Restricted expansion dissector

Abstract

A surgical apparatus is disclosed that is configured and dimensioned to create an internal surgical worksite. The surgical apparatus includes a dissection element that is repositionable between an unexpanded condition, wherein the dissection element defines a first outer transverse cross-sectional dimension, and an expanded condition, wherein the dissection element defines a second, larger outer transverse cross-sectional dimension. The surgical apparatus further includes a restrictor that is in contact with the dissection element in order to restrict expansion of the dissection element in at least one direction.

Claims

1. A surgical apparatus configured and dimensioned to create an internal surgical worksite, the surgical apparatus comprising: an expandable dissection element having a first resiliency and being expandable to an expanded configuration; and a restrictor formed of a single piece of material having a second resiliency less than the first resiliency, the restrictor being fixedly secured to the dissection element, the restrictor including a pair of first arms and a pair of second arms, the pair of first arms being secured together with a hinge element, wherein the hinge element is a living hinge, and the pair of second arms being secured together, the restrictor being configured to restrict expansion of the dissection element in at least one direction such that the dissection element defines a generally planar configuration in the expanded configuration.

2. The surgical apparatus of claim 1, wherein the dissection element is formed from a first material and the restrictor is formed from a second material different than the first material.

3. The surgical apparatus of claim 2, wherein the first material has a first durometer, and the second material has a second, greater durometer.

4. The surgical apparatus of claim 3, wherein the dissection element is formed from urethane, and the restrictor is formed from nylon.

5. The surgical apparatus of claim 1, wherein the dissection element and the restrictor are configured as discrete structures.

6. The surgical apparatus of claim 5, wherein the restrictor is positioned externally of the dissection element.

7. The surgical apparatus of claim 5, wherein the restrictor is positioned internally within the dissection element.

8. The surgical apparatus of claim 5, wherein the restrictor is positioned between adjacent layers of the first material.

9. The surgical apparatus of claim 1, wherein the pair of first arms are welded together, and the pair of second arms are welded together.

10. The surgical apparatus of claim 1, wherein the dissection element and the restrictor are formed from the same material.

11. The surgical apparatus of claim 10, wherein the dissection element and the restrictor are monolithically formed with one another.

12. The surgical apparatus of claim 11, wherein the dissection element defines a first thickness, and the restrictor element defines a second, greater thickness.

13. The surgical apparatus of claim 1, wherein the dissection element is at least partially formed from a material permitting at least some light to pass therethrough.

14. A surgical apparatus configured and dimensioned to create an internal surgical worksite, the surgical apparatus comprising: an expandable dissection element having a first resiliency and being expandable to an expanded configuration; and a restrictor having a second resiliency less than the first resiliency, the restrictor being fixedly secured to the dissection element, the restrictor including a pair of first arms and a pair of second arms, the pair of first arms being secured together with a living hinge, and the pair of second arms being secured together, the restrictor being configured to restrict expansion of the dissection element in at least one direction to control the expanded configuration of the expandable dissection element.

15. A surgical apparatus configured and dimensioned to create an internal surgical worksite, the surgical apparatus comprising: an expandable dissection element having a first resiliency and being expandable to an expanded configuration; and a restrictor having a second resiliency less than the first resiliency, the restrictor being monolithically formed with the dissection element, the restrictor including a pair of first arms and a pair of second arms, the pair of first arms being secured together by a living hinge, and the pair of second arms being secured together, the restrictor being configured to restrict expansion of the dissection element in at least one direction such that the dissection element defines a generally planar configuration in the expanded configuration of the expandable dissection element.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a partial cross-sectional illustration showing the use of a dissector assembly including an expandable dissection element and a restrictor in accordance with one embodiment of the present disclosure to create an internal worksite during a surgical procedure;

(2) FIG. 2 illustrates the dissector assembly seen in FIG. 1 removed from the internal worksite;

(3) FIG. 3 illustrates an alternate embodiment of the presently disclosed dissector assembly;

(4) FIG. 4 is a cross-sectional illustration of the dissection element and the restrictor seen in FIG. 1 along line 4-4;

(5) FIGS. 5 and 6 are cross-sectional illustrations of alternate embodiments of the presently disclosed dissection element and restrictor;

(6) FIG. 7 is a plan view of the restrictor seen in FIGS. 1 and 2;

(7) FIG. 7A is a plan view of an alternate embodiment of presently disclosed restrictor;

(8) FIG. 8 is a plan view of an alternate embodiment of the restrictor seen in FIG. 7;

(9) FIGS. 9-11 are cross-sectional illustrations of alternate embodiments of the presently disclosed dissection element and restrictor;

(10) FIG. 12 is a rear view of an alternate embodiment of the presently disclosed dissection element;

(11) FIG. 13 is a top view of the embodiment of the dissection element seen in FIG. 12;

(12) FIG. 14 is a cross-sectional illustration of the dissection element seen in FIG. 13 along line 14-14; and

(13) FIG. 15 is a cross-sectional illustration of another embodiment of the presently disclosed dissection element.

DETAILED DESCRIPTION

(14) Embodiments of the present disclosure will now be described in detail with reference to the drawings, wherein like reference numerals identify similar or identical elements. As used herein, the term patient refers to a human or animal patient, and the term clinician refers to a doctor, nurse, support personnel, or other care provider. While the devices, systems, and methodologies described herein are discussed and illustrated in the context of an abdominal procedure, the principles of the present disclosure are equally applicable to other surgical procedures performed in alternate locations within a patient's body, e.g., vascular procedures, cardiac procedures, and urinary procedures.

(15) FIGS. 1 and 2 illustrate a dissector assembly 1000 in accordance with the principles of the present disclosure that includes a cannula assembly 100, shown in communication with a fluid source 200, and an expandable dissection element 300, e.g., a balloon, bladder, or the like, that is supported by the cannula assembly 100. The dissector assembly 1000 is configured and dimensioned to create, and facilitate access to, an internal worksite W within a patient. For example, the dissector assembly 1000 may be utilized beneath a patient's external tissue T to form the internal worksite W between adjacent tissue layers TL.sub.1, TL.sub.2.

(16) The cannula assembly 100 includes a shaft 102 having a proximal end 104 that is in communication with the fluid source 200, and a distal end 106 that supports the dissection element 300. The shaft 102 includes a lumen 108 extending therethrough that facilitates the communication of fluid, e.g., a liquid, a gas, or a combination thereof, from the fluid source 200 into the dissection element 300 to permit expansion thereof. To regulate the flow of fluid from the fluid source 200 to the dissection element 300, the cannula assembly 100 may include one or more valves (not shown).

(17) The dissection element 300 is repositionable from an initial, unexpanded condition to an expanded condition via the communication of fluid into the dissection element 300, during which time, the dissection element 300 is enlarged in three dimensions, i.e., along the X, Y, and Z axes (FIG. 2). In the unexpanded condition, the dissection element 300 defines a first outer transverse cross-sectional dimension, and in the expanded condition, (FIGS. 1 and 2), the dissection element 300 is enlarged to define a second outer transverse cross-sectional dimension larger than the first outer transverse cross-sectional dimension. For example, in moving from the unexpanded condition to the expanded condition, the dimensions of the dissection element 300 may be increased along one or more of the X, Y, and Z axes (FIG. 2).

(18) In addition to the configurations seen in FIGS. 1 and 2, the dissection element 300 may be configured to achieve any desired shape in the expanded condition, dependent upon the particular requirements of the surgical procedure in which the dissector assembly 1000 is employed. For example, in the expanded condition, the dissection element 300 may be configured as illustrated in FIG. 3, or alternatively, the dissection element 300 may define a circular configuration, an oval configuration, a kidney-shaped configuration, a triangular configuration, a toroidal configuration, etc. The dissection element 300 may be formed from any material of construction suitable for the intended purpose of permitting expansion of the dissection element 300 in the manner described herein.

(19) In one embodiment of the disclosure, in order to facilitate visualization through the dissection element 300, e.g., during the separation of tissue and formation of the internal worksite W (FIG. 1), the dissection element 300 may be formed, either in whole or in part, from a material permitting at least some light to pass therethrough, e.g., clear urethane. For example, the dissection element 300 may include translucent portions, transparent portions, or combinations thereof, as well as opaque portions.

(20) With reference now to FIG. 4, in one embodiment, the dissection element 300 includes, e.g., is formed from, one or more layers 302 of material that are secured together to define an interior space S. For example, in the embodiment illustrated in FIG. 4, the dissection element 300 is formed by securing together two layers 302.sub.A, 302.sub.B of material at the perimeters thereof, or any other suitable location. The layers 302.sub.A, 302.sub.B of material may be secured together through any suitable manufacturing procedure, including, but not limited to, welding via impulse, laser, or RF, or through the use of an adhesive. Alternatively, the layers 302 may be formed monolithically, either partially or entirely.

(21) In order to restrict expansion of the dissection element 300, and achieve a desired configuration in the expanded condition, the dissector assembly 1000 further includes a restrictor 400 (FIGS. 1, 2, 4, and 7). In the embodiment of the disclosure illustrated in FIGS. 1, 2, 4, and 7, the restrictor 400 is provided as an additional, discrete component of the dissector assembly 1000 that is in contact with, e.g., secured to, the dissection element 300. For example, the restrictor 400 may be secured to an outer surface 304 of the dissection element 300, either fixedly or removably, so as to at least partially envelop the dissection element 300, as seen in FIGS. 1, 2, and 4. Alternatively, as seen in FIG. 5, the restrictor 400 may be secured to an internal surface 306 of the dissection element 300 such that the restrictor 400 is positioned within the interior space S. In another embodiment of the disclosure, which is illustrated in FIG. 6, it is envisioned that the restrictor element 400 may be embedded between adjacent layers 302.sub.A, 302.sub.B and between adjacent layers 302.sub.C, 302.sub.D of the material from which the dissection element 300 is formed. Alternatively, the restrictor 400 may be monolithically formed with at least one of the layers 302 of the dissection element 300.

(22) The restrictor 400 may entirely prevent expansion of one or more portions of the dissection element 300 in one or more directions. It is also contemplated, however, that the restrictor 400 may simply limit expansion of one or more portions of the dissection element 300, and permit a certain degree of expansion of the one or more portions.

(23) The resiliency of the restrictor 400 may be less than that of the dissection element 300. For example, the dissection element 300 may be at least partially formed from a first material having a first durometer, e.g., clear urethane, and the restrictor 400 may be at least partially formed from a second, different material having a second, higher durometer, and/or increased rigidity, and/or decreased flexibility, e.g., ripstop nylon, a metallic alloy, a textile, or combinations thereof. Alternatively, it is contemplated that portions of the restrictor 400 may include the same material as the dissection element 300.

(24) The reduced resiliency of the restrictor 400 compared to that of the dissection element 300 may be accomplished in various ways. For example, the restrictor 400 may include more layers 302 of material than the dissection element 300, or the restrictor 400 may be of a greater thickness than the dissection element 300. Additionally, or alternatively, the restrictor 400 may include a substantially rigid material, or may define a perimeter having lesser flexibility than the remainder of the restrictor 400.

(25) The reduced resiliency of the restrictor 400 compared to that of the dissection element 300 allows the restrictor 400 to selectively inhibit expansion of the dissection element 300 along one or more of the axes X, Y, Z (FIG. 2), dependent upon the particular configuration of the restrictor 400, and the orientation of the restrictor 400 in relation to the dissection element 300. As seen in FIG. 4, for example, the restrictor 400 may be configured, dimensioned, and positioned to restrict expansion of the dissection element 300 along the Y axis in order to prevent the dissection element 300 from assuming a spherical configuration, and instead, realize a flattened, oblong, or otherwise generally planar configuration in the expanded condition. Throughout the present disclosure, the term generally planar is used to describe the configuration of the dissection element 300 in the expanded condition, in which the dissection element 300 may not be perfectly planar in configuration, and may include both curvilinear portions and straight portions. For example, dependent upon the particular configuration of the restrictor 400, the portions of the dissection element 300 immediately adjacent to, or in contact with, the restrictor 400 may be either flat, or may include a slight curvature, e.g., less than 20, whereas those portions of the dissection element 300 further from the restrictor 400 may include a greater curvature. In the context of the particular embodiment show in FIG. 4, the portions of the dissection element 300 immediately adjacent to the restrictor 400 are generally flat, with a relatively constant dimension along the Y axis, in contrast to those portions of the dissection element 300 spaced outwardly from the restrictor 400, i.e., along the X axis, which include a more variable dimension along the Y axis.

(26) In one embodiment, the restrictor 400 defines a contour corresponding to that defined by the outer surface 304 (FIG. 4) of the dissection element 300. For example, with reference to FIG. 7, which illustrates the restrictor 400 separated from the dissection element 300, the restrictor 400 may include first and second portions 402.sub.A, 402.sub.B, respectively, wherein the first portion 402.sub.A includes a first arm 404.sub.A1, a second arm 404.sub.A2, and a third arm 404.sub.A3, and the second portion 402.sub.B includes a first arm 404.sub.B1, a second arm 404.sub.B2, and a third arm 404.sub.B3. In order to mimic the contour defined by the dissection element 300 in the expanded condition, each of the arms 404.sub.A1, 404.sub.A2, and 404.sub.A3 of the first portion 402.sub.A, and the arms 404.sub.B1, 404.sub.B2, and 404.sub.B3 of the second portion 402.sub.B, may include a curvature matching that defined by the dissection element 300, as can be appreciated through reference to FIGS. 1 and 2.

(27) To secure the restrictor 400 relative to the dissection element 300, the arms 404.sub.A1, 404.sub.B1 and the arms 404.sub.A2, 404.sub.B2 may be secured together through any suitable manufacturing procedure, including, but not limited to, welding using impulse, laser, or RF, or through the use of an adhesive. To further secure the restrictor 400 relative to the dissection element 300, one or more portions of the restrictor 400, e.g., one or more of the arms 404.sub.A1, 404.sub.A2, 404.sub.B1, 404.sub.B2, 404.sub.C1, 404.sub.C2, may also be secured to, or monolithically formed with, the material from which the dissection element 300 is formed, e.g., the layers 302.sub.A, 302.sub.E (FIG. 4).

(28) In one embodiment, such as that represented in FIG. 7, the restrictor 400 may be formed from a single piece of material in order to eliminate separation between the arms 404.sub.A3, 404.sub.B3 of the respective first and second portions 402.sub.A, 402.sub.B. In such embodiments, in positioning the restrictor 400 relative to the dissection element 300, the arms 404.sub.A3, 404.sub.B3 may be bent or deformed as required.

(29) In another embodiment, such as that represented in FIG. 8, one or more of the arms, e.g., the arms 404.sub.A3, 404.sub.B3, may be connected to one another via a hinge element 406, e.g., a living hinge 408.

(30) The restrictor 400 may include any number of arms, or be configured in any manner, which facilitates the intended purpose of restricting expansion of the dissection element 300 in one or more directions. The restrictor 400 may be positioned such that portions of the restrictor 400 are positioned adjacent portions of the dissection element 300 that are capable of greater expansion than other portions of the dissection element 300.

(31) In another embodiment, which is illustrated in FIG. 7A, the restrictor 400 includes a single body portion 402 having a first arm 404.sub.A1, a second arm 404.sub.A2, and a third arm 404.sub.A3, and is configured and dimensioned for positioning adjacent one side of the dissection element 300 only, rather than adjacent opposing sides of the dissection element 300, e.g., as illustrated in FIG. 4, for example.

(32) The restrictor 400 may be of varying rigidity or flexibility, for example, via the inclusion of various material(s) of construction, by varying the thicknesses of the materials of construction, and/or by varying the number of layers of material. For example, with reference to FIG. 2, the restrictor 400 may be of greater rigidity at the location wherein the arms 404.sub.A1, 404.sub.A2, 404.sub.A3 intersect relative to the rigidity of the arms 404.sub.A1, 404.sub.A2, 404.sub.A3 themselves. Alternatively, one or more of the arms 404.sub.A1, 404.sub.A2, 404.sub.A3 may be of different flexibility.

(33) With reference now to FIGS. 1, 2, and 4, a method of performing a surgical procedure with the dissector assembly 1000 will be discussed. Initially, the dissector assembly 1000 is advanced through an opening O in the tissue T, which may be either naturally occurring or surgically created, such that the dissection element 300 is positioned internally, beneath the tissue T, in a desired location. Thereafter, fluid is communicated into the dissection element 300, e.g., through the cannula assembly 100, to move the dissection element 300 into the expanded condition seen in FIG. 1. During expansion of the dissection element 300, the adjacent tissue layers T.sub.1, T.sub.2 are separated in order to create the internal worksite W. As the dissection element 300 is expanded, an inwardly directed force F (FIG. 4) is applied to the dissection element 300 by the restrictor 400 in order to inhibit expansion of the dissection element in at least one direction. For example, in the particular embodiment illustrated in FIG. 4, the restrictor 400 inhibits expansion of the dissection element 300 along the Y axis, thereby limiting tissue displacement along the Y axis, such that the dissection element 300 defines the illustrated generally planar configuration in the expanded condition.

(34) During expansion of the dissection element 300, an endoscope (not shown), or other suitable viewing instrument may be inserted into the dissection element 300, e.g., via the cannula assembly 100, in order to facilitate visualization of the tissue, e.g., the internal worksite W. As mentioned above, the dissection element 300 may include translucent portions, transparent portions, or combinations thereof, whereby the tissue, e.g., the internal worksite W, can be visualized directly through the dissection element 300.

(35) Following creation of the internal worksite W, fluid can be withdrawn from the dissection element 300 so as to return to the dissection element 300 to the unexpanded condition, and the dissector assembly 1000 can be withdrawn from the patient.

(36) With reference now to FIGS. 9-11, alternate embodiments of the dissection element and the restrictor will be discussed, which are identified by the reference characters 1300 and 1400, respectively. The dissection element 1300 and the restrictor 1400 are identical to the dissection element 300 and the restrictor 400 discussed above with respect to FIGS. 1, 2, and 4, for example, but for the differences described below.

(37) In the embodiments shown, the restrictor 1400 is integrally formed with the dissection element 1300, and is formed from the same material of construction as the dissection element 1300, e.g., clear urethane. In order to reduce the resiliency of the restrictor 1400 relative to the dissection element 1300, the restrictor 1400 defines an increased thickness, i.e., a larger cross-sectional dimension along the axis in which limited expansion of the dissection element 1300 is desired. For example, with reference to FIG. 9, the thickness T.sub.1 of the restrictor 1400 is increased in relation to the thickness T.sub.2 of the dissection element 1300 along the Y axis in order to limit expansion of the dissector element 1300 along the Y axis. Since it may be desirable to limit expansion of the dissector element 1300 in additional dimensions, in additional embodiments of the disclosure, the thickness T.sub.1 of the restrictor 1400 may be increased in additional locations. For example, with reference to FIG. 10, the thickness T.sub.1 of the restrictor 1400 may be increased in relation to the thickness T.sub.2 of the dissection element 1300 to limit expansion of the dissector element 1300 along the X axis in addition to the Y axis.

(38) It is envisioned that the restrictor 1400 may extend outwardly from the dissection element 300, as seen in FIGS. 9 and 10, for example. Alternatively, it is envisioned that the restrictor 1400 may extend inwardly into the interior space S defined within the dissection element 1300, as seen in FIG. 11, for example.

(39) With reference now to FIGS. 12-14, another embodiment of the dissection element will be discussed, which is identified by the reference character 2300. The dissection element 2300 is identical to the dissection element 300 discussed above with respect to FIGS. 1, 2, and 4, for example, but for the differences described below.

(40) The dissection element 2300 is formed from one or more materials of construction that inherently restrict expansion of the dissection element 2300 in one or more directions beyond a certain predetermined measure. For example, the materials of construction may restrict expansion of the dissection element 2300 beyond a particular volume, or may restrict expansion of the dissection element 2300 such that the expansion element 2300 defines a particular configuration in the expanded condition.

(41) The particular materials of construction for the dissection element 2300 obviate the need for a separate, discrete restrictor element, and thus, reduce the cost and complexity of manufacture. For example, in one embodiment, the dissection element 2300 may be formed entirely from ripstop nylon, or from one or more layers of film having a high modulus of elasticity, e.g., high durometer polyurethane, polyethylene, mylar, or other suitable laminates. Alternatively, the dissection element 2300 may include one or more layers of a first material, e.g., a urethane film, that are reinforced with one or more layers, strips, ribs, or other such portions of a second material, e.g., ripstop nylon or flashspun high-density polyethylene fibers.

(42) With reference to FIG. 14 in particular, in the illustrated embodiment, the dissection element 2300 is formed from layers 2302 of material, e.g., layers 2302.sub.A, 2302.sub.B, that are secured together at one or more junction points J, e.g., junction points J.sub.1, J.sub.2, through any suitable manufacturing procedure, including, but not limited to, welding using impulse, laser, or RF, or through the use of an adhesive. The dissection element 2300 is configured and formed to restrict expansion in a direction perpendicular to the junction points J.sub.1, J.sub.2, i.e., along the Y axis in the illustrated embodiment.

(43) Although illustrated as being formed from multiple layers 2302 of material that are secured together at multiple junction points, i.e., the aforedescribed junction points J.sub.1, J.sub.2, it should be appreciated that the dissection element 2300 may also be formed from a single layer 2302 of material secured to itself at single junction point, or at a plurality of junction points. For example, a single layer 2302 of material may be folded onto itself.

(44) FIG. 15 illustrates another embodiment of the dissection element, which is identified by the reference character 3300. The dissection element 3300 is identical to the dissection element 2300 discussed above with respect to FIGS. 12-14, but for the differences described below.

(45) The dissection element 3300 includes layers 3302 of material, e.g., layers 3302.sub.A, 3302.sub.B, 3302.sub.C, 3302.sub.D, that are secured together at junction points J.sub.1, J.sub.2, J.sub.3, J.sub.4. As discussed in connection with the dissection element 2300 illustrated in FIG. 14, the dissection element 3300 is configured and formed to restrict expansion in directions perpendicular to the junction points J.sub.1, J.sub.2, J.sub.3, J.sub.4. As such, in the embodiment illustrated in FIG. 15, the layers 3302 of material restrict expansion of the dissection element 3300 in multiple dimensions, i.e., along the X and Y axes.

(46) Persons skilled in the art will understand that the various apparatus, and corresponding methods of use described herein and shown in the accompanying drawings, constitute non-limiting, exemplary embodiments of the present disclosure, and that additional components and features may be added to any of the embodiments discussed herein above without departing from the scope of the present disclosure. For example, the various embodiments of the dissector assemblies described herein may be modified to include a pressure sensor in order to monitor pressure within the various dissection elements, and/or an escape valve in order to inhibit over expansion.

(47) Additionally, persons skilled in the art will understand that the elements and features shown or described in connection with one exemplary embodiment may be combined with those of another embodiment without departing from the scope of the present disclosure, and will appreciate further features and advantages of the presently disclosed subject matter based on the above-described embodiments and the claims. Accordingly, the present disclosure is not limited by what has been particularly shown and described.