WO2021211404A1

WO2021211404A1 - Entry system with imaging for minimally invasive surgery

Info

Publication number: WO2021211404A1
Application number: PCT/US2021/026784
Authority: WO
Inventors: Abraham J. YAARI
Original assignee: Yaari Abraham J
Priority date: 2020-04-17
Filing date: 2021-04-12
Publication date: 2021-10-21

Abstract

A system for entry into a body cavity of a patient including a trocar having a sheath and a penetrating tip at a distal portion, the sheath having a first lumen configured and dimensioned to receive an ultrasonic probe for visualization during entry of the trocar into the body cavity. A sleeve has a second lumen dimensioned and configured to removably receive the trocar, the penetrating tip of the trocar extending past a distal end of the sleeve during insertion of the trocar into the body cavity. An ultrasonic probe is removably insertable into the first lumen of the sheath of the trocar, the ultrasonic probe terminating adjacent or within the penetrating tip of the trocar for visualization via ultrasound in real time during entry of the trocar and sleeve into the body cavity.

Description

ENTRY SYSTEM WITH IMAGING FOR MINIMALLY INVASIVE SURGERY

BACKGROUND

This application claims priority from provisional application 63/011,660, filed April 17, 2020, the entire contents of which are incorporated herein by reference. Technical Field

This application relates to a minimally invasive entry system, and more particularly, to a minimally invasive entry system with ultrasound imaging.

Background

More than 15 million laparoscopic surgeries are performed worldwide each year and the number is increasing not only because of the population growth but because of the spread of the technique and the fact that more and more procedures that used to require a laparotomy are now performed in a minimally invasive fashion. Laparoscopy offers the benefit of minimizing perioperative morbidity and mortality as well as shortening hospital stay, shortening recovery time and reducing medical costs.

However, laparoscopy is associated with its own morbidity and mortality risks and these risks have not decreased significantly over the years. The injuries involving laparoscopic surgery can be divided into two categories: a) injuries related to the entry into the abdominal cavity - the primary entry with the Veress needle and the initial trocar placement and the secondary entries with the other trocars; and b) injuries caused during the performance of the surgery itself. Many of the bowel and vascular injuries are not diagnosed at the time of injury contributing to mortality rates.

More than 50% of injuries occur in the initial entry to the peritoneal cavity and the establishment of the pneumoperitoneum. This complication rate has stayed the same for the last three decades. According to Entry Complications in Laparoscopic Surgery,

S. Krishnakumar and P. TambeJ, Gynecol Endoscop Surg, 2009 Jan-Jun; 1(1): 4-11, the mortality rate from large vessel injury is 15% while the mortality rate from bowel injury is 2.5%-5% mostly due to delayed diagnosis. Injuries during laparoscopy include large vessel injuries to the aorta, vena cava and iliac vessels. According to Major Vascular Injury in Laparoscopic Urology, N. Simforoosh, MD et al, Journal of the Society of Laparoendoscopic Surgeons, 2014 Jul- Sep; 18(3): e2014.oo283, such injuries occur in 0.05% - 0.26% of cases.

Injuries during laparoscopy also include organ injury. According to Bowel Injury in Gynecologic Laparoscopy, A Systematic Review, Natalia C. Llarena, BA, Anup B. Shah, MS, and Magdy P. Milad, MD, MS, bowel injury occurs in 0.13% of gynecologic laparoscopies. The rate of bowel injury varied by procedure, ranging from 1 in 3,333 (0.03%, 95% Cl 0.01-0.03%) for sterilization to 1 in 256 (0.39%, 95% Cl 0.34-0.45%) for hysterectomy. According to Bowel and Bladder Injury Repair and Follow-up After Gynecologic Surgery, Laura Glaser, MD and Magdy P.Milad, MD, MS. Obstetrics & , Gynecology, Vol. 133, NO. 2, 313-322, February 2019, 37.3%-55% of such injuries occur during entry. Other organs that can be injured during entry are the bladder, ureters, spleen and liver. In addition, emphysema can develop in the abdominal wall and this may lead to hypercarbia, acidosis, pneumomediastinum and pneumothorax. These developments can negatively affect the cardiac function.

Injuries during laparoscopy can include the blood vessels of the abdominal wall including the Inferior epigastric artery, Superficial epigastric artery, Superficial circumplex iliac artery and the corresponding veins. It is estimated that injuries to these vessels occur in 0.2-2% of laparoscopic surgeries. Safety Zones for Anterior Abdominal Wall Entry During Laparoscopy, A CT Scan Mapping of Epigastric Vessels, Alan A. Saber, MD, MS, Ali M. Meslemani, MD, Robert Davis, MD, and Ronald Pimentel, MS Annals of Surgery · Volume 239, Number 2, February 2004. The picture below illustrates the patient anatomy and entry points:

The majority of injuries during laparoscopy occur at the establishment of the pneumoperitoneum and the placement of the laparoscopic ports. This is caused because the placement of the initial port or the Veress needle is performed “blindly” and not under direct visualization.

Several techniques have been developed in attempts to minimize injury during the initial peritoneal entry. These techniques include;

1. The use of a Veress needle to create the pneumoperitoneum. Afterwards, the laparoscopic ports are placed. Several techniques arc used to test that the tip of the Veress needle is indeed in the peritoneal cavity.

2. Open entry ~ the Hasson method. Although this method reduces large vessel injuries it does not reduce bowel injuries. This method requires dissection by layers (usually near the umbilicus) and involves time and postoperative pain.

3. Direct entry with the trocar instead of establishing pneumoperitoneum first with the Veress needle. There is no real difference in the rate of injuries between these two methods. After entering the peritoneal cavity blindly and without pneumoperitoneum, the laparoscope is inserted to check location.

4. ^"The use of trocars that allow inspection of the entry process with a laparoscope Direct. Optical Entry (e.g.. Endopath, Ethicon). This detects injury subsequent to placement,

5. Entry in areas where underlying bowel adhesions are less likely such as the Palmer area and Jain area. This limits entry areas and still has risks of injury.

6. Direct inspection and transillismination to identify abdominal wall vessels. This method can only be used during the placement of the secondary trocars. Direct inspection and transillismination will not work with obese patients. 7. The use of conical shaped blunt trocars instead of pyramidal shaped trocars with a covered blade. This can affect entry ability and increase difficulty of entry.

8. The use of ultrasound to identify areas with underlying bowel adhesions before placement. These include a) the Visceral Sliding Sign method used before placing the trocar; b) PUGSI (Periumbilical Ultrasound Guided Saline Infusion) used before placing the trocar; and c) ultrasound Doppler to identify the abdominal wall vessels.

Over the last thirty years, despite the advances in the laparoscopic technique and instrumentation there has been little or no change in the technique and instrumentation that are used to establish pneumoperitoneum and enter the peritoneal cavity and therefore little or no change in rate of injuries. The foregoing techniques have the disadvantage of not showing the surgeon in real time where the tip of the trocar during insertion is heading, but instead employ one of two strategies: a) identify areas in the abdomen that the surgeon should avoid in order to prevent injury; or b) identify misplacement or injury AFTER they have happened. Additionally, transillumination will only work after the initial trocar is placed and pneumoperitoneum has been established.

Therefore, the need exists to improve initial (primary) trocar insertion to reduce complications, morbidity and mortality associated with current trocars and their insertion methods. Such improvement could also be used for subsequent (secondary) trocar insertions.

There are several prior patents which disclose the use of ultrasonic vibrations to aid insertion of a needle or trocar. However, although these may aid insertion, they do not solve, let alone address, the aforementioned deficiencies of current systems since the surgeon is still unable to obtain feedback in real time of the instrument insertion.

SUMMARY OF THE INVENTION

The present invention provides a minimally invasive access system for placement of a trocar under visualization to enable viewing in front of the penetrating tip of the trocar. This forward viewing reduces injury as the user can see ahead of time any anatomical structure that should be avoided. In accordance with one aspect of the present invention, a system for entry into a body cavity of a patient is provided comprising a trocar having a sheath and a penetrating tip at a distal portion, the sheath having a first lumen configured and dimensioned to receive an ultrasonic probe for visualization during entry of the trocar into the body cavity. A sleeve having a second lumen is dimensioned and configured to removably receive the trocar, the penetrating tip of the trocar extending past a distal end of the sleeve during insertion of the trocar into the body cavity. An ultrasonic probe is removably insertable into the first lumen of the sheath of the trocar, the ultrasonic probe terminating adjacent or within the penetrating tip of the trocar for visualization via ultrasound in real time during entry of the trocar and sleeve into the body cavity. The ultrasonic probe terminates distally of the distal end of the sleeve during entry of the trocar into the body cavity.

In some embodiments, the trocar has an additional lumen for injection of fluids. The fluids can include for example an anesthetic or saline. In some embodiments, the first lumen and the additional lumen are substantially parallel. In other embodiments, the additional lumen is non-linear so that at least a portion is not parallel with the first lumen. In some embodiments, the trocar has a first port in communication with the first lumen and a second port in communication with the additional lumen. In some embodiments, the additional lumen provides a passage for an anesthetic through the penetrating tip of the trocar.

In some embodiments, the system includes a covering attached to a proximal region of the trocar, the covering providing a protective sheath for a cable extending from the ultrasonic probe to an ultrasound generator.

In some embodiments, the sleeve has a lumen for insertion of fluids.

In accordance with another aspect of the present invention, a trocar for entry into a body cavity of a patient is provided, the trocar having a sheath and a penetrating tip. The sheath has a first lumen configured and dimensioned to removably receive an ultrasonic probe for visualization during entry of the trocar into the body cavity and the trocar is insertable solely via manual insertion without application of electrosurgical or ultrasonic energy to the penetrating tip. In some embodiments, the sheath has a second lumen configured for infusion of fluids. In some embodiments, the penetrating tip is configured such that a tip of the ultrasonic probe extends within an internal space in the penetrating tip.

In accordance with another aspect of the present invention, a method of trocar entry into a body cavity of a patient is provided, the method comprising the steps of: a) inserting an ultrasonic probe into a lumen of a trocar so that the probe terminates adjacent or within a penetrating tip of the trocar; b) inserting the trocar into the body cavity while visualizing via ultrasound entry during insertion, the trocar inserted within an outer sleeve and the ultrasonic probe and penetrating tip of the trocar extending beyond a distal edge of the outer sleeve; and c) removing the trocar from the body cavity leaving the outer sleeve in the body for access to the body cavity of the patient; and d) either before, during or after step (c), removing the ultrasonic probe from the trocar.

In the illustrated embodiments, the trocar is inserted solely by manual insertion without the application of electrosurgical or ultrasonic energy to the penetrating tip.

The method may further comprise the step of infusing a fluid, such as a local anesthetic or saline, into the tissue layers and/or into the body cavity through a second lumen in the trocar.

In some embodiments, the method further comprises the step of infusing a fluid through the outer sleeve.

In some embodiments, during insertion the probe allows the user to see in real time blood vessels and visceral organs close to the advancing tip of the trocar.

BRIEF DESCRIPTION OF THE DRAWINGS:

Preferred embodiment(s) of the present disclosure are described herein with reference to the drawings wherein:

Figure 1 is a schematic view the trocar system of the present invention with the ultrasonic probe shown inside the trocar; Figure 2 is a cross-sectional view of the trocar system of Figure 1 illustrating the two lumens and further showing schematically the connection of the trocar to an ultrasonic generator;

Figure 3 A is a side view of the trocar system of Figure 1;

Figure 3B is a perspective view of the trocar system of Figure 1;

Figure 3C is a perspective view of the trocar system of Figure 1;

Figure 4A is a side view of the trocar system of Figure 1 with parts removed to show the ultrasonic probe within the trocar;

Figure 4B is a side view of the trocar system of Figure 1 with parts removed to show the ultrasonic probe within the trocar;

Figure 4C is a perspective view of the ultrasound probe and connector of the trocar system of Figure 1;

Figure 5A is a side view of the obturator (trocar), sleeve and ultrasonic probe components of the trocar system of Figure 1, the components shown separated;

Figure 5B is a close up view of the trocar of the system of Figure 5A (and Figure

1); and

Figure 5C is a close up view of the sleeve of the trocar system of Figure 5 A (and Figure 1).

DESCRIPTION OF PREFFERED EMBODIMENTS

As discussed above, the initial step in laparoscopic surgery is establishing pneumoperitoneum with a Veress needle or directly with an access device such as a trocar. The insertion of these devices into the peritoneal cavity is typically done blindly.

The present invention provides an access system, i.e., a trocar port system, that allows the surgeon to place the trocar and establish pneumoperitoneum while seeing in real time that there are no abdominal wall vessels, bowel adhesions or large blood vessels in front of the advancing tip of the trocar. Injury is thereby prevented and not just diagnosed retroactively. By viewing in real time, the surgeon can evaluate the process during insertion and make insertion decisions/adjustments accordingly.

The system of the present invention incorporates an ultrasound transducer at the tip of the trocar (obturator) and allows injection of fluid in front of the advancing tip, thus permitting the inspection of the abdominal wall layers in front of the tip, allowing the surgeon to inspect the Visceral Sliding Sign Test as well as the PUGSI (Periumbilical Ultrasound Guided Saline Infusion) test in real time. The ultrasound imaging of the present invention allows the surgeon to see if there are visceral organs (bowel, liver, spleen, etc.) close to the advancing tip. With the use of the ultrasonic function, e.g., a Doppler function, an imaging (vision) system is provided so blood vessels of the abdominal wall can be identified before injury occurs. The access system and method of the present invention can be used for laparoscopic surgery or other minimally invasive surgery.

The system of the present invention places the ultrasonic transducer at the tip of the obturator. However, it is a separate component from the obturator. In this way, the obturator is disposable and the transducer just goes inside of it and does not have to be sterilized. This decreases cost compared to an obturator which itself functions as a transducer and needs to be sterilized. Also, by being a separate component, the user has the option of utilizing the ultrasound for trocar insertion/sleeve placement.

As used herein, the term “distal” refers to the section or portion further from the user an the term “proximal” refers to the section or portion closer to the user.

With reference now to the drawings (Figures 1-5C), and particular embodiments of the present disclosure, wherein like reference numerals identify similar structural features of the systems/devices disclosed herein, the trocar system of the present invention is designated generally by reference numeral 10. As shown in Figures 4B and 5 A, the trocar entry system includes a body penetrating device or trocar 12 (also referred to herein as an obturator), an outer sleeve 18 (also referred to herein as a cannula) with connection to a CO2 source, and an ultrasonic transducer probe 16 positioned within trocar 12 and connected to an external ultrasound imaging system (also referred to herein as an ultrasonic generator). Trocar 12 is removably received in lumen 25 of sleeve 18 (Figure 5 A). The ultrasonic probe 16 is removably received within the trocar 12. The trocar 12, sleeve 18 and probe 16 components of the system 10 are shown separated in Figure 5A and illustrated together in the arrangement (system) for insertion into the patient's body in Figure 3A. Trocar 12 has a hub 15 and an elongated shaft or sheath 13 extending from hub 15 terminating in penetrating tip 14. In preferred embodiments, the hub 15 and sheath 13 are integrally formed, however, in alternate embodiments, they can be separate components. Penetrating trocar tip 14 can be conical shaped as shown, or alternatively, pyramidal shaped or other shapes and configurations to facilitate penetration through the tissue and into the body cavity. The tip 14 can be solid or can be hollow to receive a tip of the ultrasonic probe 16 as described below. Sheath 13 includes an internal lumen (channel) 15b extending therethrough and terminating at the tip 14. Hub 15 includes a port 15a (Figure 4B) communicating with the internal lumen 15b of sheath 13 for insertion of gas or liquid, e.g., local anesthetic, saline, etc., through the lumen 15b into the body cavity.

Sheath 13 has a second lumen 15c extending therein to receive ultrasonic probe 16 (Figure 2). Thus, trocar 12 has two lumens - a fluid injection lumen 15b which opens at a distal opening in the tissue layers or the body cavity, preferably in the penetrating tip 14, and a probe lumen 15c which terminates in or proximal of trocar tip 14. That is, the fluid injection lumen 15b extends from the port 15a through almost the entire length of the trocar sheath 13 terminating in a distal opening 15d (Figure 5B) which is preferably adjacent but proximal to the distal tip of the penetrating tip 14. The secondary lumen 15c extends from the opening 17 at the proximal end of hub 15 through almost the entire length of the sheath 13, terminating either just at the tip 14 or alternatively extending further within the conical (or other shaped) penetrating tip. In either case, the opening 15d is positioned distal of the distal edge of the sleeve 18 during insertion to ensure flow into the body cavity is not obstructed by the distal of the sleeve 18. The probe 16 also extends distal of the distal edge of the sleeve 18 during insertion so as not to be obstructed by the sleeve 18. In embodiments wherein the tip 14 is hollow, the tip of the probe 16 can extend into the tip.

One example of the relative size of the lumens 15b and 15 c, also referred to herein as channels, is illustrated in the cross-sectional view of Figure 2. The lumen can be smaller or larger than those shown. In the embodiment of Figure 2, the probe lumen 15c is larger than the fluid lumen 15b, however, in alternate embodiments, the lumens can be the same or substantially the same size, or in other alternate embodiments, the fluid lumen 15b could be larger than the probe lumen 15c. The lumens 15b and 15c are shown as circular in configuration, however, other shaped lumens are also contemplated for one or both of the lumens. Further one or both of the lumens can vary in cross- sectional configuration along a part of its length. Also, note that additional lumens can be provided for infusion of fluids.

In preferred embodiments, lumens 15b and 15c are parallel to each other within the sheath 13 of trocar 12. In alternate embodiments, the two lumens 15b and 15c are not parallel to each other. For example, at the distal end, or at the proximal end, or at an intermediate portion, one or both of the channels can angle. In any case, the two channels 15b and 15c are preferably independent so as not to communicate with each other. In alternate embodiments, the two channels can communicate with each other. Channel 15c can have a small volume of an ultrasound gel or liquid to limit or fully block air interface. In addition, or in lieu of such gel or liquid in the channel 15c, ultrasound probe 16 can be dipped in gel before being placed into channel 15c or before being placed through the sleeve 32, if provided as in the embodiment described below.

Sleeve (cannula) 18 includes a lumen 25 with a proximal opening 27 at hub 24 and a distal opening 22 as shown in Figure 5C. When inserted into opening 27 and through the lumen 25 of sleeve 18, trocar tip 14 of trocar 12 extends out of distal opening 22 of the sleeve 18, and past the distal edge 23 of the sleeve 18 (see e.g., Figure 3A) for penetration through tissue into the body cavity. The penetrating tip 14 of trocar 12 is sonolucent to allow passage of ultrasonic waves. That is, the trocar tip 14 is composed of material that encases the advancing head of the ultrasound probe 16 while being sonolucent and not creating shadows. Wavelengths utilized will allow differentiating between the different layers of the abdominal wall. The penetrating tip 14 also allows for passage of gas or of liquid into the body through the distal opening for transduction and pain reduction and/or Periumbilical Ultrasound Guided Saline Infusion. With the provision of two lumens in the trocar sheath 13, the positioning of the probe 16 within the sheath 13 does not interfere with such infusion of liquid.

As noted above, the lumen 15c of sheath 13 of trocar 12 is dimensioned and configured to receive ultrasonic probe 16. The probe 16 extends through the length of the lumen 15c terminating at a distal end 16a (Figure 4B) adjacent to or within trocar tip 14. The probe 16 can extend in some embodiments all the way to the very tip of trocar 12 if the tip is designed with an opening of sufficient dimension to receive the probe, such as a cylindrical tip with a beveled edge. At the proximal end of the probe 16 is a cable or cord 20 for connection to an ultrasound machine (generator) S (Figure 2) for generating ultrasonic waves to the probe 16 to enable visualization. The ultrasonic waves are used solely for visualization and thus the trocar is insertable solely via manual insertion without the aid of electrosurgical or ultrasonic energy.

The cable 20 in some embodiments is contained in a sterile sheath 32 to protect the cord 20 of the ultrasound probe 16 as shown in Figures 1 and Cable (cord) 20 connects the probe 16 to the machine S for generation of ultrasonic waves. The sheath 32 can be of flexible material such as nylon and can be attached to the proximal end of the trocar 12, as shown schematically in Figure 1, and can for example be attached to the hub 15, e.g., attached to the proximal flange 15e (Figure 5B) of hub 15. Alternatively, the sheath can just be positioned over the cable as in Figure 2. The cable sheath 32 also provides for sterility of the cord 20 so the cord does not have to be resterilized for subsequent use.

It is also contemplated that the ultrasonic probe can be connected wirelessly to an ultrasonic generator so that a cord is not required. In such wireless connection, sheath 32 would also not be required.

Sleeve 18 includes a hub 24 with a port 24a (Figure 5C) for insertion of a fluid, e.g., gas, through the lumen 25 and into the body cavity, e.g., to establish pneumoperitoneum via connection to a source of CO2. As discussed above, trocar 12 is positioned within lumen 25 of sleeve 18. The sleeve length is designed so the trocar length can extend past its distal edge.

The miniature ultrasound transducer is therefore housed in the sheath 13 of trocar 12 of the present invention. The transducer 16 is positioned at the tip of the trocar 13 and allows injection of fluid in front of the advancing tip 14, thus permitting the inspection of the abdominal wall layers in front of the tip 14. The transducer 16 thereby allows for visualization via ultrasonic waves while the sharp trocar itself is used to penetrate the tissue into the body cavity. In this way, as noted above, the ultrasound is not used as a source of energy to aid insertion; the ultrasound is used solely for visualization. As discussed above, the sheath 13 has two lumens extending therein. One lumen, lumen 15c, as noted above, is dimensioned and configured to receive the ultrasonic probe 16; the other lumen, lumen 15b (Figure 2), is radially spaced from lumen 15c and provides a channel for a) injection of saline (PUGSI - Periumbilical Ultrasound Guided Saline Infusion), b) for injection of anesthetic material, e.g., local anesthetic solution to create pain blocks for regional anesthesia, and/or c) for injection of other fluids. (Note “fluid” denotes a gas or liquid).

As noted above, lumens 15b and 15c can be of a size and shape other than that depicted in Figure 2. The sleeve 18 has a lumen 25 dimensioned and configured to receive trocar 12. Thus, the trocar system 10, which includes the sleeve (cannula) 18, trocar 12 and ultrasound probe 16 in preferred embodiments, has the ability to provide for placement of anesthetic solutions in the appropriate planes of the abdominal wall and perform Rectus Sheath Plane Block and Transverse Abdominis Plane block or any other blocks. The system can also be used to inject extended release formulations of local anesthetic to create a block that will persist after the surgery without the need to use catheters and a pump. The injection of saline or local anesthetic through the injection channel is provided in front of the penetrating tip 14 of the trocar system.

In alternate embodiments, a fluid channel for saline, anesthetic, etc., can be provided in sleeve 18 in lieu of or in addition to the fluid channel of sheath 13 of trocar 12. Thus, it is also contemplated that three or more lumens can be provided in the trocar system - one for the ultrasound probe and the others for injection of various fluids which can be in the trocar sheath 13 and/or the cannula 18.

The hub can be part of the trocar as described above or alternatively part of the sleeve. As part of the sleeve, infusion can be provided in a lumen in the sheath, e.g., within a wall of the sheath.

As discussed above, the system 10 of the present invention includes a trocar 12 with an ultrasonic probe 16 and sleeve 18 to form a complete port system. These three components can be packaged as a unit or a kit with the trocar 12 used with the sleeve 18 of the present invention. In alternate embodiments, the trocar 12 with ultrasonic probe 16 can be used with sleeves other than sleeve 18. In such systems, the trocar and ultrasonic probe can be packaged as a unit or kit without a sleeve or alternately packaged with sleeve(s) other than sleeve 18. One or more of the components (trocar, probe and sleeve) can also in alternate embodiments be packaged separately.

The transducer can be provided as part of the system or alternatively is already available in the OR as part of other systems.

The transducer can be disposable or sterilizable.

In alternate embodiments, the trocar system includes an elastic sleeve. The trocar can be used for entry at several different locations on the abdomen, each time leaving behind another elastic sleeve (or sleeve of other materials) for port use. That is, the trocar can be used as the insertion tool for placement of several cannulas (sleeves) at desired locations of the surgical procedure, each time the trocar being withdrawn from the cannula after insertion and temporarily/removably placed within another cannula for insertion of that cannula. It should be appreciated that the trocar can also be used for entry into other body cavities or regions.

In some embodiments, the probe 16 can be reusable and the trocar 13 and sleeve 18 disposable. The probe is protected within the trocar tip 14 and not exposed within the body cavity.

In use, the trocar 12, with the ultrasonic probe 16 positioned therein, is inserted into sleeve 18 outside the patient's body. Alternatively, the trocar 12 can first be inserted into the sleeve 18 and then the ultrasonic probe 16 inserted therein. In another alternate embodiment, the probe 16 and trocar 12 are provided as a single attached integral unit (the probe 16 non-removably positioned (secured) in the trocar 12, and protected/shielded therein, which is then inserted into sleeve 18. In any of these embodiments, the assembled unit is then inserted through the abdomen (or other body region) into the body cavity under visualization (forward imaging) as the surgeon can view insertion on the monitor via the ultrasonic waves emitted by the probe 16 through the sonolucent tip 14 of the trocar 12 to ensure in real time that there are no abdominal wall vessels, bowel adhesions or large blood vessels in front of the advancing tip 14 of trocar 12. Once safely inserted, the trocar 12 and probe 16 are removed from the sleeve 18 and the sleeve 18 is left in place to provide an entry port into the abdominal cavity (or other body cavity) for insertion of laparoscopic instruments through the port into the body cavity. The trocar 12 with the ultrasonic prove 16 therein can then be inserted into another sleeve 18 and inserted into the body cavity for placement of the sleeve 18, and then the trocar 12 and probe 16 withdrawn from the sleeve 18. Note the trocar 12 and probe 16 can be used for placement of multiple cannulas, or if desired, the probe 16 removed, and just the trocar 12 used for placement of subsequent cannulas.

The trocar 12 can be dimensioned to fit through various sized trocar ports. In some embodiments, it is dimensioned to fit through a 3 mm port. In other embodiments it is dimensioned to fit through a 5mm port. It is also contemplated that the trocar can be dimensioned, i.e., have an outer diameter, to fit through other size trocar ports.

The trocar system components can be composed of disposable materials so they are discarded after a single use. Alternatively, one or more of the components can be composed of reusable materials and sterilized after use for use in another surgical procedure.

Although the apparatus, system and methods of the subject disclosure have been described with respect to preferred embodiments, which constitute non-limiting examples, those skilled in the art will readily appreciate that changes and modifications may be made thereto without departing from the spirit and scope of the present disclosure as defined in the claims herein.

Additionally, persons skilled in the art will understand that the elements and features shown or described in connection with one embodiment may be combined with those of another embodiment without departing from the scope of the present invention and will appreciate further features and advantages of the presently disclosed subject matter based on the description provided.

Throughout the present disclosure, terms such as “approximately,” “about”, “generally,” “substantially,” and the like should be understood to allow for variations in any numerical range or concept with which they are associated. It is intended that the use of terms such as “approximately” and “generally” and “about” should be understood to encompass variations on the order of 25%, or to allow for manufacturing tolerances and/or deviations in design.

Although terms such as “first,” “second,” “third,” etc., may be used herein to describe various operations, elements, components, regions, and/or sections, these operations, elements, components, regions, and/or sections should not be limited by the use of these terms in that these terms are used to distinguish one operation, element, component, region, or section from another. Thus, unless expressly stated otherwise, a first operation, element, component, region, or section could be termed a second operation, element, component, region, or section without departing from the scope of the present disclosure.

Each and every claim is incorporated as further disclosure into the specification and represents embodiments of the present disclosure. Also, the phrases “at least one of A, B, and C" and “A and/or B and/or C” should each be interpreted to include only A, only B, only C, or any combination of A, B, and C.

Claims

WHAT IS CLAIMED IS

1. A system for entry into a body cavity of a patient, the system comprising: a. a trocar having a sheath and a penetrating tip at a distal portion, the sheath having a first lumen configured and dimensioned to receive an ultrasonic probe for visualization during entry of the trocar into the body cavity; b. a sleeve having a second lumen dimensioned and configured to removably receive the trocar, the penetrating tip of the trocar extending past a distal end of the sleeve during insertion of the trocar into the body cavity; and c. an ultrasonic probe removably insertable into the first lumen of the sheath of the trocar, the ultrasonic probe terminating adjacent or within the penetrating tip of the trocar for visualization via ultrasound in real time during entry of the trocar and sleeve into the body cavity, the ultrasonic probe terminating distally of the distal end of the sleeve during entry of the trocar into the body cavity.

2. The system of claim 1 , wherein the trocar has an additional lumen for injection of fluids.

3. The system of claim 2, wherein the first lumen and the additional lumen are substantially parallel.

4. The system of claim 2, wherein the additional lumen is non-linear so that at least a portion is not parallel with the first lumen.

5. The system of claim 2 wherein the trocar has a first port in communication with the first lumen and a second port in communication with the additional lumen.

6. The system of claim 2, wherein the additional lumen has a cross-sectional dimension smaller than a cross-sectional dimension of the first lumen.

7. The system of claim 1, further comprising a covering attached to a proximal region of the trocar, the covering providing a protective sheath for a cable extending from the ultrasonic probe to an ultrasound generator.

8. The system of claim 1 , wherein the sleeve has a lumen for infusion of fluids.

9. The system of claim 2, wherein the additional lumen provides a passage for an anesthetic through the penetrating tip of the trocar.

10. A trocar for entry into a body cavity of a patient, the trocar having a sheath and a penetrating tip, the sheath having a first lumen configured and dimensioned to removably receive an ultrasonic probe for visualization during entry of the trocar into the body cavity and the trocar insertable solely via manual insertion without the application of electrosurgical or ultrasonic energy to the penetrating tip.

11. The trocar of claim 10, wherein the sheath has a second lumen configured for infusion of fluids, the second lumen having a distal opening for passage of fluid through the penetrating tip of the trocar.

12. The trocar of claim 10, wherein the penetrating tip is configured such that a tip of the probe extends within an internal space in the penetrating tip.

13. The trocar of claim 11. wherein the second lumen provides passage for a local anesthetic.

14. A method of insertion of a trocar into a body cavity of a patient, the method comprising the steps of: a) inserting an ultrasonic probe into a lumen of a trocar so that the probe terminates adjacent or within a penetrating tip of the trocar; b) inserting the trocar into the body cavity while visualizing via ultrasound entry during insertion, the trocar inserted within an outer sleeve and the ultrasonic probe and penetrating tip of the trocar extending beyond a distal edge of the outer sleeve; and c) removing the trocar from the body cavity leaving the outer sleeve in the body for access to the body cavity of the patient; and d) either before, during or after step (c), removing the ultrasonic probe from the trocar.

15. The method of claim 14, wherein the trocar is inserted solely by manual insertion without the application of electrosurgical or ultrasonic energy to the penetrating tip.

16. The method of claim 15, further comprising the step of infusing a fluid into the body cavity or tissue layers through a second lumen in the trocar.

17. The method of claim 16, wherein the fluid is an anesthetic.

18. The method of claim 16, wherein the fluid is saline.

19. The method of claim 14, further comprising the step of infusing a flood through the outer sleeve.

20. The method of claim 14, wherein the probe allows the user to see in real time blood vessels and visceral organs close to the advancing tip of the trocar.