cavity or the body opening of the patient. Additionally, in either method, it is contemplated that a lubricant be applied to the outer surface of instrument introducer10in order to facilitate insertion of instrument introducer10into the cavity or body opening of the patient and optionally to the inner surface of instrument introducer10and/or the outer surface of the surgical instrument in order to facilitate the insertion of the surgical instrument into instrument introducer10.

Although the illustrative embodiments of the present disclosure have been described herein, it is to be understood that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be affected therein by one skilled in the art without departing from the scope or spirit of the disclosure. All such changes and modifications are intended to be included within the scope of the disclosure.