The present invention relates to a body cavity access assembly and a procedure for dispensing a liquid, which may contain a biologically active compound, into a patient.
Minimally invasive surgical techniques, such as laparoscopic surgery, typically include the use of a trocar assembly. A trocar assembly includes an obturator (also known as a trocar) positioned within the channel of a cannula. The obturator and cannula are advanced through a body cavity wall so as to create a small opening or a port site wound therein. The obturator is then completely removed from the lumen of the cannula such that the cannula""s channel 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 CO2, to provide easier access and visualization of 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 in this manner is associated with a lower post-operative pain, quicker recovery and improved immune function. (1, 2, 3, 4, 5, 6). Because of these advantages, laparoscopic surgery has experienced exponential growth. Benign laparoscopic surgery is now well accepted, and surgeons have progressed into the next field of laparoscopic surgery, i.e. laparoscopic cancer surgery. In particular, laparoscopic colon cancer surgery is now being evaluated in a National Institute of Health study. An initial result from this study confirms the laparoscopic method does have advantages over the conventional open surgery. (5, 6, 14).
However, the development of laparoscopic surgery for cancer has been hindered because of the major concern regarding the implantation of tumor cells in the port site wound. (2, 3, 6, 7). In fact, numerous port site recurrences have been documented in the medical literature heretofore, and these recurrences are associated with a decreased survival rate for patients who may have had a curative cancer (2, 3, 6, 7).
Specifically, the medical literature reports that the incidence of tumor cell implantation ranges from as high as 20% to a low of 0% (8). The follow-up evaluation of this wide incidence of port site implantation places a large emphasis on the surgeons learning curve. In particular, the beginning surgeon (less than 25-50 cases) will have a much higher incidence of port site implantation than the advanced surgeon (greater than 50 cases). In spite of using some of the most advanced surgeons in the world, the NIH study confirms an incidence of 1.3% port site implantation for laparoscopic methods (10) as compared to a 0.6% incidence for the open techniques (9).
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).
As briefly mentioned above, studies have shown that a physician will 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. For example, 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.
Regardless of how these cells contaminate the wound, once implanted therein, viable tumor cells can cause a subcutaneous metastases or xe2x80x9cport site recurrencexe2x80x9d after the resection of malignant tissue. These xe2x80x9cport site recurrencesxe2x80x9d 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 intraabdominal/intra-thoracic 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 increasing their hospital bill.
What is needed therefore is an assembly and procedure which addresses on or more of the above described drawbacks and may be used for other situations in which dispensing a liquid during a laparoscopic or similar procedure would be desirable.
1. Lord et al., Dis. Col. Rect. 39(2):148 (1996)
2. Berman, Important Advances in Oncology 1996, Laparoscopic Resection for Colon Cancer: Cause for Pause, Vincent DeVita Ed., p. 231
3. Falk et al., Dis. Col. Rect. 36:28 (1993)
4. Liberman et al., Surg. Endo. 10:15 (1996)
5. Whelan et al., Dis. Col. Rect. 41(5):564 (1998)
6. Wexner et al., Am. Surg. 64(1):12-18 (1998)
7. Greene, Semin. Lap. Surg. 2(3):153 (1995)
8. Kazemier, Surg. Endo. 9:216 (1995)
9. Reilly et al., Dis. Col. Rect. 39(2):200 (1996)
10. Jacquet et al., Dis. Col. Rect. 38(10):140 (1995)
11. Reymond et al., Surg. Endo. 11:902 (1997)
12. Allardyce et al., Dis. Col. Rect. 40(8):939 (1997)
13. Caushaj et al., Dis. Col. Rect. 37(4):21 (Podium Abstract 1994)
14. Lee et al., (oral presentation, 6th World Congress of Endoscopic Surgery, June 1998) Surgical Endoscopy 12 (5):14 (1998)
15. Russell et al., Dis. Col. Rect. 40(11):1294 (1997)
16. Neuhaus S J, (oral presentation, 6th World Congress of Endoscopic Surgery, June 1998) Surgical Endoscopy 12 (5): 515 (1998)
17. Schneider C, (oral presentation, 6th World Congress of Endoscopic Surgery, June 1998) Surgical Endoscopy 12 (5): 517 (1998)
The invention generally relates to a body cavity access assembly including a conduit having a lumen through which a medical instrument may be advanced, an exterior surface, a liquid input adapted to be coupled to a source of liquid, and communicating with a plurality of exit ports defined along a portion of the exterior surface. A dispensing mechanism is operatively coupled to the conduit and is adjustable to selectively open the exit ports to allow the liquid to flow therefrom and also to selectively close at least one of the exit ports to prevent the liquid from flowing.
The invention also generally relates to a method for dispensing a liquid during a surgical procedure. The method includes creating an opening in a wall of a body cavity and advancing a conduit through the opening. The conduit includes a lumen through which a medical instrument may be advanced and further includes an exterior surface having a variable sized dispensing zone extending along a length thereof. The method further includes discharging the liquid from the dispensing zone, changing the size of the dispensing zone, and discharging the liquid from the dispensing zone of changed size.
In accordance with one more specific embodiment of the present invention, there is provided a body cavity access assembly. The assembly includes a conduit having (i) a lumen through which a medical instrument may be advanced, (ii) an exterior surface, (iii) a first exit port defined in the exterior surface, and (iv) a second exit port defined in the exterior surface. The assembly also includes a reservoir having an interior void for receiving a biologically active compound. The interior void of the reservoir is in fluid communication with the first exit port and the second exit port. The assembly further includes a dispensing mechanism operatively coupled to the conduit. The dispensing mechanism is positionable between a first position, a second position, and a third position. When the dispensing mechanism is positioned in the first position the biologically active compound is prevented from being advanced through the first exit port and the second exit port. When the dispensing mechanism is positioned in the second position the biologically active compound is advanced through the first exit port, and prevented from being advanced through the second exit port. When the dispensing mechanism is positioned in the third position the biologically active compound is advanced through the first exit port and the second exit port.
Pursuant to another embodiment of the present invention, there is provided a body cavity access assembly. The assembly includes a reservoir having an interior void for receiving a biologically active compound. The assembly also includes a conduit having (i) a lumen through which a medical instrument may be advanced, (ii) an exterior surface, (iii) a first exit port defined in the exterior surface, the first exit port being (A) operable between an open mode of operation and a closed mode of operation and (B) in fluid communication with the interior void of the reservoir and (iv) a second exit port defined in the exterior surface, the second exit port being (A) operable between an open mode of operation and a closed mode of operation and (B) in fluid communication with the interior void of the reservoir. The assembly further includes a dispensing mechanism operatively coupled to the first exit port and the second exit port, such that (i) the dispensing mechanism can selectively place the first exit port in (A) the open mode of operation so that the biologically active compound is advanced through the first exit port or (B) the closed mode of operation so that the biologically active compound is prevented from being advanced through the first exit port and (ii) the dispensing mechanism can selectively place the second exit port in (A) the open mode of operation so that the biologically active compound is advanced through the second exit port or (B) the closed mode of operation so that the biologically active compound is prevented from being advanced through the first exit port.
According to yet another embodiment of the present invention, there is provided a medical procedure for dispensing a biologically active compound. The method includes creating an opening in a wall of a body cavity. The method also includes advancing a body access assembly through the opening and into the body cavity. The body access assembly includes (1) a reservoir having an interior void for receiving a biologically active compound, (2) a conduit having (i) a lumen through which a medical instrument may be advanced, (ii) an exterior surface, (iii) a first exit port defined in the exterior surface, the first exit port being (A) operable between an open mode of operation and a closed mode of operation and (B) in fluid communication with the interior void of the reservoir and (iv) a second exit port defined in the exterior surface, the second exit port being (A) operable between an open mode of operation and a closed mode of operation and (B) in fluid communication with the interior void of the reservoir; and (3) a dispensing mechanism operatively coupled to the first exit port and the second exit port, such that (i) the dispensing mechanism can selectively place the first exit port in (A) the open mode of operation so that the biologically active compound is advanced through the first exit port or (B) the closed mode of operation so that the biologically active compound is prevented from being advanced through the first exit port and (ii) the dispensing mechanism can selectively place the second exit port in (A) the open mode of operation so that the biologically active compound is advanced through the second exit port or (B) the closed mode of operation so that the biologically active compound is prevented from being advanced through the first exit port. The method also includes selectively placing the first exit port in the open mode of operation with the dispensing mechanism. The method further includes advancing the biologically active compound from the interior void of the reservoir through the first exit port.
In accordance with another embodiment of the present invention, there is provided a body cavity access assembly. The assembly includes a conduit having (i) a lumen through which a medical instrument may be advanced, (ii) an exterior surface, and (iii) an exit port defined in the exterior surface. The assembly also includes a reservoir having an interior void for receiving a biologically active compound. The interior void of the reservoir is in fluid contact with the exit port. The assembly further includes a dispensing mechanism operatively coupled to the conduit. The dispensing mechanism is positionable between a first position and a second position. When the dispensing mechanism is positioned in the first position the biologically active compound is prevented from being advanced through the exit port. When the dispensing mechanism is positioned in the second position, the biologically active compound is advanced through the exit port.
Pursuant to another embodiment of the present invention, there is provided a body cavity access assembly. The assembly includes a reservoir having an interior void for receiving a biologically active compound. The assembly also includes a conduit having (i) a lumen through which a medical instrument may be advanced, (ii) an inside sleeve, (iii) a first exit port defined in the inside sleeve, the first exit port being operable between an open mode of operation and a closed mode of operation and in fluid communication with the interior void of the reservoir, (iv) a second exit port defined in the inside sleeve, the second exit port being operable between an open mode of operation and a closed mode of operation and in fluid communication with the interior void of the reservoir, (v) a third exit port defined in the inside sleeve, the third exit port being operable between an open mode of operation and a closed mode of operation and in fluid communication with the interior void of the reservoir. The assembly further includes a dispensing mechanism, an outside sleeve, and alignment ports defined in the outside sleeve. The dispensing mechanism rotates the outside sleeve relative to the inside sleeve and is positionable between a first position, second position, third position and fourth position. When the dispensing mechanism is positioned in the first position the biologically active compound is prevented from being advanced through the exit ports. When the dispensing mechanism is positioned in the second position, the biologically active compound is advanced through the first exit port. When the dispensing mechanism is positioned in the third position, the biologically active compound is advanced through the second exit port. When the dispensing mechanism is positioned in the fourth position, the biologically active compound is advanced through the third exit port. The biologically active compound is delivered to the reservoir from the storage reservoir by the pressure inside the storage reservoir created by the pump. Once the storage reservoir pressure exceeds a limit a relief valve lifts allowing the compound to transfer from the storage reservoir to the reservoir.
Various additional objectives, advantages and features of the invention will become more readily apparent to those of ordinary skill in the art upon review of the detailed description of the illustrative embodiments.
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USPTO Backgrounds