US20070073268A1 - Integrated Infusion and Aspiration System and Method - Google Patents
Integrated Infusion and Aspiration System and Method Download PDFInfo
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- US20070073268A1 US20070073268A1 US11/560,754 US56075406A US2007073268A1 US 20070073268 A1 US20070073268 A1 US 20070073268A1 US 56075406 A US56075406 A US 56075406A US 2007073268 A1 US2007073268 A1 US 2007073268A1
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- catheter
- infusion
- aspiration
- wound site
- solution
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/74—Suction control
- A61M1/743—Suction control by changing the cross-section of the line, e.g. flow regulating valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P23/00—Anaesthetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/74—Suction control
- A61M1/75—Intermittent or pulsating suction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/84—Drainage tubes; Aspiration tips
- A61M1/85—Drainage tubes; Aspiration tips with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/92—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing with liquid supply means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0039—Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M2025/018—Catheters having a lateral opening for guiding elongated means lateral to the catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
Definitions
- the present invention relates generally to the post-surgical treatment of closed wounds and specifically to methods and systems for concurrent aspiration and infusion of a wound site to manage pain, swelling, bleeding and infection.
- opioid analgesics are administered post-operatively to counter the pain associated with wound healing and recovery.
- systemic opioid analgesics whether administered by oral, intramuscular, or intravenous methods, includes a host of possible undesirable side effects, including: respiratory depression, renal function depression, nausea, constipation, ataxia, confusion, sweating, and itching.
- the length of hospital stay for patients undergoing a major surgical procedure is, in part, determined by the need to monitor and control the side effects of systemically administered opioid analgesics.
- infusion pumps have been used to percutaneously deliver local anesthetics directly to the surgical wound.
- systemic opioid analgesics are avoided.
- medication dosage is considerably less than systemic delivery since the medication is delivered directly to the affected site.
- contemporary percutaneous pain medication infusion pumps do not provide consistent relief of pain.
- Another challenge associated with percutaneous pain medication infusion pumps is the need to concurrently address edema, or fluid build-up and swelling, at the wound site. Aspiration of excess fluid has been attempted by the use of a separate and discrete percutaneous catheter connected to a vacuum source.
- concurrent use of a pain medication infusion pump and an aspiration catheter creates two significant compromises to the patient. First, two percutaneous catheters, one for the aspiration catheter and one for the infusion pump, potentially doubles the risk of infection since two percutaneous tracts are maintained.
- an aspiration catheter coupled with an active vacuum source that is designed for the removal of fluid build-up tends to remove the infused pain medication before it has effectively produced the desired local anesthetic effect.
- FIG. 1 is a schematic view of an integrated infusion and aspiration system applied to the knee of a patient.
- FIG. 2 is a cross sectional side view of the catheter assembly shown in FIG. 1 taken along sections lines 2 - 2 .
- FIG. 3 is a cross section side view of an alternative embodiment of the catheter assembly shown in FIG. 2 .
- FIG. 4 is a schematic view of an alternative embodiment of the catheter assembly of the integrated infusion and aspiration system shown in FIG. 1 .
- FIG. 5 is a schematic view of another alternative embodiment of the catheter assembly of the integrated infusion and aspiration system shown in FIG. 1 .
- FIG. 6 is a schematic view of still another alternative embodiment of the catheter assembly of the integrated infusion and aspiration system shown in FIG. 1 .
- FIG. 7 is a schematic view of yet another alternative embodiment of the catheter assembly of the integrated infusion and aspiration system shown in FIG. 1 .
- FIG. 8 is a cross sectional side view of the catheter assembly shown in FIG. 6 taken along section lines 8 - 8 .
- FIG. 9 is a cross sectional side view of an alternative embodiment of the catheter assembly shown in FIG. 8 .
- FIG. 1 Shown in FIG. 1 is one embodiment of an integrated infusion and aspiration system 35 incorporating features of the present invention.
- System 35 is applied to a knee 25 of a patient to treat a surgical wound that would result from, for example, a total knee arthroplasty surgery.
- FIG. 1 demonstrates use of one embodiment of integrated infusion and aspiration system 35 for a knee, it is understood that the present invention can be used for any internal body wound created by surgery, trauma, or disease.
- integrated infusion and aspiration system 35 comprises a catheter assembly 20 coupled with a flow control system 19 .
- catheter assembly 20 has a proximal section 21 , an opposing distal section 22 , and a middle section 23 extending therebetween.
- catheter assembly 20 comprises an infusion catheter 10 and an aspiration catheter 15 .
- Infusion catheter 10 comprises a proximal section 40 , an opposing distal section 42 , and a middle section 44 (see FIG. 2 ) extending therebetween.
- Distal section 42 terminates at a distal end tip 17 .
- Infusion catheter 10 bounds a first lumen 46 ( FIG. 2 ) that extends along the length thereof and exits through an end port 26 at distal end tip 17 .
- a plurality of longitudinally spaced apart side ports 16 extend through infusion catheter 10 at distal section 42 so as to communicate with first lumen 46 .
- the plurality of side ports 16 can be eliminated or replaced with one or more side ports.
- side ports 16 can be spaced laterally and/or radially.
- Aspiration catheter 15 comprises a proximal section 50 , an opposing distal section 52 , and a middle section 54 extending therebetween. Distal section 52 terminates at a distal end tip 12 . Aspiration catheter 15 bounds a second lumen 56 ( FIG. 2 ) that extends along the length thereof and exits through an end port 27 at distal end tip 12 . A plurality of spaced apart side ports 11 extend through aspiration catheter 15 at distal section 52 so as to communicate with second lumen 56 . As with infusion catheter 10 , the plurality of side ports 11 can be eliminated or replaced with one or more side ports 11 . Furthermore, side ports 11 can be spaced laterally and/or radially.
- the plurality of ports of infusion catheter 10 and aspiration catheter 15 each have a predetermined number and a predetermined spacing, the number and spacing of the plurality of ports on infusion catheter 10 being substantially the same as the number and spacing of the plurality of ports on aspiration catheter 15 . In other embodiments, the number and/or spacing of the ports on the infusion catheter 10 and aspiration catheter 15 can be different.
- infusion catheter 10 passes through a sidewall of aspiration catheter 15 and into second lumen 56 at a proximal junction 60 . This is typically accomplished by forming a hole in the sidewall of aspiration catheter 15 and then passing infusion catheter 10 therethrough. Once infusion catheter 10 is positioned, infusion catheter 10 and aspiration catheter 15 are sealed together at the hole such as by welding, adhesive, or other conventional forms.
- Infusion catheter 10 travels distally within second lumen 56 and exits aspiration catheter 15 through end port 27 at distal end tip 12 .
- infusion catheter 10 occupies an internal, coaxial position with respect to aspiration catheter 15 between proximal junction 60 and distal end tip 12 of aspiration catheter 15 .
- infusion catheter 10 is smaller than the inner diameter of aspiration catheter 15 so that fluid is free to flow within second lumen 56 of aspiration catheter 15 . Furthermore, this arrangement provides the advantage of protecting infusion catheter 10 from possible kinking or pinching when is it positioned internal to the more substantially larger sized aspiration catheter 15 . Another advantage of this arrangement is that by positioning infusion catheter 10 within aspiration catheter 15 , only a single tract through the skin is required to pass both catheters 10 and 15 from an extracorporeal site to the internal wound site.
- infusion catheter 10 extends distally from the distal end tip 12 of aspiration catheter 15 a predetermined distance so that distal end tips 12 and 17 are spaced apart.
- the spaced distance is sufficient so that ports 16 and 26 of infusion catheter 10 and ports 11 and 27 of aspiration catheter 15 can be positioned on opposing sides of a wound.
- the spacing between ports 11 , 27 and 16 , 26 is dependent upon wound size, but in one embodiment is more than ten times the largest external transverse dimension of aspiration catheter 15 .
- flow control system 19 comprises a flow control 5 , a pump 2 , and medication reservoir 1 each operably coupled with proximal section 40 of infusion catheter 10 .
- a flow control 6 , pump 4 , and aspiration reservoir 3 are operably coupled with proximal section 50 of aspiration catheter 15 .
- Reservoirs 1 and 3 can comprise a flexible bag, such as an IV bag, a syringe barrel, or any other conventional hard of soft sided container adapted to hold a fluid.
- the infusion solution used by the present invention can contain a number of different medications to best address the post surgical concerns of the wound.
- the infusion solution can contain, separately or in combination, an analgesic agent, an anesthetic agent, an antibiotic, an antiseptic, an anticoagulant, or an anti-inflammatory.
- an analgesic agent an anesthetic agent
- an antibiotic an antiseptic
- an anticoagulant an anti-inflammatory
- concurrent prophylactic treatment for infection and treatment to reduce swelling can be achieved by including an antibiotic and anti-inflammatory in the infusion solution.
- Pumps 2 and 4 can be any standard pump known by those skilled in the art, such as a squeeze bulb, syringe, syringe pump, syringe plunger, centrifugal pump, persistaltic pump, diaphragm pump, screw pump, IV pump, or the like.
- the flow controls 5 and 6 can be any standard flow control device known to those skilled in the art, such as an orifice, capillary tube, or valve. Valves include solenoid valves, servo valves, and flow restricting valves, such as a needle valve, gate valve, pinch valve, and the like.
- Connected to pump 2 is a power source 7
- a power source 8 Connected to pump 2 is a power source 7
- Power sources 7 and 8 can be selected from a number of power sources known by those skilled in the art, including manual actuation, spring, dc motor, ac motor, and the like.
- Controller 9 is generally electronic, and preferably controller 9 is a microprocessor based control device.
- reservoirs 1 and 3 , pumps 2 and 4 , flow controls 5 and 6 , powers sources 7 and 8 and controller 9 collectively comprise flow control system 19 .
- FIG. 1 shows the various elements of flow control system 19 in a defined order, it is appreciated that the various elements can be reorganized in a variety of different orientations using different combination of parts.
- one configuration for flow control system 19 comprises the following selections: flow control 5 is a solenoid valve, medication reservoir 1 is a syringe barrel, pump 2 is a syringe plunger, and power source 7 is a spring which is disposed between the syringe plunger and the syringe barrel.
- the syringe plunger is initially drawn back relative to the syringe barrel so as to fill the syringe barrel with a desired solution.
- the resilient spring is stretched so that there is a constant force attempting to drive the syringe plunger back into the syringe barrel and, in turn, discharge the solution therefrom.
- the syringe barrel is connected in fluid communication with the proximal section of infusion catheter 10 . Accordingly, the solution is passed from the syringe barrel, through infusion catheter 10 , and out through ports 16 , 26 .
- the solenoid valve is disposed so as to selectively control the flow of solution from the syringe barrel into the infusion catheter.
- flow control 6 is an adjustable flow restricting valve, such as a pinch valve
- aspiration reservoir 3 is a syringe barrel
- pump 4 is a syringe plunger
- power source 8 is a spring positioned between the syringe barrel and the syringe plunger.
- the spring is compressed as the syringe plunger is pressed into the syringe barrel.
- the syringe barrel is in fluid communication with the proximal section of aspiration catheter 15 .
- the spring produces a constant force seeking to push the syringe plunger out of the syringe barrel.
- a relative vacuum is produced which causes fluid to be sucked into aspiration catheter 15 through ports 11 , 27 and into the syringe barrel.
- Controller 9 is connected to the flow control 5 and the flow control 6 , but not to power sources 7 and 8 since they are passive devices. Controller 9 is a microprocessor with embedded firmware that selectively opens and closes the flow control 5 , the solenoid valve, and also increases or decreases the flow rate through partial actuation of flow control 6 , the pinch valve.
- flow control system 19 An alternative configuration for flow control system 19 is comprised of the same selections as above, except that flow control 5 is an orifice that creates a flow rate proportional to the fluid pressure. Furthermore, the controller 9 is only connected to flow control 6 , since flow control 5 is, in this instance, a passive device. With this configuration, a relatively constant flow rate of the infusion solution is achieved while the aspiration flow rate can be increased or decreased based the amount and time of accumulation of the infusion solution at the wound site.
- catheter assembly 20 is inserted through a single incisions 62 in the skin so that at least a portion of ports 11 , 27 and 16 , 26 are positioned on opposing sides of an internal wound site.
- the ports 11 , 27 and 16 , 26 and corresponding catheters are disposed outside of a blood vessel.
- Catheter assembly 20 is coupled with flow control system 19 .
- fluid control system 19 administers at set periodic intervals a dose of infusion solution to infusion catheter 10 .
- the dose of infusion solution passes through infusion catheter 10 and out through ports 16 , 26 to one side of the wound site.
- flow control system 19 draws fluid on the opposite side of the wound site into aspiration catheter 15 by way of ports 11 , 27 at a first flow rate.
- Ports 16 , 26 and ports 11 , 27 are positioned so that aspiration of fluid by aspiration catheter 15 causes the infused dose to uniformly travel over the wound site.
- fluid is drawn into aspiration catheter 15 at a second flow rate, the second flow rate being faster than the first flow rate.
- the flow rate in aspiration catheter 15 is again lowered to the first flow rate and the process is repeated.
- the flow in aspiration catheter 15 is never interrupted, i.e., is continuous, throughout the repeated periodic infusion of the infusion solution. This is because a standing fluid column of blood and other body fluids is likely to coagulate, thereby clogging the aspiration catheter 15 .
- the dose in the case of the administration of a local anesthetic, such as lidocaine, bupivacaine, or ropivicaine, the dose is between about 0.5 cc and about 4 cc.
- the set periodic interval between administration of the doses is approximately one hour.
- the first flow rate at which fluid is drawn into aspiration catheter 15 during administration of the dose and the predetermined time period thereafter is between about 10% to about 30% of the dose per hour.
- the predetermined time period at which the aspiration catheter 15 operates at the first flow rate following infusion is equal to or longer than the time required for the medications in the infusion solution to effectively treat the wound. As such, the length of the predetermined time period is typically between about 5 minutes to about 15 minutes.
- the flow rate in the aspiration catheter is controlled at a rate generally between about 4 cc/hr and about 50 cc/hr, and preferably between about 10 cc/hr and about 30 cc/hr.
- the above method of operation provides a resident time for the infusion solution that allows the infusion solution to effectively treat the wound, and thereafter the infusion solution along with other accumulated body fluids are rapidly evacuated from the wound site to reduce swelling and to ameliorate associated pain.
- each dose is delivered over an extended period of time such that aspiration catheter 10 aspirates at the first flow rate during infusion of a discrete dose and then immediately aspirates at the second flow rate upon completion of infusing that dose.
- predetermined time period there is no delay, i.e., “predetermined time period,” between completion of the infusion and changing the aspiration to the second flow rate.
- the infusion solution is delivered at a relatively constant flow rate.
- the flow rate of the infusion solution is preferably between about 0.5 cc/hr and about 4.0 cc/hr.
- the flow rate within aspiration catheter 15 is cycled between a low flow rate, generally at a rate between 10% and 30% of the infusion solution flow rate, and a high flow rate, generally between 4 cc/hr and 50 cc/hr, and preferably between 10 cc/hr and 30 cc/hr.
- the cycle for the low flow rate generally endures for 15 to 30 minutes, and the low flow rate cycle generally repeats approximately every 60 minutes.
- this alternate method of operation provides for a period time when the flow rate within infusion catheter 10 is higher than the flow rate within aspiration catheter 15 , thus creating an accumulation of the infusion solution so that it may effectively treat the wound.
- integrated percutaneous infusion and aspiration system 35 takes advantage of the presence of a relative negative pressure source, or vacuum, provided within aspiration catheter 15 .
- the negative pressure created by aspiration catheter is used in the present invention to control the flow of the infusion solution as it egresses from infusion catheter 10 so as to cause the infusion solution to perfuse the entire wound site as it travels toward aspiration catheter 15 .
- the multitude of ports on both infusion catheter 10 and aspiration catheter 15 provide an array of opposing egress and ingress sites such that cross flow can be created between the two catheters to fully bathe the wound site with the infusion solution.
- catheter assembly 20 can be efficiently and cleanly inserted into a single percutaneous tract to the wound. As a result, further incisions are not required and the potential for infection is minimized.
- Flow control system 19 can be connected to a number of different embodiments of catheter assembly 20 .
- Alternate embodiments of catheter assembly 20 are shown in FIGS. 3-9 with like elements being identified by like reference characters.
- FIG. 3 depicted in FIG. 3 is a transverse cross sectional view of a catheter assembly 38 .
- infusion catheter 10 and aspiration catheter 15 are discrete catheters where, for a portion of the length, infusion catheter 10 resides within aspiration catheter 15 .
- infusion catheter 10 and aspiration catheter 15 are integrally formed as a single unit, i.e., they share a common sidewall.
- either a separate catheter or a separate portion of catheters 10 and 15 is used to connect one and/or both of the integrally formed catheters to flow control system 19 .
- FIG. 4 Depicted in FIG. 4 is an alternative catheter assembly 64 where aspiration catheter 15 has an outside diameter smaller than the outside diameter of infusion catheter 10 .
- aspiration catheter 15 passes through the sidewall of infusion catheter 10 at proximal junction 60 so as to be disposed within first lumen 46 of infusion catheter 10 .
- Aspiration catheter 15 extends distally within infusion catheter 10 and exits through end port 27 at distal end tip 17 . Aspiration catheter 15 then continues to project beyond distal end tip 17 of infusion catheter 10 .
- the coaxial portion of catheter assembly 64 can either comprise two discrete catheters or a single integrally formed catheter.
- FIG. 5 shows a catheter assembly 66 similar to catheter assembly 20 shown in FIG. 1 .
- infusion catheter 10 exits aspiration catheter 15 by passing through the sidewall thereof proximal of distal end tip 12 .
- catheter assembly 66 is bifurcated at both opposing ends.
- the bifurcated distal end of infusion catheter 10 is shown as being longer than the free distal end of aspiration catheter 15 , in alternative embodiments the bifurcated distal ends can be the same length or the distal end of aspiration catheter 15 can be longer.
- FIG. 6 shows a catheter assembly 68 similar to catheter assembly 64 shown in FIG. 4 .
- catheter assembly 66 shown in FIG. 5 Aspiration catheter 15 exits infusion catheter 10 by passing through the sidewall thereof proximal of distal end tip 12 . Accordingly, catheter assembly 68 is also bifurcated at both opposing ends.
- FIG. 7 shows a catheter assembly 70 wherein a least a portion of middle sections 42 and 52 of infusion catheter 10 and aspiration catheter 15 , respectively, are integrally joined in a side-by-side arrangement.
- the opposing ends of catheter assembly 70 have been bifurcated.
- Depicted in FIG. 8 is a transverse cross sectional side view of one embodiment of the side-by-side arrangement. This integral connection between catheters 10 and 15 enables catheter assembly 70 to be inserted through a single incision in the skin.
- a catheter assembly 72 which comprises two discrete catheters 10 and 15 . At least a portion of the middle sections 42 and 52 of catheters 10 and 15 , respectively, are held together by an encircling outer tube 74 . Outer tube 74 can be replaced by a wrap or a variety of other forms of connectors.
Abstract
An integrated infusion and aspiration system includes of a flow control system and a catheter assembly. The catheter assembly includes an infusion catheter and an aspiration catheter, each having ports located at the distal end of thereof. The distal ends of the catheters are separated so that the aspiration catheter ports can be positioned on an opposing side of a surgical wound site from the infusion catheter ports. Methods of operation of the integrated infusion and aspiration system provides for uninterrupted aspiration with concurrent controlled delivery of an infusion solution such that the infusion solution is substantially evenly dispersed of over the wound site.
Description
- This application is a continuation of:
- U.S. patent application Ser. No. 10/896,515, filed Jul. 22, 2004, which carries Applicants' Docket No. 13447.26.1 and is entitled INTEGRATED INFUSION AND ASPIRATION SYSTEM AND METHOD, which is a divisional of:
- U.S. patent application Ser. No. 10/218,106, filed Aug. 12, 2002, now U.S. Pat. No. 6,893,414, which carries Applicants' Docket No. 13447.26 and is entitled INTEGRATED INFUSION AND ASPIRATION SYSTEM AND METHOD.
- All of the above are incorporated herein by reference.
- The present invention relates generally to the post-surgical treatment of closed wounds and specifically to methods and systems for concurrent aspiration and infusion of a wound site to manage pain, swelling, bleeding and infection.
- One of the most difficult aspects of enduring a major surgical procedure is coping with the post-operative pain and swelling. Commonly, opioid analgesics, sometimes referred to as narcotics, are administered post-operatively to counter the pain associated with wound healing and recovery. However, the use of systemic opioid analgesics, whether administered by oral, intramuscular, or intravenous methods, includes a host of possible undesirable side effects, including: respiratory depression, renal function depression, nausea, constipation, ataxia, confusion, sweating, and itching. The length of hospital stay for patients undergoing a major surgical procedure is, in part, determined by the need to monitor and control the side effects of systemically administered opioid analgesics.
- More recently, infusion pumps have been used to percutaneously deliver local anesthetics directly to the surgical wound. Thus, many of the undesirable side effects of systemic opioid analgesics are avoided. Furthermore, medication dosage is considerably less than systemic delivery since the medication is delivered directly to the affected site. However, contemporary percutaneous pain medication infusion pumps do not provide consistent relief of pain.
- Another challenge associated with percutaneous pain medication infusion pumps is the need to concurrently address edema, or fluid build-up and swelling, at the wound site. Aspiration of excess fluid has been attempted by the use of a separate and discrete percutaneous catheter connected to a vacuum source. However, concurrent use of a pain medication infusion pump and an aspiration catheter creates two significant compromises to the patient. First, two percutaneous catheters, one for the aspiration catheter and one for the infusion pump, potentially doubles the risk of infection since two percutaneous tracts are maintained. Second, an aspiration catheter coupled with an active vacuum source that is designed for the removal of fluid build-up tends to remove the infused pain medication before it has effectively produced the desired local anesthetic effect.
- Various embodiments of the present invention will now be discussed with reference to the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope.
-
FIG. 1 is a schematic view of an integrated infusion and aspiration system applied to the knee of a patient. -
FIG. 2 is a cross sectional side view of the catheter assembly shown inFIG. 1 taken along sections lines 2-2. -
FIG. 3 is a cross section side view of an alternative embodiment of the catheter assembly shown inFIG. 2 . -
FIG. 4 is a schematic view of an alternative embodiment of the catheter assembly of the integrated infusion and aspiration system shown inFIG. 1 . -
FIG. 5 is a schematic view of another alternative embodiment of the catheter assembly of the integrated infusion and aspiration system shown inFIG. 1 . -
FIG. 6 is a schematic view of still another alternative embodiment of the catheter assembly of the integrated infusion and aspiration system shown inFIG. 1 . -
FIG. 7 is a schematic view of yet another alternative embodiment of the catheter assembly of the integrated infusion and aspiration system shown inFIG. 1 . -
FIG. 8 is a cross sectional side view of the catheter assembly shown inFIG. 6 taken along section lines 8-8. -
FIG. 9 is a cross sectional side view of an alternative embodiment of the catheter assembly shown inFIG. 8 . - Shown in
FIG. 1 is one embodiment of an integrated infusion andaspiration system 35 incorporating features of the present invention.System 35 is applied to aknee 25 of a patient to treat a surgical wound that would result from, for example, a total knee arthroplasty surgery. WhileFIG. 1 demonstrates use of one embodiment of integrated infusion andaspiration system 35 for a knee, it is understood that the present invention can be used for any internal body wound created by surgery, trauma, or disease. - In general, integrated infusion and
aspiration system 35 comprises acatheter assembly 20 coupled with aflow control system 19. Viewed as a whole,catheter assembly 20 has a proximal section 21, an opposingdistal section 22, and amiddle section 23 extending therebetween. More specifically,catheter assembly 20 comprises aninfusion catheter 10 and anaspiration catheter 15.Infusion catheter 10 comprises a proximal section 40, an opposingdistal section 42, and a middle section 44 (seeFIG. 2 ) extending therebetween.Distal section 42 terminates at adistal end tip 17.Infusion catheter 10 bounds a first lumen 46 (FIG. 2 ) that extends along the length thereof and exits through anend port 26 atdistal end tip 17. A plurality of longitudinally spaced apartside ports 16 extend throughinfusion catheter 10 atdistal section 42 so as to communicate withfirst lumen 46. In alternative embodiments, the plurality ofside ports 16 can be eliminated or replaced with one or more side ports. Furthermore,side ports 16 can be spaced laterally and/or radially. -
Aspiration catheter 15 comprises a proximal section 50, an opposingdistal section 52, and amiddle section 54 extending therebetween.Distal section 52 terminates at adistal end tip 12.Aspiration catheter 15 bounds a second lumen 56 (FIG. 2 ) that extends along the length thereof and exits through anend port 27 atdistal end tip 12. A plurality of spaced apartside ports 11 extend throughaspiration catheter 15 atdistal section 52 so as to communicate withsecond lumen 56. As withinfusion catheter 10, the plurality ofside ports 11 can be eliminated or replaced with one ormore side ports 11. Furthermore,side ports 11 can be spaced laterally and/or radially. - In one embodiment, the plurality of ports of
infusion catheter 10 andaspiration catheter 15 each have a predetermined number and a predetermined spacing, the number and spacing of the plurality of ports oninfusion catheter 10 being substantially the same as the number and spacing of the plurality of ports onaspiration catheter 15. In other embodiments, the number and/or spacing of the ports on theinfusion catheter 10 andaspiration catheter 15 can be different. - In the embodiment of
catheter assembly 20 shown inFIG. 1 ,infusion catheter 10 passes through a sidewall ofaspiration catheter 15 and intosecond lumen 56 at aproximal junction 60. This is typically accomplished by forming a hole in the sidewall ofaspiration catheter 15 and then passinginfusion catheter 10 therethrough. Onceinfusion catheter 10 is positioned,infusion catheter 10 andaspiration catheter 15 are sealed together at the hole such as by welding, adhesive, or other conventional forms. -
Infusion catheter 10 travels distally withinsecond lumen 56 and exitsaspiration catheter 15 throughend port 27 atdistal end tip 12. Thus, as shown inFIG. 2 ,infusion catheter 10 occupies an internal, coaxial position with respect toaspiration catheter 15 betweenproximal junction 60 anddistal end tip 12 ofaspiration catheter 15. - It is noted that the outer diameter of
infusion catheter 10 is smaller than the inner diameter ofaspiration catheter 15 so that fluid is free to flow withinsecond lumen 56 ofaspiration catheter 15. Furthermore, this arrangement provides the advantage of protectinginfusion catheter 10 from possible kinking or pinching when is it positioned internal to the more substantially larger sizedaspiration catheter 15. Another advantage of this arrangement is that by positioninginfusion catheter 10 withinaspiration catheter 15, only a single tract through the skin is required to pass bothcatheters - Continuing with the embodiment of
catheter assembly 20 shown inFIG. 1 ,infusion catheter 10 extends distally from thedistal end tip 12 of aspiration catheter 15 a predetermined distance so thatdistal end tips ports infusion catheter 10 andports aspiration catheter 15 can be positioned on opposing sides of a wound. The spacing betweenports aspiration catheter 15. - As shown in
FIG. 1 ,flow control system 19 comprises aflow control 5, apump 2, andmedication reservoir 1 each operably coupled with proximal section 40 ofinfusion catheter 10. Similarly, aflow control 6, pump 4, and aspiration reservoir 3 are operably coupled with proximal section 50 ofaspiration catheter 15.Reservoirs 1 and 3 can comprise a flexible bag, such as an IV bag, a syringe barrel, or any other conventional hard of soft sided container adapted to hold a fluid. - The infusion solution used by the present invention can contain a number of different medications to best address the post surgical concerns of the wound. For example, the infusion solution can contain, separately or in combination, an analgesic agent, an anesthetic agent, an antibiotic, an antiseptic, an anticoagulant, or an anti-inflammatory. Thus, in addition to pain relief provided by analgesic and anesthetic agents, concurrent prophylactic treatment for infection and treatment to reduce swelling can be achieved by including an antibiotic and anti-inflammatory in the infusion solution.
-
Pumps power source 7, and connected to pump 4 is apower source 8.Power sources - When the
power sources controls power sources controls - In one embodiment,
reservoirs 1 and 3, pumps 2 and 4, flow controls 5 and 6,powers sources flow control system 19. AlthoughFIG. 1 shows the various elements offlow control system 19 in a defined order, it is appreciated that the various elements can be reorganized in a variety of different orientations using different combination of parts. For example, one configuration forflow control system 19 comprises the following selections: flowcontrol 5 is a solenoid valve,medication reservoir 1 is a syringe barrel, pump 2 is a syringe plunger, andpower source 7 is a spring which is disposed between the syringe plunger and the syringe barrel. - In this configuration, the syringe plunger is initially drawn back relative to the syringe barrel so as to fill the syringe barrel with a desired solution. In so doing, the resilient spring is stretched so that there is a constant force attempting to drive the syringe plunger back into the syringe barrel and, in turn, discharge the solution therefrom. The syringe barrel is connected in fluid communication with the proximal section of
infusion catheter 10. Accordingly, the solution is passed from the syringe barrel, throughinfusion catheter 10, and out throughports - Continuing with the example,
flow control 6 is an adjustable flow restricting valve, such as a pinch valve, aspiration reservoir 3 is a syringe barrel, pump 4 is a syringe plunger, andpower source 8 is a spring positioned between the syringe barrel and the syringe plunger. In this embodiment, the spring is compressed as the syringe plunger is pressed into the syringe barrel. The syringe barrel is in fluid communication with the proximal section ofaspiration catheter 15. In this configuration, the spring produces a constant force seeking to push the syringe plunger out of the syringe barrel. As the syringe plunger is pushed out of the syringe barrel by the spring, a relative vacuum is produced which causes fluid to be sucked intoaspiration catheter 15 throughports - Controller 9 is connected to the
flow control 5 and theflow control 6, but not topower sources flow control 5, the solenoid valve, and also increases or decreases the flow rate through partial actuation offlow control 6, the pinch valve. - An alternative configuration for
flow control system 19 is comprised of the same selections as above, except thatflow control 5 is an orifice that creates a flow rate proportional to the fluid pressure. Furthermore, the controller 9 is only connected to flowcontrol 6, sinceflow control 5 is, in this instance, a passive device. With this configuration, a relatively constant flow rate of the infusion solution is achieved while the aspiration flow rate can be increased or decreased based the amount and time of accumulation of the infusion solution at the wound site. - As discussed above, during
operation catheter assembly 20 is inserted through asingle incisions 62 in the skin so that at least a portion ofports ports Catheter assembly 20 is coupled withflow control system 19. In one method of operation,fluid control system 19 administers at set periodic intervals a dose of infusion solution toinfusion catheter 10. The dose of infusion solution passes throughinfusion catheter 10 and out throughports - Simultaneously with the infusion of the dose, and for a predetermined time period thereafter,
flow control system 19 draws fluid on the opposite side of the wound site intoaspiration catheter 15 by way ofports Ports ports aspiration catheter 15 causes the infused dose to uniformly travel over the wound site. At the conclusion of the predetermined time period following the infusion, fluid is drawn intoaspiration catheter 15 at a second flow rate, the second flow rate being faster than the first flow rate. When the next dose of infusion solution is administered, the flow rate inaspiration catheter 15 is again lowered to the first flow rate and the process is repeated. - Although not required, in one method of operation the flow in
aspiration catheter 15 is never interrupted, i.e., is continuous, throughout the repeated periodic infusion of the infusion solution. This is because a standing fluid column of blood and other body fluids is likely to coagulate, thereby clogging theaspiration catheter 15. - By way of example of the operation process, in the case of the administration of a local anesthetic, such as lidocaine, bupivacaine, or ropivicaine, the dose is between about 0.5 cc and about 4 cc. The set periodic interval between administration of the doses is approximately one hour. The first flow rate at which fluid is drawn into
aspiration catheter 15 during administration of the dose and the predetermined time period thereafter is between about 10% to about 30% of the dose per hour. The predetermined time period at which theaspiration catheter 15 operates at the first flow rate following infusion is equal to or longer than the time required for the medications in the infusion solution to effectively treat the wound. As such, the length of the predetermined time period is typically between about 5 minutes to about 15 minutes. Following the predetermined time period but prior to administration of the next dose, the flow rate in the aspiration catheter is controlled at a rate generally between about 4 cc/hr and about 50 cc/hr, and preferably between about 10 cc/hr and about 30 cc/hr. - The above method of operation provides a resident time for the infusion solution that allows the infusion solution to effectively treat the wound, and thereafter the infusion solution along with other accumulated body fluids are rapidly evacuated from the wound site to reduce swelling and to ameliorate associated pain.
- In an alternative method of operation, each dose is delivered over an extended period of time such that
aspiration catheter 10 aspirates at the first flow rate during infusion of a discrete dose and then immediately aspirates at the second flow rate upon completion of infusing that dose. As such, there is no delay, i.e., “predetermined time period,” between completion of the infusion and changing the aspiration to the second flow rate. This alternative method of operation is an advantage where low pressure injections are necessary to prevent disruption of delicate internal structures that are starting to heal. Although less efficient in some situations, it is also appreciated that aspiration can be changed to the increased second flow rate prior to completion of infusion of a discrete dose. - In yet another alternate method of operation, the infusion solution is delivered at a relatively constant flow rate. In the case of the administration of a local anesthetic, such as lidocaine, bupivacaine, or ropivicaine, the flow rate of the infusion solution is preferably between about 0.5 cc/hr and about 4.0 cc/hr. The flow rate within
aspiration catheter 15 is cycled between a low flow rate, generally at a rate between 10% and 30% of the infusion solution flow rate, and a high flow rate, generally between 4 cc/hr and 50 cc/hr, and preferably between 10 cc/hr and 30 cc/hr. The cycle for the low flow rate generally endures for 15 to 30 minutes, and the low flow rate cycle generally repeats approximately every 60 minutes. Thus, this alternate method of operation provides for a period time when the flow rate withininfusion catheter 10 is higher than the flow rate withinaspiration catheter 15, thus creating an accumulation of the infusion solution so that it may effectively treat the wound. - As previously, mentioned, contemporary percutaneous pain medication infusion pumps do not provide consistent relief of pain. It is theorized that this is because the medication that egresses from the percutaneous catheter is not fully bathing the entire volume of the wound site. Many of these infusion devices rely on very low flow rates of 0.5 cc to 4.0 cc per hour, and localized pooling of the medication can occur, leaving other portions of the wound untouched by the pain medication.
- Based on the foregoing, integrated percutaneous infusion and
aspiration system 35 takes advantage of the presence of a relative negative pressure source, or vacuum, provided withinaspiration catheter 15. The negative pressure created by aspiration catheter is used in the present invention to control the flow of the infusion solution as it egresses frominfusion catheter 10 so as to cause the infusion solution to perfuse the entire wound site as it travels towardaspiration catheter 15. The multitude of ports on bothinfusion catheter 10 andaspiration catheter 15 provide an array of opposing egress and ingress sites such that cross flow can be created between the two catheters to fully bathe the wound site with the infusion solution. - Furthermore, although not required, by integrating
infusion catheter 10 withaspiration catheter 15,catheter assembly 20 can be efficiently and cleanly inserted into a single percutaneous tract to the wound. As a result, further incisions are not required and the potential for infection is minimized. - Furthermore, as discussed above, to achieve the desired flow of the infusion solution across the wound and the desired residency time of the infusion solution, a coordinated operation of the infusion and aspiration catheters has been developed. The flow rate within the aspiration and infusion catheters are controlled and synchronized to ensure that the infusion solution is not evacuated too quickly and to further ensure that the flow in the aspiration catheter is uninterrupted in order to minimize the potential for clot formations within the aspiration catheter that might otherwise clog the aspiration catheter.
-
Flow control system 19 can be connected to a number of different embodiments ofcatheter assembly 20. Alternate embodiments ofcatheter assembly 20 are shown inFIGS. 3-9 with like elements being identified by like reference characters. For example, depicted inFIG. 3 is a transverse cross sectional view of acatheter assembly 38. As discussed above with regard toFIG. 2 , incatheter assembly 20infusion catheter 10 andaspiration catheter 15 are discrete catheters where, for a portion of the length,infusion catheter 10 resides withinaspiration catheter 15. In contrast, although at least a portion ofinfusion catheter 10 resides withinaspiration catheter 15 incatheter assembly 38,infusion catheter 10 andaspiration catheter 15 are integrally formed as a single unit, i.e., they share a common sidewall. In this embodiment, either a separate catheter or a separate portion ofcatheters control system 19. - Depicted in
FIG. 4 is analternative catheter assembly 64 whereaspiration catheter 15 has an outside diameter smaller than the outside diameter ofinfusion catheter 10. In this embodiment,aspiration catheter 15 passes through the sidewall ofinfusion catheter 10 atproximal junction 60 so as to be disposed withinfirst lumen 46 ofinfusion catheter 10.Aspiration catheter 15 extends distally withininfusion catheter 10 and exits throughend port 27 atdistal end tip 17.Aspiration catheter 15 then continues to project beyonddistal end tip 17 ofinfusion catheter 10. As withFIGS. 2 and 3 , the coaxial portion ofcatheter assembly 64 can either comprise two discrete catheters or a single integrally formed catheter. -
FIG. 5 shows acatheter assembly 66 similar tocatheter assembly 20 shown inFIG. 1 . In contrast toinfusion catheter 10 exitingaspiration catheter 15 atdistal end tip 12, however,infusion catheter 10exits aspiration catheter 15 by passing through the sidewall thereof proximal ofdistal end tip 12. As aresult catheter assembly 66 is bifurcated at both opposing ends. Although the bifurcated distal end ofinfusion catheter 10 is shown as being longer than the free distal end ofaspiration catheter 15, in alternative embodiments the bifurcated distal ends can be the same length or the distal end ofaspiration catheter 15 can be longer. -
FIG. 6 shows acatheter assembly 68 similar tocatheter assembly 64 shown inFIG. 4 . Likecatheter assembly 66 shown inFIG. 5 , however,aspiration catheter 15exits infusion catheter 10 by passing through the sidewall thereof proximal ofdistal end tip 12. Accordingly,catheter assembly 68 is also bifurcated at both opposing ends. -
FIG. 7 shows acatheter assembly 70 wherein a least a portion ofmiddle sections infusion catheter 10 andaspiration catheter 15, respectively, are integrally joined in a side-by-side arrangement. The opposing ends ofcatheter assembly 70 have been bifurcated. Depicted inFIG. 8 is a transverse cross sectional side view of one embodiment of the side-by-side arrangement. This integral connection betweencatheters catheter assembly 70 to be inserted through a single incision in the skin. - Finally, depicted in
FIG. 9 is acatheter assembly 72 which comprises twodiscrete catheters middle sections catheters outer tube 74.Outer tube 74 can be replaced by a wrap or a variety of other forms of connectors. - The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. Thus the described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
Claims (15)
1. A method for percutaneous infusion and aspiration of an internal wound site, the method comprising:
infusing a wound site with a dose of a solution at a periodic interval;
aspirating the wound site at a first flow rate during the infusion of the solution and for a first time period thereafter; and
aspirating the wound site at a second flow rate after expiration of the first time period but prior to the next infusing of the solution, the second flow rate being greater than the first flow rate.
2. The method of claim 1 , wherein the periodic interval between infusions is greater than the sum total of the duration of the infusion and the predetermined time period.
3. The method of claim 1 , wherein the aspirating is continuous.
4. The method of claim 1 , wherein the solution comprises an analgesic, anesthetic, antibiotic, antiseptic, anticoagulant, anti-inflammatory, or combinations thereof.
5. A method for percutaneous infusion and aspiration of an internal wound site, the method comprising:
infusing the wound site with a dose of a solution;
aspirating the wound site at a first flow rate during the infusion of the solution; and
aspirating the wound site at a second flow rate either immediately upon completion of infusing the solution or at a time period after completion of infusing the solution.
6. The method of claim 5 , further comprising repeating at periodic intervals the act of infusing the wound site with a dose of a solution.
7. The method of claim 6 , wherein the aspirating is continuous.
8. The method of claim 5 , wherein the solution comprises an analgesic, anesthetic, antibiotic, antiseptic, anticoagulant, anti-inflammatory, or combinations thereof.
9. A method for percutaneous infusion and aspiration of an internal wound site, the method comprising:
infusing the wound site with the solution at a substantially constant rate; and
aspiration the wound site at alternating flow rates.
10. A method of claim 9 , wherein the aspiration is continuous.
11. The method of claim 9 , wherein the solution comprises an analgesic, anesthetic, antibiotic, antiseptic, anticoagulant, anti-inflammatory, or combinations thereof.
12. A method for percutaneous infusion and aspiration of an internal wound site, the method comprising:
passing a catheter assembly through a single incision, the catheter assembly comprising:
an aspiration catheter having at least one port formed thereon; and
an infusion catheter having at least one port formed thereon;
positioning the at least one port of the aspiration catheter on one side of the internal wound site and the at least one port of the infusion catheter on a substantially opposing side of the internal wound site;
periodically infusing the wound site with a dose of a solution through the infusion catheter; and
aspirating the wound site through the aspiration catheter at alternating flow rates.
13. The method as recited in claim 12 , wherein the act of passing the catheter comprises at least a portion of the aspiration catheter or infusion catheter being disposed within a lumen of the other of the aspiration catheter or infusion catheter.
14. The method of claim 12 , wherein the aspirating is continuous.
15. The method as claim 12 , wherein the at least one port of the aspiration catheter and the at least one port of the infusion catheter are each disposed outside of a blood vessel.
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Also Published As
Publication number | Publication date |
---|---|
US20040260231A1 (en) | 2004-12-23 |
CA2495925A1 (en) | 2004-02-19 |
US20070078381A1 (en) | 2007-04-05 |
US20040030281A1 (en) | 2004-02-12 |
WO2004014459A3 (en) | 2004-10-07 |
EP1545649A2 (en) | 2005-06-29 |
CA2495925C (en) | 2009-02-10 |
WO2004014459A2 (en) | 2004-02-19 |
AU2008202494A1 (en) | 2008-06-26 |
AU2003259743A1 (en) | 2004-02-25 |
US6893414B2 (en) | 2005-05-17 |
EP1545649A4 (en) | 2008-06-04 |
US7462163B2 (en) | 2008-12-09 |
JP2005535393A (en) | 2005-11-24 |
AU2003259743B2 (en) | 2008-03-13 |
US7163521B2 (en) | 2007-01-16 |
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