Patent Application
20080097391
Referring initially to
The laparoscopic fluid delivery device of the present invention further includes a catheter 6 having at least a flexible distal end tip portion 8 and defining a lumen 10 extending axially along the length thereof for the passage of medical fluids therethrough. The distal tip portion 8 has an opening 12 formed at the axial end of the catheter 6. The catheter 6 also includes a proximal end 14 situated opposite the distal end 8, which also has an opening 16 formed in the axial end thereof. The openings 12, 16 in the distal and proximal ends 8, 14 of the catheter communicate with the catheter lumen 10 to allow the passage of medical fluid through the proximal end opening 16, the lumen 10 and the distal end opening 12 formed in the tip portion to a targeted tissue site within the patient. The inner tubular member 4 is movable axially within the outer tubular member 2 to cover and uncover the tip portion 8 of the catheter 6, as will be described in greater detail.
The internal catheter 6 is preferably an elastomeric flexible catheter that has been pre-shaped to about a ninety degree (90°) angle at its distal end, and is maintained beneath the inner tubular member 4 of the device, with its distal end 8 being covered and uncovered when the inner tubular member is moved in relation to the catheter and the outer tubular member 2. When the inner tubular member 4 is moved axially, it covers and uncovers the tip portion 8 of the flexible catheter 6, allowing selectable lengths of the tip portion 8 of the catheter to be exposed. Since at least the tip portion 8 of the catheter is pre-shaped, exposing selectable lengths of the tip portion provides for a variable degree of curvature of the exposed portion of the catheter 6. Thus, by maneuvering the inner tubular member 4, the physician may select whatever angle, from zero degrees (0°) to ninety degrees (90°), he or she desires as being appropriate for reaching the targeted tissue site to apply the medical fluid (e.g., adhesive, sealant, haemostatic agent, antibiotic or the like) thereat.
It is envisioned to be within the scope of the present invention to have the catheter 6 formed entirely from a flexible elastomeric material, or just the articulating tip portion 8 thereof, where the tip portion 8 is pre-shaped to a ninety degree (90°) angle or some other curvature. A suitable elastomeric material which may be used for the catheter 6, or at least the articulating tip portion 8 thereof, is PEBAX 7033 polyester block amide, a plasticizer-free thermoplastic polymer elastomer manufactured by Arkema of Puteanx, France. It is also envisioned to be within the scope of the present invention to make the catheter 6 from materials other than a flexible elastomeric material, including those materials having shape memory properties, such as the material commonly referred to as Nitinol, which is a shape-memory alloy being formed from an intermetallic compound of nickel and titanium.
The laparoscopic fluid delivery device of the present invention may be used with or without a trocar 18, such as that shown in
As shown in
Return now to
In the embodiment of the laparoscopic fluid delivery device of the present invention, the moveable inner tubular member 4 is operatively linked to an actuator that includes a lap collar 28 which is grasped by the surgeon and which is used by the surgeon to move the inner tubular member 4 axially within the outer tubular member 2 to cover and uncover the articulating distal end tip portion 8 of the catheter 6. More specifically, the lap collar 28 is preferably formed as a unitary, generally cylindrical body 30 having a first flange 32 radially extending from the cylindrical body 30 and a second flange 34 radially extending from the cylindrical body 30 which is spaced apart axially from the first flange 32 to define a finger slot 36 therebetween. The surgeon places two fingers (preferably his or her index and middle finger) to straddle the finger slot 36 to maneuver the inner tubular member 4 with respect to the outer tubular member 2 and the catheter 6 by retracting the inner tubular member 4 towards the proximal end 14 of the catheter or pushing the inner tubular member towards the distal end of the catheter 6 to respectively uncover or cover a selectable axial length of the catheter tip portion 8, in order to vary the curvature of the articulating tip portion to that which is desired. The surgeon then removes his or her fingers from the finger slot 36 so as not to inadvertently change the selected curvature of the articulating tip 8, and may then place his or her fingers on the neck of the syringe 20. Then, the surgeon uses his or her thumb to depress the plunger 22 within the syringe 20 to force medical fluid contained therein through the proximal end opening 16, lumen 10 and distal tip opening 12 of the catheter 6 to precisely direct the medical fluid through the laparoscopic fluid delivery device to a targeted tissue site. This embodiment of the laparoscopic fluid delivery device is structured to permit one-handed operation by the physician in selecting the degree of articulation of the catheter tip 8 and the delivery of fluids to the targeted site.
In the embodiment of the laparoscopic fluid delivery device shown in
In a second embodiment of the present invention, the articulating laparoscopic medical fluid delivery device of the present invention may include an actuator constituted as a handle with a trigger operatively linked to the inner tubular member 4 to move the inner tubular member with respect to the flexible catheter 6 and the outer tubular member 2. As shown in
The trigger arm 64, near the end opposite from where it is pivotally mounted in the handle housing 56, is joined to one axial end of a rod 70 whose opposite other axial end is joined to a collar 72 which is operatively linked to the moveable inner tubular member 4 through a wire protrusion 40, such as described previously with respect to the embodiment shown in
With this second embodiment of the laparoscopic fluid delivery device of the present invention, the surgeon grasps the handle portion 58 with his hand, places his index finger (the second finger) on the exposed finger portion 66 of the trigger arm 64 to uncover the articulating tip 8 of the catheter and adjust the articulation thereof to any desired angle, and places his thumb on the plunger 22 of the syringe 20 located in the barrel 54 of the handle 52, exerting pressure on the plunger to force medical fluid from the syringe through the lumen 10 of the catheter 6 and out the distal tip opening 12 to precisely provide the medical fluid to the targeted tissue site. As with the previous embodiment of the present invention, the laparoscopic medical fluid delivery device shown in
A laparoscopic medical fluid delivery device constructed in accordance with a third embodiment of the present invention is shown in
The handle 74 also includes a trigger arm 84 which moves in a linear fashion and is connected preferably directly (but may be connected indirectly) to the proximal end 46 of the inner tubular member 4 for moving the member axially with respect to the outer tubular member 2 and the catheter 6. More specifically, the trigger arm 84 includes a main body 86 which slides reciprocatingly within a slot 88 formed in the housing 76 of the handle 74, the trigger arm 84 preferably being held captive within the slot 88. For this purpose, the trigger arm 84 may include a rail 85 extending longitudinally along the top surface thereof, which is received by the slot 88 formed in the handle housing 76. The trigger arm 84 includes a forward portion 90 which extends longitudinally from the main body 86 thereof, which forward portion 90 has a bore 92 formed axially through the thickness thereof which closely receives the proximal end 46 of the moveable inner tubular member 4 and thus secures with adhesive, for example, the trigger arm 84 to the inner tubular member. The innermost catheter 6 passes through the bore 92 to a luer lock connector fitting 94 held in place within the handle housing cavity 96. The longitudinal front portion 90 of the trigger arm 84 moves within a cavity 98 defined by the nose piece 82 of the housing situated at the front of the handle 74. The outer tubular member 2 has its proximal end fixed to the nose piece 82 so that it cannot move in relation to the handle.
The rearward portion of the trigger arm 84 is formed with an open loop or C-shaped member 100 which acts as a finger piece so that the surgeon may rest his or her index finger thereon to effect movement of the inner tubular member 4 to cover and uncover the articulating distal end 8 of the catheter 6.
The proximal end 14 of the catheter is joined to a luer lock fitting or connector 94, which engages and cooperates with a mating luer lock fitting or connector 24 situated on the syringe 20 to effect a fluidtight seal between the catheter 6 and the syringe 20. Again, as in the previous embodiments described, the lumen 10 and proximal opening 16 of the catheter 6 are co-axially situated with the syringe tip opening to effect the passage of medical fluid from the syringe 20 through the proximal opening 16, lumen 10 and distal opening 12 of the catheter to the targeted tissue site.
An alternative version of the third embodiment of the laparoscopic medical fluid delivery device of the present invention is illustrated by
More specifically, the luer lock fitting or connector 102 which is mounted to the proximal end 14 of the catheter, or other syringe adaptor that mates with the syringe, is situated within the cavity 96 of the handle housing 76 and is free to rotate therein. The sidewall of the fitting or connector 102 includes one or more spaced apart openings 106 radially formed therein and arcuately spaced about the circumference of the fitting. A lock pin 108 is mounted on the housing of the handle 74 and is biased upwardly by a coil spring 110, leaf spring or other biasing means so that it is normally not received by one of the plurality of openings 106 formed in the fitting or connector 102. The syringe 20, which is connected by its luer lock fitting or connector 24 to the fitting or connector 102 situated on the proximal end of the catheter 6, is loosely received by the barrel 80 formed in the handle housing 76 so that it may rotate with its fitting 24, the fitting 102 on the catheter and the catheter 6 itself within the inner tubular member 4. Thus, preferably all four components, that is, the syringe 20, its fitting 24, the catheter fitting 102 and the catheter 6, can rotate in unison on the handle 74.
A starwheel 109, knurled knob or other structure that may be readily turned by the surgeon using his or her fingers is securely mounted on the syringe body 21, with the syringe body 21 being closely received by an opening 113 formed through the thickness of the starwheel 109. Alternatively, the syringe 20 may be formed with the starwheel 109 integrally joined to the syringe body 21. Thus the surgeon can easily turn the starwheel 109 which, in turn, will rotate the syringe 20, the fittings 102, 24 and the catheter 6 in order to direct the articulating catheter tip 8 to any desired position.
The lock pin 108 is normally disengaged from the catheter fitting 102. When the syringe 20 is inserted into the barrel 80 of the handle of the laparoscopic fluid delivery device, the lock pin 108 is depressed by the surgeon against the force of the coil spring 110 so that it engages one of the plurality of openings 106 formed in the fitting 102 at the proximal end of the catheter. This holds the catheter fitting 102 steady so that the syringe 20 may be inserted into the barrel 80 and connected to the catheter fitting. Pressure on the lock pin 108 is then released, and the coil spring 110 biases the lock pin upwardly and away from the circumference of the catheter fitting 102 so that the syringe 20, catheter fitting 102 and catheter 6, including the catheter tip 8, are free to rotate within the handle 74 and inner tubular member 4 of the device when the surgeon turns the starwheel 109.
In a modification to the starwheel embodiment described above, the catheter fitting 102 itself may extend at least partially out of a slot (not shown) formed in the handle housing 76 so that at least a portion of its circumference is exposed to the surgeon who can turn the fitting 102 to effect rotation of the articulating distal tip 8 of the catheter, without the need for including the starwheel 109.
With this third embodiment, and the alternative versions thereof, shown in
A further variation of the third embodiment of the laparoscopic fluid delivery device of the present invention is shown in
More specifically, the plunger linkage 118 is an elongated member which is mounted to one side of the handle 74 of the laparoscopic fluid delivery device. It includes a main body 120 having an inner side surface which faces the outer surface of one side of the handle housing 76. A rail 122 extends outwardly from the inside surface of the main body 120 of the plunger linkage 118, which rail 122 includes either a bulbous or enlarged free end or a T-shaped free end 124, as shown in
The plunger linkage 118 includes a thumb rest formed as a shoulder 132 extending outwardly from the opposite outside surface of the main body 120 thereof. The shoulder 132 may be sloped at an angle which is less than ninety degrees (90°) with respect to the axis of the outer tubular member 2 so that the surgeon may rest his or her hand thereon in a more comfortable position.
An L-shaped member 134 extends axially rearwardly from the main body 120 of the plunger linkage 118. The L-shaped member 134 has a relatively long first leg portion 136 extending from the main body 120 of the plunger linkage, and a shorter second leg portion 138 attached to an end of the first leg portion 136 and extending transversely therefrom. The second leg portion 138 of the plunger linkage 118 engages and secures thereto the distal end of the plunger 22. For example, the second leg portion 138 of the plunger linkage may have a slot 140 formed therein to form an open pocket for receiving and captively holding the end of the plunger 22, as shown in
As shown in
The plunger linkage 118 may be situated on one lateral sidewall 130 of the handle housing 76, such as on the right side of the housing, as illustrated by
A fourth embodiment of the laparoscopic medical fluid delivery device of the present invention is shown in
The proximal end of the inner tubular member 4 passes through the nose piece bore 150 and is axially slidably mounted to the handle housing 156 on which the nose piece 144 is mounted, or is slidably mounted to nose piece 144 which in turn is mounted to handle housing 156. It is prevented from rotating by any number of ways known to one skilled in the art, for example, by having a radially protruding leg (not shown) being slidably received by an axially extending slot (not shown) formed on the inside surface of the handle housing 156. However, a portion 162 of the inner tubular member 4 is formed with threads 157 on the outer surface thereof, which threads 157 engage the threaded bore 150 of the nose piece 144. Thus, by rotating the nose piece 144, the engagement of the nose piece threads and those of the inner tubular member 4 results in axial movement of the inner tubular member on the handle housing 156, as the inner tubular member 4 is prevented from rotating by the engagement of housing edges defining the slot (not shown) mentioned above with the radially extending leg (not shown) also mentioned above. The axial movement of the inner tubular member 4 by rotating the nose piece 144 covers and uncovers the articulating distal tip 8 of the catheter and allows the surgeon to select a desired curvature for the catheter tip with precision.
This fourth embodiment of the present invention may include a plunger linkage 118 having a thumb rest 159 which engages the plunger 22 of the syringe 20 in a manner and with structure similar to that described in relation to the variation of the third embodiment shown in
An alternative version of the laparoscopic medical fluid delivery device shown in
The nose piece 202 has an axial bore 220 in which is situated a generally cylindrical collar 222. The proximal axial end 224 of the inner sleeve 226 is closely received by a central bore 228 formed in the collar 222 so that the inner sleeve 226 is affixed to the distal axial end 230 of the collar 222 and movable with it. The opposite proximal end 232 of the collar 222 includes a radially inwardly extending boss 234 having an inner wall 236 that is complementary threaded to receive and engage the threads 216 of the inner tubular member 214.
A rib 238 extending radially from the outer surface of the collar 222 and at least partially axially along the length thereof is slidably received by a channel 240 formed axially in the inner surface of the rotatable nose piece 202 to operatively link the nose piece 202 to the collar 222 so that the nose piece 202 and collar 222 rotate together when the nose piece 202 is turned by the surgeon, but which allows the collar 222 to move axially forward and backward in the nose piece bore 220 when the nose piece 202 is turned. The front portion 212 of the handle portion 200 is formed with a luer lock fitting 242 or other connector which mates with the luer lock fitting 244 or connector of the syringe, as shown in
The structure of the nose piece 202 and cooperating components of the laparoscopic medical fluid delivery device shown in
Since the proximal end 224 of the inner sleeve 226 is affixed to the collar 222, as the collar 222 moves axially, so will the inner sleeve 226 to cover and uncover the articulating tip portion of the catheter 6, depending on the direction of rotation of the nose piece 202.
The laparoscopic medical fluid delivery device shown in
The laparoscopic fluid delivery devices described herein generally have an overall length, including the handle portion, of between about 46 centimeters and about 63 centimeters, with the outer and inner tubular members extending from the handle or actuator portion of the device a distance of between about 28 centimeters and about 45 centimeters, although the device may be constructed in shorter versions that are perfectly suitable for use in open surgical procedures.
It should be noted here that the various embodiments of the laparoscopic medical fluid delivery device of the present invention described herein are perfectly adaptable for receiving a single syringe 20 or a dual syringe system both with and without static mixers. This capability is illustrated in
More specifically, sterilization and stability of medical fluids, such as a sealant combined with an anti-adhesion component, have been a challenge for chemists for many years. The two components cannot be mixed prematurely, and should be mixed just prior to delivery to a surgical site.
The barrel 54 of the laparoscopic fluid delivery device of the present invention can accept a single syringe 20 or a dual syringe system. The dual syringe system would include two syringes 20, each having plungers 22 that are ganged together by a linkage 164 for comparable axial movement within their respective syringe bodies. The syringe tips are joined to respective inlet ports of a static mixer 166, whose outlet is fitted with a luer lock fitting or connector 168 that mates with the luer lock fitting or connector 94 on the proximal end of the catheter 6 of the laparoscopic fluid delivery device.
Accordingly, the dual syringe system may have its static mixer 166 received by the barrel 80 formed in the handle housing 76 of the laparoscopic fluid delivery device of the present invention, and fluid may be expressed from each syringe 20 concurrently by thumb pressure or by using a plunger linkage 118, as described previously, mixed in the static mixer 166, and delivered to the surgical site through the lumen 10 and opening 12 in the articulating catheter tip 8 of the laparoscopic medical fluid delivery device of the present invention. Accordingly, the laparoscopic fluid delivery device of the present invention allows effective delivery of expensive components mixed during or just prior to their use.
Another problem which occurs with conventional laparoscopic devices is that the medical fluid remains trapped in the internal lumen 10 of the catheter 6. These medical fluids, such as sealants, adhesives, flowable haemostatic agents, antibiotics and the like, are usually relatively expensive, and it is the desire of surgeons to utilize all of the medical fluid in a delivery device with little waste.
As mentioned previously, a laparoscopic instrument is typically about 28 to about 45 centimeters long and, depending on the internal lumen diameter of the catheter 6, can trap a considerable amount of medical fluid. Accordingly, the method and structure of the present invention, now further described in greater detail, address this concern of physicians and solve the problem of medical fluids being trapped in the catheter lumen of a laparoscopic instrument.
As shown in
After medical fluid has been previously delivered to a patient by a laparoscopic fluid delivery device using a syringe 20 containing the medical fluid, the specially designed syringe 172 of the present invention may be substituted therefor. This syringe 172 is placed in the barrel 80 of the laparoscopic fluid delivery device formed in the top portion of the handle 74, such as described previously and shown in
The syringe 172 includes a barrel 176 having a bore formed axially therethrough, which receives a plunger 178 that may reciprocatingly slide axially in the barrel 176. The syringe 172 is filled with a gas, such as air, although it may contain a liquid, such as a saline solution, which is relatively incompressible to force more viscous medical fluids, e.g., adhesives and sealants, from the lumen 10 of the catheter 6 of the laparoscopic fluid delivery device. The syringe 172 further has a luer lock fitting 174 at the tip of the syringe, the luer lock fitting 174 having an orifice 180 which is in fluid communication with the barrel bore.
The syringe 172 includes a seal assembly 182, which preferably includes a lap seal 184 and a connecting line 186, such as a suture, which is affixed to the end of the lap seal 184 and to the syringe barrel 176 or tip or to the forward end of the plunger 178 that is received by the syringe barrel. For example, the forward end of the syringe plunger 178 received by the barrel 176 may include a mounting point, such as a protruding eyelet 188, through which the end of the connecting line 186 is passed and to which it is tied. Preferably, the lap seal 184 is formed with a bulbous head 190, having a diameter which is equal to or slightly less than the inner diameter of the catheter lumen 10. A rod 192 extends radially from the bulbous head 190, the rod 192 having a diameter which is equal to or slightly less than the inner diameter of the syringe tip orifice 180 defined by the luer lock fitting or connector 174 situated thereon. The free end of the rod 192 is attached to the connecting line 186 (e.g., the suture). For example, the free end of the rod may have a bore 194 formed axially at least partially therethrough to which the end of the connecting suture 186 is received and adhesively secured therein. The lap seal 184 is preferably situated on the syringe 172, with the rod 192 being seated in the syringe tip, and with the bulbous head 190 of the lap seal resting thereon. The connecting line 186, or suture, is coiled within the barrel bore of the syringe 20 prior to use. Although the preferred form of the lap seal 184 includes a bulbous head 190 and a rod 192 connected thereto as described above, it is envisioned to be within the scope of the present invention to form the lap seal with other shapes and configurations, such as a sphere, elliptical capsule and the like.
During use, the specially designed syringe 172 is loaded into the barrel 80 of the laparoscopic device, and its luer lock fitting 174 is mated to the luer lock fitting 94 of the catheter 6. The surgeon uses the laparoscopic fluid delivery device of the present invention in the manner described previously, or another laparoscopic delivery device, by forcing the plunger 178 of the syringe into the barrel 176 thereof to express the fluid or gas contained within the syringe. Since the fluid or gas is upstream of the adhesive, sealant or other medical fluid entrapped in the catheter lumen 10 of the delivery device, and separated therefrom by the lap seal 184, the fluid or gas does not come in direct contact with the entrapped medical fluid.
When the plunger 178 of the syringe 172 is actuated, the lap seal 184 is pushed by air or other fluid into the catheter lumen 10 of the laparoscopic fluid delivery device. Because of the relatively large diameter of the bulbous head 190 of the lap seal closely engaging the interior walls of the catheter 6 defining the lumen 10, the lap seal 184, under pressure from the gas or fluid forced out of the syringe 172, will travel down the length of the catheter lumen 10, pushing out the trapped sealant or other medical fluid therefrom.
The connecting line 186 or suture has a length which is selected to ensure that the lap seal 184 does not escape out the distal opening 12 in the catheter tip 8 of the laparoscopic fluid delivery device and into the patient's body cavity. The connecting line 186, which is attached to the free end of the rod 192 of the lap seal, will uncoil from inside the syringe barrel 176 and feed through the syringe tip and lumen 10 as the lap seal 184 travels axially along the length of the catheter lumen. The syringe 172 contains enough air or fluid to push the lap seal 184 to the distal end of the catheter tip of the laparoscopic fluid delivery device, and the length of the connecting line 186 limits the travel of the lap seal 184 through the catheter lumen 10.
In accordance with a second embodiment of the present invention, and as shown in
More specifically, and as shown in
Of course, it is envisioned to be within the scope of the present invention to provide other structure to prevent the lap seal 184 from being expelled from the catheter tip opening 12. A thin wire (not shown) may be positioned diametrically across the inner sidewall of the catheter tip defining the lumen thereat, which wire is small enough so as not to impede the flow of medical fluid therethrough but prevent the lap seal 184 from passing through the distal end opening 12 of the catheter tip 8. Alternatively, the catheter tip 8 may be formed with a slightly smaller inner diameter of its lumen 10 at the catheter tip as opposed to over other portions of the lumen, thus preventing the lap seal 184 from being expressed under pressure through the distal end opening 12 of the catheter tip 8.
It is preferred that the lap seal 184, and in particular the length and diameter of the rod 192 and the diameter and overall size of the bulbous head 190 thereof, is dimensioned such that the lap seal 184 does not become lodged in the articulating tip 8 of the catheter due to its curvature.
The laparoscopic fluid delivery device of the present invention, in the form of the various embodiments described herein, and with its pre-shaped catheter, is simple to manufacture and uncomplicated in structure. It omits the need for ganged pieces defining a multi-slotted catheter tip controlled by one or more wires to effect the articulation of the tip found in the rather complicated structure of conventional laparoscopic devices. The laparoscopic delivery device of the present invention provides one-handed operation for the surgeon to precisely dispense medical fluid at a desired tissue site in the patient, and decreases the likelihood of depositing fluid inadvertently on non-targeted areas.
The laparoscopic fluid delivery device of the present invention has the capability of rotating the articulating catheter tip 8 three hundred, sixty degrees (360°) for precise deposition of medical fluids. It also has the ability to handle single syringes 20 filled with medical fluid, as well as dual syringe systems both with and without static mixers 166, thus addressing the problems of sterilization and stability of medical fluids, such as a sealant with an anti-adhesion component, that have challenged chemists in the past. The present invention also allows for the effective delivery of expensive medical fluid components mixed during or just prior to use. Also, although the catheter 6 is described and shown as having a single lumen 10, it may be formed with multiple, parallelly extending lumens, and such a structure would be quite advantageous when using multiple component fluids that only come into contact with one another when dispensed at the surgical site.
The subsequent-use special syringe 172 for expelling entrapped sealants, adhesives or other medical fluids from the catheter lumen 10 also advantageously minimizes any waste of such expensive fluids. The fluid-expelling syringe 172 of the present invention is a cost effective approach for dispensing trapped medical fluid. The syringe 172 is relatively small, unlike the conventional ramrod device. Furthermore, it does not change the tactile feel of the laparoscopic fluid delivery device when used to expel trapped medical fluid in the catheter lumen 10, and the surgeon is enabled to precisely deliver a medical fluid to a targeted tissue site without having to vary or change his grasp or operation of the laparoscopic fluid delivery device.
Although illustrative embodiments of the present invention have been described herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the invention.
