1. Technical Field
The present disclosure relates to specimen retrieval and, more particularly, to apparatus and methods for minimizing the risk of seeding during specimen retrieval.
2. Background of Related Art
Laparoscopic and endoscopic surgical procedures are minimally invasive procedures in which operations are carried out within the body by using elongated instruments inserted through small entrance openings in the body. The initial opening in the body tissue to allow passage of the endoscopic or laparoscopic instruments to the interior of the body may be a natural passageway of the body, or it can be created by a tissue piercing instrument such as a trocar. Laparoscopic procedures generally require that any instrumentation inserted in the body be sealed, i.e. provisions must be made to ensure that gases do not enter or exit the body through the instrument or the entrance incision so that the surgical region of the body, e.g. the peritoneum, may be insufflated. Mechanical actuation of such instruments is for the most part constrained to the movement of the various components along a longitudinal axis with structure provided to convert longitudinal movement to lateral movement where necessary.
Because the endoscopic or laparoscopic tubes, instrumentation, and any required punctures or incisions are relatively narrow, endoscopic or laparoscopic surgery is less invasive as compared to conventional surgical procedures in which the surgeon is required to cut open large areas of body tissue. Therefore, laparoscopic or endoscopic surgery minimizes trauma to the patient and reduces patient recovery time.
Minimally invasive procedures may be used for partial or total removal of body tissue or organs from the interior of the body, e.g. nephrectomy, cholecystectomy, and other such procedures such as minimally invasive thoracic procedures. During such procedures, it is common that a cyst, tumor, or other affected tissue or organ must be removed via the access opening in the skin, or through a cannula. In many of these procedures, especially where cancerous tumors are removed, removal of the specimen in an enclosed environment is highly desirable to prevent seeding.
Accordingly, various types of entrapment devices have been disclosed to facilitate the removal of specimens. For example, U.S. Pat. No. 5,037,379 to Clayman et al. discloses a surgical tissue bag for percutaneously debulking tissue by morcellation. The bag includes a layer of puncture-resistant material, a layer of moisture-resistant material and a drawstring. In a disclosed method of use, the bag is placed within the body cavity, the body tissue or organ is placed within the bag, the opening of the bag is pulled through the incision in the skin leaving the distal end of the bag containing the tissue or organ within the body cavity, a morcellator is then inserted into the bag, and then the tissue or organ is debulked and suctioned out of the bag.
U.S. Pat. No. 5,074,867 to Wilk discloses a planar membrane having filaments attached to its corners. The membrane is placed within a body cavity with the filaments extending through the trocar cannula to the outside of the body. The organ or tissue to be removed is placed on the membrane and the filaments are pulled to close the membrane around the organ and draw it through the cannula, if the organ is sufficiently deformable. If the organ is not sufficiently deformable, e.g. because of the presence of gallstones, a forceps or other instrument is used to crush the stones or tissue.
Improvements to prior art entrapment devices are disclosed in U.S. Pat. No. 5,647,372 to Tovey et al. and in U.S. Pat. No. 5,465,731 to Bell et al., the disclosures of which are hereby incorporated by reference in their entirety.
It would be advantageous to provide a method and apparatus for tissue specimen removal which reduces the risk of seeding and minimizes tissue damage during removal.
The present disclosure provides apparatuses and methods for modifying a tissue specimen in such a way as to prevent seeding during removal. The present disclosure is also related in some aspects to an access port for use during retrieval of a tissue specimen from inside a patient's body. The present disclosure is applicable in conjunction with an entrapment device, or in place of an entrapment device, both embodiments being configured to prevent seeding and tissue damage during specimen removal.
In accordance with one aspect of the present disclosure, a method for modifying a tissue specimen includes providing a specimen modifying apparatus configured to modify the specimen thereby preventing the specimen from seeding upon removal from a body cavity. The specimen modifying apparatus is inserted through an opening in tissue and positioned adjacent the tissue specimen to be modified. The specimen modifying apparatus is then activated to modify the tissue specimen thereby inhibiting the tissue specimen from seeding. The method may also include retrieving the tissue specimen.
In one embodiment, the method includes positioning an access port within the opening in tissue. The tissue modifying apparatus is then inserted through the access port. The specimen may also be retrieved, or removed, through the access port.
In some embodiments, the access port can include a tubular body defining a longitudinal axis. The access port is configured for positioning within an opening in tissue and has a proximal end and a distal end. In some embodiments, a proximal radial flange extends radially outwardly from the proximal end of the tubular body and is configured to extend along an exterior surface of tissue adjacent the opening in tissue. The access port can be used for passage of the various specimen modifying apparatus described herein, as well as used for passage of other instrumentation.
In one embodiment of the present disclosure, the specimen modifying apparatus includes a housing having an elongated shaft extending from a distal end thereof. The shaft can include a lumen therein for the passage of tissue sealant therethrough and is configured for insertion through an opening in tissue. A dispensing assembly can be disposed at a distal end of the shaft and in communication with the lumen of the shaft. The dispensing assembly in one embodiment is in the form of a nozzle positionable adjacent a tissue specimen and configured to selectively dispense tissue sealant onto a surface of the specimen to seal the specimen, inhibiting the passage of cellular material between the tissue specimen and surrounding tissue. The tissue sealant may be a fibrin glue.
In accordance with another embodiment of the present disclosure, the specimen modifying apparatus includes a housing having an elongated shaft disposed at a distal end thereof and connected to a radiation source. The shaft is insertable through an opening in tissue. An end effector assembly is disposed at a distal end of the shaft and is positionable adjacent a tissue specimen. The end effector assembly can include a pair of insulated cups moveable from an open position to a closed position. The cups preferably form a closed cavity in the closed position to retain the tissue specimen therein. The cavity in one embodiment can be spherical. The cups are preferably insulated to minimize the passage of radiation therethrough, and upon activation, radiation energy is supplied from the radiation source to the tissue specimen retained within the cups to terminate the cells of the tissue specimen with radiation. The cups may be lead-lined to minimize the passage of radiation through the cups.
In another embodiment of the present disclosure, the specimen modifying apparatus includes a housing having an elongated shaft disposed at a distal end thereof, the housing configured to operably couple to a source of electrical energy. An end effector assembly is disposed at a distal end of the shaft and is positionable at least partially through an opening in tissue. The end effector assembly can include a pair of electrically conductive plates spaced apart from one another and configured for positioning a tissue specimen therebetween. Preferably electrical energy is selectively applicable from the electrical energy source to the pair of electrically conductive plates to thereby pass a voltage through the specimen. The voltage passed between the electrically conductive plates may in some embodiments be about 4 kV. The voltage passed through the specimen may be above a threshold, thereby resulting in nonreversible electroporation, or termination of cells therein. Alternatively, the voltage passed through the specimen may be below the threshold, thereby resulting in electroporation of the cells to permit permeation therethrough of fluids which would otherwise be impermeable.
In another aspect, a specimen modifying apparatus is provided comprising a housing having an elongated shaft extending from a distal end thereof. The shaft includes a lumen therein for the passage of tissue sealant therethrough and is configured for insertion through an opening in tissue. A dispensing assembly is disposed at a distal end of the shaft and in communication with the lumen of the shaft, the dispensing assembly positionable adjacent a tissue specimen and configured to selectively dispense tissue sealant onto a surface of the tissue specimen to thereby seal the tissue specimen, inhibiting passage of cellular material between the tissue specimen and surrounding tissue.
In another aspect, a specimen modifying apparatus is provided comprising a housing having an elongated shaft disposed at a distal end thereof, the housing being connected to an energy source. The shaft is insertable through an opening in tissue. An end effector assembly is disposed at a distal end of the shaft. The end effector assembly is positionable adjacent a tissue specimen and includes a pair of members moveable from an open position to a closed position, wherein, upon activation, energy is supplied from the energy source to the tissue specimen retained within the cups to modify the tissue specimen for removal from a body.
In some embodiments, the energy source is a source of radiation and the end effector assembly includes a pair of insulated cups which form a closed cavity in the closed position to thereby retain the tissue specimen therein, the cups being insulated to inhibit the passage of radiation therethrough.
In some embodiments, the energy source is a source of electrical energy and the end effector assembly includes a pair of electrically conductive plates spaced apart from one another and configured for positioning with a tissue specimen disposed therebetween, wherein electrical energy is selectively applicable from the electrical energy source to the pair of electrically conductive plates to thereby pass a voltage through the specimen to modify the tissue specimen.
Various embodiments of the subject instrument are described herein with reference to the drawings wherein:
Turning now to
Access port 100 may in some embodiments also include a seal 150 disposed within tubular body 110 to seal off and prevent the exchange of fluids between internal body cavities or tissues and the external environment. As can be appreciated, when access port 100 is positioned within opening 18 in tissue 10, access port 100 lines the opening 18 in tissue 10 and the immediate surrounding external 12 and internal 14 surfaces of tissue 10. Seal 150, if provided, prevents fluid exchange through opening 18 in tissue 10.
It is envisioned that access port 100 may be formed of flexible material and be compressible to fit within an opening before expanding towards an uncompressed size. Further, the access port 100 may be dimensioned according to the diameter and thickness of tissue 10 through which access port 100 is to be inserted. More specifically, tubular body 110 of access port 100 may have a diameter substantially equal to a diameter of the opening 18 in tissue 10 such that tubular body 110 is securely positionable within opening 18 in tissue 10. Similarly, tubular body 110 of access port 100 may have a length that is substantially equal to the thickness of tissue 10 such that proximal and distal flanges 120 and 130 are securely positionable on the external 12 and internal 14 surfaces of tissue 10, respectively. In other words, it is envisioned that access port 10 be dimensioned to fit securely within an opening 18 in tissue 10, held in place by the forces acting on access port 100 by surrounding tissue.
It is further envisioned that surgical instrumentation (see
With continued reference to
The operation of access port 100 will now be described in detail with reference to
In order to modify and/or remove a tissue specimen “S” from inside a patient's body, a surgical instrument (not shown) is inserted through access port 100. The surgical instrument may then be activated to modify or otherwise treat the specimen. When the specimen is a cancerous mass, or tumor, for example, it would be advantageous to seal the specimen or terminate the cell mass prior to removal to prevent seeding. Once the specimen has been modified, e.g., sealed or terminated, a surgical instrument is used to enclose, grasp, suction, or otherwise retain specimen “S” thereon. The instrument is then translated proximally to remove the specimen “S” from the body via the opening 18 in tissue 10. During removal of a relatively large specimen, the relatively narrow opening 18 in tissue 10 may contact the specimen “S,” causing tearing of tissue, detachment of the specimen “S” from the surgical instrument and/or seeding. Modification of the specimen prior to removal reduces the risks of seeding. The access port 100 aids in the removal process and protects against the potential for seeding from tissue that has not been effectively modified.
Further, during removal, the specimen “S” may become misaligned with the access port and/or may be too wide to pass through the opening 18 in tissue 10 without the use of force. In such situations, as specimen “S” is translated toward the opening 18 in tissue 10, specimen “S” may brush internal surface 14 of tissue 10 and/or wall 16 defining opening 18 of tissue 10. This tissue on tissue brushing may cause damage to either tissue and/or may result in seeding. However, with the presence of access port 100 disposed through opening 18 in tissue 10, specimen “S” contacts distal flange 130, rather than internal surface 14 of tissue upon misalignment. The configuration of distal flange 130 provides a less abrasive surface such that the potential for tissue damage and/or seeding is reduced. Additionally, distal flange 130 acts to funnel specimen “S” toward lumen 112 defined within tubular body 110 of access port 100, thereby facilitating removal of specimen “S.” A lubricant (not shown) may also be applied to the inner surface of wall 114 of access port 100 to facilitate removal of the specimen “S.”
Once specimen “S” is translated into lumen 112 of tubular body 110, access port 100, in part due to its flexibility, allows specimen “S” to pass proximally though lumen 112 of tubular body 110 with minimal forces acting on specimen “S”. The relatively smooth surfaces of tubular body 110 help prevent specimen “S” from catching or tearing during translation through access port 100. As specimen “S” is translated proximally past proximal end 116 of tubular body 110, proximal flange 120 of access port 100 acts to prevent tissue damage and/or seeding during the emergence of specimen “S” from access port 100. More specifically, if specimen “S” had been deformed during passage through tubular body 110, specimen “S” may reform, e.g. extend radially outwardly, to its original shape upon exiting tubular body 110. However, proximal flange 120 prevents contact of reforming specimen “S” with an external surface 12 of tissue 10.
Thus, specimen “S” may be removed from inside a patient's body through a relatively narrow opening 18 in tissue 10 without contacting the exterior surface 12, interior surface 14, or internal wall 16 of tissue 10 surrounding opening 18 in tissue 10. This configuration helps prevent seeding, tissue damage, and specimen damage without requiring bagging the specimen for removal.
With reference now to
Elongated shaft 210 is insertable through an opening in tissue such that dispensing assembly 230 may be positioned adjacent a tissue specimen “S” to be modified, or sealed. Further, elongated shaft 210 may be flexible and/or steerable for improved access to tissue. The nozzle assembly 230 may be rotatable and/or radially deflectable with respect to the longitudinal axis to provide a larger coverage area for dispensing tissue sealant 250. A control mechanism, e.g., joystick, may be provided on the housing 205 for controlling the manipulation of the nozzle assembly 230. This is especially helpful where the opening in tissue is small, thereby limiting the radial movement of shaft 210 of tissue sealant applicator 200 when disposed through the opening in tissue. Additionally, nozzle assembly 230 may include a plurality of settings, e.g., solid stream, rain drops, pulsed stream, spray, etc., for selectively dispensing tissue sealant 250. For example, a solid stream setting may be chosen where the specimen to be sealed is relatively small and/or is positioned adjacent other tissue. On the other hand, a spray setting may be preferred where the specimen is relatively large and/or remote from other tissue.
Tissue sealant 250 may be any suitable tissue sealant capable of sealing and isolating a tissue specimen “S.” Such tissue sealants 250 may include, but are not limited to fibrin glues, gelatin matrix/thrombin sealants, cyanoacrylate sealants, bovine serums and polyethylene glycol hydrogels. Fibrin glues are advantageous in that they are made from biological materials, seal relatively quickly, and present a low risk of site inflammation or infection. More recent developments allow fibrin sealant to be made from the patient's own blood, thus lowering the risk of allergic reaction and/or rejection. As will be described in more detail below, nozzle assembly 230 is used to apply tissue sealant 250 to a tissue specimen “S,” i.e. to coat tissue specimen “S” with tissue sealant 250, to thereby seal specimen “S” in an isolated environment, such that cellular materials may not pass between the tissue specimen “S” and the surrounding environment 22. As can be appreciated, sealing the tissue specimen “S” inhibits seeding during the retrieval process without damaging the integrity of the tissue specimen “S.”
The operation of tissue sealant applicator 200 will now be discussed in detail with reference to
Once specimen “S” has been coated with tissue sealant 250, tissue sealant applicator 200 may be removed from the opening in tissue. At this point, a surgical instrument may be inserted through the opening in tissue to grasp or otherwise retrieve the modified/treated specimen “S” therefrom. Although specimen “S” may in some embodiments be placed in a receptacle, e.g., a bag, prior to removal, this is not required because it is sealed. That is, the coating of tissue sealant 250 provides protection to specimen “S” and surrounding tissue, isolates specimen “S” thereby preventing seeding, and aids in the removal process by providing a more uniform, smooth outer surface on specimen “S.” Additionally, after specimen “S” has been sealed with tissue sealant 250, a lubricant may be applied to the sealed surface of specimen “S” to further facilitate the removal of specimen “S.” The lubricant (not shown) may be applied from tissue sealant applicator 200, e.g., via a separate lumen extending to nozzle assembly 230, or from a new instrument (not shown) inserted into the body cavity through an access port or body opening. Further, the access port 100, as mentioned above, may be similarly coated on an interior surface with a lubricant to facilitate removal of the specimen “S.” As such, relatively large specimens may be removed through relatively small openings in tissue without the need for a receptacle.
Further, access port 100 may aid in the removal of the sealed specimen “S.” More particularly, the surface features of access port 100 and sealed specimen “S” may be configured to allow for smooth translation of sealed specimen “S” through lumen 112 of access port 100, thereby facilitating removal from the body. Lubricant added to the sealed specimen “S” and/or the inner surface of wall 114 of access port 100 may also aid in the removal of the sealed specimen “S,” as mentioned above.
Turning now to
End effector assembly 330 includes a pair of opposed cups 332, 334 movable between an open position wherein cups 332, 334 are substantially overlapping with one another to form a open, partial-sphere cavity 336 (
With continued reference to
The operation of endoscopic radiation device 300 will now be described in detail with reference to
It is also envisioned that cups 332, 334 can be retractable from a substantially linear configuration to a spherical configuration shown in
Referring now to
End effector assembly 430 includes a pair of opposed electrically conductive members, e.g. plates 432, 434, electrically coupled to the energy source (not shown). As will be described in more detail below, end effector assembly 430 and shaft 420 are configured for insertion through an access port or opening in tissue such that electrically conductive plates 432, 434 are disposable on opposing sides of a tissue specimen “S.” End effector assembly 430 may be rotatable together with shaft 420 by rotation knob 413, rotatable with respect to shaft 420 and/or deflectable with respect to the shaft 420, e.g. via control knob 451 linked to cables connected to end effector support 431 which can be pivotably attached (not shown) to the end of shaft 420. Electrical energy from the energy source may be provided to the end effector assembly 430 to pass a voltage between the plates 432, 434, and thus through the tissue specimen “S” disposed therebetween. When the voltage passing through the tissue specimen “S” reaches a specific threshold, which is dependent on the size and characteristics of the specimen disposed between the plates 432, 434, the voltage begins to terminate the cells making up the specimen “S.” A sufficient voltage passed between plates 432 and 434 may be about 4 kV, for example. This process of passing a voltage through tissue to kill the cells therein is generally known as irreversible electroporation. Irreversible electroporation is advantageous in that, while the tissue specimen “S” disposed between the plates 432, 434 is killed, surrounding tissue and organs are left unharmed. Alternatively, a lower voltage may be provided to effect reversible electroporation. Reversible electroporation involves sending a specific voltage through cellular membrane to create micropores therein. The micropores allow fluids to pass therethrough that would otherwise be impermeable through an unmodified cell membrane. As in previous embodiments, once the specimen “S” is modified/treated, the specimen “S” may be removed from the body, or may simply be left therein.
The operation of electroporation device 400 will now be described in detail with reference to
The instruments described above can be used in minimally invasive procedures such as laparoscopic surgery and thoracic surgery, e.g. VATS (video assisted thoracic surgery), where access to the thoracic cavity is achieved less invasively through the intercostal space (between adjacent ribs).
From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the present disclosure without departing from the scope of the same. While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
This application claims priority from provisional application Ser. No. 61/327,850, filed Apr. 26, 2010, the entire contents of which are incorporated herein by reference.
Number | Date | Country | |
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61327850 | Apr 2010 | US |