Minimally invasive medical apparatus for dispensing a biologically active compound and an associated medical procedure for dispensing a biologically active compound

Information

  • Patent Grant
  • 6695815
  • Patent Number
    6,695,815
  • Date Filed
    Tuesday, August 21, 2001
    22 years ago
  • Date Issued
    Tuesday, February 24, 2004
    20 years ago
Abstract
A medical apparatus for dispensing a biologically active compound. The medical apparatus includes a sleeve, wherein (1) the sleeve has a working channel defined therein through which medical instruments may be advanced, (2) the sleeve includes a fluid delivery channel which is distinct from the working channel, (3) the fluid delivery channel has an exit, and (4) the sleeve includes a housing having an interior cavity defined therein. The medical apparatus also includes an insufflation valve in fluid communication with the working channel. The insufflation valve is positionable between an open position and a closed position such that (i) when the insufflation valve is located in the open position an insufflation gas can be advanced into the working channel and (ii) when the insufflation valve is located in the closed position the insufflation gas is prevented from being advanced into the working channel. The medical apparatus further includes a chemical container having an interior void defined therein for receiving the biologically active compound, wherein the interior void is in fluid communication with the exit through the fluid delivery channel when the chemical container is positioned within the interior cavity of the housing such that the biologically active compound may be delivered through the fluid delivery channel to an outer surface of the sleeve.
Description




BACKGROUND OF THE INVENTION




The present invention generally relates to a medical apparatus and procedure for dispensing a biologically active compound. The present invention particularly relates to a medical apparatus and procedure for dispensing a biologically active compound during a minimally invasive surgical technique, such as laparoscopic surgery.




Minimally invasive surgical techniques, such as laparoscopic surgery, typically include the use of a trocar assembly. A trocar assembly includes a trocar (sometimes referred to as an “obturator”) positioned within the lumen of a cannula. The trocar and cannula are advanced through a body cavity wall so as to create a small opening or a port site wound therein. The trocar is then completely removed from the lumen of the cannula such that the cannula's lumen provides an entrance for laparoscopic instruments into the interior of the body cavity. The body cavity is then insufflated with an inert gas, such as CO


2


, to provide easier access to the organs contained therein. An alternative to insufflation, which also aids in intra-abdominal visualization and provides access to the organs, is a mechanical lifting device. Once the surgery is complete the cannula is completely removed from the port site wound to rapidly desufflate the body cavity.




Surgery performed by using minimally invasive techniques is generally associated with lower postoperative morbidity, slower tumor growth, shorter postoperative stay, less postoperative pain, decreased cost, and quicker recovery as compared to “open” or conventional surgical techniques


(1, 2, 3, 4, 5, 6)


. Because of the aforementioned advantages, these minimally invasive techniques are being applied to an increasing variety of all surgical procedures. For example, laparoscopic procedures for the resection of malignancies have emerged. In particular, laparoscopic colectomy for carcinoma of the colon has been developed, and it has been reported that the initial results of these procedures have advantages over operations performed in the traditional open manner


(5, 6, 14)


. Moreover, it is hoped that the long term results of these procedures will be comparable, or better than, those performed in the traditional open manner.




However, the development of laparoscopic surgery for cancer has been hindered because of the major concern regarding the implantation of tumor cells in the port site wound


(2, 3, 6, 7)


. In fact, numerous port site recurrences have been documented in the medical literature heretofore, and these recurrences are associated with a decreased survival rate for patients who may have had a curative cancer


(2, 3, 6, 7)


. Specifically, the medical literature reports that the incidence of tumor cell implantation ranges from as high as 20% to as low as 0%


(8)


. The studies generating the aforementioned data utilized highly skilled and experienced laparoscopic surgeons practicing at major university programs. However, in spite of utilizing highly skilled and experienced laparoscopic surgeons, the data indicates that the incidence of tumor cell implantation in the surgical wound is greater when employing laparoscopic techniques as compared to when conventional surgical techniques are used (i.e. 0.6% implantation incidence for conventional techniques


(9)


compared to 1% incidence for laparoscopic techniques


(10)


.




Several mechanisms may be responsible for the above discussed implantation of tumor cells in the port site wound. For example, minimally invasive surgical techniques for treating cancer require the insertion and removal of laparoscopic instruments or cameras through the lumen of the cannula. In addition, these surgical techniques require that the cannula itself be moved relative to the port site wound such that the cannula is advanced further into, or withdrawn from, the body cavity


(11)


. Moving the cannula in the above described manner facilitates a surgeon's ability to optimally locate instruments within the body cavity thereby helping to ensure the successful completion of the medical procedure. However, the aforementioned manipulations of the laparoscopic instruments and cannula may result in the exposure of the port site wound to exfoliated cancer cells which creates a risk of implanting tumor cells in the walls of the port site wound


(11, 12)


. In particular, exfoliated cancer cells may adhere to and thus contaminate a portion of the exterior surface of the cannula


(11, 12)


. The contaminated portion of the exterior surface of the cannula may then be advanced into contact with the port site wound during insertion and removal from the port site wound


(11, 12)


. This contact may dislodge the exfoliated cancer cells from the exterior surface of the cannula and thus cause the exfoliated cancer cells to be implanted in the port site wound


(11, 12)


.




Furthermore, studies have shown that a physician may undergo a significant learning curve before becoming proficient in the performance of advanced laparoscopic surgery, such as cancer surgery


(3, 13, 16)


. As a result, a relatively inexperienced surgeon may have a tendency to manipulate or handle a tumor to a greater degree during a surgical procedure than an experienced surgeon. Studies have shown a 14.6% incidence of viable tumor cells in proximity of the specimen where the surgeon is working with his or her instruments


(15)


. In addition, an inexperienced surgeon may have a tendency to insert and withdraw an instrument through the lumen of the cannula a greater number of times than an experienced surgeon. The above described increased manipulation of the instrument or the tumor can result in a greater incidence of tumor cell implantation in the port site wound


(11, 12)


.




Regardless of how these cells contaminate the wound, once implanted therein, viable tumor cells can cause a subcutaneous metastases or “port site recurrence” after the resection of malignant tissue. These “port site recurrences” have delayed the advancement of laparoscopic cancer surgery


(2, 6, 7, 8, 9, 10, 11, 12)


into all fields of cancer surgery, and is one reason why the benefits of laparoscopic surgery have not been available to cancer patients.




Furthermore, laparoscopic surgery performed for general surgery, gynecological surgery, urological surgery, or any other intra-abdominal infection is associated with a small but real incidence of port site wound infection


(1)


. The infecting bacteria causing these illnesses can contaminate the port site wound in the same manner as discussed above with regard to tumor cell contamination, and these infections can increase a patient's morbidity and consequently the length of a patient's hospital stay, thereby considerably increasing their hospital bill.




One way of addressing the problem of potential tumor or infectious cell implantation in the port site wound is to apply a biologically active compound, such as a cytotoxic agent which kills tumor or infectious cells, on a medical apparatus (e.g. a trocar assembly) utilized in the laparoscopic procedure. By placing such a compound on the medical apparatus the biologically active compound becomes disposed on the interior surface of the body cavity and on the surface of the port site wound. Having the biologically active compound disposed on the medical apparatus, the interior surface of the body cavity, and the surface of the port site wound establishes a “pharmacological barrier” which prevents any viable tumor or infectious cells from becoming implanted in the port site wound.




Heretofore, biologically active compounds were disposed on the medical apparatus by various methods. For example, dipping the medical apparatus in a solution or suspension of the biologically active compound, applying the biologically active compound to the medical apparatus with an applicator such as a cotton swab, or injecting the intraperitoneal surface with the biologically active compound


(16, 17)


. However, the aforementioned methods of administering the biologically active compound suffer from several drawbacks. For example, these methods are inconvenient, messy, inexact, or highly variable. In addition, these methods do not allow the amount of the biologically active compound administered to the patient via the medical apparatus to be appropriately controlled. Controlling the amount administered to a patient is important since it allows the physician to carefully adjust the dose of the biologically active compound and thus avoid any undesirable side effects while maximizing the delivery of the biologically active compound. In addition, controlling the dose allows the physician to collect dose response data, and thus measure the effectiveness of various pharmacological regimens. With the recent advances in the fields of biotechnology, genetic engineering, and pharmacology, there is a need to accurately, efficiently, and reproducibly deliver current and future biologically active agents during the performance of a minimally invasive surgical technique.




What is needed therefore is a medical apparatus and procedure for disposing a biologically active compound which addresses the above described drawbacks.




TABLE OF REFERENCES CITED IN THE BACKGROUND




1. Lord et al.,


Dis. Col. Rect.


39(2):148 (1996)




2. Berman,


Important Advances in Oncology


1996,


Laparoscopic Resection for Colon Cancer: Cause for Pause


, Vincent DeVita Ed., p. 231




3. Falk et al.,


Dis. Col. Rect.


36:28 (1993)




4. Liberman et al.,


Surg. Endo.


10:15 (1996)




5. Whelan et al.,


Dis. Col. Rect.


41(5):564 (1998)




6. Wexner et al.,


Am. Surg.


64(1):12-18 (1998)




7. Greene,


Semin. Lap. Surg.


2(3):153 (1995)




8. Kazemier,


Surg. Endo.


9:216 (1995)




9. Reilly et al.,


Dis. Col. Rect.


39(2):200 (1996)




10. Jacquet et al.,


Dis. Col. Rect.


38(10):140 (1995)




11. Reymond et al.,


Surg. Endo.


11:902 (1997)




12. Allardyce et al.,


Dis. Col. Rect.


40(8):939 (1997)




13. Caushaj et al.,


Dis. Col. Rect.


37(4):21 (Podium Abstract 1994)




14. Lee et al., (oral presentation, 6


th


World Congress of Endoscopic Surgery, June 1998)


Surgical Endoscopy


12 (5):14 (1998)




15. Russell et al.,


Dis. Col. Rect.


40 (11):1294 (1997)




16. Neuhaus S J, (oral presentation, 6


th


World Congress of Endoscopic Surgery, June 1998)


Surgical Endoscopy


12 (5): 515 (1998)




17. Schneider C, (oral presentation, 6


th


World Congress of Endoscopic Surgery, June 1998)


Surgical Endoscopy


12 (5): 517 (1998)




SUMMARY OF THE INVENTION




In accordance with one embodiment of the present invention, there is provided a medical apparatus for dispensing a biologically active compound. The medical apparatus includes a trocar assembly including a cannula and a trocar, wherein (1) the cannula has a working channel defined therein through which medical instruments may be advanced, (2) the cannula includes a fluid delivery channel which is distinct from the working channel, and (3) the fluid delivery channel has an exit. The medical apparatus also includes a valve in fluid communication with the working channel. The valve is positionable between an open position and a closed position such that (i) when the valve is located in the open position a gas can be advanced into the working channel and (ii) when the valve is located in the closed position the gas is prevented from being advanced into the working channel. The medical apparatus further includes a chemical container having an interior void defined therein for receiving the biologically active compound. The interior void is in fluid communication with the exit through the fluid delivery channel, whereby the biologically active compound may be delivered through the fluid delivery channel to an outer surface of the cannula.




Pursuant to another embodiment of the present invention, there is provided a medical procedure for dispensing a biologically active compound. The medical procedure includes the steps of (a) creating an opening in a wall of a non-vascular body cavity, (b) advancing a medical apparatus through the opening and into the non-vascular body cavity, the medical apparatus including a trocar assembly having (1) a cannula and a trocar, wherein (A) the cannula has a working channel defined therein through which medical instruments may be advanced, (B) the cannula includes a fluid delivery channel which is distinct from the working channel, and (C) the fluid delivery channel has an exit, and (2) a chemical container having an interior void defined therein for receiving the biologically active compound, the interior void being in fluid communication with the exit through the fluid delivery channel, and (c) advancing the biologically active compound from the interior void of the chemical container onto an exterior surface of the cannula through a fluid path defined by the fluid delivery channel.




According to yet another embodiment of the present invention, there is provided a medical apparatus for dispensing a biologically active compound. The medical apparatus includes a sleeve, wherein (1) the sleeve has a working channel defined therein through which medical instruments may be advanced, (2) the sleeve includes a fluid delivery channel which is distinct from the working channel, and (3) the fluid delivery channel has an exit. The medical apparatus also includes a housing secured to the sleeve. The housing has an interior void defined therein for receiving the biologically active compound, wherein the interior void is in fluid communication with the exit through the fluid delivery channel such that the biologically active compound may be delivered through the fluid delivery channel to an outer surface of the sleeve. The medical apparatus further includes an insufflation valve in fluid communication with the working channel. The insufflation valve is positionable between an open position and a closed position such that (i) when the insufflation valve is located in the open position an insufflation gas can be advanced into the working channel and (ii) when the insufflation valve is located in the closed position the insufflation gas is prevented from being advanced into the working channel.




According to yet another embodiment of the present invention, there is provided a medical apparatus for dispensing a biologically active compound. The medical apparatus includes a trocar assembly including a cannula and a trocar. The cannula has a working channel defined therein, and the working channel has a cross-sectional area sized for passage of a laparoscope therethrough. The cannula includes a fluid delivery channel which is distinct from the working channel. The fluid delivery channel has an exit. The medical apparatus also includes a chemical container having an interior void defined therein for receiving the biologically active compound. The interior void is in fluid communication with the exit through the fluid delivery channel, whereby the biologically active compound may be delivered through the fluid delivery channel to an outer surface of the cannula.




According to still another embodiment of the present invention, there is provided a medical procedure for dispensing a biologically active compound. The medical procedure includes the steps of (i) creating an opening in a wall of a body cavity, (ii) advancing a medical apparatus through the opening and into the body cavity, the medical apparatus including a trocar assembly having (1) a cannula and a trocar, wherein (A) the cannula has a working channel defined therein through which medical instruments may be advanced, (B) the cannula includes a fluid delivery channel which is distinct from the working channel, and (C) the fluid delivery channel has an exit port, and (2) a chemical container having an interior void defined therein for receiving the biologically active compound, the interior void being in fluid communication with the exit port through the fluid delivery channel, (iii) advancing a gas into the body cavity, and (iv) advancing the biologically active compound from the interior void of the chemical container onto an exterior surface of the cannula through a fluid path defined by the fluid delivery channel.




According to yet another embodiment of the present invention, there is provided an arrangement for delivering a biologically active compound. The arrangement includes a chemical container configured to be removably disposed in a void of a housing of a trocar assembly.




It is therefore an object of the present invention to provide a new and useful medical apparatus for protecting a port site wound.




It is another object of the present invention to provide an improved medical apparatus for protecting a port site wound.




It is still another object of the present invention to provide a new and useful medical apparatus for dispensing a biologically active compound.




It is another object of the present invention to provide an improved medical apparatus for dispensing a biologically active compound.




It is moreover an object of the present invention to provide a new and useful medical procedure for protecting a port site wound.




It is still another object of the present invention to provide an improved medical procedure for protecting a port site wound.




It is moreover an object of the present invention to provide a new and useful medical procedure for dispensing a biologically active compound.




It is still another object of the present invention to provide an improved medical procedure for dispensing a biologically active compound.




The above and other objects, features, and advantages of the present invention will become apparent from the following description and attached drawings.











BRIEF DESCRIPTION OF THE DRAWINGS





FIG. 1

is an exploded perspective view of a medical apparatus inserted through a body cavity wall which incorporates the features of the present invention therein, with the body cavity wall shown in cross-section for clarity of description;





FIG. 2

is an enlarged fragmentary cross sectional view of the medical apparatus of

FIG. 1

, showing the chemical containers inserted into the housing;





FIG. 3

is an enlarged fragmentary perspective view of the medical apparatus of

FIG. 1

, showing the interior cavity of the housing;





FIG. 4

is an enlarged perspective view of one of the chemical containers shown in

FIG. 1

;





FIG. 5

is a view similar to

FIG. 4

, but showing an under portion of the chemical container;





FIG. 6

is a fragmentary perspective view of the medical apparatus of

FIG. 1

, but with a pressure source schematically shown coupled thereto;





FIG. 7

is a cross sectional view of a second embodiment of the medical apparatus of the present invention; and





FIG. 8

is an enlarged view of a portion of

FIG. 3

which is encircled and indicated as

FIG. 8

;





FIG. 9

is an exploded perspective view of another medical apparatus inserted through a body cavity wall which incorporates the features of the present invention therein;





FIG. 10

is an enlarged fragmentary cross sectional view of the medical apparatus of

FIG. 9

, showing the chemical containers inserted into the housing;





FIG. 11

is a view similar to the one shown in

FIG. 9

, but having the grooves of the medical device defined on an interior surface of the medical apparatus; and





FIG. 12

is a view similar to the one shown in

FIG. 10

, but having the grooves of the medical device defined on an interior surface of the medical apparatus.











DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT




While the invention is susceptible to various modifications and alternative forms, a specific embodiment thereof has been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the invention to the particular form disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.




First Embodiment of the Invention




Referring to

FIGS. 1

,


2


, and


3


, there is shown a medical apparatus


10


of the present invention advanced through an opening


52


(i.e. the port site wound) in a wall


54


of a body cavity


56


. The medical apparatus


10


includes a trocar assembly


14


and a pair of chemical containers


26


. Trocar assembly


14


includes a cannula


16


and a trocar


18


. Cannula


16


includes (1) a wall having an outer surface


30


, (2) a working channel


20


defined by wall


32


, (3) a housing


34


, and (4) a pair of fluid delivery channels


22


which are distinct from working channel


20


.




Housing


34


includes an exterior wall segment


110


and an interior wall segment


112


(see FIGS.


2


and


3


). Housing


34


also includes an annular shaped interior cavity


36


defined between exterior wall segment


110


and an interior wall segment


112


. As shown more clearly in

FIG. 1

, exterior wall segment


110


has a pair of passageways


88


defined therein which lead to interior cavity


36


. As shown in

FIG. 3

, exterior wall segment


110


also has a track


90


defined therein such that one track


90


is positioned within each passageway


88


. In addition, each passageway has a door


94


positioned therein such that door


94


is located within track


90


. Having the above described arrangement allows each door


94


to slide within track


90


relative to exterior wall segment


110


in the directions indicated by arrow


96


. Sliding doors


94


in the aforementioned manner allows each door


94


to be located in an open or a closed position. For example,

FIG. 3

shows door


94


in an open position so as to provide access to interior cavity


36


of housing


34


.




Referring now to

FIGS. 2 and 6

, housing


34


also has an insufflation valve


108


and a pressure control valve


50


attached thereto. Insufflation valve


108


and pressure control valve


50


extend through exterior wall segment


110


and are attached to interior wall segment


112


. Insufflation valve


108


is in fluid communication with working channel


20


. As shown in

FIG. 2

, insufflation valve


108


is also in fluid communication with pressure control valve


50


via a bleed line


106


defined in interior wall segment


112


. Pressure control valve


50


is positioned within a pressure line


46


defined in interior wall segment


112


. Pressure line


46


has a pair of entrance ports


114


(also see

FIGS. 3 and 8

) which lead to interior cavity


36


of housing


34


. Each entrance port


114


defines an entrance port end wall


40


(also see FIGS.


3


and


8


).




As shown in

FIG. 8

, housing


34


includes a fluid delivery needle


38


having a base


100


attached thereto which is positioned in contact with each entrance port end wall


40


of pressure line


46


such that each fluid delivery needle


38


extends into interior cavity


36


of housing


34


(see FIG.


3


). Base


100


is secured to each entrance port end wall


40


with an appropriate adhesive (not shown). Each fluid delivery needle


38


has a needle aperture


102


defined therein. Needle aperture


102


leads to a lumen


104


which in turn leads to pressure line


46


in fluid communication with interior cavity


36


through fluid delivery needle


38


.




Referring back to

FIGS. 1-3

, it should be understood that each fluid delivery channel


22


is preferably defined in wall


32


of cannula


16


. Each fluid delivery channel


22


extends substantially along the entire length of cannula


16


. In addition, each fluid delivery channel


22


has a number of exit ports


24


in fluid communication therewith which lead to outer surface


30


of cannula


16


. As shown in

FIG. 3

, each fluid delivery channel


22


has a branched end


98


which extends into housing


34


. Branched end


98


of each fluid delivery channel


22


defines three additional entrance ports


114


in interior wall segment


112


which lead to interior cavity


36


of housing


34


(i.e. there are a total of six entrance ports


114


defined by the pair of fluid delivery channels


22


and two entrance ports defined by pressure line


46


). Each entrance port


114


defines an entrance port end wall


40


. It should be understood that having entrance ports


114


positioned in the above described manner places fluid delivery channels


22


in fluid communication with interior cavity


36


of housing


34


. In a manner substantially identical as that described above in reference to

FIG. 8

, a fluid delivery needle


38


is attached to each entrance port end wall


40


via a base


100


so as to place each fluid delivery channel


22


in fluid communication with interior cavity


36


through fluid delivery needle


38


(see FIG.


3


).




As shown in

FIG. 6

, a pressure source


48


is connected to insufflation valve


108


via hose


116


. It should be understood that when insufflation valve


108


is located in an open position (see FIG.


6


), a pressurized fluid such as CO


2


can be advanced from pressure source


48


through hose


116


and insufflation valve


108


, and into working channel


20


of cannula


16


. Once in working channel


20


, the fluid is advanced into body cavity


56


to cause insufflation thereof. It should be understood that insufflation valve


108


can also be located in a closed position (not shown) so as to prevent fluid from being advanced from pressure source


48


to body cavity


56


. In addition, it should be appreciated that insufflation valve


108


can be located in a desufflate position (not shown) so as to allow pressurized fluid contained within an insufflated body cavity


56


to escape. Specifically, placing insufflation valve


108


in the desufflate position allows the pressurized fluid contained within an insufflated body cavity


56


to be advanced from body cavity


56


to the surrounding environment through working channel


20


, insufflation valve


108


, and an escape port


118


attached to insufflation valve


108


.




It should also be understood that insufflation valve


108


and pressure control valve


50


can be positioned such that pressure line


46


(see

FIG. 2

) is in fluid communication with pressure source


48


via a fluid path defined by hose


116


, insufflation valve


108


, bleed line


106


(see FIG.


2


), and pressure control valve


50


. Therefore, it should be appreciated that pressurized fluid can be advanced from pressure source


48


to the pair of fluid delivery needles


38


in fluid communication with pressure line


46


(see FIG.


2


).




Referring now to

FIGS. 1

,


2


,


4


, and


5


, each chemical container


26


has an interior void


28


defined therein (see

FIGS. 2 and 4

) for receiving a biologically active compound


12


. Each chemical container


26


also includes three exit apertures


42


defined therein (see

FIG. 4

) which are in fluid communication with interior void


28


. Each exit aperture


42


has a diaphragm


44


positioned therein so as to prevent biologically active compound


12


from leaking out of interior void


28


. Each diaphragm


44


can be made of, for example, silicone rubber. Each chemical container


26


also includes a pressure aperture


120


(see

FIG. 4

) in fluid communication with interior void


28


. Each pressure aperture


120


has a diaphragm


44


positioned therein so as to form a fluid tight seal between interior void


28


and the exterior of chemical container


26


. As shown in

FIG. 5

, each chemical container


26


further includes a loading aperture


122


with a diaphragm


44


positioned therein so as to prevent biologically active compound


12


from leaking out of interior void


28


. Chemical containers


26


also include (1) a pressure relief valve


124


in fluid communication with interior void


28


and (2) three ribs


126


defined thereon.




Biologically active compound


12


includes chemical substances such as antibiotics, cytotoxic agents or compounds which effectively inhibit tumor cell adherence to a membrane. A large number of antimicrobial agents (i.e. antibiotics) or antiseptics are contemplated for use as biologically active compound


12


in the present invention. Preferably, where possible, the antibiotic should be active against both Gram-positive and Gram negative pathogens. The following are illustrative of the antibiotics and/or antiseptics which can be disposed in interior void


28


to aid in the control, inhibition, or prevention of infections of opening


52


: (i) metal salts, or like compounds with antibacterial metal ions, e.g. copper or silver, and optionally with additional nonmetallic ions of antibacterial properties; (ii) topical antibiotics, e.g. neomycin, soframycin, bacitracin, polymcin; (iii) antibacterials such as chlorhexidine and its salts; (iv) quaternary ammonium compounds, e.g. centrimide, domiphen bromide, and polymeric quaternaries; (v) iodophors such as povidone iodine, and polyvinylpyrrolidone-iodine (PVP-I); (vi) acridine compounds such as 9-aminoacridine, 3,6-diaminoacridine and 6,9-diamino-2-ethoxyacridine; and (vii) biguanidine compounds such as 1,6-di(4-chlorophenylbiguanido)hexane, diaminohexylbiguanide, 1,6-di(aminohexylbiguanido)hexane, and polyhexamethylenebiguanide. Additional suitable antibiotics include aminoglycoside antibiotics such as amikacin, butirosin, dideoxykanamycin B (DKP), fortimycin, gentamycin, kanamycin, lividomycin, neomycin, netilmicin, ribostamycin, sagamycins, seldomycins and their epimers, sisomicin, sorbistin, tobramycin, streptomycins, linkomycins such as clindamycin, lincomycin and rifamycins such as rifampicin and rifamycin. Antibiotics such as polymyxin B sulfate-neomycin sulfate, cleocin phosphate (available from the Upjohn Company, Kalamazoo, Mich.) and erythromycin ethylsuccinate are also contemplated.




Examples of suitable antiseptics include bromchlorophen, hexetidine, buclosamide, salicylic acid, cerium nitrate, chlorhexidine, 5-chloro-8-hydroxyquinoline, copper 8-hydroxyquinolate, acridine orange, undecenoic acid, undecoylium chloride and silver salts such as silver sulfadiazine, mafenide, nitrofurazole, cloflucarban, tribromasalan, taurolin and noxythiolin.




With respect to aiding in the control, inhibition or prevention of tumor cell adhesion and implantation and the subsequent metastasis via opening


52


, compounds which effectively block or inhibit tumor cell adhesion (please note that tumor cell adhesion is a step in the metastasis cascade), or destroy tumor cells before adhering to a side wall


58


of opening


52


, or other sites, can be disposed in interior void


28


. Types of compounds which effectively block or inhibit tumor cell adherence include anticoagulants, fibrinolytic agents and compounds which alter the electrical charge of a membrane surface. For example, the surface charge altering and anticoagulant heparin can be disposed in interior void


28


. Additionally, any of several water-soluble high molecular weight glucose polymers (average molecular weight (MW) 75 kdal) otherwise known as dextrans, can also be disposed in interior void


28


to alter the surface electrical charge of any contacted membranes thereby blocking tumor cell adhesion. Preferably a dextran having an average MW of about 40 kdal is used to coat outer surface


30


.




As stated above, tumor cell destroying compounds, hereinafter referred to as cytotoxic compounds, can also be disposed in interior void


28


. These compounds include cisplatin, carboplatin, 5-fluorouracil, providoneiodine, tumor necrosis factor (TNF)-α, tauromustine, mitomycin C, camptothecin, bleomycin, indomethacin, N-methyl formamide, tamoxifen, sodiumhypochlorite, chlorhexidinecetrimide, adriamycin, methotrexate. Tumor cell destroying compounds also include antimetabolites such as cytarabine, azaribine, mercaptopurine, thioguanine; natural products such as vinblastine, vincristine, dactinomycin, daunorubicin, doxorubicin, bleomycin, mithramycin, mitomycin; and other miscellaneous agents such as cisplatin, hydroxyurea, procarbazine and mitotane, Alkylating agents such as mechlorethamine, nitrogen mustards, ethlenimine derivatives, alkyl sulfonates, nitrosoureas, and triazenes are also contemplated. Moreover, the compounds disclosed by Krakoff, Irwin H. in


Systemic Treatment of Cancer


, CA Cancer J. Clin., vol. 46, No. 3, pages 134-141 (May/June 1996), which is incorporated herein by reference, are contemplated for being disposed in interior void


28


.




In addition antiangiogenesis agents such as angiostatin and endostatin are included in the group of cytotoxic compounds to be disposed in interior void


28


. Moreover, antibodies, including human monoclonal antibodies are included as cytotoxic compounds. Preferably, the human monoclonal antibody HuMab SK1 as described by Chang, Helena R. et al. in


Human Monoclonal Antibody SK


1-


Mediated Cytotoxicity Against Colon Cancer Cells


, Dis. Colon Rectum, vol. 36, No. 12, pages 1152-1157 (December 1993) which is incorporated herein by reference, is disposed in interior void


28


. Other monoclonal antibodies can also be disposed in interior void


28


, for example those produced from hybridomas having the accession numbers HB8573, HB8232 and HB8250 available from the American Type Culture Collection, located at 12301 Parklawn Drive, Rockville Md., 20852. Furthermore, interieukin 2 (IL-2), cytokines or lymphokines are also included in the group of cytotoxic compounds of the present invention. Also contemplated are hyaluronate coating solutions. In addition, gene based cancer drugs are contemplated. Examples of such include gene based cancer drugs directed toward the RAS gene. Another example of a gene based cancer drug is a drug directed toward the EGF receptor (i.e. EGFR). It should also be understood that a combination of any of the above compounds can be disposed in interior void


28


.




During use of medical apparatus


10


, trocar


18


is initially located in a first trocar position as shown in phantom in

FIG. 1

(i.e. trocar


18


is positioned within working channel


20


of cannula


16


). In addition, chemical containers


26


are located outside of interior cavity


36


of housing


34


and doors


94


(see

FIG. 3

) are located in the closed position (not shown). Trocar


18


of medical apparatus


10


is then placed in contact with, and advanced through, wall


54


of body cavity


56


to create opening


52


as shown in FIG.


1


. Preferably, medical apparatus


10


is advanced through a wall


54


of a non-vascular body cavity


56


. What is meant herein by non-vascular body cavity


56


is a body cavity which is not defined by one or more blood vessels. Examples of non-vascular body cavities


56


in which medical apparatus


10


is preferably used include the peritoneal cavity and the thoracic cavity. Once medical apparatus


10


is positioned as described above, trocar


18


is moved to a second trocar position (i.e. trocar


18


is completely removed from working channel


20


of cannula


16


). Insufflation valve


108


is then located in the open position (see

FIG. 6

) so that pressurized CO


2


is advanced from pressure source


48


through hose


116


and insufflation valve


108


, and into working channel


20


of cannula


16


. Once in working channel


20


, the pressurized CO


2


is advanced into body cavity


56


to cause insufflation thereof. Once body cavity


56


is insufflated a medical instrument, such as a laparoscope (not shown), is inserted down through working channel


20


and into body cavity


56


such that a surgeon can visually inspect the interior of body cavity


56


for possible signs of cancer (e.g. the presence of a tumor in body cavity


56


) or an infection. Therefore, it should be appreciated that the cross-sectional area of working channel


20


should be sized for the passage of a laparoscope therethrough. For example, typical laparoscopes have diameters of about 5 mm to about 10 mm. Thus, working channel


20


should have a diameter or cross-sectional area sized to accommodate the insertion of a laparoscope therethrough. After inspecting the interior of body cavity


56


with a laparoscope and no signs of cancer or infection are detected, and the surgeon is satisfied that no cancer or infection is present within body cavity


56


, the surgical procedure can proceed in a manner that is well known in the art.




However, if cancer or infection is detected within body cavity


56


, or if the surgeon suspects cancer or an infection is present, each chemical container


26


is loaded, under the surgeon's direction, with a predetermined amount of an appropriate biologically active compound


12


. Specifically, a syringe (not shown) is filled with a predetermined amount of the appropriate biologically active compound


12


and the hypodermic needle of the syringe is inserted through diaphragm


44


of loading aperture


122


(see FIG.


5


). The predetermined amount of biologically active compound


12


is then advanced from the syringe through the hypodermic needle and into interior void


28


(see

FIG. 4

) of chemical container


26


in a well known manner. Once an appropriate amount of biologically active compound


12


has been disposed within interior void


28


the hypodermic needle of the syringe is withdrawn from diaphragm


44


of loading aperture


122


. It should be understood that diaphragm


44


will self seal once the hypodermic needle is removed therefrom to prevent any biologically active compound


12


from leaking out through loading aperture


122


. It should also be understood that having a posterior wall


128


(see

FIG. 5

) of chemical container


26


made from a transparent or translucent substance (e.g. plastic) is contemplated so that the surgeon can visually confirm that the chemical container


26


is loaded with biologically active compound


12


.




Once both chemical containers


26


are loaded in the above described manner, each door


94


(see

FIG. 3

) is located in the open position and each chemical container


26


is positioned within housing


34


of cannula


16


. Specifically, as shown in

FIG. 1

, each chemical container


26


is positioned relative to housing


34


such that exit apertures


42


and pressure aperture


120


face passageways


88


. Each chemical container


26


is further positioned relative to housing


34


such that ribs


126


(see

FIG. 5

) formed on chemical container


26


are aligned with corresponding grooves


130


(see

FIG. 3

) defined in exterior wall segment


110


. Both chemical containers


26


are then advanced toward passageways


88


such that ribs


126


are positioned within grooves


130


and both chemical containers


26


are partially located within interior cavity


36


of housing


34


.




It should be understood that positioning ribs


126


within grooves


130


in the above described manner aligns each fluid delivery needle


38


in fluid communication with fluid delivery channel


22


(see

FIG. 3

) with a corresponding diaphragm


44


positioned within an exit aperture


42


(see FIG.


4


). In addition, positioning ribs


126


within grooves


130


aligns each fluid delivery needle


38


in fluid communication with pressure line


46


(see

FIG. 3

) with a corresponding diaphragm


44


positioned within a pressure aperture


120


(see FIG.


4


). Once aligned in the above described manner, both chemical containers


26


are advanced further into interior cavity


36


until each fluid delivery needle


38


in fluid communication with a fluid delivery channel


22


pierces and is advanced through the corresponding diaphragm


44


positioned within an exit aperture


42


(see FIG.


2


). In a similar manner, both fluid delivery needles


38


in fluid communication with pressure line


46


pierce and are advanced through the corresponding diaphragm


44


positioned within pressure aperture


120


(see FIG.


2


). Advancing fluid delivery needles


38


through diaphragms


44


in the above described manner places each fluid delivery channel


22


in fluid communication with interior void


28


of the corresponding chemical container


26


. In addition, pressure line


46


is placed in fluid communication with interior void


28


of each chemical container


26


.




However, it should be appreciated that, in contrast to having chemical containers


26


removable from housing


34


as described above, chemical containers


26


can be integrally formed with housing


34


of cannula


16


. In this situation, chemical containers


26


function in a substantially identical manner as described above, with the exception that chemical containers


26


are never removed from housing


34


. In particular, chemical containers


26


are loaded with a predetermined amount of biologically active compound


12


while the chemical containers


26


are positioned within and secured to housing


34


. Moreover, it should be understood that chemical containers can be integrally formed with cannula


16


such that chemical containers are never removed from cannula


16


.




After placing fluid delivery channels


22


and pressure line


46


in fluid communication with interior void


28


of each chemical container


26


doors


94


are located in the closed position. Insufflation valve


108


and pressure control valve


50


are then positioned such that pressure line


46


(see

FIG. 2

) is in fluid communication with pressure source


48


. Pressurized fluid (i.e. CO


2


) is then advanced from pressure source


48


into interior void


28


of each chemical container


26


via the fluid delivery needles


38


extending through pressure apertures


120


. Advancing fluid into interior void


28


increases the pressure therein. However, it should be understood that pressure control valve


50


can be adjusted to control the pressure within interior void


28


of each chemical container


26


. It should also be understood that pressure relief valve


124


is designed to release an amount of the pressurized fluid if the pressure within interior void


28


becomes to great. Since interior void


28


of each chemical container


26


is in fluid communication with body cavity


56


via a fluid path defined by exit ports


24


, fluid delivery channels


22


, and fluid delivery needles


38


, having pressure relief valve


124


designed in the above described manner also ensures that the pressure within body cavity


56


does not become to great.




Once biologically active compound


12


is located in fluid delivery channel


22


, biologically active compound


12


is advanced along the length of cannula


16


in a direction indicated by arrow


132


as shown in FIG.


2


. While being advanced in the above described manner, biologically active compound


12


comes into fluid communication with exit ports


24


(see FIG.


2


). As biologically active compound


12


encounters each exit port


24


a portion of biologically compound


12


advances through each exit port


24


and is delivered to outer surface


30


of cannula


16


as shown in FIG.


1


. The above described process of delivering biologically active compound


12


to outer surface


30


can be continued until both chemical containers


26


are substantially emptied and essentially all of biologically active compound


12


has been delivered to outer surface


30


of cannula


16


. However, if required, the surgeon can reopen doors


94


and inject an additional predetermined amount of biologically compound


12


into each interior void


28


of chemical containers


26


as described above so as to continue the process of delivering biologically active compound


12


to outer surface


30


.




It should be appreciated that as biologically active compound


12


is delivered to outer surface


30


of cannula


16


an amount of biologically active compound


12


is transferred from outer surface


30


to side wall


58


of opening


52


as shown in FIG.


1


. In addition it should be appreciated that as biologically active compound


12


is delivered to outer surface


30


of cannula


16


an amount of biologically active compound


12


can be transferred from outer surface


30


to an inside surface


57


of body cavity


56


(see

FIG. 1

) by positioning cannula


16


at an angle relative to side wall


58


. It should further be appreciated that biologically active compound


12


can be continuously transferred to side wail


58


and inside surface


57


such that essentially the entire amount of biologically active compound


12


contained in chemical containers


26


is transferred to side wall


58


and inside surface


57


. Once located in contact with side wall


58


or inside surface


57


, biologically active compound


12


establishes a “pharmacological barrier” that helps prevent tumor cell implantation in opening


52


and/or the contamination of opening


52


with viable infectious microbes. Therefore, once opening


52


is protected in the above described manner the surgical procedure can proceed.




If necessary, in order to keep biologically active compound


12


from falling or sliding off outer surface


30


due to gravity, or being advanced out of exit ports


24


to quickly, biologically active compound


12


can contain a suitable pharmaceutically acceptable carrier. Such pharmaceutically acceptable carriers include known excipients and auxiliaries which facilitate the processing of biologically active compound


12


into a preparation which has the appropriate consistency to be advanced out of exit ports


24


in a controlled manner and thus disposed on outer surface


30


, side wall


58


, and interior surface


57


.




Suitable excipients which may be used to prepare a pharmaceutically acceptable carrier, such as a paste or a viscous solution, include fillers such as saccharides, for example lactose or sucrose, mannitol or sorbitol, cellulose preparations and/or calcium phosphates, for example tricalcium phosphate or calcium hydrogen phosphate, as well as binders such as starch paste, using, for example, maize starch, wheat starch, rice starch, potato starch, gelatin tragacanth, methyl cellulose, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, and/or polyvinyl pyrrolidone. If desired, disintegrating agents may be added such as the above-mentioned starches and also carboxymethyl-starch, cross-linked polyvinyl pyrrolidone, agar, or alginic acid or a salt thereof, such as sodium alginate. Additionally, silica, talc, stearic acid or salts thereof such as magnesium stearate or calcium stearate, and/or polyethylene glycol can be used.




In addition, a suspension of biologically active compound


12


may be disposed on outer surface


30


or side wall


58


. Suitable vehicles for such suspensions include sesame oil or synthetic fatty acid esters, for example, ethyl oleate or triglycerides. Such suspensions can include substances which increase the viscosity of the suspension including, for example, sodium carboxymethyl cellulose, sorbitol and/or a dextran.




The exact formulation of a pharmaceutically acceptable carrier will depend upon the particular nature of biologically active compound


12


to be disposed upon outer surface


30


and is easily determinable by one of ordinary skill in the art from only routine experimentation.




Being able to deliver essentially all of biologically active compound


12


contained within chemical containers


26


to side wall


58


or into body cavity


56


allows a surgeon to accurately determine the total amount of biologically active compound


12


administered to a patient during a surgical procedure. Knowing the total amount of biologically active compound


12


administered to the patient allows the surgeon to accurately control the dose administered to the patient and thus ensure that a proper dosage regimen for that particular patient is followed. The proper dosage regimen for a particular patient is dependent upon several factors including the age, sex, weight, condition of the recipient, kind of concurrent treatment, if any, frequency of treatment and the nature of the effect desired. In addition, the dosage regimen will also depend upon the immunologic status of the patient and the aggressiveness of the tumor. Moreover, the amount of biologically active compound


12


administered to the patient should be large enough to produce the desired effect but not so large as to cause adverse side effects, such as unwanted cross reactions, impaired wound healing, bleeding, impaired platelet function, anaphylactic reactions and the like. Counterindication, if any, immune tolerance and other variables will also affect the proper amount administered to the patient. The exact formulation of a pharmaceutically acceptable carrier and the amount of biologically active compound


12


contained therein (and therefore the amount administered to the patient) is easily determinable by one of ordinary skill in the art from only routine experimentation and by applying well know principles of therapeutics as set forth, for example, in Gilman, Alfred G. et al., eds.,


The Pharmacological Basis of Therapeutics,


6


th


Edition, Macmillan Publishing Co., Inc. New York, N.Y. (1980) which is herein incorporated by reference. Preferably, such preparations will contain about 0.001 to about 99 percent biologically active compound


12


together with the pharmaceutically acceptable carrier.




The above described ability of the present invention which allows a surgeon to accurately determine the total amount of biologically active compound


12


disposed on outer surface


30


(and thus administered to a patient) during a surgical procedure represents a significant advantage over other methods of disposing biologically active compound


12


onto a medical apparatus (e.g. dipping the medical apparatus in a solution or suspension of biologically active compound


12


or the unquantified irrigation of opening


52


with biologically active compound


12


). Specifically, many of the less accurate methods do not allow the surgeon to accurately control the amount of biologically active compound


12


administered to the patient. Therefore, these less accurate methods of disposing biologically active compound


12


onto the medical apparatus make it very difficult for the surgeon to ensure that a proper dosage regimen for a particular patient or cancer is being followed.




The present invention also allows a surgeon to avoid utilizing a biologically active compound


12


until it is deemed necessary. This is not possible with the aforementioned less accurate methods. For example, the dipping of a medical apparatus (i.e. a medical apparatus similar to medical apparatus


10


) in a solution or suspension of biologically active compound


12


must be performed prior to the beginning of the surgery at a time when the surgeon has not visually confirmed the presence of cancer or infection in body cavity


56


. The surgeon must dispose biologically active compound


12


on the medical device before the beginning of the surgery since withdrawing the medical apparatus after the surgery has started would cause a loss of the insufflation of body cavity


56


which can complicate the surgical procedure. Therefore, in many circumstances the surgeon will unnecessarily utilize biologically active compound


12


when no cancer or an infection is present which increases the cost of the surgical procedure. This is in contrast to the present invention which allows the surgeon to (1) begin the surgical procedure, (2) confirm whether biologically active compound


12


is required, and (3) only if needed, administer an accurate controllable amount of biological compound


12


to the patient without interrupting the surgical procedure and withdrawing medical apparatus


10


from body cavity


56


.




Second Embodiment of the Invention




Now referring to

FIG. 7

, there is shown a medical apparatus


60


similar to the medical apparatus


10


shown in FIG.


1


. Medical apparatus


60


is shown advanced through an opening


134


in a wall


136


of a body cavity


138


. Medical apparatus


60


includes a trocar assembly


78


, a sleeve


62


, and a pair of chemical containers


74


. Trocar assembly


78


includes a trocar


82


positioned within a lumen


140


of a cannula


80


. Trocar


82


is positionable between a first trocar position and a second trocar position as described above for trocar


18


(i.e. trocar


82


is positioned with lumen


140


of cannula


80


in the first trocar position and completely removed from lumen


140


in the second trocar position).




Sleeve


62


is substantially identical in construction to cannula


16


discussed above in reference to

FIGS. 1

,


2


,


3


, and


6


with the exception that sleeve


62


includes a sealing member


86


extending therefrom. For example, sleeve


62


also includes (1) a wall


84


having an outer surface


76


, (2) a working channel


64


defined by wall


84


, (3) a housing


70


, and (4) a pair of fluid delivery channels


66


which are distinct from working channel


64


and are in fluid communication with a number of exit ports


68


. As shown in

FIG. 7

, fluid delivery channels


66


are preferably defined in wall


84


of sleeve


62


and extend all the way to an end


142


of sealing member


86


. It should be understood that sealing member


86


operates in a substantially identical manner, and has a substantially identical construction and function, as sealing members described in a United States Patent Application filed on Oct. 21, 1997 having application Ser. No. 08/955,256 (inventor Stephen P. Moenning) which is incorporated herein by reference, with the exception that sealing member


86


has fluid delivery channels


66


and exit ports


68


defined therein.




It should be understood that housing


70


is substantially identical in construction to housing


34


discussed above. Furthermore, fluid delivery channels


66


are in fluid communication with the interior cavity (not shown) of housing


70


in a substantially identical manner as described above in reference to fluid delivery channels


22


.




Moreover, each chemical container


74


is constructed in a substantially identical manner as that described above for chemical containers


26


. For example, each chemical container


74


has an interior void (not shown; see

FIG. 3

) defined therein for receiving biologically active compound


12


.




Medical apparatus


60


is used in a similar fashion as that described above for medical apparatus


10


with some modifications to account for the presence of sleeve


62


. Specifically, trocar


82


is initially located in the first trocar position, and trocar assembly


78


is positioned within working channel


64


of sleeve


62


as shown in phantom in FIG.


7


. Sealing member


86


is then positioned in a substantially parallel relationship with working channel


64


of sleeve


62


. Trocar


82


of medical apparatus


60


is then placed in contact with, and advanced through, wall


136


of body cavity


138


to create opening


134


. Once medical apparatus


60


is positioned as described above, trocar


82


is moved to the second trocar position. Sealing member


86


is then positioned in a substantially orthogonal relationship with working channel


64


of sleeve


62


as shown in FIG.


7


. Sleeve


62


is then positioned relative to opening


134


such that sealing member


86


makes contact with an interior surface


144


of body cavity


138


.




Body cavity


138


is then insufflated in a similar manner as that described above in reference to

FIG. 6

(i.e. body cavity


134


is insufflated via the insufflation valve (not shown) attached to housing


70


and pressure source


48


. Once body cavity


138


is insufflated, and as previously discussed a determination is made that biologically active compound


12


is required based upon the presence of a cancer or an infection within body cavity


138


, chemical containers


74


are loaded with biologically active compound


12


as previously described. Once loaded, chemical containers


74


are positioned within the interior cavity (not shown) of housing


70


in a substantially identical manner as that previously described above in reference to

FIGS. 1-5

. That is, chemical containers


74


are positioned within the interior cavity of housing


74


such that the interior void of each chemical container


74


is in fluid communication with (1) a fluid delivery channel


66


and (2) a pressure line defined in housing


70


which is substantially identical to pressure line


46


defined in housing


34


(see FIG.


2


).




Once chemical containers


74


are positioned in the above described manner, the insufflation valve (not shown) and a pressure control valve (not shown) attached to housing


70


(i.e. a pressure control valve substantially identical to pressure control valve


50


) are manipulated such that the interior void of each chemical container


74


is in fluid communication with pressure source


48


. Bringing the interior void of each chemical container


74


into fluid communication with pressure source


48


advances biologically active compound


12


contained therein into each fluid delivery channel


66


.




Once biologically active compound


12


is located in fluid delivery channel


66


, biologically active compound


12


is advanced along the length of sleeve


62


and sealing member


86


in a direction indicated by arrows


146


and


147


as shown in FIG.


7


. While being advanced in the above described manner, biologically active compound


12


comes into fluid communication with exit ports


68


. As biologically active compound


12


encounters each exit port


68


a portion of biologically compound


12


advances through each exit port


68


and is delivered to outer surface


76


of sleeve


62


in a manner similar to that shown in FIG.


1


. In addition, an amount of biologically active compound


12


is delivered to a contact surface


150


of sealing member


86


. It should be appreciated that as biologically active compound


12


is delivered to outer surface


76


of sleeve


62


an amount of biologically active compound


12


is transferred from outer surface


76


to side wall


148


of opening


134


as shown in FIG.


7


. In addition, it should be appreciated that as biologically active compound


12


is delivered to contact surface


150


of sealing member


86


an amount of biologically active compound


12


is transferred from contact surface


150


into contact with interior surface


144


of body cavity


138


. It should further be appreciated that biologically active compound


12


can be continuously transferred to side wall


148


and interior surface


144


such that essentially the entire amount of biologically active compound


12


contained in chemical containers


74


is transferred to side wall


148


and interior surface


144


. Once located in contact with side wall


148


and interior surface


144


, biologically active compound


12


establishes a “pharmacological barrier” that helps prevent tumor cell implantation in opening


134


and/or the contamination of opening


134


with viable infectious microbes. Therefore, it should be understood that medical apparatus


60


has all of the advantages as described above in reference to medical apparatus


10


.




Third Embodiment of the Invention




Referring to

FIGS. 9 and 10

, there is shown a medical apparatus


200


of the present invention advanced through opening


52


(i.e. the port site wound) in wall


54


of body cavity


56


. Medical apparatus


200


is substantially identical to medical apparatus


10


, therefore the components of medical apparatus


200


have the same reference numbers as medical apparatus


10


. In addition, it should be understood that medical apparatus


200


functions in substantially the same way, and has the same advantages as, medical apparatus


10


. Therefore, only the differences between medical apparatus


10


and medical apparatus


200


will be discussed in detail herein.




With respect to the differences between medical apparatus


10


and medical apparatus


200


, rather than having delivery channels


22


defined in cannula


16


, medical apparatus


200


has grooves


202


defined in outer surface


30


of cannula


16


. Similar to delivery channels


22


, grooves


202


function to deliver a biologically active compound to outer surface


30


of cannula


16


. As shown in

FIG. 10

, each groove


202


is in fluid communication with interior void


28


of a chemical container


26


via a conduit


204


defined in housing


34


.




Medical apparatus


200


is used in a substantially identical fashion as that described above for medical apparatus


10


. Once medical apparatus


200


is positioned as shown in

FIG. 9

, body cavity


56


is insufflated in an identical manner as that described above in reference to FIG.


6


. Once body cavity


56


is insufflated, and as previously discussed a determination is made that biologically active compound


12


is required based upon the presence of a cancer or an infection within body cavity


56


, chemical containers


26


are loaded with biologically active compound


12


as previously described. Once loaded, chemical containers


26


are positioned within the interior cavity


36


of housing


34


in a substantially identical manner as that previously described above in reference to

FIGS. 1-5

. That is, chemical containers


26


are positioned within the interior cavity


36


of housing


34


such that the interior void of each chemical container


26


is in fluid communication with (1) a conduit


204


and (2) a groove


202


.




Once chemical containers


26


are positioned in the above described manner, the insufflation valve


108


and pressure control valve


50


are manipulated such that the interior void of each chemical container


26


is in fluid communication with pressure source


48


. Bringing the interior void of each chemical container


26


into fluid communication with pressure source


48


advances biologically active compound


12


contained therein into each groove


202


via conduits


204


.




Once biologically active compound


12


is located in grooves


202


, biologically active compound


12


is advanced along the length of cannula


16


in a direction indicated by arrow


206


as shown in FIG.


9


. It should be appreciated that as biologically active compound


12


is advanced through grooves


202


an amount of biologically active compound


12


is transferred from outer surface


30


to side wall


58


of opening


52


as shown in FIG.


9


. In addition, it should be appreciated that as biologically active compound


12


is advanced through grooves


202


, an amount of biologically active compound


12


is transferred from outer surface


30


to side wall


58


of opening


52


as shown in FIG.


9


. In addition, it should be appreciated that as biologically active compound


12


is advanced through grooves


202


and transferred to side wall


58


of opening


52


, biologically active compound


12


establishes a “pharmacological barrier” that prevents tumor cell implantation in opening


52


and/or the contamination of opening


52


with viable infectious microbes. Therefore, once opening


52


is protected in the above described manner the surgical procedure can proceed.




If necessary, the distal portion of each groove


202


can have a sponge material


214


disposed therein, as shown in FIG.


9


. For example, the distal two thirds of each groove


202


can have sponge material


214


disposed therein. Having sponge material


214


disposed within each groove


202


ensures that no insufflation gas is allowed to escape from within body cavity


56


through grooves


202


. In particular, as biologically active compound


12


advances down each groove


202


in the direction indicated by arrow


206


biologically active compound


12


comes into contact with sponge material


214


disposed within groove


202


. Contacting sponge material


214


with biologically active compound


12


results in sponge material


214


swelling so as to fill groove


202


and thus prevent any insufflation from escaping from body cavity


56


via groove


202


. However, it should be understood that sponge material


214


still allows biologically active compound


12


to pass therethrough and be disposed upon side wall


58


of opening


52


. It should be understood that sponge material


214


can be any porous, liquid absorbent material, which allows the passage of biologically active compound


12


therethrough while preventing the leakage of insufflation gas, and can be temporarily inserted into a body cavity such as body cavity


56


. For, example sponge material


214


can be made from a surgical sponge.




As shown in

FIGS. 11 and 12

, in contrast to having groves


202


defined in outer surface


30


of cannula


16


, grooves


202


can also be defined in an interior surface


208


of cannula


16


. When grooves


202


are defined in interior surface


208


, medical apparatus


200


functions is a substantially identical manner as described above in reference to

FIGS. 9 and 10

with the exception that each groove


202


is in fluid communication with an exit port


210


defined in cannula


16


. Each exit port


210


leads from interior surface


208


to outer surface


30


. Therefore, as biologically active compound


12


is advanced through each groove


202


in the direction indicated by arrow


206


(see

FIG. 11

) biologically active compound


12


comes into contact with, and is advanced through, an exit port


210


such that biologically active compound


12


is transferred from interior surface


208


to outer surface


30


of cannula


16


in the direction indicated by arrow


212


(see FIG.


12


). (Note that while exit ports


210


are shown being defined in substantially the entire length cannula


16


, it is also contemplated that exit ports


210


are only defined in, for example, the distal two thirds of cannula


16


.) Once biologically active compound


12


is transferred to outer surface


30


of cannula


16


, biologically active compound


12


is transferred to side wall


58


of opening


52


where it establishes a “pharmacological barrier” that prevents tumor cell implantation in opening


52


and/or the contamination of opening


52


with viable infectious microbes.




While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description is to be considered as exemplary and not restrictive in character, it being understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected. For example, while chemical containers


26


and


74


are described above as being separate from housings


34


and


70


, respectively, other arrangements are contemplated. As discussed above, one such arrangement incorporates chemical containers


26


and


74


into housings


34


and


70


, respectively, such that each chemical container is “built in” or integral to the housing.



Claims
  • 1. A laparoscopic medical apparatus for dispensing a biologically active compound, comprising:a trocar assembly including a cannula and a an elongated trocar having a closed converging tip at a distal end thereof and a fluid delivery channel, wherein (1) said cannula has a working channel defined therein through which laparoscopic medical instruments may be advanced, (2) said fluid delivery channel is distinct from said working channel, and (3) said fluid delivery channel including a groove defined on an outer surface of said cannula and an inlet and an exit on said outer surface of said cannula surface of said cannula; said inlet being in fluid communication with said exit through said fluid delivery channel, whereby said biologically active compound may be delivered through said fluid delivery channel to said outer surface of said cannula.
  • 2. The medical apparatus of claim 1, wherein:said trocar is positionable between a first trocar position and a second trocar position, said trocar is positioned within said working channel of said cannula when said trocar is positioned at said first trocar position, and said trocar is completely removed from said working channel of said cannula when said trocar is positioned at said second trocar position.
  • 3. The medical apparatus of claim 1, wherein:said fluid delivery channel is defined in a wall of said cannula.
  • 4. The medical apparatus of claim 1, further comprising:a sponge material disposed in said groove.
  • 5. The medical apparatus of claim 1, further comprising:a housing secured to said cannula, and a chemical container coupled with said housing and including an interior void in communication with said inlet.
  • 6. A laparoscopic medical apparatus for dispensing a biologically active compound, comprising:a trocar assembly including a cannula and a an elongated trocar having a closed converging tip at a distal end thereof, wherein (1) said cannula has a working channel defined therein, said working channel having a cross-sectional area sized for passage of a laparoscope therethrough, (2) said cannula includes a fluid delivery channel which is distinct from said working channel, and (3) said fluid delivery channel includes a groove defined on an outer surface of said cannula and an exit on said outer surface of said cannula; and a housing having an interior void defined therein for receiving said biologically active compound, said interior void being in fluid communication with said exit through said fluid delivery channel, whereby said biologically active compound may be delivered through said fluid delivery channel to an outer surface of said cannula.
  • 7. The medical apparatus of claim 6 further comprising:a valve in fluid communication with said working channel, said valve being positionable between an open position and a closed position such that (i) when said valve is located in said open position a gas can be advanced into said working channel and (ii) when said valve is located in said closed position said gas is prevented from being advanced into said working channel.
  • 8. The medical apparatus of claim 6, wherein:said housing includes a chemical container integrally formed with said cannula and including said interior void.
  • 9. A laparoscopic medical apparatus for dispensing a biologically active compound, comprising:a trocar assembly including a cannula and a an elongated trocar having a closed converging tip at a distal end thereof, wherein (1) said cannula has a working channel defined therein through which laparoscopic medical instruments may be advanced (2) said cannula includes a fluid delivery channel which is distinct from said working channel, and (3) said fluid delivery channel included a groove defined on an outer surface of said cannula and an exit on said outer surface of said cannula; and a housing having an interior void defined therein for receiving said biologically active compound, said interior void being in fluid communication with said exit through said fluid delivery channel, whereby said biologically active compound may be delivered through said fluid delivery channel to an outer surface of said cannula.
  • 10. A laparoscopic medical apparatus for dispensing a biologically active compound, comprising:a trocar assembly including a cannula and a an elongated trocar having a closed converging tip at a distal end thereof, wherein (1) said cannula has a working channel defined therein through which laparoscopic medical instruments may be advanced, said working channel having a diameter of about 5 mm or greater (2) said cannula includes a fluid delivery channel which is distinct from said working channel, and (3) said fluid delivery channel includes a groove defined on an outer surface of said cannula and an exit on said outer surface of said cannula; and a chemical container having an interior void defined therein for receiving said biologically active compound, said interior void being in fluid communication with said exit through said fluid delivery channel, whereby said biologically active compound may be delivered through said fluid delivery channel to an outer surface of said cannula.
Parent Case Info

This application is a continuation of U.S. application Ser. No. 09/511,100 filed on Feb. 23, 2000, now U.S. Pat. No. 6,302,873.

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Continuations (1)
Number Date Country
Parent 09/511100 Feb 2000 US
Child 09/934399 US