Information
-
Patent Grant
-
6302873
-
Patent Number
6,302,873
-
Date Filed
Wednesday, February 23, 200024 years ago
-
Date Issued
Tuesday, October 16, 200122 years ago
-
Inventors
-
-
Examiners
- Seidel; Richard K.
- Thanh; LoAn
Agents
-
CPC
-
US Classifications
Field of Search
US
- 604 506
- 604 500
- 604 16401
- 604 158
- 604 160
- 604 16409
- 604 16411
- 604 171
- 604 272
- 604 264
- 604 265
- 604 266
-
International Classifications
-
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,)
. 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 at, (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 SJ, (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 FIG.
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, 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 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 wall
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 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.
- 2. The medical procedure of claim 1, wherein:said biologically active compound advancing step includes a 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.
- 3. The medical procedure of claim 1, wherein:said fluid delivery channel includes a groove defined in a surface of said cannula.
- 4. The medical procedure 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.
- 5. The medical procedure of claim 1, wherein:said fluid delivery channel is defined in a wall of said cannula.
- 6. 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; visualizing the 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.
US Referenced Citations (29)