WO2004023987A1

WO2004023987A1 - A medical irrigation set

Info

Publication number: WO2004023987A1
Application number: PCT/AU2003/001182
Authority: WO
Inventors: Leo Arieh Pinczewski; Stephen John Parker; Robert Steel
Original assignee: Tuta Healthcare Pty Ltd
Priority date: 2002-09-10
Filing date: 2003-09-10
Publication date: 2004-03-25

Abstract

A medical irrigation set including a delivery tube (11) for delivering irrigation liquid to a patient, one way valves (30) to restrict the liquid to flow towards the patient, at least one pump inlet tube (24) communicating a reservoir (25) of irrigation liquid with first and second pumps (18, 19). Multiple reservoirs may be used, each supplying an individual pump. The first and second manual pump bodies (18, 19) are connected to the delivery tube and are arranged to pump in parallel with each other to enable sequential pumping of the irrigation liquid to assist in maintaining liquid flow. Whilst one pump is recharging the other pump can be pumping. Both pumps (18, 19) can be separably connected e.g. by solvent weld (31 Fig 3) or perforated web. The web can be integrally formed with the pump bodies. The device can be arranged for use with medical imaging investigation/surgical apparatus, for example, arthroscopy, endoscopy, laparoscopy, cystoscopy.

Description

A MEDICAL IRRIGATION SET TECHNICAL FIELD

The present invention relates to medical irrigation devices and more particularly to irrigation sets that employ a pump mechanism, for example, arthroscopy irrigation sets.

BACKGROUND OF THE INVENTION

Investigative and/or surgical procedures can now be conducted using devices which enter a patient through a small incision. This type of procedure is intended to help reduce invasion and subsequent trauma to the patient. Such procedures include arthroscopy, cystoscopy, laparoscopy, endoscopy etc apparatus, where the relevant investigative and/or surgical/imaging apparatus may be irrigated with a liquid to assist the procedure. For example, an arthroscope enables a surgeon to examine and if necessary perform an operation within joints, commonly the knee or shoulder, whilst a laparoscope allows investigation of the lower abdominal organs, such as fallopian tubes and/or ovaries. Other devices are available for cystoscopy or trans-urethral resection etc. Irrigation devices are generally used in such procedures to flush the field of view with liquid to permit clearer viewing and/or flush unwanted material from the site, for example, blood or cartilage. With particular regard to arthroscopy, arthroscopic surgery began in the knee, and the vast majority of arthroscopic procedures still involve the knee joint. However, the continued demand for less invasive surgery, together with rapid advances in visualisation technology, has led to the development of arthroscopic surgical techniques involving most of the body's joint spaces. Currently, the fastest growing area of arthroscopic surgery is diagnostic and operative shoulder arthroscopy.

Arthroscopic knee surgery is usually performed in a bloodless surgical field, which has meant the performance of arthroscopic irrigation sets or visualisation systems per se have been the critical determinant in the successful adoption of arthroscopic knee surgery. In arthroscopic shoulder surgery, it is currently not possible to restrict blood flow into the shoulder joint. Consequently, the surgical field quickly fills with blood and other products (eg: bone chips, etc. from arthroscopic acromioplasty, a common shoulder procedure in which part of the acromion is removed with a high speed burr). This severely limits the surgeon's view and may lead to abandonment of the arthroscopic approach.

In order to ensure the benefits of minimally invasive surgery, for example arthroscopic shoulder surgery or cystoscopy, medical device companies introduced a number of fluid management systems during the nineties, which are designed to regulate intra joint fluid pressure (to staunch blood flow through a tamponade effect) and irrigation fluid inflow/outflow rate (to ensure any blood and surgical debris is "washed away").

The rapid growth in minimal invasive procedures including arthroscopic procedures applied to joints other than the knee have highlighted some of the shortcomings of gravity fed irrigation systems. However, the disposable components of these systems are almost marketed at premium prices. Consequently, forced fed irrigation systems have been developed, ranging from the use of relatively simple pumps to complex electronically controlled systems that seek to regulate fluid pressure within the body cavity to be visualised, together with fluid inflow and outflow.

Most of these systems are not only expensive with respect to the gravity fed alternatives, but with increased complexity there is a corresponding decrease in reliability. Operating room staff and surgeons have to adapt their routines to accommodate additional set up protocols, and the equipment itself is more prone to intermittent failures.

A relatively simple medical irrigation set is known to employ a hand operated pump, for example, in arthroscopy procedures. The otherwise gravity fed irrigation set incorporates a resiliently flexible cylindrical pump body in a fluid supply line from a liquid reservoir that can be squeezed by an operator to cause increased liquid flow and delivery to the examination / operation site. One-way valve mechanisms may be used to restrict flow to the joint. As the pump is hand operated, the liquid flow is delivered in separated pulses. The pulses are separated by a period of zero flow to the joint, a period during which the pump is being recharged or primed. This is one disadvantage of this known type of arthroscopy irrigation set. Restricted flow rates are especially problematic in some procedures, for example arthroscopy surgery in respect of the shoulder, where larger volumes of irrigation fluid may be required from time to time, but otherwise a constant supply is desired. OBJECT OF THE INVENTION

It is an object of the present invention to provide a medical irrigation device which ameliorates the problem of relatively low and/or intermittent irrigation fluid supply identified in the aforementioned prior art devices. SUMMARY OF THE INVENTION

With the aforementioned in view, the present invention provides a medical irrigation set, including; a delivery tube arranged for delivering irrigation liquid to a patient; first and second, manually squeezable pump bodies in communication with the delivery tube and arranged for connection with at least one reservoir of irrigation liquid to receive irrigation fluid from the reservoir; and a valve arrangement to restrict the irrigation liquid to flow towards the patient; wherein the first and second pumps bodies are arranged to pump in parallel with each other and deliver irrigation liquid to the delivery tube sequentially from alternate said pump bodies.

The parallel pump arrangement has a number of advantages. The operator is provided with an essentially lag-free, hand-pump-assisted irrigation set.

Sequential pumping through alternate squeezing of the two pump bodies

(parallel, alternate pumping action) enables the operator to deliver irrigation liquid to the patient without lag-time when and if desired, ie whilst one pump body is refilling with irrigation fluid after having been emptied consequential upon squeezing in a prior operation, the other pump body, which at that stage would be filled with irrigation fluid, may be squeezed to deliver irrigation fluid to the patient.

On the other hand, the operator is also provided with an increased flow volume / pressure irrigation set, in that both pumps may be operated simultaneously

(parallel, simultaneous pumping action) to help provide increased fluid volume, eg to increase flow pressure at the irrigation site and/or increase fluid volume delivery to the irrigation site over a single such pump.

Preferably, one or both of the first and second pump bodies include a resiliently-deformable pumping member that defines a variable-volume pump chamber. Thus, pumping action is effected by squeezing the pumping member from an operational state, in which the chamber is at least partially filled with liquid, thereby to reduce the pump chamber volume and cause flow of said liquid from the pump chamber towards the patient. The resilient nature of the pumping member provides a self-priming construction of the pump body whereby upon the squeezing action being terminated, the pump chamber will seek to attain its original volume and in the process refill with irrigation liquid.

Preferably each pump body includes a one-way, fluid outlet valve to restrict the irrigation liquid to flow towards the patient. However, it is envisaged that a one-way valve may be incorporated anywhere in the line of flow of the liquid between the/each pump and the patient. Equally, whilst a one-way, fluid inlet valve to permit priming of the pumping members may be included at each pump body, such back-flow preventing valve(s) may be provided close to the pump body inlet in the liquid supply line connecting the pump bodies with the irrigation fluid reservoir. One or more of the fluid outlet or inlet valves may be a ball or flap type valve.

The pumping member may be of cylindrical, spherical or of other such configuration that is ergonometric for hand-squeezing. The deformation characteristics of the pumping member are preferably such as to enable an easy, hand-controllable delivery of irrigation liquid at a desired flow rate to the irrigation site.

Preferably each pumping member is of a generally cylindrical configuration having opposite ends at which the fluid inlet and outlet, respectively, are located, each opposite end being provided with one-way valves. The one-way valve may be incorporated integrally with or connected to that end of the pump member to provide a practical combined pump and valve arrangement.

The pump bodies are preferably manufactured by a moulding process and can be made from plastics, silicone, rubber or other such material.

Preferably, the pump bodies are formed together in a unitary construction, joined or otherwise located adjacent to one another in such manner that they may be operated simultaneously or separately, for example, by a one handed operation, such as squeezing one or both resilient pump chamber members. In a further preferred form, individually moulded or formed pump bodies may be secured together with a solvent weld which may be ruptured by a user so that the pump bodies may be separated in use. Alternatively or in addition, the attachment means may be a web of material such as a thermoplastic web. In yet another form, the pump bodies are formed side-by-side with a severable joint. The joint may include a perforated tear line and/or a thinned section of joining material to aid separation of the pump bodies.

The irrigation set may advantageously incorporate conduits and flow restriction elements that are typically found in conventional arthroscopic irrigation sets for providing irrigation liquid during an arthroscopic procedure. It will be immediately apparent that the set may be modified (eg by incorporating other components) to suit other medical irrigation procedures, for example, cystoscopy, laparoscopy, trans-urethral resection, endoscopy. Thus, it is envisaged that one or more embodiments of the present invention may be arranged for use with a variety of such medical apparatus including an arthroscope, cystoscope, laparoscope or the like.

Preferably the device may be arranged to irrigate an arthroscope, laparoscope, endoscope, cystoscope, trans-urethral resection device, or the like.

A preferred form of the present invention provides the irrigation set as a kit of parts including the first and second pumps, the delivery tube, one way valves, flow restriction clamps and flexible conduits as is otherwise known with prior art sets.

Further features and advantages of the invention will become apparent from the following description of a preferred form of the present invention with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 shows a schematic illustration of an arthroscopy irrigation device (set) in accordance with a first embodiment of the invention;

Figure 2 is a schematic side elevation view of a pump employed in the set of Figure 1 ; and

Figure 3 is a schematic illustration of a modification of the device of Figure 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Although the following provides a description of particular embodiments of the present invention, the skilled reader will appreciate that the present invention may be arranged to be used in conjunction with a variety of medical imaging and surgical/investigation devices. In the accompanying drawings, there is schematically depicted an arthroscopy irrigation device (set) 10. As will be appreciated, the set may alternatively be arranged to irrigate for example, a cystoscopy, laparoscopy, or endoscopy procedure. The set 10 includes a downstream tube 11 that extends to a patient via a connector 12. Extending from the connector 12 is a tube 13 that is to be attached to an orthoscopic cannula. Attached to the tube 11 is a clamp 14 that is operable to restrict or prevent flow of liquid through the tube 11.

The upstream end of the tube 11 is attached to a Y-junction 15, which junction 15 attaches the tube 11 to a pair of tubes 16 and 17. The tubes 16 and 17 are attached to respective manually squeezable pumps, ie pump bodies 18 and 19 that are arranged in parallel which permits sequential or simultaneous manual pumping of irrigation liquid.

The upstream end of each pump body 18 and 19 receives a tube 20 and 21 , with each tube 20, 21 being attached to a further "Y" junction 22 or 23. Each junction 22 and 23 has extending from it at least one tube 24 that is to be attached to a reservoir (bag) 25 containing the irrigation liquid. More particularly, each tube 24 is attached to a perforator 26 that engages within an outlet of one of the bags 25. It will be appreciated that each tube 24 could be attached to a single common reservoir for feeding both pumps. If so required, each tube 24 may be provided with a clamp 27. Each clamp 27 is operable to restrict or prevent flow through the associated tube 27.

Each pump body 18 and 19 includes an elastically resiliently deformable cylindrical pumping member 28 that defines a variable-volume pump chamber 29. At the axial opposite ends of each pump body 18, 19 is provided a one way valve 30 that restricts the flow of liquid to flow towards the patient, that is, toward the tube 13 from the perforators 26. Each one way valve 30 includes a valve seat that is engaged by a spherical valve member. Alternatively, integrally formed one-way flap-type valves may be employed.

In addition, the backflow preventing valves (inlet valves) between the pump body and reservoir act to prevent irrigation liquid from flowing towards the reservoir during pumping of the associated pump body. Each one-way inlet valve also acts to allow inflow of liquid into the pump body during recharging.

Valves 30 positioned on the outlet side of each pump body 18, 19 prevent backflow of irrigation liquid from the patient towards the pump body during recharging.

In operation of the above described device 10, an operator grips each member 28 and squeezes it to cause a variation in the volume of the chambers 29. This variation causes the flow of liquid from the reservoirs 25 toward the tube 13. The pump bodies 18 and 19 are constructed so that each is receivable within a respective hand of an operator. An operator can sequentially squeeze the members 28 and 29 such that one pump body is recharged whilst the other is pumping. By operating the pump bodies 18 and 19 in this manner the flow rate delivered to the tube 13 is less variable, with the average flow rate being higher as the operator can manipulate the pump bodies 18 and 19 so that there is no or almost no period of zero flow unless the operator chooses otherwise. Thus, greater flow outlet is achieved.

After squeezing, each pump member resiliently returns to its original shape when recharging with liquid. In this way the relevant pump primes with liquid via the associated inlet valve ready for a subsequent pumping action. During priming the relevant outlet valve remains shut.

In the embodiment of Figure 3 the pump bodies 18 and 19 are connected by a solvent weld 31 so that the pump devices 18 and 19 may be simultaneously operated, that is to provide a higher volume pulse of flow. The weld 31 may also be ruptured so that the pump devices 18 and 19 may be separated. More particularly the weld 31 connects the cylindrical members 28. Alternatively connection may be via a perforated and/or thinned web of material. However, it will be appreciated that the pump bodies 18, 19 may be joined directly together without the option of separation or joint for separation by other means. In the case of pump bodies joined by a web the web may be integrally formed between and with portions of the pumps, for example, a one piece moulded arranged including body portions for the first and second pumps. The connecting portion may form a hinge which allows the pumps to be brought together for single handed simultaneous pumping.

The irrigation set 10 can include parts made of silicone, rubber, plastics or such like materials suitable for medical application.

Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.

Claims

CLAIMS:

1. A medical irrigation set, including; a delivery tube arranged for delivering irrigation liquid to a patient; first and second, manually squeezable pump bodies in communication with the delivery tube and arranged for connection with at least one reservoir of irrigation liquid to receive irrigation fluid from the at least one reservoir; and a valve arrangement to restrict the irrigation liquid to flow towards the patient; wherein the first and second pump bodies are arranged to pump in parallel with each other and deliver irrigation liquid to the delivery tube sequentially from alternate said pump bodies.

2. A set according to claim 1 , wherein at least one of the first and second pump bodies include a resiliently-deformable pumping member that defines a variable-volume pump chamber.

3. A set according to claims 1 or 2, wherein each pump body includes a oneway, fluid outlet valve to restrict the irrigation liquid to flow towards the patient.

4. A set according to any one of claims 1 to 3, further including at least one, one-way fluid inlet valve to prevent backflow of irrigation liquid towards the relevant at least one reservoir during pumping.

5. A set according to claim 4, wherein the at least one of the one-way fluid inlet and/or outlet valves are ball or flap valves

6. A set according to claim 2 or any one of claims 3 to 5, when dependent upon claim 2, wherein either or both pumping members are cylindrical, spherical or of other such configuration that is ergonometric for hand-squeezing.

7. A set according to claim 2 or any one of claims 3 to 6 when dependent upon claim 2, wherein each pumping member is of a generally cylindrical configuration having opposite ends at which the fluid inlet and outlet, respectively, are located, each opposite end being provided with one-way valves.

8. A set according to claim 2, or any one of the preceding claims when dependent upon claim 2, wherein each pumping member includes an elastically deformable resilient material.

9. A set according to any one of the preceding claims, wherein the pump bodies are moulded from plastics, silicone or rubber material.

10. A set according to any one of the preceding claims wherein, the pump bodies are formed together in a unitary construction, joined or otherwise located adjacent to one another in such manner that they can be operated simultaneously or separately.

11. A set according to any one of the preceding claims, wherein the pump bodies are individually moulded or formed pump bodies and secured together with a solvent weld which may be ruptured by a user so that the pump bodies may be separated in use.

12. A set according to any one of the preceding claims wherein the pump bodies are attached together by a web of material, such as a thermoplastic web.

13. A set according to any one of the preceding claims, wherein the pump bodies are connected side-by-side with a severable joint.

14. A set according to claim 13, wherein the joint includes a perforated tear line and/or a thinned section of joining material to aid separation of the pump bodies.

15. A set according to any one of the preceding claims, further including conduits and flow restriction elements thereby providing an irrigation set for arthroscopic, laparoscopic, cystoscopic, endoscopic, trans-resection, or similar procedures.