US20050107815A1 - Penetrating tip for trocar assembly - Google Patents

Abstract

A tissue penetrating instrument of the type used in the medical field and which may or may not be embodied in the form of an obturator associated with a trocar assembly, wherein the instrument includes an elongated shaft having a penetrating tip mounted on one end thereof. The penetrating tip includes a base secured to the one end of the shaft and a distal extremity spaced longitudinally outward from the base and formed into an apex which may be defined by a point or other configuration specifically structured to facilitate penetration or puncturing of bodily tissue. The apex may be substantially aligned with a linear extension of the central longitudinal axis of the shaft or alternatively, may be spaced laterally outward or off-set from the central longitudinal axis of the shaft. The penetrating tip further includes an exterior surface extending continuously between the apex and the base and configured to facilitate puncturing of the tissue and an enlargement of an access opening formed in the tissue, in a manner which facilitates separation of the tissue and minimizes cutting, severing or otherwise damaging the contiguous bodily tissue surrounding the access opening.

Description

CLAIM OF PRIORITY
• This application is a continuation-in-part (CIP) of and a claim of priority it made to currently pending patent application having Ser. No. 09/859,009 which was filed in the U.S. Patent and Trademark Office (PTO) on May 16, 2001, which application is based on and claims priority under 35 U.S.C. Section 119(e) to an earlier provisional patent application filed in the U.S. PTO on May 16, 2000 and having Ser. No. 60/204,396, all of which are incorporated herein in their entireties by reference.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention is directed towards a medical instrument of the type structured for use in laparoscopic A and/or endoscopic surgery such as, but not limited to, a trocar assembly which includes an obturator having an elongated shaft with a penetrating tip formed on one end thereof. The penetrating tip includes an exterior surface configuration structured to facilitate the forming of an access opening in a patient's bodily tissue in a manner which requires a minimum application of an inwardly directed, linear pushing force on the instrument, but which nevertheless results in the dilation of body tissue. The configuration of the inventive penetrating tip is at least partially characterized by a perpendicular cross-section of the exterior surface having a substantially elliptical configuration along at least a majority of the tip.
• 2. Description of the Related Art
• In the past when patients were in need of certain routine surgical operations, it was common for the medical doctor(s) to make a substantially large incision into, through and across the patient's abdominal cavity in order to reach the affected ad organ(s) and/or other body tissue. While the size of the incision made would vary dependent upon the type of surgery needed, for some surgeries it was relatively common to make a large incision, which would be closed using conventional techniques upon completion of the surgical procedure. However, the making of large incisions in the patient's body itself causes trauma and the period of time required for the patient to completely heal was and is significant. In addition, the pain or discomfort endured by the patient during the recuperative period was a serious problem.
• Because of such disadvantages, new surgical procedures have been developed, as well as instruments utilized in the support of such procedures, which are widely used today. The most common and popular is laparoscopic and/or endoscopic surgery, wherein one or more small openings, utilizing appropriate penetrating instruments, are formed to provide access into the intended body cavities. A trocar assembly is typically used to create and maintain the small opening extending across the abdominal wall and into the body cavity and also to provide a channel through which instruments can be inserted and manipulated to perform the surgery inside the body cavity. As part of these procedures, the abdomen is inflated with an insufflation gas to maintain the abdomen in a distended state, and the trocar assembly usually carries one or more valves to form seal(s) to maintain insufflation. Laparscopic surgery has proven effective in greatly reducing the healing period for patients who have had to undergo surgery and have resulted in significantly less pain and discomfort to the patient.
• The medical instruments used during laparscopic surgery to form the one or more small access openings and during the surgery itself are commonly referred to as trocars or trocar assemblies. Typically, the trocar assembly includes a trocar having a housing and a sleeve or cannula and separately, an obturator which is slidably inserted into the trocar housing and cannula. In almost all cases, the obturator is formed to have a sharply pointed tip, usually defined by a multi-sided pyramide-like configuration, and serves as the penetrating instrument in that upon being inserted and positioned within the lumen of the cannula or trocar sleeve, the sharp pointed tip is exposed at the distal end of the trocar sleeve. The exposed sharpened tip of the obturator is forced into the patient's skin and through all of the various layers of body tissue with the trocar sleeve being forced through the perforation formed by the sharpened obturator tip. Typically, significant pressure must be applied once the peritoneum is reached, i.e., the toughened lining or membrane that defines the exterior wall of the body cavity, in order to penetrate through it and gain access to the body cavity and organs contained therein, in order that laparoscopic surgery may be performed. Once access to the body cavity is established, the obturator is typically withdrawn, leaving the trocar sleeve or cannula as a channel or access passage to the body cavity and intended organ. In some laparoscopic surgical techniques, the obturator or other sharp penetrating instrument may be used without a trocar, i.e., as a “stand alone” device to puncture through the skin and underlying bodily tissues. In such cases, it is understood that once a small access opening is formed, a separate access cannula, catheter or other surgical instrument is inserted into communication with the now accessed body cavity and/or organ.
• While the design of trocars currently available on the market, and the obturators with their sharpened penetrating tips in particular, are capable of quickly forming the small access openings and channels into a patient's abdominal cavity, there are potentially serious drawbacks. Specifically, and as described briefly above, a significant amount of pressure—namely, an inwardly directed pushing force—must typically be applied to the trocar assembly in order to pierce through and penetrate the tough lining or membrane adjacent to and protecting the patient's body cavity and internal organs housed therein. Especially in forming the first access opening, where the surgeon does not have the benefit of observation via a camera instrument disposed within a trocar in a previously formed opening, the pressure applied to penetrate into the body cavity may momentarily result in the sharpened obturator tip extending too far into the cavity, such that an organ may inadvertently be nicked or scratched, without the surgeon's knowledge. If left untreated, such events can result in the rise of an infection and the patient may undergo serious complications, including the possibility of death or further surgery. Less significantly, the sharp pointed tips of the obturators can cause other damage, in terms of cutting small blood vessels and/or other delicate structures found within the body tissue surrounding the access opening during its formation.
• To address this drawback, some in the art have endeavored to provide the trocar assembly with a protective shield, which in some cases, is intended to automatically move into a protective covering relation over the sharpened obturator tip once it has pierced into the abdominal cavity. Others have similarly noted this problem and attempted to provide the trocar with a sharpened tip that can automatically retract once it has penetrated the abdominal cavity or with some sort of visual signal to indicate that the empty space of the abdominal cavity has been reached. It is believed, however, that all such efforts have resulted in trocar assemblies that are overly complicated, difficult to implement and/or repair, and which may not reliably achieve the intended goal, especially in those situations where the surgeon is making the very first access opening and is unable to observe the body cavity with the aid of a small camera instrument.
• Accordingly, there is a need in the medical field for an improved instrument which may be used independently, or more preferably, as part of a trocar assembly and/or associated components such as, but not limited to, a trocar sleeve, etc. to forming an access opening into a patient's body cavity in a manner which requires minimum application of an inwardly directed, linear pushing force. If any such improved instrument were developed, it should be structured to include a penetrating tip that facilitates clean formation of a small access opening extending through a patient's body tissue without severing blood vessels or causing similar damage to the outer tissues being penetrated. Ideally, any such improved instrument would have a penetrating tip that is cooperatively structured and configured relative to the distal end of the trocar sleeve so as to effectively enlarge the access opening, as the penetrating instrument is advanced there-through and into communicating relation with a predetermined body cavity, while simultaneously preventing pieces of the body tissue from entering into the internal passage of the trocar sleeve. Moreover, if any such improved instrument were developed, it should also be structured to allow for puncturing into the peritoneum or tough lining of the body cavity with little or no risk that an organ within the body cavity would be punctured or nicked.
SUMMARY OF THE INVENTION
• The present invention is intended to address these and other needs in the art and as such, is directed towards a penetrating instrument of the type used in laparoscopic, A endoscopic or like, minimally invasive surgical procedures, and which is preferably, but not necessarily, embodied in a trocar assembly. In such embodiment, the trocar assembly includes a trocar housing and a trocar sleeve or cannula having an open distal end communicating with a centrally disposed lumen or passage within the trocar sleeve and within the housing. The trocar assembly further includes an obturator comprising an elongated shaft having a proximal end and an oppositely disposed distal end on which a penetrating tip is either formed or secured. Whether or not embodied in a trocar assembly, the elongated shaft and the penetrating tip of the obturator are specifically structured to create a small access opening in the body wall or outer tissue of a patient so as to establish communication with an internal body cavity or organ on which a surgical procedure is to be performed.
• The penetrating instrument of this invention is designed and structured to effectively create the small access opening by penetrating through the skin and underlying body tissue of a patient in a manner which serves to separate and enlarge the created access opening, as the penetrating tip, shaft and/or trocar sleeve pass there-through and into the patient's abdominal body cavity. As explained in greater detail herein, the overall structure, configuration, dimension and disposition of the penetrating instrument is such as to accomplish an effective separation of the bodily tissue being penetrated with a minimal application of an inwardly directed linear force. In doing so, the structure of the penetrating instrument dilates the outer tissue in a manner which minimizes damage to the tissue. Also, the possibility of inadvertently injuring blood vessels, etc. is minimized, as is the possibility of injuring internal organs once the instrument's penetrating tip enters the intended body cavity. More specifically, the instrument of the present invention, whether associated with a trocar assembly or used independently thereof, comprises an obturator having an elongated shaft and a penetrating tip integrally formed on or otherwise secured to the distal end thereof. When in the preferred embodiment of a trocar assembly, the penetrating tip is cooperatively disposed, dimensioned and configured relative to and/or with the trocar sleeve, and in particular, with the open distal end thereof. The penetrating tip includes a base and a distal extremity configured to define an apex. It is pointed out, here, that the term “apex” is meant to include a variety of different configurations, which may vary from a sharpened point to a tapered locale, as may be defined by the converging of the penetrating tip's exterior surface from a base thereof and extending continuously to the distal extremity or apex. In a preferred embodiment of the present invention, described in greater detail herein, the apex of the penetrating tip is disposed coincident to a central longitudinal axis of the elongated obturator shaft. Other embodiments of the present invention contemplate the apex of the penetrating tip being spaced laterally outward or in an off-set, somewhat eccentric position relative to the central longitudinal access of the elongated obturator shaft.
• Although it may assume a variety of configurations as further described herein, the penetrating tip of this invention is preferably structured to facilitate the separation of the body tissue and penetration of the body cavity wall or lining in a manner which minimizes damage to the tissue and other risk of injury to the patient. More specifically, the penetrating tip includes an exterior surface, preferably extending between the base and the apex thereof, that comprises a cross section having a “substantially elliptical” configuration. The interior of the penetrating tip may include a variety of different structures, such as being solid, hollow or partially hollow. It is pointed out that the term “substantially elliptical” as used herein to describe the configuration of the cross section of the exterior surface of the penetrating tip is not meant to define a true or precise ellipse, alone. Rather, the term “substantially elliptical” as used herein is meant to include a variety of different configurations, all of which substantially conform to an ellipse. More specifically, the outer circumference or sectional configuration of the exterior surface of the penetrating tip, preferably taken along a plane perpendicular to the central longitudinal access of the shaft, may include one or more curvilinear segments, a combination of curvilinear segments and linear segments or a plurality of linear segments, wherein the various linear and/or curvilinear segments are collectively interconnected in a closed or continuous configuration.
• Accordingly, the structure of the instrument of the present invention, whether or not embodied in a trocar assembly, includes an elongated shaft having a penetrating tip with an exterior surface configuration and/or other components thereof, which are cooperatively dimensioned, configured, and disposed to more safely facilitate the formation of an access opening and the dilation of the surrounding bodily tissue during the insertion of the penetrating instrument into the patient. More specifically, the preferred exterior surface configuration of the penetrating tip enters the designated bodily tissue in a manner which minimizes damage and/or cutting or severing of the tissue during the passage of the penetrating tip, as well as an adjacent portion of the shaft and/or trocar sleeve, through the created access opening.
• The objects, features and advantages of the present invention noted above, as well as others, will become more clear when the drawings as well as the detailed description of the invention in various embodiments, below, are taken into consideration.
BRIEF DESCRIPTION OF THE DRAWINGS
• For a fuller understanding of the nature of the present A invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which:
• FIG. 1 is a perspective view of a penetrating instrument according to the present invention embodied in a trocar assembly wherein the distal extremity or apex of the penetrating tip is disposed coincident to a central longitudinal axis of the instrument shaft.
• FIG. 2 is a perspective view of another penetrating instrument according to the present invention which is also embodied in a trocar assembly wherein the distal extremity or apex of the penetrating tip is disposed in off-set relation to the central longitudinal axis of the instrument shaft.
• FIG. 3 is a perspective view of another penetrating instrument shown in partial cutaway to better illustrate a penetrating tip associated with the present invention.
• FIG. 4 is a top view of the embodiment ofFIG. 3.
• FIG. 5 is a side view of the embodiment ofFIGS. 3 and 4.
• FIG. 5A, 5B,5C and5D are sectional views of the embodiment shown inFIG. 5 and taken alonglines5A-5A,5B-5B,5C-5C, and5D-5D, respectively.
• FIG. 6 is a perspective view of a penetrating instrument, similar to that ofFIG. 2, but shown in partial cutaway to better illustrate the penetrating tip associated therewith.
• FIG. 7 is a top view in partial cutaway of the embodiment ofFIG. 6.
• FIG. 8 is a side view in partial cutaway of the embodiment ofFIGS. 6 and 7.
• FIG. 8A, 8B,8C, and8D are sectional views of the embodiment shown inFIG. 8 and taken alonglines8A-8A,8B-8B,8C-8C, and8D-8D, respectively.
• FIG. 9 is a top view of another embodiment of a penetrating instrument according to the present invention including a penetrating tip and associated shaft, in partial cutaway.
• FIG. 10 is a side view of the embodiment ofFIG. 9.
• FIG. 11 is a side view of a structural variation of the embodiment ofFIG. 10.
• FIG. 12 is a front end view of the embodiment ofFIGS. 9 through 11.
• FIG. 13 is a schematic representation of a substantially elliptical configuration representative of a transverse or perpendicular cross-section taken from the exterior surface of a preferred penetrating tip according to the present invention.
• FIG. 13A is a schematic representation of another embodiment of a substantially elliptical configuration representative of a cross section taken from the exterior surface of another penetrating tip according to the present invention.
• FIG. 13B is a schematic representation of yet another embodiment of a substantially elliptical configuration representative of a cross section taken from the exterior surface of another penetrating tip according to the present invention.
• FIG. 13C is a schematic representation of yet another embodiment of a substantially elliptical configuration representative of a cross section taken from the exterior surface of another penetrating tip according to the present invention.
• FIG. 14 is a longitudinal view in partial section and cutaway of yet another preferred embodiment of the present invention showing the penetrating tip in an operative position relative to a trocar sleeve.
• FIG. 15 is a perspective view in partial cutaway of yet another preferred embodiment of the present invention directed to structural components associated with a trocar assembly embodying the instrument of the present invention.
• Like reference numerals refer to like parts throughout the several views of the drawings.
DETAILED DESCRIPTION OF THE INVENTION IN PREFERRED EMBODIMENTS
• As shown in the accompanying Figures, the present invention is directed towards a medical instrument of the type structured for use in minimally invasive surgery, such as laparoscopic or endoscopic surgery. Moreover, the instrument of the present invention is preferably, but not necessarily, embodied in a trocar assembly, such as, but in no way limited to, the trocar assemblies shown inFIGS. 1, 2,12,14 and15 and generally indicated as10 and10′, which assemblies depict a distinctive shape developed by and proprietary to Taut, Inc. of Geneva, Ill.
• A trocar assembly, whether that indicated byreference numeral10,10′ or another, typically includes atrocar housing12, which may include aconnector structure14 communicating with the interior of thehousing12 and structured to establish interconnection with a supply of fluid, such as carbon dioxide gas, used to inflate a body cavity as typically performed during laparoscopic or endoscopic surgery.Trocar assembly10,10′ also includes an elongated cannula ortrocar sleeve16 dimensioned and structured to removably receive anobturator20, perhaps best shown inFIGS. 3-5, comprising anelongated shaft26, along the interior, centrally disposed passage or lumen associated with thesleeve16. Theelongated shaft26 has a penetrating tip, generally indicated as22, secured to the distal end ofshaft26 and extending outwardly from a distalopen end18 of thetrocar sleeve16.
• It is pointed out that the present invention can be utilized with trocar assemblies, such as10 and10′ as well as others. While the trocar assemblies shown inFIGS. 1, 2 and15 appear to be substantially equivalent structures, they differ from one another primarily in the structural configuration of theobturators20 and20′, and mostly in the structure of the respective penetratingtips22 and22′. Also, in each of the embodiments ofFIGS. 1, 2 and15 it is preferred that a mountinghub24 be connected or secured to a proximal end of thetrocar sleeve16, adjacent and/or contiguous to thetrocar housing12. As explained hereinafter with primary reference toFIG. 15, the mountinghub24, secured to a proximal end of thetrocar sleeve16, is structured for mounting or interconnection with an end portion or grippingportion25 secured to aproximal end25′ of theelongated shaft26 defining theobturator20.
• As indicated above, the preferred embodiments of the present invention includes theelongated shaft26, at least partially defining theobturator20. Theshaft26 or26, has a distal end integrally formed with or otherwise fixedly connected or secured to the corresponding penetratingtip22 or22′. Theelongated shaft26 also has aproximal end25′ which is oppositely disposed to the penetratingtip22 and which is preferably secured to the grippingportion25, as noted above and inFIG. 15. While theelongated shafts26 and26′ are primarily disclosed as including a solid material construction, it is emphasized that either may include a substantially hollow, elongated configuration terminating in the respective penetratingtip22 or22′. Alternatively, the penetratingtips22,22,′ of the various embodiments may be formed to be substantially or at least partially hollow. It is to be understood that the penetratingtips22,22′ may have a variety of other interior structures, such as being solid or at least partially solid.
• With primary reference now to the embodiment ofFIG. 1,FIGS. 3 through 5, andFIG. 14, theshaft26 of the present invention comprises the penetratingtip22 having a base28 integrally formed with or otherwise fixedly secured to the distal end ofshaft26. The opposite end of the penetratingtip22 terminates in a distal extremity generally indicated as30. Further, the penetratingtip22 has an exterior surface extending continuously between the base28 and thedistal extremity30. Thedistal extremity30 may be more specifically defined as an “apex”32 which may be structured to have, but does not necessarily require, a slightly blunted configuration. However, the apex32 may also assume a variety of other configurations, such as that shown in the embodiment ofFIG. 2 and indicated as32′. That is, while the term “point” may be used to describe an apex32, this is not necessarily meant to define a true, sharply point structure. On the contrary, in the most preferred embodiments, the apex32 and/or32′ is structured to be sufficiently blunt to eliminate or significantly reduce the danger of inadvertent puncturing of a patient's organ once the penetrating tip has passed through exterior bodily tissue and entered into the patient's abdominal cavity. In that the apex32 and32′ of the inventive penetratingtip30 may assume a variety of different structural configurations, all of which are intended to facilitate the clean, efficient passage through the outer body wall of a patient, the term apex, rather than point, is used to generically and more accurately describe each of the plurality of tip configurations. Further, the apex32,32′, regardless of its specific shape, may be defined as a convergent locale of theexterior surface40 of each of the corresponding penetratingtips22,22′, as theexterior surface40 extends from therespective bases28,28′ to and including thedistal extremity30,30′.
• Still referring toFIGS. 1, 3 through5 and14, the invention in the more preferred embodiments comprise the apex32 being disposed coincident with the central,longitudinal axis27 of theelongated shaft26, or more precisely, alinear extension27′ of the centrallongitudinal axis27. Further, at least one preferred embodiment comprises theexterior surface40 including at least twosurface segments42 and44. As shown inFIGS. 3 and 4, thesurface segments42 and44 are at least minimally segregated by two at least partially, oppositely disposed andcurved edge portions46 and48. Theedge portions46 and48 may be specifically shaped or configured to define cutting and/or dilating edges and extend along at least a portion of the distance between the apex32,32′ and thebase28,28′.
• For example, the longitudinal curvilinear configuration of thesurface segments42 and44 are preferably at least partially defined by a complex curve. In turn, the complex curvilinear configuration of each of thesurface segments42 and44, as viewed longitudinally from the apex32 to thebase28, comprises at least one substantiallyconcave segment49 and either a linear or minimally convex curve portion orsection49′, shown inFIG. 5. As a result, the overall configuration of the exterior surface of the penetratingtip22 and its cooperative structuring with the apex32 facilitates the forming and subsequent enlargement of an access opening in the body wall of a patient, without requiring a heavily applied, inwardly directed, linear pushing force. As such, the access opening is formed in a manner more of a dilating action, which minimizes cutting of and/or other damage to bodily tissue as the penetratingtip22, as well as a portion of theshaft26 and/orsleeve16 passes through the access opening into a patient's abdominal cavity or other anatomical structure.
• In the more preferred embodiments of the present invention, theexterior surface40 of the penetratingtip22 has a transverse or perpendicular cross section which is substantially elliptical. It is to be understood that the term “substantially elliptical,” when referring to the cross sectional configuration of theexterior surface40 or the transverse circumferential configuration thereof, is not meant to be limited to a true or precise elliptical configuration, only. To the contrary, the substantially elliptical configuration of the penetratingtip22 or22′ may assume differently shaped exterior surfaces and yet still be included or intended for inclusion within the phrase “substantially elliptical,” as used herein.
• To better illustrate this, reference will is now made toFIGS. 13, 13A,13B and13C. As represented therein,FIG. 13 is a schematic representation of a true or precise elliptical configuration, indicated as100. This elliptical configuration orellipse100 includes a primarylongitudinal dimension102 and a primarytransverse dimension104. Upon reviewing the various embodiments of the penetrating tip disclosed herein (such as22,22′,64, etc.), it will be noted that the size of the cross sectional configuration of theexterior surface40 will change. In other words, the size of the cross section taken from any given penetratingtip22,22′, etc. will be larger or smaller dependent upon whether the section is taken closer to the apex32 or closer to thebase28. This is due to the converging structure of theexterior surface40 as it extends from the base28 to the apex32.
• Therefore, with reference toFIG. 13, the term “substantially elliptical” configuration is meant to include variations in the shape of the sectional configuration of theexterior surface40, due to the fact that either the primarylongitudinal dimension102 may be longer or shorter and/or the primarytransverse dimension104 may be longer or shorter. The result is a sectional configuration of theexterior surface40, which while not precisely conforming to a precise elliptical configuration, schematically represented as100, may still be considered a substantially elliptical configuration even though the overall shape is characterized by a flattened, elongated, oblong or other elliptical configuration having a variant shape.
• In order to further clarify that the intended meaning of the term “substantially elliptical” when referring to the penetrating tip'sexterior surface40 can apply to varied equivalent shapes, reference is now made to FIGS.13-A,13-B and13-C. It is emphasized that the schematic representations illustrated in these Figures are intended to be representative only of a plurality of possible “substantially elliptical” configurations which theexterior surface40 may assume. In these Figures, a true or precise elliptical configuration is indicated in phantom lines and marked withreference numeral100′ and the exterior surface is shown in a variety of different shapes as schematically represented at40′,40″ and40′″ respectively, inFIGS. 13A, 13B and13C. These Figures illustrate that the specific shape(s) of the representativeexterior surface configurations40′,40″ and40′″, etc. generally conform to the trueelliptical configuration100′, and therefore, are intended to be included within the generically descriptive term “substantially elliptical.” With specific reference toFIG. 13A, theexterior surface40′ may include a plurality oflinear segments106 interconnected to one another to form a continuous, closed configuration.FIG. 13B is representative of anexterior surface40″ including a plurality of plane curves, or more specifically,curvilinear segments108 connected to a plurality oflinear segments106. The embodiment ofFIG. 13C discloses theexterior surface40′″ having at least one elongated plane curve orcurvilinear segment110 interconnected with at least one but preferably a plurality oflinear segments106 to collectively form a continuous, closed configuration.
• In the various preferred embodiments of the penetratingtip20,20′,64, etc., of the present invention, the cross sectional configuration of theexterior surface40 is preferably oriented transverse or perpendicular to thelinear extension27′ of the centrallongitudinal axis27 of theshaft26. Also, the cross section or an infinite number of such cross sections extend along at least a majority of the length of the penetratingtip22, as demonstrated by the schematic and representative cross-sectional configurations inFIGS. 5B, 5C and5D. Again, it is to be emphasized that the cross sectional configurations ofFIGS. 5B through 5D are schematic representations and may be defined by other than a true or precise or elliptical configuration such as that disclosed in, but not limited to,FIGS. 13A through 13C. Further by way of reference, the perpendicular cross-sectional configuration of thebase28, taken along theimaginary line5A-5A, may be, but does not in all cases have to be, defined by a circumferential configuration in the form of a circle.
• It is pointed out that some variation in the substantially elliptical configuration of the cross section of the exterior surface of the penetrating tip may also be due to the existence of the aforementioned, segregatingedge portions46 and48. As set forth above, the structure of theedge portions46 and48 may vary as they may or may not be structured to serve as cutting edges. Accordingly, the opposite ends of each of the representative elliptical configurations shown inFIGS. 5B,5C, and5D may also be varied to more accurately represent the inclusion of theedge portions46 and48. These edges may vary in cross-sectional configuration from a true cutting edge, as best demonstrated inFIG. 3, to a more rounded configuration, as indicated by the representative elliptical shapes ofFIGS. 5B, 5C and5D.
• The various embodiment of the present invention, however, will preferably provide for efficient penetration of the outer bodily tissue and passage there-through in a manner which minimizes the danger of inadvertent puncturing of internal organs. More specifically, such initial penetration and passage of the either of thetips22 and22′ as well as therespective shafts26 and26′ and/orsleeve16 will ideally be accomplished by the exertion of only a minimal amount of a linearly directed, “pushing” force on the instrument. Instead, penetration may be facilitated by applying a twisting motion, and preferably a back and forth or “reciprocal twisting” motion, to the device. In the more preferred embodiment incorporating a somewhat blunted point or apex32 or32′, the chances are minimized of inadvertently puncturing and/or damaging an internal organ subsequent to the penetratingtip22 or22′ passing through the exterior bodily tissue and into the body cavity in which the organ is located. With primary reference now to the embodiment ofFIGS. 2 and 6 through8, one distinguishing structural feature is the location of the apex32′ in an eccentric or laterally spaced, off-set relation to an imaginary co-linear extension of the central longitudinal axis of theshaft26′. Accordingly, theexterior surface40 comprises twosurface segments42′ and441 which are non-symmetrical, in thatsurface segment42′ has a significantly smaller overall dimension than that of thesurface segment44′. As a result, the base28′ has a circumferential configuration preferably defined by an elongated ellipse, schematically represented inFIG. 8A and taken alonglines8A-8A ofFIG. 8.
• Similar to the embodiment ofFIGS. 1 and 3 through5, both of theexterior surface segments42′ and44′ have a longitudinal curvilinear configuration defined by a longitudinally oriented complex curve including at least a minimallyconcave portion49″ and alinear portion49′″. Similarly, thesurface segments42′ and44′ are at least minimally segregated from one another through the provision of the elongatedcurved edges46′ and48′, extending from the apex32′ towards the base28′ and at least along a majority of the length of the penetratingtip22′. Theedges46′ and48′ may have a more rounded or transversely curved configuration than that of the embodiment ofFIG. 3, thereby providing a somewhat “blunted”edge configuration46′ and48′ which, differs from theedge portions46 and48 of the embodiment ofFIG. 3.
• However, theexterior surface40 of the embodiment ofFIGS. 2 and 6 through8 is structured to define an overall exterior surface configuration shaped to enlarge or at least partially dilate an access opening formed in the outer body wall by the penetratingtip22′, while minimizing any cutting, severing or damaging of the contiguous bodily tissue surrounding the formed access opening. Such a preferred structural configuration is further demonstrated inFIGS. 8B, 8C and8D which represent a transverse circumferential configuration of theexterior surface40 as also being substantially elliptical, within the intended meaning of this term, as has been described herein.
• As with the embodiment ofFIGS. 1 and 3 through5, the opposite ends of the representative elliptical configurations of the perpendicular cross-sections of the penetratingtip22′ shown inFIGS. 8B, 8C, and8D, may be more precisely represented by narrowing the opposite ends to more accurately represent theedges46′ and48′. Also, since the apex32′ is laterally off-set from the central longitudinal axis of theshaft26′, the apex32′ is not centered or centrally coincident with any of the elliptically configured cross-sections represented inFIGS. 8A through 8D. To the contrary, in the embodiment ofFIG. 5, the apex32 is coincident to the linear extension of the central longitudinal axis of theshaft26 and would therefore be substantially centered relative to the circular cross-section of thebase28, as shown inFIG. 5A, as well as the elliptically configured cross-sections ofFIGS. 5B through5D.
• Another preferred embodiment of the penetrating instrument of the present invention is shown inFIGS. 9 through 12 and comprises anobturator60 including anelongated shaft62 having a penetratingtip64 integrally formed with or otherwise secured to the distal end ofshaft62. Penetratingtip64 includes abase66, which in the preferred embodiments ofFIGS. 9 through 12, is extended along a predetermined angular orientation of generally about45 degrees relative to a central longitudinal axis of theshaft62, schematically indicated as68 inFIG. 10. Thebase66 is integrally or otherwise attached to the distal end of theelongated shaft62, as shown. The opposite end of the penetratingtip64 terminates in a distal extremity generally indicated as70, and more specifically, defined by an apex72. One feature of this embodiment is the disposition of the apex72 coincident with the centrallongitudinal axis68 of theshaft62, or more precisely, alinear extension68′ of the centrallongitudinal axis68.
• Additional structural features of this preferred embodiment include theexterior surface74 including longitudinally extending, curvedexterior surface segments76 and78. Due at least in part to the angular orientation of thebase66, theexterior surface segments76 and78 have different lengths, as best shown inFIG. 10, and are non-symmetrical even though the apex72 is disposed coincident with the centrallongitudinal axis68 or the linear extension thereof68′.
• Referring now to bothFIGS. 10 and 11, theexterior surface74 of the penetratingtip64, particularly including theexterior surface segments76 and78, can define an at least partially concave, convex and/or complex, longitudinal extending curve(s). As a result, the perpendicular cross-sectional configuration of the penetratingtip64, such as alongschematic cross-section lines80 and82, comprises a substantially elliptical configuration. These elliptical configurations ofsections80 and82 are also meant to be schematically representative of a variety of different shapes intended to be included within the meaning of the generic term “substantially elliptical,” as has already been discussed in detail.
• As noted, structural differences of the embodiment ofFIGS. 9 through 12 include the apex72 being coincident with thelongitudinal axis68,681 of theshaft62, rather than being off-set therefrom. In addition, the complex curve of at least one of theexterior surface segments76 or78 would preferably include an elongated concave configuration extending from the apex70 to towards the base66 in order to facilitate the penetrating capabilities of the penetratingtip64. A concave configuration of one or both of theexterior surface segments74 and76 may be important, especially when the apex72 assumes a more blunted shape as opposed to a sharpened point. It is further emphasized that theexterior surface74, including theexterior surface segments76 and78 may vary from that shown inFIGS. 10 and 11. Accordingly, dependent upon the configurations of theexterior surface74, any of an infinite number of perpendicular sections, such as those taken alongschematic lines80 and82, will have the aforementioned substantially elliptical configuration. Also, the centers as at80′ and82′ of the respective elliptical configurations as shown inFIGS. 10 and 11 may be disposed along an imaginary straight line as at86 and/or along an imaginary curved line as at88.
• As set forth above, the apex72 may be somewhat blunted rather than a true sharpened point, and thereby, as illustrated inFIG. 11, be at least partially defined by anend ellipse84. Again, the location of thecenters80′ and82′ as well as the center841 of theend ellipse84 may be disposed along astraight line86 or acurved line88 depending, at least in part, on the overallexterior surface configuration74, while the apex and/or the center point841 of theend ellipse84 remains coincident with thelongitudinal axis68,68′. Naturally, as with the embodiments ofFIGS. 1 through 8, theobturator60 may be of the type to be used in combination with a trocar assembly generally indicated as10 including theelongated trocar sleeve16 as shown in bothFIGS. 1 and 12.
• Still referring to the embodiments shown inFIGS. 9 through 11, it is noted that thebase66, being angularly oriented at a preferred angle of 45 degrees relative to thelongitudinal axis68 and68′, defines an elliptical configuration somewhat similar to that shown in the embodiment ofFIG. 8A. The precise shape of the preferred elliptical configuration will, of course, vary, dependent on the angular orientation of the base66 relative to thelongitudinal axis68 being greater or less than the preferred 45 degree angle of incline, as indicated.
• Another feature of at least one preferred embodiment of the present invention is shown inFIG. 14, wherein the laparoscopic instrument is embodied in atrocar assembly10 having atrocar sleeve16 with an opendistal end18. As will also be explained with regard to the embodiment ofFIG. 15, theelongated shaft26 is positioned within the interior passage of thesleeve16 and is longitudinally dimensioned to facilitate the positioning of the penetratingtip22 in an operative position having a most preferred orientation. This operative position is at least partially defined by the penetratingtip22 being disposed in a “closing” relation to the opendistal end18 so as to restrict or block the passage of any unwanted material, such as body tissue, from passing through the opendistal end18 into the interior of thesleeve16. The aforementioned operative position may be further defined by the penetratingtip22, and more specifically thebase28 thereof, having a common angular orientation relative to the opendistal end18, or more specifically the plane defined by the opendistal end18, as schematically represented by the plane orsection line18′.
• Accordingly, when the penetratingtip22 is in the aforementioned operative position, thebase28 of the penetratingtip22 is substantially aligned with theopen end18 and theplane18′ defined thereby. The closing or blocking relation between the base28 and theopen end18 is facilitated by the base having a somewhat common transverse dimension to theopen end18, thereby effectively filling, blocking or closing theopen end18, when the penetratingtip22 is in the preferred, operative position, as shown inFIG. 14. Further, in this preferred embodiment thebase28 of the penetratingtip22 is disposed at a predetermined angular orientation relative9 to thecentral axis27 of theshaft26. This angular orientation corresponds to substantially the same angular orientation of the plane of the opendistal end18, schematically demonstrated by the plane orsection line18′. Therefore, the aforementioned operative position of the penetratingtip22 may be further defined by the penetratingtip22, and more specifically, thebase28 being oriented at the same angle of inclination as theopen end18.
• As set forth above, theobturator20 and in particular, theelongated shaft26 is selectively positioned within the interior passage or lumen of thetrocar sleeve16. Theshaft26 can be rotated within, as well as longitudinally positioned within the interior of thesleeve16. In order to properly position theshaft26 relative to thesleeve16 such that the operative position of the penetratingtip22 is accomplished, theshaft26 includes the aforementioned grippingportion25 secured or otherwise connected to theproximal end25′ thereof. To facilitate a precise positioning of theshaft26, in a manner which is convenient to a surgeon, the present invention includes an indexing assembly, generally indicated as90, which is preferably mounted at least partially on the grippingportion25 and partially on the mountinghub24. As set forth above, the mountinghub24 may be connected to the trocar housing and/or may at least partially defines the proximal end of thetrocar sleeve16. More specifically, theindexing assembly90 includes afirst indexing member91 and asecond indexing member92 respectively formed on the grippingportion25 and the mountinghub24. When thetrocar assembly10 is in use, the physician or other medical personnel places theelongated shaft26 on the interior of thetrocar sleeve16 while exerting a pushing and/or rotating force on the grippingportion25. Proper angular alignment between the penetratingtip22 and thesleeve16, and more specifically, between the base28 and theplane18′ of the opendistal end18 is accomplished when the first andsecond indexing members91 and92 are brought into aligned registry with one another.
• Further structural features of this preferred embodiment includes the provision of a stop structure. As set forth above, the longitudinal dimension of theshaft26 is such as to dispose the penetratingtip22 in the aforementioned operative position as demonstrated inFIG. 14. The operative position is at least partially obtained when theshaft26 is fully extended through the mountinghub24,trocar housing12 and remainder of thesleeve16. To facilitate proper positioning of theshaft26 in this manner, a stop member as at93 is mounted on the positioningmember25. Thestop member93 is disposed to abut and come into “stopping” engagement with a portion of the mountinghub24, such as about the periphery thereof as at24′.
• Accordingly, when indexingmembers91 and92 are aligned in the manner set forth above and when thestop member93 engages the predetermined, interruptive portion of the proximal end of thesleeve16, such as theperiphery24′ of the mountinghub24, the medical personnel are sure that the instrument is operatively assembled and that the penetratingtip22 is in the aforementioned operative position.
• A connecting or locking assembly may also be included and may comprise one or more connecting or lockingtabs94, which may be biased due to the structure or the material from which thetabs94 are formed. The connectingtabs94 are disposed and dimensioned to be removably received within connecting compartments or recesses95 correspondingly disposed within thehub24 or other portion of the proximal end of thetrocar sleeve16, dependent on the type of thetrocar assembly10,10′ etc. being utilized.
• Since many modifications, variations and changes in detail can be made to the described preferred embodiment of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents.
• Now that the invention has been described,

Claims (41)

1. A laparoscopic instrument comprising:

a) a trocar assembly including an elongated sleeve having an open distal end,

b) an elongated shaft movably disposed within said sleeve and including a penetrating tip secured to one end thereof,

c) said penetrating tip including an apex and a base and an exterior surface extending there between, and

d) said exterior surface having a cross section comprising a substantially elliptical configuration extending along at least a majority of said penetrating tip between said base and said apex.

2. (canceled)

3. A laparoscopic instrument as recited inclaim 1 wherein said cross section is oriented transverse to a length of said penetrating tip.

4. A laparoscopic instrument as recited inclaim 1 wherein said cross section is oriented perpendicular to a central longitudinal axis of said shaft.

5. A laparoscopic instrument as recited inclaim 1 wherein said cross section is oriented transverse to a length of said penetrating tip.

6. A laparoscopic instrument as recited inclaim 1 wherein said cross section is oriented perpendicular to a central longitudinal axis of said shaft.

7. A laparoscopic instrument as recited inclaim 1 wherein said base is disposed at an angular orientation relative to a central longitudinal axis of said shaft.

8. A laparoscopic instrument as recited inclaim 7 wherein said apex is linearly coincident with the central longitudinal axis of said shaft.

9. A laparoscopic instrument as recited inclaim 7 wherein said angular orientation is substantially 45 degrees.

10. A laparoscopic instrument as recited inclaim 7 wherein said base comprises a substantially elliptical configuration.

11. A laparoscopic instrument as recited inclaim 7 wherein said exterior surface of said penetrating tip comprises at least two surface segments extending longitudinally between said apex and said base, said two surface segments having different lengths.

12. laparoscopic instrument as recited inclaim 11 wherein said apex is linearly coincident with the central longitudinal axis of said shaft.

13. A laparoscopic instrument as recited inclaim 11 wherein each of said surface segments comprises a substantially concave configuration extending along at least a portion of a length thereof.

14. A laparoscopic instrument as recited inclaim 11 wherein said base comprises a substantially elliptical configuration.

15. A laparoscopic instrument as recited inclaim 1 wherein said base comprises a substantially circular cross sectional configuration.

16. A laparoscopic instrument as recited inclaim 1 wherein said substantially elliptical configuration comprises a plane curve.

17. A laparoscopic instrument as recited inclaim 16 wherein said plane curve includes at least one substantially linear segment connected thereto.

18. A laparoscopic instrument as recited inclaim 16 wherein said plane curve includes a plurality of substantially linear segments connected thereto.

19. A laparoscopic instrument as recited inclaim 1 wherein said elliptical configuration comprises at least one curvilinear segment and at least one substantially linear segment connected to said curvilinear segment.

20. A laparoscopic instrument as recited inclaim 19 wherein said substantially elliptical configuration comprises a plurality of linear segments interconnected to said curvilinear segment and to one another.

21. A laparoscopic instrument as recited inclaim 19 wherein said substantially elliptical configuration comprises a plurality of linear segments and a plurality of curvilinear segments interconnected to one another.

22. A laparoscopic instrument as recited inclaim 21 wherein said plurality of linear segments and said plurality of curvilinear segments are collectively interconnected to define a continuous configuration.

23. A laparoscopic instrument as recited inclaim 19 wherein said elliptical configuration comprises a plurality of curvilinear segments.

24. A laparoscopic instrument as recited inclaim 1 wherein said substantially elliptical configuration comprises a plurality of linear segments interconnected together and collectively defining a continuous configuration.

25. An instrument structured for use in laparoscopic surgery, said instrument comprising:

a) a trocar assembly including an elongated sleeve having an open distal end and an elongated shaft disposable within said sleeve,

b) a penetrating tip secured to a distal end of said shaft and disposable in a predetermined operative position relative to said sleeve,

c) said penetrating tip comprising a base and a apex and an exterior surface extending there between,

d) said operative position comprising a portion of said penetrating tip disposed in substantially closing relation to said open distal end, and

e) said exterior surface having a cross section comprising a substantially elliptical configuration extending along at least a majority of said penetrating tip between said base and said apex.

26. (canceled)

27. An instrument as recited inclaim 25 wherein said cross section is oriented substantially perpendicular to a central longitudinal axis of said shaft.

28. An instrument as recited inclaim 25 wherein said operative position further comprises said base disposed in substantially aligned relation with said open distal end.

29. An instrument as recited inclaim 28 wherein said base and said open distal end are correspondingly dimensioned, said base disposable in said closing relation to said open distal end.

30. An instrument as recited inclaim 29 wherein said closing relation is defined by said base being disposed to prevent passage of tissue through said open distal end into said sleeve.

31. An instrument as recited inclaim 28 wherein said operative position further comprises said base and said open distal end having a common angular orientation relative to a central longitudinal axis of said shaft.

32. An instrument as recited inclaim 25 wherein said apex is linearly coincident with a central longitudinal axis of said shaft.

33. (canceled)

34. (canceled)

35. (canceled)

36. (canceled)

37. (canceled)

38. (canceled)

39. (canceled)

40. A laparoscopic instrument comprising:

a) a trocar assembly including an elongated sleeve having an open distal end,

b) an elongated shaft movably disposed within said sleeve and including a penetrating tip secured to one end thereof,

c) said penetrating tip including an apex and a base and an exterior surface extending there between,

d) said base comprising a substantially circular cross-sectional configuration, and

e) said exterior surface having a cross section comprising a substantially elliptical configuration along at least a portion of said penetrating tip between said base and said apex.

41. A laparoscopic instrument comprising:

a) a trocar assembly including an elongated sleeve having an open distal end,

b) an elongated shaft movably disposed within said sleeve and including a penetrating tip secured to one end thereof,

c) said penetrating tip including an apex and a base and an exterior surface extending there between,

d) said base disposed at an angular orientation relative to a central longitudinal axis of said shaft,

e) said exterior surface of said penetrating tip comprising at least two surface segments extending longitudinally between said apex and said base, said two surface segments having different lengths,

f) each of said surface segments comprising a substantially concave configuration extending along at least a portion of a length thereof, and

g) said exterior surface having a cross section comprising a substantially elliptical configuration along at least a portion of said penetrating tip between said base and said apex.

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