Patent Description:
The present disclosure relates to surgical instruments and methods of their use, and more particularly to minimally invasive surgical instruments, an exchanger surgical access port, and methods of using an exchanger surgical access port so that multiple instruments can be used therein.

Examples of minimally invasive surgical assemblies and related equipment are described in <CIT>, <CIT>, <CIT>, <CIT>, <CIT>. (published as <CIT>), <CIT> (published as <CIT> ), <CIT>. (published as <CIT>), and <CIT> (published as <CIT>). <CIT> presents various surgical instruments for laparoscopic procedures is provided, which are adapted and configured to aspirate and retract a hollow organ, such as a gallbladder. The surgical instruments can includes a needle body, an anchor that is deployable with respect to the needle body, which is adapted and configured for engaging and retracting the hollow organ. Moreover, an aperture can be provided in connection with the needle body, which is adapted and configured for permitting aspiration of contents of the hollow organ. The anchor can be held within, and deployable from, a lumen of the needle body, or held on, and deployable from, an outside surface of the needle body.

<CIT> Al discloses a needle with a hub and fixing means for fixing the surgical assembly relative to the body of the patient. The fixing means comprises a compressible ball and an actuating body.

Over the last two decades, minimally invasive surgery has become the standard for many types of surgeries which were previously accomplished through open surgery. Minimally invasive surgery generally involves introducing an optical element (e.g., laparoscopic or endoscope) through a surgical or natural port in the body, advancing one or more surgical instruments through additional ports or through the endoscope, conducting the surgery with the surgical instruments, and withdrawing the instruments and scope from the body. In laparoscopic surgery (broadly defined herein to be any surgery where a port is made via a surgical incision, including but not limited to abdominal laparoscopy, arthroscopy, spinal laparoscopy, etc.), a port for a scope is typically made using a surgical trocar assembly.

The trocar assembly often includes a port, a sharp pointed element (trocar) extending through and beyond the distal end of the port, and at least in the case of abdominal laparoscopy, a sealing valve on the proximal portion of the port. The term trocar typically includes a combination of cooperating elements such as a cannula, a seal housing, and an obturator. First the obturator cuts or pierces the body wall so that the cannula may be inserted. The cannula defines a pathway through a body wall through which the surgical instruments are inserted. Finally, the seal housing provides an isolation of the cannula so that if insufflation is employed the body region remains distended and sealed. All three components are usually fitted together and used as a single unit for passage by one or more surgical instruments through the body wall and into a body cavity.

Laparoscopic surgery typically begins as the surgeon inserts a large bore needle through a body wall and into the internal region associated with the body wall. Next, an inflation or insufflation gas is pumped into the internal region until it is properly distended. The body wall and internal region are now ready for insertion of trocars.

Typically, a small incision is made in the skin at a desired location in the patient. The incision may be made via a scalpel or other sharp instrument. The trocar assembly, with the trocar extending out of the port, is then forced through the incision via the obturator which cuts or pierces the body wall, thereby widening the incision and permitting the port to extend through the incision, past any fascia, and into the body (cavity). The trocar is then withdrawn, leaving the port in place.

If not already distended, an insufflation element may be attached to the trocar port in order to insufflate the surgical site. An optical element may then be introduced through the trocar port. Additional ports are then typically made so that additional laparoscopic instruments may be introduced into the body.

Trocar assemblies are manufactured in different sizes. Typical trocar port sizes include diameters of about <NUM>, <NUM>, and <NUM>, which are sized to permit variously sized laparoscopic instruments to be introduced therethrough including, e.g., graspers, dissectors, staplers, scissors, suction/irrigators, clamps, forceps, biopsy forceps, etc. While <NUM> diameter trocar ports are relatively small, in some circumstances where internal working space is limited (e.g., children), it is difficult to place multiple <NUM> diameter ports in the limited area of the patient. In addition, <NUM> diameter trocar ports tend to limit movement of instruments inside the abdominal cavity to a great extent. Such a conventional <NUM> diameter trocar has a sealing valve and sealing mechanism and therefore the opening for the surgical instrument is limited.

Further, while laparoscopic surgery has reduced the trauma associated with various surgical procedures and has concomitantly reduced recovery time from these surgeries, there always remains a desire in the art to further reduce the trauma to the patient.

One area of trauma associated with laparoscopic surgery identified by the inventors hereof as being susceptible of reduction are the scars which result from the trocar ports used. In many laparoscopic surgeries, three or more trocar incisions are made. For example, in laparoscopic hernia repair surgery, four trocar incisions are typically made, with one incision for insufflating the abdomen and inserting the optical device, two incisions for trocar ports for inserting graspers therethrough, and a fourth port for passing a stapler therethrough. Those skilled in the art and those who have undergone surgical procedures understand that even the <NUM> diameter trocar ports leave holes which must be stitched and which result in scars. Scar tissue may affect the internal portion of the fascia as well as the cosmetic appearance of the skin, which may be detrimental for the patient or even a surgeon if that area of the skin is subject to a later incision or medical procedure.

A second area of trauma associated with laparoscopic surgery relates to trauma resulting from the manipulation (e.g., angling) of the trocar ports required in order to conduct the surgery due to inexact placement. Angling of the port can cause tearing at the incision periphery. Such tearing can lead to extensive scar tissue and in general an extension of the incision area. Again, conventional <NUM> diameter trocars including a valve and sealing mechanism are hard to angle in regard to the opening for the surgical instrument. Thus a need exists for a surgical access port which is not subject to tearing fascia at the point of incision into the patient.

A further problem with surgical instruments including a needle tip is inadvertent needle penetration in tissue and resulting scarring or even more serious complications during the surgery if other tissue is nicked or penetrated unintentionally. Indeed, placing a sharp instrument such as an inflation needle or trocar obturator through a body wall and into an associated internal region comes with considerable risk. The human abdomen, for example, is a tightly packed region that is filled with delicate structures and organs. There is no open space between the abdominal wall and those structures or organs until inflation gas is inserted and a pneumoperitoneum is established. Great care must be taken when placing inflation needles so as to avoid penetration of intestine, bowel or other structures. Even after insufflation is established, there is a risk of injury during placement of additional sharp instruments through the distended body wall. The body wall is comprised of skin, muscle, fat, and a thin membrane. The wall may be thick, muscular and tough or it may be lean and soft. As such, placement of a sharp obturator through the body wall requires great skill and knowledge of what lies within the internal region. The force required to insert a sharp trocar through a body wall can exceed 178N (forty pounds) in some cases. This applied force easily overcomes the pneumoperitoneum and forces the body wall down and against delicate structures where there is the danger of piercing or cutting those structures.

To combat the need for such force of insertion of a typical trocar, some surgeons have also used a technique referred to as a "cut down" procedure where successive small incisions are made until the body wall is cut through, at which time a blunt trocar or a trocar obturator is inserted with a certain level of force. This process may incur less force but it is time-consuming and may leave a deeper and larger scar. As such, a need exists for a surgical access port which is easier to insert into a body wall.

A further need exists for a surgical access port which is secured to the outer fascia of the patient. Certain known securing means include pinching of the skin which can lead to scarring and other complications, while other securing means include various adhesive measures. A less obtrusive (less scarring) yet secure means is needed so that the trocar does not move when in use.

There continues to be a need in the art for a surgical access port which reduces trauma to the patient, reduces complications to the patient, does not lead to extension of the incision area, does not lead to increased scar tissue generation, is easy to make and use, and improves safety while reducing costs to health care providers and patients and reducing the surgical time for a procedure which in turn may reduce costs and complications. The surgical access port disclosed includes a trocar having a cannula with a diameter of about <NUM> to about <NUM> including a removable obturator having a diameter of about <NUM> to about <NUM> which is capable of insertion into a patient's skin and body wall.

While conventional trocars including an obturator are known, the conventional art includes a cannula with a diameter exceeding about <NUM>. Thus there exists a need for a surgical access port which includes a smaller diameter cannula.

Further, the conventional trocars are inserted manually through force and thus a need exists where a surgical access port may be inserted via a surgical instrument itself having a needle for insertion into the patient's skin and body wall. These and other needs are met by the surgical access port disclosed and the exemplary method for insertion and the exemplary method of use.

Further, conventional trocars include a valve and sealing means so as to prevent gas leakage during insufflation. A need exists for a more streamlined trocar without an additional valve or sealing means while still maintaining sufficient insufflation during surgery. A need exists for a surgical access port without a valve or sealing means while still maintaining an acceptable gas pressure level or minimal leakage.

Other advantages of the present disclosure will become apparent from the following description and appended claims.

The surgical access port assembly of the invention is defined in claim <NUM>. The methods disclosed are not explicitly recited by the wording of the claims, they are considered useful for understanding the invention.

According to one aspect, the disclosure describes an access port assembly. The access port assembly comprises an obturator having a longitudinally extending obturator shaft including a sharp tip disposed at a distal end of the obturator shaft and a handle disposed at a proximal end of the obturator shaft, the handle including at least one finger extending spaced from the handle. The access port assembly further comprises a surgical access port having a cannula defining a hollow cannula shaft, and a tapered hub attached to a proximal end of the cannula. The tapered hub includes at least one inner ring configured to abut against the at least one finger while the obturator is inserted within the cannula of the surgical access port.

According to one aspect, the disclosure describes a surgical instrument access port assembly. The surgical instrument access port assembly comprises a surgical instrument having a needle lumen extending in a longitudinal direction including a needle tip at a distal end, and a body portion at a proximal end, the body portion including at least one recess or finger. The surgical instrument access port assembly further comprises a surgical access port having a cannula defining a hollow cannula shaft, and a tapered hub attached to a proximal end of the cannula. The tapered hub includes at least one inner ring configured to abut against the at least one recess or finger while the surgical instrument is inserted into the cannula of the surgical access port.

According to one aspect, the disclosure describes an exemplary method of using a surgical instrument access port assembly comprising a surgical instrument having a needle lumen extending in a longitudinal direction including a needle tip at a distal end, and a body portion at a proximal end, the body portion including at least one recess or finger, and including a surgical access port having a cannula defining a hollow cannula shaft, and a tapered hub attached to a proximal end of the cannula, the tapered hub including at least one inner ring configured to abut against the at least one recess or finger while the surgical instrument is inserted into the cannula of the surgical access port. The method comprises piercing a hole in a body wall with the needle tip of the needle lumen, inserting at least a portion of the needle lumen through the hole into a body cavity, advancing the surgical access port along the needle lumen in a distal direction towards the hole, and inserting the cannula of the surgical access port through the hole into the body cavity.

In accordance with aspects of the disclosure, a surgical access port assembly <NUM> may include a surgical access port with a cannula, a hub, and an obturator. In one aspect, the surgical access port may be connected or usable with a laparoscopic instrument having an elongated cannula such that the surgical access port is placed over the cannula of the laparoscopic instrument and thus does not require an obturator as the laparoscopic surgical instrument. In one aspect, the laparoscopic instrument may include a needle and the needle may pierce a patient's skin and thereafter the surgical access port may be inserted into the surgical site.

Now referring to the drawings, wherein like reference numerals refer to like elements, <FIG> shows the surgical access port assembly <NUM>, which may include a surgical access tube or a cannula <NUM> having a diameter of about <NUM> to about <NUM> thereby reducing trauma to the patient and eliminates the need for a larger incision point or for a series of small incision cuts through the various layers of fascia. In one aspect, the diameter of the cannula <NUM> may be less than about <NUM>, such as between <NUM> to about <NUM>. The incision point may be <NUM> or less depending on a diameter of the distal tip portion of the obturator or the needle of the laparoscopic surgical instrument.

Referring now to <FIG>, the surgical access port assembly <NUM> may include a surgical access port <NUM>, an obturator <NUM>, and a locking mechanism <NUM>. In one aspect, the obturator <NUM> may be eliminated and the surgical access port assembly <NUM> may be affixed over a cannula of a surgical instrument as will be described in further detail below with reference to Figures <NUM>-<NUM>.

As shown in <FIG>, the surgical access port <NUM> may have an elongated cannula <NUM>. A distal end <NUM> of the elongated cannula <NUM> may be blunt or beveled. The elongated cannula <NUM> may define a hollow cannula shaft <NUM>, through which surgical instruments or the obturator <NUM> may be inserted and pass through when the surgical access port <NUM> is in use. The elongated cannula <NUM> may include a proximal end connected to a hub <NUM>. The hub <NUM> may define an outer diameter which expands outwardly, relative to a central axis, in a proximal direction from the proximal end of the elongated cannula <NUM>. The hub <NUM> may include a portion <NUM> connected to the proximal end of the elongated cannula <NUM>, an outer ring portion <NUM> which may be used by a surgeon for manual manipulation of the surgical access port <NUM>, and a tapered open end portion <NUM> of the hub <NUM> with a diameter exceeding that of the elongated cannula <NUM>. The tapered open end portion <NUM> of the hub <NUM> may be capable of housing the obturator <NUM>, as well as providing access for surgical instruments and devices during surgery. The surgical access port <NUM> may be made of various materials that may have rigid material properties and may include metals or plastics. For example, the materials may include stainless steel, liquid crystal polymer or polycarbonate, glass-filled polycarbonate, or the like. The material should be compatible with the human fascia, body wall and any body cavity into which the surgical access port <NUM> is inserted so as to prevent or reduce any allergic reaction by the patient upon insertion. Of course, other compatible materials are of course contemplated.

Additionally, the surgical access port <NUM> may be covered or coated on the outside, and/or within the hollow cannula shaft <NUM>, with an insulating material (not shown) to prevent electrical current transfer to the patient, for instance, upon inadvertent contact with an electrical surgical apparatus such as a monopolar or bipolar surgical instrument. The insulating material may be a plastic shrink wrap or any other insulating materials such as plastics, polymers, elastomers and the like, and combinations thereof.

Turning to <FIG>, the hub <NUM> of the surgical access port <NUM> may have an inner portion including at least one inner ring, shown in <FIG> as inner rings 118A, 118B and 118C. Each of the inner rings 118A, 118B, 118C, may define a rib or groove on an inner surface of the hub <NUM>. The inner rings 118A, 118B, 118C may be used as a securing means for attaching and securing the obturator <NUM> via fingers <NUM> to the hub <NUM>. In one aspect, the inner rings 118A, 118B, 118C may be used to connect the surgical access port <NUM> to a surgical instrument or device over such instrument's cannula. In one aspect, at least one of the inner rings 118A, 118B, 118C may include an O-ring made with a compressible material so as to seal a portion of the surgical access port <NUM> and deter leakage of gas during surgical insufflation. For example, the O-ring may be made of rubbers, foams, plastics, silicones, fluorocarbons, polymers, elastomers, nitriles and the like, including combinations thereof. In one aspect, the at least one inner ring 118A, 118B, 118C including the O-ring may abut the fingers <NUM> of the obturator <NUM> when the obturator <NUM> is secured to the surgical access port <NUM>. Alternatively, the at least one inner ring 118A, 118B, 118C including the O-ring may located downstream or upstream of the fingers <NUM> of the obturator <NUM> when the obturator <NUM> is secured to the surgical access port <NUM>.

The surgical access port <NUM> may include a cap <NUM> (as shown in <FIG>) connected to the hub <NUM> via a cap tether <NUM> and a ring <NUM> secured to the hub <NUM>. In one aspect, once the surgical access port <NUM> has been inserted into the patient's body during surgery, there may be instances where a surgical instrument is not employed through the surgical access port <NUM>. The cap <NUM> may be mounted or attached to the tapered open end portion <NUM> of the hub <NUM> in order to seal the surgical access port <NUM>, thereby preventing gas leakage associated with surgical insufflation and/or to prevent contaminates from entering the body cavity.

For instance, when one surgical instrument is removed from the surgical access port <NUM> and before another surgical instrument can be inserted into the surgical access port <NUM>, the cap <NUM> may be secured to the tapered open end portion <NUM>. As a further safety measure, the cap <NUM> may also be mounted or attached to the tapered open end portion <NUM> of the hub <NUM>, prior to the surgical access port <NUM> being used on a patient, to prevent contaminates from entering into the hollow cannula shaft <NUM>. In one aspect, a tip <NUM> may be employed to engage the distal end <NUM> of the surgical access port <NUM> to also prevent contaminates from entering into the hollow cannula shaft <NUM>. Additionally, the tip <NUM> may also be used as a cover for a sharp tip <NUM> of the obturator <NUM> when the obturator <NUM> is not in use, thereby serving as a guard for the sharp tip <NUM> and preventing accidental needle tip trauma.

Turning to <FIG>, the obturator <NUM> may include an obturator shaft <NUM>, which may include a diameter that is less than or equal to a diameter of the hollow cannula shaft <NUM>. The diameter of the obturator shaft <NUM> may be less than about <NUM>, and may be in one aspect, between <NUM> to about <NUM>. As shown in <FIG>, the sharp tip <NUM> may be provided at the distal end <NUM> of the obturator shaft <NUM>. The sharp tip <NUM> may be conical in shape, blunt in shape, or may include a needle or blade (not shown) to assist in insertion of the surgical access port <NUM> into a patient's fascia and through the body cavity wall. A handle <NUM> may be disposed at a proximal end of the obturator shaft <NUM>, and may be used by a user for manual manipulation of the surgical access port assembly <NUM>. The handle <NUM> may include an end or handle <NUM> for grasping by the user, and at least one finger <NUM> for securing the obturator <NUM> to at least one inner ring 118A, 118B, 118C of the hub <NUM>, or an inner surface of the hollow cannula shaft <NUM>.

As shown in <FIG>, the finger <NUM> may connect to an inner ring 118A by flexing and snapping into place, but may be moved by light manipulation of the handle <NUM> by the user so as to remove the obturator <NUM> once the surgical access port <NUM> is in place on the patient. In use, the obturator <NUM> may be directed to penetrate the patient's fascia and a body wall to provide the surgical access port <NUM> and its cannula <NUM> with access across the body wall and into a body cavity. The obturator <NUM> may be made of various materials which are compatible with the human fascia, body wall and any body cavity into which it is inserted so as to prevent or reduce any allergic reaction by the patient upon insertion. The obturator <NUM> may be made may be a rigid plastic, rubber, polymer, elastomer, metal, and the like, and combinations thereof. Of course, other compatible materials are of course contemplated.

The surgical access port assembly <NUM> may further include a locking mechanism <NUM> to secure the surgical access port <NUM> to an outer layer of fascia of the patient. <FIG> and <FIG> illustrate exploded views of the locking mechanism <NUM>. The locking mechanism <NUM> may include a lock base <NUM> having an aperture <NUM> through which the cannula <NUM> of the surgical access port <NUM> may be inserted through. The lock base <NUM> may include at least one tab 312A, 312B, and preferably two tabs spaced apart from one another to provide a grip to the user and/or provide limits to a locking member <NUM>. The lock base <NUM>, including the tabs 312A, 312B, form a part of the locking mechanism <NUM> that is secured to the outer fascia layer of the patient such that the surgical access port <NUM> remains in a set position relative to the patient when in use. The lock base <NUM> may further include at least one screw thread or ramp <NUM> which connectable with at least one snap or finger <NUM> of the locking member <NUM>.

The locking member <NUM> may define an aperture <NUM> through which the cannula <NUM> of the surgical access port <NUM> is inserted. The locking member <NUM> may include at least two lock tabs 322A, 322B which may extend radially from the locking member <NUM> and may be used as a grip by the user, and/or to limit the rotational movement of the locking member <NUM> relative to lock base <NUM>. The locking mechanism <NUM> may be made of various materials which are compatible with the human fascia so as to prevent or reduce any allergic reaction by the patient upon adhesion thereof. The locking mechanism <NUM> may be made may be a rigid plastic, rubber, polymer, elastomer, metal, and the like, and combinations thereof. Of course, other compatible materials are of course contemplated.

The locking member <NUM> of the locking mechanism <NUM> may be rotatably attached to the lock base <NUM>. In one aspect, the locking mechanism <NUM> may include a plurality of snaps or fingers <NUM>, which may correspond to a number of screw threads <NUM> of the lock base <NUM>. Each of the plurality of snaps may extend downwardly parallel to a central axis of the locking member <NUM>. Each of the snaps or fingers <NUM> may further include a radially extending protrusion to engage with a groove of a respective screw thread or ramp <NUM>. The snaps or fingers <NUM> may engage with the screw threads or ramps <NUM>, and the locking member <NUM> may be rotated relative to the lock base <NUM>. In one aspect, as the locking member <NUM> is rotated clockwise to a locked position, the snaps or fingers <NUM> may be guided by the grooves of the screw threads to displace the locking member <NUM> axially towards the lock base <NUM>. Conversely, as the locking member <NUM> is rotated counter-clockwise to an unlocked position. The snaps or fingers <NUM> may be guided by the grooves of the screw threads to displace the locking member <NUM> axially away the lock base <NUM>. Additionally, the groove of the screw threads <NUM> may cooperate with a taper of the aperture <NUM> such that as the locking member <NUM> is threaded axially towards the lock base <NUM>, the snaps or fingers <NUM> may apply a compressive force inwardly towards a center of the aperture <NUM>, and may cause the aperture <NUM> is compress inwardly. Of course, it will be appreciated to one skilled in the art in view of this disclosure that the direction of the threading may be reversed such that a counter-clockwise rotation of the locking member <NUM> may be used to place the locking mechanism <NUM> in the locked position, while a clockwise rotation of the locking member <NUM> may be used to place the locking mechanism <NUM> in the unlocked position.

The locking mechanism <NUM> may further include a ball <NUM>, shown in detail in <FIG>, and may be disposed between the lock base <NUM> and the locking member <NUM>. The ball <NUM> may be housed between the apertures <NUM> and <NUM> of the lock base <NUM> and the locking member <NUM>, respectively. The ball <NUM> may include an opening or aperture <NUM> through which the cannula <NUM> of the surgical access port <NUM> may be inserted. The ball <NUM> may be made of a material which is compressible, such as plastic, polymers, elastomers, rubber or the like. The ball <NUM> may also include at least one slit <NUM> which is compressible when the locking mechanism <NUM> is in a locked position, as will be described in further detail below. The slit <NUM> may enable the surgical access port <NUM> to be moved at an angle within the apertures <NUM>, <NUM>, and <NUM>. In one aspect, when the locking mechanism <NUM> is in an unlocked position, the ball <NUM> may be rotated about <NUM>° relative to a horizontal plane defined by the lock base <NUM> and <NUM>° relative to a horizontal plane of the locking member <NUM>. The locking mechanism <NUM> may then be placed in a locked position, whereby the locking member <NUM> compresses the aperture <NUM> inwardly, which may in turn cause the ball <NUM> to compress inwardly by displacing at least a surface of the ball <NUM> via the at least one slit <NUM>, thus securing a position of the ball <NUM> relative to the lock base <NUM> and the locking member <NUM>.

Once an angle of the surgical access port <NUM> is chosen or finalized, the locking mechanism <NUM> is actuated by rotating the lock tabs 322A, 322B relative to the base tabs 312A, 312B. In one aspect, the user may squeeze or pinch tabs 312A and 322A together using a thumb and index finger, for example, which may in turn squeeze and collapse the at least one slit <NUM> of the ball <NUM>. To unlock the locking mechanism <NUM> the user may squeeze or pinch the opposite tabs, such as tabs 312B and 322B together, using a thumb and index finger, which may in turn release the at least one slit <NUM> of the ball <NUM>.

The locking mechanism <NUM> may further be secured to the patient's skin and thus secure the surgical access port <NUM> when it is inserted into the patient's fascia. An underside of the base <NUM> may be coated with an adhesive and the adhesive may be covered and protected by a paper liner <NUM> prior to use. The paper liner <NUM> may include a tab <NUM> to assist the user in gripping and removing the paper liner <NUM> from the base <NUM>. In one aspect, the paper liner <NUM> may be perforated or may include a separation line to assist in the removal of the paper liner <NUM> even if one or more of the surgical access port <NUM>, the obturator <NUM>, and the surgical instrument has been inserted through the locking mechanism <NUM>. Once the paper liner <NUM> is removed, the adhesive is exposed such that the adhesive may be placed onto the fascia of the patient to thereby secure the locking mechanism <NUM> and surgical access port <NUM> to the patient's fascia. Any known adhesive compatible to the fascia of a patient may be used. By securing the locking mechanism <NUM> to the fascia of the patient, the surgical access port <NUM> may be secured without the need for pinching or other securing means which may be harmful to the patient. This benefit is of immediate notice and effect to the surgeon and to the patient's fascia.

As shown in <FIG> and <FIG>, the lock base <NUM> may comprise of a base platform <NUM>, having a flat bottom surface, on which an adhesive layer and a peelable protective paper liner <NUM> may be applied, a top surface which defines at least two finger tabs 312A, 213B, and a central ring <NUM> with an inner surface defining the aperture <NUM>. The central ring <NUM> may include a slightly tapered frustoconical inner surface for receiving the ball <NUM> and may further include at least two or three separate outer screw threads or ramps on an outer surface which are recessed into the central ring <NUM> and start at the top surface of the ring <NUM> and descend as they extend clockwise about the ring <NUM> until they reach a top of the base platform <NUM>, thereby forming small ledges for purposes explained hereinafter.

In one aspect, the ball <NUM> may be a hollow plastic ball provided with opposite circular openings sized to closely receive the cannula <NUM> of the surgical access port assembly <NUM>, and a plurality of slits <NUM> which extend about <NUM>° from the opening in the direction of the axis defined by openings. With the slits <NUM>, the ball <NUM> may be compressed such that if a circumferential force is applied to the ball <NUM>, the lobes <NUM> formed between the slits <NUM> will move toward each other. The locking member <NUM> may comprise a cap with at least two extending arms or tabs 322A, 322B. The cap <NUM> may have a top wall <NUM> with a central opening <NUM> defining the aperture <NUM> through which the top portion of the ball <NUM> can extend. The cap <NUM> may also have a side wall with cut-outs which define engagement fingers or snaps or fingers <NUM>. The engagement fingers <NUM> may have bosses which are sized to ride in the ramps of the central ring <NUM> of the lock base <NUM> and the inward facing bosses may be ramped or beveled.

With reference to <FIG> and <FIG>, assembly of the locking mechanism <NUM> will now be described. In one aspect, the ball <NUM> may be placed between the lock base <NUM> and the locking member <NUM> with the bosses 324a of the engagement fingers <NUM> being forced over the ledges and into engagement with the ramps <NUM> of the lock base <NUM>. In this position a bottom of the side wall of the cap <NUM> of the locking member <NUM> is spaced relative to a top surface of the base platform <NUM> of the lock base <NUM>, and the ball <NUM> is free to rotate as guided by the ring <NUM> and central opening <NUM>. Thus, when the cannula <NUM> of the surgical access port assembly <NUM> is inserted through the circular openings <NUM> of the ball <NUM>, the cannula <NUM> will have considerable freedom of movement, limited only by the size of the central opening <NUM> of the locking member <NUM> and the frustoconical central opening <NUM> of the lock base <NUM>. In one aspect, the locking mechanism <NUM> may be provided a freedom of movement of at least <NUM>° relative to the vertical in all directions for the cannula <NUM> of the present disclosure, thereby resulting in a range of angles for insertion of the surgical access port assembly <NUM>. However, when the locking member <NUM> is rotated clockwise relative to the lock base <NUM> (typically by squeezing finger tabs 312A, 322A together with a thumb and forefinger), the bosses 324a ride down the ramps <NUM> and pull the locking member <NUM> closer to the lock base <NUM>. Since the ball <NUM> cannot move downward in the ring <NUM>, the central opening <NUM> provides a circumferential force to the ball <NUM> (i.e., it compresses the ball), thereby forcing the lobes <NUM> inward, and applying friction to the cannula <NUM> of the surgical access port assembly <NUM>, when installed. As a result, not only is the cannula <NUM> locked in place relative to the ball <NUM>, but the ball <NUM> is fixed in its rotational orientation relative to the locking mechanism <NUM>. The ball <NUM> and cannula <NUM> may be released by rotating the locking member <NUM> counterclockwise relative to the lock base <NUM> (typically by squeezing the other finger tabs 312B, 322B together). The locking member <NUM>, however, cannot lift off the lock base <NUM> because the ledges act as stops.

<FIG> show the surgical access port <NUM> connected to a needle lumen <NUM> having a lumen shaft <NUM> and an end effector such as a needle <NUM>, in accordance with an aspect of the present disclosure. The needle lumen <NUM> may be inserted into a reposable handgrip surgical instrument or any other surgical instrument. The needle lumen <NUM> may be inserted into an aperture of the surgical access port <NUM> via the open end tapered portion <NUM> of the hub <NUM> and through the hollow cannula shaft <NUM> of the elongated cannula <NUM> (as shown in <FIG>). The surgical access port <NUM>, including the locking mechanism <NUM> (as generally shown in <FIG>), may thus be connected to the needle lumen <NUM> by friction and light compression of the inner rings 118A, 118B, and 118C of the hub <NUM>. In one aspect, the needle lumen <NUM> may comprise a body portion <NUM> defining a recessed portion <NUM>. The body portion <NUM> may be inserted into the tapered open end portion <NUM> such that the recessed portion <NUM> extends beyond at least one of the inner rings 118A, and abuts against the inner ring 118A. In one aspect, a distal portion <NUM> of the body portion <NUM> may define a tapered outer surface corresponding with a tapered inner surface of the hub <NUM>, as shown in <FIG>.

The recessed portion <NUM> of the needle lumen <NUM> may be provided to abut at least one of the inner rings 118A, 118B, and 118C to thereby secure the needle lumen <NUM> to the hub <NUM>. Additionally, or alternatively, fingers like the ones found on the obturator <NUM> may be provided to interact with one or more of the inner rings 118A, 118B, and 118C of the hub <NUM>. In use the needle <NUM> of the needle lumen <NUM> may be used to penetrate the patient's fascia, the surgical access port <NUM> may be moved in an axial movement down the needle lumen <NUM> via manual manipulation of the outer ring <NUM> and the surgical access port <NUM> may be inserted into the patient's fascia and through the body wall.

In accordance with an aspect of the present disclosure, the surgical access port <NUM> including the locking mechanism <NUM> may be connected to a lumen of a surgical instrument or device wherein the lumen has a needle or other insertion means. The lumen of the surgical instrument may be inserted into the patient's fascia and the surgical access port <NUM> may be slid down the length of the lumen and inserted into the patient's fascia and the body wall. Generally, prior to the lumen of the surgical instrument being inserted into the patient, the surgical access port <NUM> may be attached to the lumen of a percutaneous instrument, or single needle lumen, by sliding the surgical access port <NUM> along a length of the lumen and connected to the instrument via the one or more inner rings 118A, 118B, 118C of the surgical access port <NUM>. After the surgical instrument has been inserted into the patient, the surgical access port <NUM> may then be advanced along the lumen, away from the percutaneous instrument if in such embodiment, into the patient's fascia, through the body wall and into a body cavity. The lumen of the surgical instrument may then be removed while the surgical access port <NUM> remains in the body cavity. In one aspect, the removed surgical instrument may be replaced with a different surgical instrument.

In one aspect, the surgical instrument may be a needlescopic instrument having a lumen with a diameter of less than about <NUM>. In one aspect, the diameter of the lumen is between <NUM> to <NUM>, with the lumen including a needle and may include additional end-effectors such as jaws. The surgical access port <NUM> may be placed around the lumen of the surgical instrument while the surgical instrument is outside of the patient, but can be unsnapped from the surgical instrument, and inserted into the patient's fascia, providing a guide for additional percutaneous instruments to be inserted therein.

As shown in <FIG>, exemplary methods of using the surgical access port <NUM> together with a surgical instrument <NUM> will now be described. The surgical instrument <NUM> may include an instrument body <NUM>, a handle <NUM>, a trigger <NUM>, a lumen <NUM>, and a needle tip <NUM> located at a distal end of the surgical instrument <NUM>. In one aspect, the surgical instrument <NUM> may be a percutaneous surgical instrument that is pre-packaged and installed with the surgical access port <NUM>, with the lumen <NUM> inserted therethrough, and the surgical access port <NUM> may be snapped in place and operatively attached to the handle <NUM>. Alternatively, the surgical access port <NUM> may be provided separately and placed onto the lumen <NUM> of the surgical instrument <NUM> by the user prior to inserting a distal end of the lumen <NUM>, including the needle tip <NUM>, of the instrument <NUM> into the patient's fascia, body wall, and/or body cavity. In one aspect, the lumen <NUM> and needle tip <NUM> may be in the form of the needle lumen <NUM> shown in <FIG>, and may be interchangeably attached to the handle <NUM>. In one aspect, the surgical access port <NUM> may be attached to the surgical instrument <NUM> as shown in <FIG>.

Next, as shown in <FIG> and <FIG>, the needle tip <NUM> of the surgical instrument <NUM> may be used to penetrate through a body wall <NUM> of the patient, piercing a hole <NUM> through the body wall <NUM>. In one aspect, the body wall <NUM> may be a part of the abdominal wall of the patient. A length of the lumen <NUM> of the surgical instrument <NUM> may be inserted into a body cavity <NUM> defined at least in part by the body wall <NUM> of the patient. Once a length of the lumen <NUM> has been inserted into the body cavity, the surgical access port may be mounted to the body wall <NUM> in order for other operative instruments to be later inserted into the same position, as will be described in further detail below.

In one aspect, once the lumen <NUM> has been inserted into the body cavity <NUM>, the surgical access port <NUM> may be slid down and advanced over the lumen <NUM>, in a distal direction, towards the body cavity <NUM>, as shown in <FIG>. The elongated cannula <NUM> of the surgical access port <NUM> may then be inserted through the hole <NUM> generally created by the needle tip <NUM> and lumen <NUM> of the surgical instrument <NUM>, as discussed above. In the process, the elongated cannula <NUM> may widen the hole <NUM> created by the needle tip <NUM> and lumen <NUM>.

The surgical access port <NUM> may then be further secured to the patient using the locking mechanism <NUM>. The locking mechanism <NUM> may be pre-packaged and installed on the surgical instrument <NUM> together with the surgical access port <NUM>. Alternatively, prior to the surgical instrument <NUM> being inserted into the patient, the locking mechanism <NUM> may be advanced over the lumen <NUM> of the surgical instrument, in a proximal direction. The locking mechanism <NUM> may then be further advanced over the elongated cannula <NUM> and locked to the surgical access port <NUM> by squeezing or pinching tabs 312A and 322A of the locking mechanism <NUM> together to place the device in a locked position. After the elongated cannula <NUM> of the surgical access port <NUM> has been inserted through the hole <NUM>, the adhesive portion of the base <NUM> may be secured onto the patient's fascia to secure the surgical access port <NUM> in place.

Referring to <FIG>, in one aspect, the surgical instrument <NUM> may be operated within the body cavity <NUM> prior to the surgical access port <NUM> being inserted into the hole <NUM>. For example, the surgical instrument <NUM> may include a pair of graspers <NUM> which may be used to perform a grasping function within the body cavity <NUM> prior to and/or after the surgical access port <NUM> has been inserted into the hole <NUM>.

Referring to <FIG>, once the surgical instrument <NUM> is no longer needed, the surgical access port <NUM> may be left in the body cavity <NUM>. In one aspect, the cap <NUM> (shown in <FIG>) may be attached to the hub of the surgical access port <NUM> in order to seal the tapered open end portion <NUM> of the hub <NUM>. When the surgical instrument <NUM> or other instruments need to be inserted into the body cavity <NUM>, the cap <NUM> may be removed and the surgical instrument <NUM> or other instruments may be inserted through the surgical access port <NUM>. As will be appreciated by one skilled in the art in view of the present disclosure, a number of different instruments may access the body cavity <NUM> via the surgical access port <NUM> throughout a surgery. Once the surgery is complete the surgical access port <NUM> may be removed manually by pulling the surgical access port <NUM> away from the body cavity <NUM>, or the surgical access port <NUM> may be slid back up the last instrument's shaft or lumen, snapped onto the back of said instrument's shaft and/or handle using the at least inner rings 118A, 118B, 118C of the surgical access port <NUM>, and removed from the patient's body cavity, back through the body wall <NUM> and out of the patient's fascia.

In one aspect, the surgical access port assembly <NUM> may be used after the surgeon has inserted an endoscope with a camera into a body cavity <NUM>, wherein the cavity <NUM> may be subject to insufflation and/or distended. Using the endoscope and camera, the surgeon would locate a part of the patient's fascia for insertion of the surgical access port <NUM>. The tip <NUM> of the surgical access port <NUM> may be removed to reveal the sharp tip <NUM> of the obturator <NUM>. The surgeon would either create a small incision in the patient's fascia or use sufficient force to insert the surgical access port <NUM> via the sharp tip <NUM> at the distal end of the obturator <NUM>. Once the surgical access port <NUM> has been inserted into the body cavity <NUM>, the obturator <NUM> may be removed. Either during the insertion step or after, the surgeon can adjust the angle of the surgical access port <NUM> via movement of the locking mechanism <NUM>, more specifically via the movements of the ball <NUM>. The locking mechanism <NUM> may be locked and also adhered to the patient's fascia via the adhesive on the lower portion of the base <NUM>, with the surgeon removing the paper liner <NUM> via the tab <NUM>. Once inserted, the distal end of the surgical access port <NUM> will be within the body cavity <NUM> while the proximal end of the cannula <NUM> and the hub <NUM> extend out of the patient's fascia. The body cavity <NUM> is therefore accessible for various surgical instruments.

Further advantages of the surgical access port assembly <NUM> of the present disclosure include retention of abdominal pressure during an abdominal surgery. Also the disclosed device when in use during a surgery may be self-sealing without compromising insufflation pressure. While not being bound by theory, the inventors of the present devices believe that dynamic friction between the outer edge of the small diameter cannula <NUM> and the patient's fascia and body wall result in minimal gas leakage during insufflation. Furthermore, in one aspect, control of an entry depth of the surgical access port <NUM> may be possible through retention and/or pivot of the locking mechanism <NUM>. Thus, in use, the surgical access port assembly <NUM> of the present disclosure may enable a smaller diameter incision point, better angle and control for surgical instrument access into the body cavity, while still maintaining sufficient insufflation. The absence of a valve and sealing mechanism may result in lower friction which in turn may improve precision during the surgery. Such improved precision also reduces the surgical time and duration of the surgery which in turn improves surgical recovery by the patient and may reduce surgical complications and scarring.

Unlike typical trocars, the surgical access port <NUM> may be attached to the back end of the percutaneous instrument and may be slid down the shaft of the instrument into the patient's body to provide re-access to the same site location if the percutaneous instrument were to be removed or exchanged. While trocars are independently inserted in to the body cavity, the surgical access port <NUM> differs from typical trocars in that the surgical access port <NUM> may be slid into the body cavity over an instrument pre inserted into the body cavity.

In one aspect, the surgical access port <NUM> and the surgical instrument <NUM> may be packaged as a kit, whereby the surgical access port <NUM> is placed onto and snapped onto the lumen of the surgical instrument <NUM>. It is also envisioned where the surgical access port <NUM> would be packaged separately, as a stand-alone product and may be attached to the surgical instrument <NUM> as needed.

The system and methods associated with the surgical access port includes improved surgical precision, reduced surgical time resulting in reduced trauma to the patient and possibly less scarring, reduced recovery time, less pain, easier handling of the device by the user via the locked rotational hub and multiple types of end-effectors, and other benefits.

<NUM> In accordance with certain embodiments there may be provided an access port assembly, comprising: an obturator having a longitudinally extending obturator shaft including a sharp tip disposed at a distal end of the obturator shaft and a handle disposed at a proximal end of the obturator shaft, the handle including at least one finger extending spaced from the handle; and a surgical access port having a cannula defining a hollow cannula shaft, and a tapered hub attached to a proximal end of the cannula, the tapered hub including at least one inner ring configured to abut against the at least one finger while the obturator is inserted within the cannula of the surgical access port. In a first variant of such embodiments, the at least one inner ring of the surgical access port may be an O-ring, and the O-ring may be disposed between an inner wall of the surgical access port and an outer wall of the obturator to prevent leakage of gas between the surgical access port and the obturator. In a second variant of embodiments according to section <NUM> above, the access port assembly may further comprises a locking mechanism for securing the surgical access port to a patient, the locking mechanism being attached to at least an outer surface of the cannula of the surgical access port. In a first sub-variant of the second variant, the locking mechanism may include a lock base with a central ring, a locking member defining an aperture, and a ball disposed between the lock base and the locking member. In a sub-variant of the preceding variant the locking member may include at least one engagement finger, and wherein the central ring of the lock base defines at least one ramp for axially and rotationally guiding the at least one engagement finger. In a further sub-variant of the first sub-variant of the second variant the central ring of the lock base may define a frustoconical inner surface for at least partially supporting the ball. In a further sub-variant of the first sub-variant of the second variant the ball of the locking member may define a circular opening configured to receive the cannula of the surgical access port. In a further sub-variant of the preceding sub-variant the ball may define a plurality of slits and the ball is configured to deform inwardly to increase a gripping force around the cannula of the surgical access port.

<NUM> In accordance with certain embodiments, there may be provided a surgical instrument access port assembly, comprising a surgical instrument having a needle lumen extending in a longitudinal direction including a needle tip at a distal end, and a body portion at a proximal end, the body portion including at least one recess or finger; and a surgical access port having a cannula defining a hollow cannula shaft, and a tapered hub attached to a proximal end of the cannula, the tapered hub including at least one inner ring configured to abut against the at least one recess or finger while the surgical instrument is inserted into the cannula of the surgical access port. In a first variant of such embodiments the needle lumen may be secured to a handle and trigger assembly of the surgical instrument. In a second variant of embodiments according to section <NUM> above, the at least one inner ring of the surgical access port may be an O-ring, and wherein the O-ring may be disposed between an inner wall of the surgical access port and an outer wall of the needle lumen to prevent leakage of gas between the surgical access port and the needle lumen of the surgical instrument. In a third variant of embodiments according to section <NUM> above, surgical instrument access port assembly may further comprise a locking mechanism for securing the surgical access port to a patient, the locking mechanism being attach to at least an outer surface of the cannula of the surgical access port. in a sub-variant of the third variant the locking mechanism may include a lock base with a central ring, a locking member defining an aperture, and a ball disposed between the lock base and the locking member, wherein the ball of the locking member defines a circular opening configured to receive the cannula of the surgical access port, and wherein the ball defines a plurality of slits and the ball is configured to deform inwardly to increase a gripping force around the cannula of the surgical access port.

<NUM> In accordance with certain embodiments, there may be provided a method of using a surgical instrument access port assembly comprising a surgical instrument having a needle lumen extending in a longitudinal direction including a needle tip at a distal end, and a body portion at a proximal end, the body portion including at least one recess or finger, and including a surgical access port having a cannula defining a hollow cannula shaft, and a tapered hub attached to a proximal end of the cannula, the tapered hub including at least one inner ring configured to abut against the at least one recess or finger while the surgical instrument is inserted into the cannula of the surgical access port, the method comprising: piercing a hole in a body wall with the needle tip of the needle lumen; inserting at least a portion of the needle lumen through the hole into a body cavity; advancing the surgical access port along the needle lumen in a distal direction towards the hole; and inserting the cannula of the surgical access port through the hole into the body cavity. In a first variant of such embodiments the method may, further comprise withdrawing the surgical instrument from the body cavity by passing the needle lumen through the cannula of the surgical access port in a proximal direction away from the body cavity. In a sub-variant of the first variant the method the withdrawing the surgical instrument may include maintaining a position of the surgical access port relative to the hole of the body wall. In a first sub-variant of the preceding sub-variant the method may further comprise attaching a cap to an open end portion of the surgical access port. in a second sub-variant of the first sub-variant the method may further comprise reinserting the surgical instrument by passing the needle lumen through the cannula of the surgical access port in the distal direction toward the body cavity. In a further sub-variant of the preceding sub-variant the method may further comprise advancing the needle lumen into the surgical access port, while maintaining a position of the surgical access port relative to the hole of the body wall, such that the at least one recess or finger of the surgical instrument abuts against the at least one inner ring of the surgical access port; and withdrawing both the surgical instrument and the surgical access port from the body cavity while the surgical access port is secured to the surgical instrument via the at least one recess or finger abutting against the at least one inner ring. In accordance with a further variant of the embodiments of paragraph <NUM> above, the method may, further comprise advancing the surgical access port along the needle lumen in the proximal direction, prior to the piercing the hole, to secure the at least one recess or finger of the surgical instrument by abutting against the at least one inner ring of the surgical access port.

It will be appreciated that the foregoing description provides examples of the surgical access port which may be used with a surgical instrument for minimally invasive surgery. However, it is contemplated that other implementations of the disclosure may differ in detail from the foregoing examples. All references to the disclosure or examples thereof are intended to reference the particular example being discussed at that point and are not intended to imply any limitation as to the scope of the disclosure more generally. All language of distinction and disparagement with respect to certain features is intended to indicate a lack of preference for those features, but not to exclude such from the scope of the disclosure entirely unless otherwise indicated.

Claim 1:
A surgical access port assembly configured to attach to a lumen of a surgical instrument, the surgical access port comprising:
a hollow cannula (<NUM>) defining an interior shaft extending longitudinally therethrough and having a diameter of less than about <NUM>; and
a tapered hub (<NUM>) on a proximal end of the hollow cannula (<NUM>), the tapered hub (<NUM>) having a tapered open end portion (<NUM>), and an inner conical surface with at least one inner ring on the inner conical surface, the at least one inner ring being configured to attach to the surgical instrument via friction or compression of the at least one inner ring(<NUM>18A, 118B, 118C) on the inner conical surface, and
a locking mechanism (<NUM>) comprising:
a lock base (<NUM>) with a central ring, having an aperture (<NUM>) configured to receive the surgical access port; and
a locking member (<NUM>), and a ball (<NUM>) disposed between the lock base (<NUM>) and the locking member (<NUM>), the locking member (<NUM>) having an opening configured to receive the surgical access port,
wherein the locking member is configured to rotate relative to the lock base (<NUM>) into a locked position to secure the surgical access port to the patient, when inserted into a fascia.