US20040111052A1 - Minimally invasive medical apparatus for dispensing a biologically active compound and an associated medical procedure for dispensing a biologically active compound - Google Patents

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.[0001]
• 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[0002]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[0003]^{(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[0004]^{(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[0005]⁽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[0006]^{(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[0007]^{(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[0008]⁽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.[0009]
• 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[0010]^{(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.[0011]
Table of References Cited in the Background
• 1. Lord et al.,[0012]Dis. Col. Rect.39(2):148 (1996)
• 2. Berman,[0013]Important Advances in Oncology1996,Laparoscopic Resection for Colon Cancer: Cause for Pause,Vincent DeVita Ed., p. 231
• 3. Falk et al.,[0014]Dis. Col. Rect.36:28 (1993)
• 4. Liberman et al.,[0015]Surg. Endo.10:15 (1996)
• 5. Whelan et al.,[0016]Dis. Col. Rect.41(5):564 (1998)
• 6. Wexner et al.,[0017]Am. Surg.64(1):12-18 (1998)
• 7. Greene,[0018]Semin. Lap. Surg.2(3):153 (1995)
• 8. Kazemier,[0019]Surg. Endo.9:216 (1995)
• 9. Reilly et al.,[0020]Dis. Col. Rect.39(2):200 (1996)
• 10. Jacquet et al.,[0021]Dis. Col. Rect.38(10):140 (1995)
• 11. Reymond et al.,[0022]Surg. Endo.11:902 (1997)
• 12. Allardyce et al.,[0023]Dis. Col. Rect.40(8):939 (1997)
• 13. Caushaj et al.,[0024]Dis. Col. Rect.37(4):21 (Podium Abstract 1994)
• 14. Lee et al., ([0025]oral presentation,6^thWorld Congress of Endoscopic Surgery,June 1998)Surgical Endoscopy12 (5):14 (1998)
• 15. Russell et al.,[0026]Dis. Col. Rect.40 (11):1294 (1997)
• 16. Neuhaus S J, ([0027]oral presentation,6^thWorld Congress of Endoscopic Surgery,June 1998)Surgical Endoscopy12 (5): 515 (1998)
• 17. Schneider C, ([0028]oral presentation,6^thWorld Congress of Endoscopic Surgery,June 1998)Surgical Endoscopy12 (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.[0029]
• 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.[0030]
• 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.[0031]
• 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.[0032]
• 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.[0033]
• 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.[0034]
• It is therefore an object of the present invention to provide a new and useful medical apparatus for protecting a port site wound.[0035]
• It is another object of the present invention to provide an improved medical apparatus for protecting a port site wound.[0036]
• It is still another object of the present invention to provide a new and useful medical apparatus for dispensing a biologically active compound.[0037]
• It is another object of the present invention to provide an improved medical apparatus for dispensing a biologically active compound.[0038]
• It is moreover an object of the present invention to provide a new and useful medical procedure for protecting a port site wound.[0039]
• It is still another object of the present invention to provide an improved medical procedure for protecting a port site wound.[0040]
• It is moreover an object of the present invention to provide a new and useful medical procedure for dispensing a biologically active compound.[0041]
• It is still another object of the present invention to provide an improved medical procedure for dispensing a biologically active compound.[0042]
• The above and other objects, features, and advantages of the present invention will become apparent from the following description and attached drawings.[0043]
BRIEF DESCRIPTION OF TH 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;[0044]
• FIG. 2 is an enlarged fragmentary cross sectional view of the medical apparatus of FIG. 1, showing the chemical containers inserted into the housing;[0045]
• FIG. 3 is an enlarged fragmentary perspective view of the medical apparatus of FIG. 1, showing the interior cavity of the housing;[0046]
• FIG. 4 is an enlarged perspective view of one of the chemical containers shown in FIG. 1;[0047]
• FIG. 5 is a view similar to FIG. 4, but showing an under portion of the chemical container;[0048]
• FIG. 6 is a fragmentary perspective view of the medical apparatus of FIG. 1, but with a pressure source schematically shown coupled thereto;[0049]
• FIG. 7 is a cross sectional view of a second embodiment of the medical apparatus of the present invention; and[0050]
• FIG. 8 is an enlarged view of a portion of FIG. 3 which is encircled and indicated as FIG. 8;[0051]
• 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;[0052]
• FIG. 10 is an enlarged fragmentary cross sectional view of the medical apparatus of FIG. 9, showing the chemical containers inserted into the housing;[0053]
• 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[0054]
• 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.[0055]
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.[0056]
First Embodiment of the Invention
• Referring to FIGS. 1, 2, and[0057]3, there is shown amedical apparatus10 of the present invention advanced through an opening52 (i.e. the port site wound) in awall54 of abody cavity56. Themedical apparatus10 includes atrocar assembly14 and a pair ofchemical containers26.Trocar assembly14 includes acannula16 and atrocar18.Cannula16 includes (1) a wall having anouter surface30, (2) a workingchannel20 defined bywall32, (3) ahousing34, and (4) a pair offluid delivery channels22 which are distinct from workingchannel20.
• [0058]Housing34 includes anexterior wall segment110 and an interior wall segment112 (see FIGS. 2 and 3).Housing34 also includes an annular shapedinterior cavity36 defined betweenexterior wall segment110 and aninterior wall segment112. As shown more clearly in FIG. 1,exterior wall segment110 has a pair ofpassageways88 defined therein which lead tointerior cavity36. As shown in FIG. 3,exterior wall segment110 also has atrack90 defined therein such that onetrack90 is positioned within eachpassageway88. In addition, each passageway has adoor94 positioned therein such thatdoor94 is located withintrack90. Having the above described arrangement allows eachdoor94 to slide withintrack90 relative toexterior wall segment110 in the directions indicated byarrow96. Slidingdoors94 in the aforementioned manner allows eachdoor94 to be located in an open or a closed position. For example, FIG. 3 showsdoor94 in an open-position so as to provide access tointerior cavity36 ofhousing34.
• Referring now to FIGS. 2 and 6,[0059]housing34 also has aninsufflation valve108 and apressure control valve50 attached thereto.Insufflation valve108 andpressure control valve50 extend throughexterior wall segment110 and are attached tointerior wall segment112.Insufflation valve108 is in fluid communication with workingchannel20. As shown in FIG. 2,insufflation valve108 is also in fluid communication withpressure control valve50 via ableed line106 defined ininterior wall segment112.Pressure control valve50 is positioned within apressure line46 defined ininterior wall segment112.Pressure line46 has a pair of entrance ports114 (also see FIGS. 3 and 8) which lead tointerior cavity36 ofhousing34. Eachentrance port114 defines an entrance port end wall40 (also see FIGS. 3 and 8).
• As shown in FIG. 8,[0060]housing34 includes afluid delivery needle38 having a base100 attached thereto which is positioned in contact with each entranceport end wall40 ofpressure line46 such that eachfluid delivery needle38 extends intointerior cavity36 of housing34 (see FIG. 3).Base100 is secured to each entranceport end wall40 with an appropriate adhesive (not shown). Eachfluid delivery needle38 has aneedle aperture102 defined therein.Needle aperture102 leads to a lumen104 which in turn leads topressure line46 in fluid communication withinterior cavity36 throughfluid delivery needle38.
• Referring back to FIGS.[0061]1-3, it should be understood that eachfluid delivery channel22 is preferably defined inwall32 ofcannula16. Eachfluid delivery channel22 extends substantially along the entire length ofcannula16. In addition, eachfluid delivery channel22 has a number ofexit ports24 in fluid communication therewith which lead toouter surface30 ofcannula16. As shown in FIG. 3, eachfluid delivery channel22 has abranched end98 which extends intohousing34.Branched end98 of eachfluid delivery channel22 defines threeadditional entrance ports114 ininterior wall segment112 which lead tointerior cavity36 of housing34 (i.e. there are a total of sixentrance ports114 defined by the pair offluid delivery channels22 and two entrance ports defined by pressure line46). Eachentrance port114 defines an entranceport end wall40. It should be understood that havingentrance ports114 positioned in the above described manner placesfluid delivery channels22 in fluid communication withinterior cavity36 ofhousing34. In a manner substantially identical as that described above in reference to FIG. 8, afluid delivery needle38 is attached to each entranceport end wall40 via abase100 so as to place eachfluid delivery channel22 in fluid communication withinterior cavity36 through fluid delivery needle38 (see FIG. 3).
• As shown in FIG. 6, a[0062]pressure source48 is connected toinsufflation valve108 viahose116. It should be understood that wheninsufflation valve108 is located in an open position (see FIG. 6), a pressurized fluid such as CO₂can be advanced frompressure source48 throughhose116 andinsufflation valve108, and into workingchannel20 ofcannula16. Once in workingchannel20, the fluid is advanced intobody cavity56 to cause insufflation thereof. It should be understood thatinsufflation valve108 can also be located in a closed position (not shown) so as to prevent fluid from being advanced frompressure source48 tobody cavity56. In addition, it should be appreciated thatinsufflation valve108 can be located in a desufflate position (not shown) so as to allow pressurized fluid contained within aninsufflated body cavity56 to escape. Specifically, placinginsufflation valve108 in the desufflate position allows the pressurized fluid contained within aninsufflated body cavity56 to be advanced frombody cavity56 to the surrounding environment through workingchannel20,insufflation valve108, and anescape port118 attached toinsufflation valve108.
• It should also be understood that[0063]insufflation valve108 andpressure control valve50 can be positioned such that pressure line46 (see FIG. 2) is in fluid communication withpressure source48 via a fluid path defined byhose116,insufflation valve108, bleed line106 (see FIG. 2), andpressure control valve50. Therefore, it should be appreciated that pressurized fluid can be advanced frompressure source48 to the pair of fluid delivery needles38 in fluid communication with pressure line46 (see FIG. 2).
• Referring now to FIGS. 1, 2,[0064]4, and5, eachchemical container26 has aninterior void28 defined therein (see FIGS. 2 and 4) for receiving a biologicallyactive compound12. Eachchemical container26 also includes threeexit apertures42 defined therein (see FIG. 4) which are in fluid communication withinterior void28. Eachexit aperture42 has adiaphragm44 positioned therein so as to prevent biologicallyactive compound12 from leaking out ofinterior void28. Eachdiaphragm44 can be made of, for example, silicone rubber. Eachchemical container26 also includes a pressure aperture120 (see FIG. 4) in fluid communication withinterior void28. Eachpressure aperture120 has adiaphragm44 positioned therein so as to form a fluid tight seal betweeninterior void28 and the exterior ofchemical container26. As shown in FIG. 5, eachchemical container26 further includes aloading aperture122 with adiaphragm44 positioned therein so as to prevent biologicallyactive compound12 from leaking out ofinterior void28.Chemical containers26 also include (1) apressure relief valve124 in fluid communication withinterior void28 and (2) threeribs126 defined thereon.
• Biologically[0065]active compound12 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 biologicallyactive compound12 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 ininterior void28 to aid in the control, inhibition, or prevention of infections of opening52: (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.[0066]
• With respect to aiding in the control, inhibition or prevention of tumor cell adhesion and implantation and the subsequent metastasis via opening[0067]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 aside wall58 ofopening52, or other sites, can be disposed ininterior void28. 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 ininterior void28. 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 ininterior void28 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 coatouter surface30.
• As stated above, tumor cell destroying compounds, hereinafter referred to as cytotoxic compounds, can also be disposed in[0068]interior void28. 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. inSystemic 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 ininterior void28.
• In addition antiangiogenesis agents such as angiostatin and endostatin are included in the group of cytotoxic compounds to be disposed in[0069]interior void28. 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. inHuman Monoclonal Antibody SK1-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 ininterior void28. Other monoclonal antibodies can also be disposed ininterior void28, 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, interleukin 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 ininterior void28.
• During use of[0070]medical apparatus10,trocar18 is initially located in a first trocar position as shown in phantom in FIG. 1 (i.e. trocar18 is positioned within workingchannel20 of cannula16). In addition,chemical containers26 are located outside ofinterior cavity36 ofhousing34 and doors94 (see FIG. 3) are located in the closed position (not shown).Trocar18 ofmedical apparatus10 is then placed in contact with, and advanced through,wall54 ofbody cavity56 to createopening52 as shown in FIG. 1. Preferably,medical apparatus10 is advanced through awall54 of anon-vascular body cavity56. What is meant herein bynon-vascular body cavity56 is a body cavity which is not defined by one or more blood vessels. Examples ofnon-vascular body cavities56 in whichmedical apparatus10 is preferably used include the peritoneal cavity and the thoracic cavity. Oncemedical apparatus10 is positioned as described above,trocar18 is moved to a second trocar position (i.e. trocar18 is completely removed from workingchannel20 of cannula16).Insufflation valve108 is then located in the open position (see FIG. 6) so that pressurized CO₂is advanced frompressure source48 throughhose116 andinsufflation valve108, and into workingchannel20 ofcannula16. Once in workingchannel20, the pressurized CO₂is advanced intobody cavity56 to cause insufflation thereof. Oncebody cavity56 is insufflated a medical instrument, such as a laparoscope (not shown), is inserted down through workingchannel20 and intobody cavity56 such that a surgeon can visually inspect the interior ofbody cavity56 for possible signs of cancer (e.g. the presence of a tumor in body cavity56) or an infection. Therefore, it should be appreciated that the cross-sectional area of workingchannel20 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, workingchannel20 should have a diameter or cross-sectional area sized to accommodate the insertion of a laparoscope therethrough. After inspecting the interior ofbody cavity56 with a laparoscope and no signs of cancer or infection are detected, and the surgeon is satisfied that no cancer or infection is present withinbody cavity56, the surgical procedure can proceed in a manner that is well known in the art.
• However, if cancer or infection is detected within[0071]body cavity56, or if the. surgeon suspects cancer or an infection is present, eachchemical container26 is loaded, under the surgeon's direction, with a predetermined amount of an appropriate biologicallyactive compound12. Specifically, a syringe (not shown) is filled with a predetermined amount of the appropriate biologicallyactive compound12 and the hypodermic needle of the syringe is inserted throughdiaphragm44 of loading aperture122 (see FIG. 5). The predetermined amount of biologicallyactive compound12 is then advanced from the syringe through the hypodermic needle and into interior void28 (see FIG. 4) ofchemical container26 in a well known manner. Once an appropriate amount of biologicallyactive compound12 has been disposed withininterior void28 the hypodermic needle of the syringe is withdrawn fromdiaphragm44 ofloading aperture122. It should be understood thatdiaphragm44 will self seal once the hypodermic needle is removed therefrom to prevent any biologicallyactive compound12 from leaking out throughloading aperture122. It should also be understood that having a posterior wall128 (see FIG. 5) ofchemical container26 made from a transparent or translucent substance (e.g. plastic) is contemplated so that the surgeon can visually confirm that thechemical container26 is loaded with biologicallyactive compound12.
• Once both[0072]chemical containers26 are loaded in the above described manner, each door94 (see FIG. 3) is located in the open position and eachchemical container26 is positioned withinhousing34 ofcannula16. Specifically, as shown in FIG. 1, eachchemical container26 is positioned relative tohousing34 such thatexit apertures42 andpressure aperture120face passageways88. Eachchemical container26 is further positioned relative tohousing34 such that ribs126 (see FIG. 5) formed onchemical container26 are aligned with corresponding grooves130 (see FIG. 3) defined inexterior wall segment110. Bothchemical containers26 are then advanced towardpassageways88 such thatribs126 are positioned withingrooves130 and bothchemical containers26 are partially located withininterior cavity36 ofhousing34.
• It should be understood that positioning[0073]ribs126 withingrooves130 in the above described manner aligns eachfluid delivery needle38 in fluid communication with fluid delivery channel22 (see FIG. 3) with a correspondingdiaphragm44 positioned within an exit aperture42 (see FIG. 4). In addition, positioningribs126 withingrooves130 aligns eachfluid delivery needle38 in fluid communication with pressure line46 (see FIG. 3) with a correspondingdiaphragm44 positioned within a pressure aperture120 (see FIG. 4). Once aligned in the above described manner, bothchemical containers26 are advanced further intointerior cavity36 until eachfluid delivery needle38 in fluid communication with afluid delivery channel22 pierces and is advanced through the correspondingdiaphragm44 positioned within an exit aperture42 (see FIG. 2). In a similar manner, both fluid delivery needles38 in fluid communication withpressure line46 pierce and are advanced through the correspondingdiaphragm44 positioned within pressure aperture120 (see FIG. 2). Advancing fluid delivery needles38 throughdiaphragms44 in the above described manner places eachfluid delivery channel22 in fluid communication withinterior void28 of thecorresponding chemical container26. In addition,pressure line46 is placed in fluid communication withinterior void28 of eachchemical container26.
• However, it should be appreciated that, in contrast to having[0074]chemical containers26 removable fromhousing34 as described above,chemical containers26 can be integrally formed withhousing34 ofcannula16. In this situation,chemical containers26 function in a substantially identical manner as described above, with the exception thatchemical containers26 are never removed fromhousing34. In particular,chemical containers26 are loaded with a predetermined amount of biologicallyactive compound12 while thechemical containers26 are positioned within and secured tohousing34. Moreover, it should be understood that chemical containers can be integrally formed withcannula16 such that chemical containers are never removed fromcannula16.
• After placing[0075]fluid delivery channels22 andpressure line46 in fluid communication withinterior void28 of eachchemical container26doors94 are located in the closed position.Insufflation valve108 andpressure control valve50 are then positioned such that pressure line46 (see FIG. 2) is in fluid communication withpressure source48. Pressurized fluid (i.e. CO₂) is then advanced frompressure source48 intointerior void28 of eachchemical container26 via the fluid delivery needles38 extending throughpressure apertures120. Advancing fluid intointerior void28 increases the pressure therein. However, it should be understood thatpressure control valve50 can be adjusted to control the pressure withininterior void28 of eachchemical container26. It should also be understood thatpressure relief valve124 is designed to release an amount of the pressurized fluid if the pressure withininterior void28 becomes to great. Sinceinterior void28 of eachchemical container26 is in fluid communication withbody cavity56 via a fluid path defined byexit ports24,fluid delivery channels22, and fluid delivery needles38, havingpressure relief valve124 designed in the above described manner also ensures that the pressure withinbody cavity56 does not become to great.
• Once biologically[0076]active compound12 is located influid delivery channel22, biologicallyactive compound12 is advanced along the length ofcannula16 in a direction indicated byarrow132 as shown in FIG. 2. While being advanced in the above described manner, biologicallyactive compound12 comes into fluid communication with exit ports24 (see FIG. 2). As biologicallyactive compound12 encounters each exit port24 a portion of biologically compound12 advances through eachexit port24 and is delivered toouter surface30 ofcannula16 as shown in FIG. 1. The above described process of delivering biologicallyactive compound12 toouter surface30 can be continued until bothchemical containers26 are substantially emptied and essentially all of biologicallyactive compound12 has been delivered toouter surface30 ofcannula16. However, if required, the surgeon can reopendoors94 and inject an additional predetermined amount of biologically compound12 into eachinterior void28 ofchemical containers26 as described above so as to continue the process of delivering biologicallyactive compound12 toouter surface30.
• It should be appreciated that as biologically[0077]active compound12 is delivered toouter surface30 ofcannula16 an amount of biologicallyactive compound12 is transferred fromouter surface30 toside wall58 of opening52 as shown in FIG. 1. In addition it should be appreciated that as biologicallyactive compound12 is delivered toouter surface30 ofcannula16 an amount of biologicallyactive compound12 can be transferred fromouter surface30 to aninside surface57 of body cavity56 (see FIG. 1) by positioningcannula16 at an angle relative toside wall58. It should further be appreciated that biologicallyactive compound12 can be continuously transferred toside wall58 and insidesurface57 such that essentially the entire amount of biologicallyactive compound12 contained inchemical containers26 is transferred toside wall58 and insidesurface57. Once located in contact withside wall58 or insidesurface57, biologicallyactive compound12 establishes a “pharmacological barrier” that helps prevent tumor cell implantation in opening52 and/or the contamination of opening52 with viable infectious microbes. Therefore, onceopening52 is protected in the above described manner the surgical procedure can proceed.
• If necessary, in order to keep biologically[0078]active compound12 from falling or sliding offouter surface30 due to gravity, or being advanced out ofexit ports24 to quickly, biologicallyactive compound12 can contain a suitable pharmaceutically acceptable carrier. Such pharmaceutically acceptable carriers include known excipients and auxiliaries which facilitate the processing of biologicallyactive compound12 into a preparation which has the appropriate consistency to be advanced out ofexit ports24 in a controlled manner and thus disposed onouter surface30,side wall58, andinterior surface57.
• 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.[0079]
• In addition, a suspension of biologically[0080]active compound12 may be disposed onouter surface30 orside wall58. 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[0081]active compound12 to be disposed uponouter surface30 and is easily determinable by one of ordinary skill in the art from only routine experimentation.
• Being able to deliver essentially all of biologically[0082]active compound12 contained withinchemical containers26 toside wall58 or intobody cavity56 allows a surgeon to accurately determine the total amount of biologicallyactive compound12 administered to a patient during a surgical procedure. Knowing the total amount of biologicallyactive compound12 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 biologicallyactive compound12 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[0083]active compound12 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^thEdition, 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 biologicallyactive compound12 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[0084]active compound12 disposed on outer surface30 (and thus administered to a patient) during a surgical procedure represents a significant advantage over other methods of disposing biologicallyactive compound12 onto a medical apparatus (e.g. dipping the medical apparatus in a solution or suspension of biologicallyactive compound12 or the unquantified irrigation of opening52 with biologically active compound12). Specifically, many of the less accurate methods do not allow the surgeon to accurately control the amount of biologicallyactive compound12 administered to the patient. Therefore, these less accurate methods of disposing biologicallyactive compound12 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[0085]active compound12 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 apparatus10) in a solution or suspension of biologicallyactive compound12 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 inbody cavity56. The surgeon must dispose biologicallyactive compound12 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 ofbody cavity56 which can complicate the surgical procedure. Therefore, in many circumstances the surgeon will unnecessarily utilize biologicallyactive compound12 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 biologicallyactive compound12 is required, and (3) only if needed, administer an accurate controllable amount ofbiological compound12 to the patient without interrupting the surgical procedure and withdrawingmedical apparatus10 frombody cavity56.
Second Embodiment of the Invention
• Now referring to FIG. 7, there is shown a[0086]medical apparatus60 similar to themedical apparatus10 shown in FIG. 1.Medical apparatus60 is shown advanced through anopening134 in awall136 of abody cavity138.Medical apparatus60 includes atrocar assembly78, asleeve62, and a pair ofchemical containers74.Trocar assembly78 includes atrocar82 positioned within alumen140 of acannula80.Trocar82 is positionable between a first trocar position and a second trocar position as described above for trocar18 (i.e. trocar82 is positioned withlumen140 ofcannula80 in the first trocar position and completely removed fromlumen140 in the second trocar position).
• [0087]Sleeve62 is substantially identical in construction to cannula16 discussed above in reference to FIGS. 1, 2,3, and6 with the exception thatsleeve62 includes a sealingmember86 extending therefrom. For example,sleeve62 also includes (1) awall84 having anouter surface76, (2) a workingchannel64 defined bywall84, (3) ahousing70, and (4) a pair offluid delivery channels66 which are distinct from workingchannel64 and are in fluid communication with a number ofexit ports68. As shown in FIG. 7,fluid delivery channels66 are preferably defined inwall84 ofsleeve62 and extend all the way to anend142 of sealingmember86. It should be understood that sealingmember86 operates in a substantially identical manner, and has a substantially identical construction and function, as sealing members described in a U.S. 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 sealingmember86 hasfluid delivery channels66 andexit ports68 defined therein.
• It should be understood that[0088]housing70 is substantially identical in construction tohousing34 discussed above. Furthermore,fluid delivery channels66 are in fluid communication with the interior cavity (not shown) ofhousing70 in a substantially identical manner as described above in reference tofluid delivery channels22.
• Moreover, each[0089]chemical container74 is constructed in a substantially identical manner as that described above forchemical containers26. For example, eachchemical container74 has an interior void (not shown; see FIG. 3) defined therein for receiving biologicallyactive compound12.
• [0090]Medical apparatus60 is used in a similar fashion as that described above formedical apparatus10 with some modifications to account for the presence ofsleeve62. Specifically,trocar82 is initially located in the first trocar position, andtrocar assembly78 is positioned within workingchannel64 ofsleeve62 as shown in phantom in FIG. 7. Sealingmember86 is then positioned in a substantially parallel relationship with workingchannel64 ofsleeve62.Trocar82 ofmedical apparatus60 is then placed in contact with, and advanced through,wall136 ofbody cavity138 to createopening134. Oncemedical apparatus60 is positioned as described above,trocar82 is moved to the second trocar position. Sealingmember86 is then positioned in a substantially orthogonal relationship with workingchannel64 ofsleeve62 as shown in FIG. 7.Sleeve62 is then positioned relative to opening134 such that sealingmember86 makes contact with aninterior surface144 ofbody cavity138.
• [0091]Body cavity138 is then insufflated in a similar manner as that described above in reference to FIG. 6 (i.e.body cavity134 is insufflated via the insufflation valve (not shown) attached tohousing70 andpressure source48. Oncebody cavity138 is insufflated, and as previously discussed a determination is made that biologicallyactive compound12 is required based upon the presence of a cancer or an infection withinbody cavity138,chemical containers74 are loaded with biologicallyactive compound12 as previously described. Once loaded,chemical containers74 are positioned within the interior cavity (not shown) ofhousing70 in a substantially identical manner as that previously described above in reference to FIGS.1-5. That is,chemical containers74 are positioned within the interior cavity ofhousing74 such that the interior void of eachchemical container74 is in fluid communication with (1) afluid delivery channel66 and (2) a pressure line defined inhousing70 which is substantially identical topressure line46 defined in housing34 (see FIG. 2).
• Once[0092]chemical containers74 are positioned in the above described manner, the insufflation valve (not shown) and a pressure control valve (not shown) attached to housing70 (i.e. a pressure control valve substantially identical to pressure control valve50) are manipulated such that the interior void of eachchemical container74 is in fluid communication withpressure source48. Bringing the interior void of eachchemical container74 into fluid communication withpressure source48 advances biologicallyactive compound12 contained therein into eachfluid delivery channel66.
• Once biologically[0093]active compound12 is located influid delivery channel66, biologicallyactive compound12 is advanced along the length ofsleeve62 and sealingmember86 in a direction indicated byarrows146 and147 as shown20 in FIG. 7. While being advanced in the above described manner, biologicallyactive compound12 comes into fluid communication withexit ports68. As biologicallyactive compound12 encounters each exit port68 a portion of biologically compound12 advances through-eachexit port68 and is delivered toouter surface76 ofsleeve62 in a manner similar to that shown in FIG. 1. In addition, an amount of biologicallyactive compound12 is delivered to acontact surface150 of sealingmember86. It should be appreciated that as biologicallyactive compound12 is delivered toouter surface76 ofsleeve62 an amount of biologicallyactive compound12 is transferred fromouter surface76 toside wall148 of opening134 as shown in FIG. 7. In addition, it should be appreciated that as biologicallyactive compound12 is delivered to contactsurface150 of sealingmember86 an amount of biologicallyactive compound12 is transferred fromcontact surface150 into contact withinterior surface144 ofbody cavity138. It should further be appreciated that biologicallyactive compound12 can be continuously transferred toside wall148 andinterior surface144 such that essentially the entire amount of biologicallyactive compound12 contained inchemical containers74 is transferred toside wall148 andinterior surface144. Once located in contact withside wall148 andinterior surface144, biologicallyactive compound12 establishes a “pharmacological barrier” that helps prevent tumor cell implantation inopening134 and/or the contamination of opening134 with viable infectious microbes. Therefore, it should be understood thatmedical apparatus60 has all of the advantages as described above in reference tomedical apparatus10.
Third Embodiment of the Invention
• Referring to FIGS. 9 and 10, there is shown a[0094]medical apparatus200 of the present invention advanced through opening52 (i.e. the port site wound) inwall54 ofbody cavity56.Medical apparatus200 is substantially identical tomedical apparatus10, therefore the components ofmedical apparatus200 have the same reference numbers asmedical apparatus10. In addition, it should be understood thatmedical apparatus200 functions in substantially the same way, and has the same advantages as,medical apparatus10. Therefore, only the differences betweenmedical apparatus10 andmedical apparatus200 will be discussed in detail herein.
• With respect to the differences between[0095]medical apparatus10 andmedical apparatus200, rather than havingdelivery channels22 defined incannula16,medical apparatus200 hasgrooves202 defined inouter surface30 ofcannula16. Similar todelivery channels22,grooves202 function to deliver a biologically active compound toouter surface30 ofcannula16. As shown in FIG. 10, eachgroove202 is in fluid communication withinterior void28 of achemical container26 via aconduit204 defined inhousing34.
• [0096]Medical apparatus200 is used in a substantially identical fashion as that described above formedical apparatus10. Oncemedical apparatus200 is positioned as shown in FIG. 9,body cavity56 is insufflated in an identical manner as that described above in reference to FIG. 6. Oncebody cavity56 is insufflated, and as previously discussed a determination is made that biologicallyactive compound12 is required based upon the presence of a cancer or an infection withinbody cavity56,chemical containers26 are loaded with biologicallyactive compound12 as previously described. Once loaded,chemical containers26 are positioned within theinterior cavity36 ofhousing34 in a substantially identical manner as that previously described above in reference to FIGS.1-5. That is,chemical containers26 are positioned within theinterior cavity36 ofhousing34 such that the interior void of eachchemical container26 is in fluid communication with (1) aconduit204 and (2) agroove202.
• Once[0097]chemical containers26 are positioned in the above described manner, theinsufflation valve108 andpressure control valve50 are manipulated such that the interior void of eachchemical container26 is in fluid communication withpressure source48. Bringing the interior void of eachchemical container26 into fluid communication withpressure source48 advances biologicallyactive compound12 contained therein into eachgroove202 viaconduits204.
• Once biologically[0098]active compound12 is located ingrooves202, biologicallyactive compound12 is advanced along the length ofcannula16 in a direction indicated byarrow206 as shown in FIG. 9. It should be appreciated that as biologicallyactive compound12 is advanced throughgrooves202 an amount of biologicallyactive compound12 is transferred fromouter surface30 toside wall58 of opening52 as shown in FIG. 9. In addition, it should be appreciated that as biologicallyactive compound12 is advanced throughgrooves202, an amount of biologicallyactive compound12 is transferred fromouter surface30 toside wall58 of opening52 as shown in FIG. 9. In addition, it should be appreciated that as biologicallyactive compound12 is advanced throughgrooves202 and transferred toside wall58 ofopening52, biologicallyactive compound12 establishes a “pharmacological barrier” that prevents tumor cell implantation in opening52 and/or the contamination of opening52 with viable infectious microbes. Therefore, onceopening52 is protected in the above described manner the surgical procedure can proceed.
• If necessary, the distal portion of each[0099]groove202 can have asponge material214 disposed therein, as shown in FIG. 9. For example, the distal two thirds of eachgroove202 can havesponge material214 disposed therein. Havingsponge material214 disposed within-eachgroove202 ensures that no insufflation gas is allowed to escape from withinbody cavity56 throughgrooves202. In particular, as biologicallyactive compound12 advances down eachgroove202 in the direction indicated byarrow206 biologicallyactive compound12 comes into contact withsponge material214 disposed withingroove202. Contactingsponge material214 with biologically-active compound12 results insponge material214 swelling so as to fillgroove202 and thus prevent any insufflation from escaping frombody cavity56 viagroove202. However, it should be understood thatsponge material214 still allows biologicallyactive compound12 to pass therethrough and be disposed uponside wall58 ofopening52. It should be understood thatsponge material214 can be any porous, liquid absorbent material, which allows the passage of biologicallyactive compound12 therethrough while preventing the leakage of insufflation gas, and can be temporarily inserted into a body cavity such asbody cavity56. For,example sponge material214 can be made from a surgical sponge.
• As shown in FIGS. 11 and 12, in contrast to having[0100]groves202 defined inouter surface30 ofcannula16,grooves202 can also be defined in aninterior surface208 ofcannula16. Whengrooves202 are defined ininterior surface208,medical apparatus200 functions is a substantially identical manner as described above in reference to FIGS. 9 and 10 with the exception that eachgroove202 is in fluid communication with anexit port210 defined incannula16. Eachexit port210 leads frominterior surface208 toouter surface30. Therefore, as biologicallyactive compound12 is advanced through eachgroove202 in the direction indicated by arrow206.(see FIG. 11) biologicallyactive compound12 comes into contact with, and is advanced through, anexit port210 such that biologicallyactive compound12 is transferred frominterior surface208 toouter surface30 ofcannula16 in the direction indicated by arrow212 (see FIG. 12). (Note that whileexit ports210 are shown being defined in substantially theentire length cannula16, it is also contemplated thatexit ports210 are only defined in, for example, the distal two thirds ofcannula16.) Once biologicallyactive compound12 is transferred toouter surface30 ofcannula16, biologicallyactive compound12 is transferred toside wall58 of opening52 where it establishes a “pharmacological barrier” that prevents tumor cell implantation in opening52 and/or the contamination of opening52 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[0101]chemical containers26 and74 are described above as being separate fromhousings34 and70, respectively, other arrangements are contemplated. As discussed above, one such arrangement incorporateschemical containers26 and74 intohousings34 and70, respectively, such that each chemical container is “built in” or integral to the housing.

Claims (23)

What is claimed is:

1. A medical apparatus for dispensing a biologically active compound, comprising:

a trocar assembly including a cannula and a trocar, wherein (1) said cannula has a working channel defined therein through which 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 has an exit,

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; 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.

2. The medical apparatus ofclaim 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 ofclaim 1, wherein:

said fluid delivery channel is defined in a wall of said cannula.

4. The medical apparatus ofclaim 3, wherein:

said fluid delivery channel includes a groove defined in a surface of said cannula.

5. The medical apparatus ofclaim 4, further comprising:

a sponge material disposed in said groove.

6. The medical apparatus ofclaim 1, wherein:

said trocar assembly further includes a housing secured to said cannula, and

said chemical container is integrally formed with said housing.

7. A medical procedure for dispensing a biologically active compound, comprising said steps of:

creating an opening in a wall of a non-vascular body cavity;

advancing a medical apparatus through said opening and into said non-vascular body cavity, said medical apparatus including a trocar assembly having (1) a cannula and a trocar, wherein (A) said cannula has a working channel defined therein through which medical instruments may be advanced, (B) said cannula includes a fluid delivery channel which is distinct from said working channel, and (C) said fluid delivery channel has an exit, and (2) 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; and

advancing said biologically active compound from said interior void of said chemical container onto an exterior surface of said cannula through a fluid path defined by said fluid delivery channel.

8. The medical procedure ofclaim 7, wherein:

said biologically active compound advancing step includes the step of positioning said medical apparatus relative to said opening such that an amount of said biologically active compound is transferred from said exterior surface of said cannula to a side wall of said opening.

9. The medical procedure ofclaim 7, 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;

10. The medical procedure ofclaim 7, wherein:

said fluid delivery channel is defined in a wall of said cannula.

11. The medical procedure ofclaim 10, wherein:

said fluid delivery channel includes a groove defined in a surface of said cannula.

12. A medical apparatus for dispensing a biologically active compound, comprising:

a sleeve, wherein (1) said sleeve has a working channel defined therein through which medical instruments may be advanced, (2) said sleeve includes a fluid delivery channel which is distinct from said working channel, and (3) said fluid delivery channel has an exit;

a housing secured to said sleeve, said housing having an interior void defined therein for receiving said biologically active compound, wherein said interior void is in fluid communication with said exit through said fluid delivery channel such that said biologically active compound may be delivered through said fluid delivery channel to an outer surface of said sleeve; and

an insufflation valve in fluid communication with said working channel, said insufflation valve being positionable between an open position and a closed position such that (i) when said insufflation valve is located in said open position an insufflation gas can be advanced into said working channel and (ii) when said insufflation valve is located in said closed position said insufflation gas is prevented from being advanced into said working channel.

13. The medical apparatus ofclaim 12, further comprising a trocar assembly including a cannula and a trocar, wherein:

said trocar assembly is positionable between a first trocar assembly position and a second trocar assembly position, said trocar assembly is located within said working channel of said sleeve when said trocar assembly is positioned at said first trocar assembly position, and

said trocar assembly is completely removed from said working channel of said sleeve when said trocar assembly is positioned at said second trocar assembly position.

14. The medical apparatus ofclaim 12, wherein:

said fluid delivery channel is defined in a wall of said sleeve.

15. The medical apparatus ofclaim 14, wherein:

said fluid delivery channel includes a groove defined in a surface of said sleeve.

16. The medical apparatus ofclaim 12, wherein:

said sleeve further includes a number of sealing members extending therefrom.

17. The medical apparatus ofclaim 12, wherein:

said housing is integrally formed with said sleeve.

18. A medical apparatus for dispensing a biologically active compound, comprising:

a trocar assembly including a cannula and a trocar, 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 has an exit; 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.

19. The medical apparatus ofclaim 18, wherein:

said fluid delivery channel includes a groove defined in a surface of said cannula.

20. The medical apparatus ofclaim 18 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.

21. The medical apparatus ofclaim 18, wherein:

said chemical container is integrally formed with said cannula.

22. A medical procedure for dispensing a biologically active compound, comprising the steps of:

creating an opening in a wall of a body cavity;

advancing a medical apparatus through the opening and into the body cavity, said medical apparatus including a trocar assembly having (1) a cannula and a trocar, wherein (A) said cannula has a working channel defined therein through which medical instruments may be advanced, (B) said cannula includes a fluid delivery channel which is distinct from said working channel, and (C) said fluid delivery channel has an exit port, and (2) 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 port through said fluid delivery channel;

advancing a gas into said body cavity; and

advancing said biologically active compound from said interior void of said chemical container onto an exterior surface of said cannula through a fluid path defined by said fluid delivery channel.

23. An arrangement for delivering a biologically active compound, comprising:

a chemical container configured to be removably disposed in a void of a housing of a trocar assembly.

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