WO2009031138A2 - Shunt implantable - Google Patents

Shunt implantable Download PDF

Info

Publication number
WO2009031138A2
WO2009031138A2 PCT/IL2008/001182 IL2008001182W WO2009031138A2 WO 2009031138 A2 WO2009031138 A2 WO 2009031138A2 IL 2008001182 W IL2008001182 W IL 2008001182W WO 2009031138 A2 WO2009031138 A2 WO 2009031138A2
Authority
WO
WIPO (PCT)
Prior art keywords
lumen
actuator
fluid
evacuation
particulate matter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IL2008/001182
Other languages
English (en)
Other versions
WO2009031138A3 (fr
Inventor
Roey Shafrir
Natanja Slager
Amir Goren
Yossi Gross
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ARTHRO VALVE Ltd
Original Assignee
ARTHRO VALVE Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ARTHRO VALVE Ltd filed Critical ARTHRO VALVE Ltd
Publication of WO2009031138A2 publication Critical patent/WO2009031138A2/fr
Publication of WO2009031138A3 publication Critical patent/WO2009031138A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another

Definitions

  • the present invention relates generally to medical devices, and specifically to implantable devices for draining fluids from body cavities .
  • Synovial joints such as the knee, normally contain synovial fluid within the joint cavity.
  • the function of the synovial fluid is to lubricate and reduce friction between the articular cartilages and other tissues in the joint.
  • the joint contains only a small amount of synovial fluid at low pressure. In some inflammatory conditions, however, the joint produces excessive amounts of fluid, which causes pain and swelling and may lead to degeneration of the joint.
  • Various surgical procedures and devices have been developed in order to relieve such fluid build-up in the joints.
  • U.S. Patent 5,807,303 whose disclosure is incorporated herein by reference, describes a valve assembly and device for relieving synovial fluid pressure in the capsule of a joint.
  • a valve is secured between the interior and exterior of the capsule so as to permit synovial fluid to drain from the capsule when the capsule exceeds a certain pressure.
  • the valve is installed in the hip joint following hip replacement surgery and permits a small volume of synovial fluid and suspended particles to be discharged into the tissue surrounding the hip capsule.
  • Embodiments of the present invention that are described hereinbelow provide devices and methods- for draining excess fluid from body cavities.
  • body cavity is used broadly to refer to any internal volume in the body that may contain a fluid.
  • joint capsules which contain synovial fluid, are considered to be body cavities in this context.
  • a fluid drainage device is designed and implanted so as to drain the fluid into the medulla (i.e., the marrow) of a bone adjacent to the body cavity.
  • an implanted shunt device drains synovial fluid from the knee joint into the medullary cavity of the femur or the tibia.
  • some embodiments of the present invention provide a mechanism for unclogging the lumen of a shunt.
  • the mechanism is actuated by power supplied by or from outside the patient's body.
  • the actuator is implanted under the skin in proximity to the shunt and is operated by manually pressing on the actuator through the skin.
  • a medical device including: a device housing, which contains a lumen having first and second ends and is configured to be implanted in a bone of a subject so that the first end opens into a body cavity in proximity to the bone and the second end opens into a medulla of the bone; and a valve, which is contained in the device housing and is configured to control a flow of a body fluid from the body cavity into the medulla.
  • a medical device including: a device housing, which is configured to be implanted in a body of a subject and contains a lumen, which is configured for flow of a body fluid therethrough; and an evacuation mechanism, which is coupled to the device housing and includes an actuator, which is configured to be implanted subcutaneously and to be actuated by a pressure exerted on the body in a vicinity of the actuator so as to cause the evacuation mechanism to force particulate matter out of the lumen.
  • a method for treatment including: implanting a device that contains a lumen having first and second ends in a bone of a subject so that the first end of the lumen opens into a body cavity in proximity to a bone and the second end of the lumen opens into a medulla of the bone so as to permit a body fluid to drain from the body cavity into the medulla.
  • a method for treatment including: implanting a device, which contains a lumen, in a body of a subject so as to permit a body fluid to flow through the lumen, the device including an evacuation mechanism, which comprises an actuator and is coupled to force particulate matter out of the lumen upon actuation; and implanting the actuator subcutaneously so as to permit the evacuation mechanism to be actuated by a pressure exerted on the body in a vicinity of the actuator.
  • FIG. 1 is a schematic sectional illustration of a knee joint in which a shunt device is implanted in accordance with an embodiment of the present invention
  • Fig. 2 is a schematic pictorial illustration of a shunt device, in accordance with an embodiment of the present invention
  • Figs. 3A and 3B are schematic sectional views of the shunt device of Fig. 2, in accordance with an embodiment of the present invention.
  • Fig. 4 is a schematic sectional view of a shunt valve, in accordance with an embodiment of the present invention.
  • Fig. 5A is a schematic pictorial illustration of a shunt device, in accordance with an alternative embodiment of the present invention.
  • Fig. 5B is a schematic sectional illustration of the shunt device of Fig. 5A;
  • Fig. 6 is a schematic sectional view of a shunt device, in accordance with another embodiment of the present invention.
  • Fig. 7 is a schematic side view of a shunt device, in accordance with yet another embodiment of the present invention.
  • Fig. 1 is a schematic sectional illustration of a knee joint 22 in which a shunt device 20 is implanted in accordance with an embodiment of the present invention.
  • Device 20 comprises a device housing 24, which in this embodiment has the form of a screw, with an external thread.
  • Housing 24 is made of a suitable biocompatible material, such as stainless steel. The housing material may be impregnated or coated with a slow- release medication, such as an antibiotic or anti-inflammatory substance.
  • Housing 24 contains a lumen 26, which passes through the entire length of the device. Fluid flow through the lumen is controlled by a valve 28. Although the valve in the pictured embodiment is roughly centered along the length of the device, it may alternatively be located at either end or in any other suitable position.
  • the lumen and valve may be filled or coated initially with a biocompatible material that is subsequently absorbed in the body, thus clearing the lumen and valve .
  • device 20 is implanted in the knee joint using a lateral approach.
  • lumen 26 extends from a lateral region 30 of the capsule of joint 22 into a medullary space 32 of femur 34.
  • the medullary spaces of long bones are also known as medullary cavities.
  • the sort of implantation that is shown in Fig. 1 may be accomplished under local anesthesia, using a small incision to insert and screw device 20 into place by means of a suitable driving tool.
  • the bone may be pre-drilled and possibly tapped before implanting the device.
  • the procedure may be performed either arthroscopically or using an open surgical approach, possibly with the assistance of radiographic visualization.
  • device 20 may similarly be implanted from an anterior region 36 of the joint capsule into space 32 or along any other suitable path.
  • device 20 may be configured and implanted to drain the joint capsule into the tibia, rather than the femur.
  • device housing 24 has the form of a straight screw in the pictured embodiment, the housing may alternatively be smooth-sided or may have any other shape and form that are suitable for implantation in the bone such that the lumen in the housing links the joint capsule to the medullary space.
  • the device housing may comprise multiple pieces, rather than a unitary assembly, and it may be curved or angled, rather than straight as shown in the figures.
  • the term "lumen,” as used in the present patent application and in the claims, should thus be understood to refer not only to a single, straight passageway as in the pictured embodiments, but more generally to any suitable sort of passageway or combination of multiple passageways.
  • the device housing may be entirely rigid, as in the present embodiment, or it may alternatively comprise one or more flexible sections.
  • Valve 28 is designed to open automatically when a sufficient pressure difference develops between the joint capsule and the medullary space. When the valve opens, it permits fluid to flow from the joint capsule into the medulla of the bone and thus relieves the excess pressure of the synovial fluid in the knee joint. The medulla rapidly absorbs the surplus fluid and transfers it into the bloodstream via the network of capillaries in the bone.
  • Valve 28 may comprise a Belleville-type valve, as shown in Fig. 4, for example, but any other suitable type of miniature pressure-relief valve may similarly be used for this purpose, as well as for preventing backflow from the medullary cavity at any pressure.
  • device 20 may comprise an additional valve or valves (not shown in the figures), in any suitable position.
  • a one-way valve may be placed in series with valve 28, in order to prevent backflow of fluid from the medullary space into the joint capsule.
  • device 20 may comprise a miniature pressure sensor, or any suitable type known in the art, in communication with the joint capsule (either within lumen 26 or at the end of the device, for example) .
  • the pressure sensor may be used for telemetric measurement of the pressure in the joint. Additionally or alternatively, the pressure sensor may be used to actively control the valve in the shunt device.
  • device 20 comprises an evacuation mechanism 37 coupled to device housing 24.
  • Mechanism 37 comprises an actuator 38, which is implanted subcutaneously near the housing.
  • actuator 38 comprises a bulb, which is implanted under the skin at the side of the knee joint and is then actuated by manual pressure exerted externally on the skin in the vicinity of the actuator. Pressing on the actuator causes the evacuation mechanism to force particulate matter out of lumen 26. This mechanism is shown in greater detail in the figures that follow.
  • the evacuation mechanism may be actuated by power supplied in another form from outside the patient' s body, or even by power supplied by the muscles of the body itself.
  • actuator 38 may be implanted in such a way that changing the knee joint position causes pressure to be exerted on the actuator and thus evacuates the particulate matter from the lumen .
  • Fig. 2 is a schematic, pictorial illustration of device 20 that shows details of evacuation mechanism 37, in accordance with an embodiment of the present invention.
  • Actuator 38 comprises reservoirs 40 and 42, which in this embodiment are configured as joined hemispheres, so that pressure on the actuator compresses both reservoirs.
  • Reservoirs 40 and 42 are respectively connected to tubes 44 and 46, which pass through a head 48 of housing 24 and are respectively connected to lumen 26 on opposing sides of valve 28.
  • reservoirs 40 and 42 and other components of evacuation mechanism 37 comprise flexible biocompatible materials, such as silicone or another suitable elastomer.
  • Figs. 3A and 3B are schematic, sectional illustrations of device 20, showing the connection and operation of reservoirs 42 and 40, respectively, in accordance with an embodiment of the present invention.
  • Reservoir 40 is connected by tube 44 to one or more ports 54 that open into a joint side 50 of lumen 26, while reservoir 42 is connected by tube 46 to another port 54 in a medullar side 52 of the lumen.
  • Sides 50 and 52 are separated by valve 28, as explained above. As long as both sides of lumen 26 are clear, excess synovial fluid will flow from side 50, through valve 28, into side 52, and from there into medullary space 32.
  • the synovial fluid will begin to accumulate in the capsule of joint 22.
  • the patient or medical caregiver presses on the skin in the area of actuator 38.
  • the pressure compresses reservoirs 40 and 42, which causes evacuation fluid to flow from the reservoirs, via tubes 44 and 46, and into sides 50 and 52, respectively, and thus force particles out of both ends of lumen 26.
  • the patient or caregiver repeats this practice as needed and may also press on the actuator intermittently as a prophylactic measure.
  • the evacuation fluid in reservoirs 40 and 42 may simply comprise synovial fluid, which flows into the reservoirs via ports 54 and tubes 44 and 46 while the reservoirs are uncompressed.
  • the fluid may exit from the reservoirs through nozzles at high speed, in order to clear occlusions more effectively.
  • these nozzles may be located in the center of the lumen and may be formed so as to direct the fluid out along the lumen axis.
  • one or both of sides 50 and 52 may contain a flexible membrane 56, which maintains a separation between the evacuation fluid (liquid or gas) and the synovial fluid.
  • the evacuation substance may comprise any suitable gas or liquid, such as saline solution.
  • Fig. 4 is a schematic sectional view of valve 28 inside housing 24, in accordance with an embodiment of the present invention.
  • Valve 28 comprises a seat 60 and a base 62, which holds a Belleville-type spring washer 64 against the seat.
  • the spring washer is preloaded so that the valve remains closed until a certain pressure difference builds up between side 50 and side 52.
  • the valve may be designed to open at any suitable pressure threshold, such as a difference of about 5-10 mm Hg. Once the pressure equalizes, the spring washer closes. As can be seen in the figure, valve 28 does not allow backflow from side 52 to side 50.
  • device 20 may comprise valves of other types, including other sorts of mechanical valves, as well as electronic or hydraulically-controlled valves. Such valves may be automatically pressure-actuated, as in the present embodiment, or they may be opened and closed on command by the patient or medical caregiver.
  • Figs. 5A and 5B schematically illustrate a shunt device 70, in accordance with an alternative embodiment of the present invention.
  • Fig. 5A is a pictorial illustration of the device, while Fig. 5B is a sectional illustration taken along the line VB-VB in Fig. 5A.
  • Device 70 contains a lumen 72, with a suitable pressure- responsive valve and means for fixing the device to the bone, as in the embodiments described above.
  • the evacuation mechanism in device 70 comprises a rod 73 having rigid sections 74, which are contained in the opposing sides of lumen 72. Rigid sections 74 are coupled to a flexible bent section 76, which serves as the actuator of the mechanism. This bent section is covered and protected by a bulb 78.
  • Fig. 6 is a schematic, sectional illustration of a shunt device 80, in accordance with another embodiment of the present invention. As in the preceding embodiment, certain functional elements are eliminated from Fig. 6 (and similarly from the embodiment shown in Fig. 7) in order to focus on the novel evacuation mechanism used in this embodiment.
  • Device 80 contains a lumen 82, in which an evacuation head 84 is mounted to move along a track 86. As head 84 moves along the track, it breaks up clogs and dislodges particulate matter within the lumen.
  • the particular pointed shape shown in Fig. 6 may be useful in breaking up clogs, but the head may alternatively be made in any other suitable shape and size.
  • evacuation head 84 is attached to a spring 88. Movement of the patient's body, such as flexing and extension of the knee joint as the patient walks, causes the evacuation head to slide back and forth along track 86. Thus, the evacuation head alternately compressing the spring and then receiving energy from the spring in a cyclical motion pattern. Alternatively or additionally, if the evacuation head comprises a suitable magnetic material, it can be made to slide back and forth along the track under the influence of a magnet moving alongside the area of the body in which device 80 is implanted.
  • Fig. 6 shows an evacuation head on only one side of the device, this mechanism may be duplicated on both sides of the valve in the shunt device, as in the preceding embodiments.
  • the other types of evacuation mechanisms that are described hereinbelow may likewise be double-sided.
  • Fig. 7 is a schematic side view of a shunt device 90, in accordance with yet another embodiment of the present invention.
  • the evacuation mechanism comprises a cover 92 with a pointed protrusion 94.
  • the cover is attached to the end of device 90 and may be spring-loaded to remain normally open.
  • cover 92 may be closed, by means of a moving magnet outside the body, for example, thus driving protrusion 94 into the lumen and breaking up the clog.
  • protrusion 94 shown in Fig. 7 is relatively short, a longer protrusion may be used to break up clogs that are deeper into the lumen.
  • the evacuation mechanism of Fig. 7 may be used together with one of the other mechanisms shown above in order to clear out particulate matter from the entire length of the lumen.
  • the evacuation mechanism may be powered by other forms of energy, such as acoustic or thermal energy or force exerted by a micro-motor.
  • a propeller-type mechanism may be mounted inside the lumen, with variable speed for clearing different types of occlusions, under internal or external control.
  • the propeller causes rapid fluid movement in the lumen, which helps to loosen any accretion of tissue.
  • Two propellers with opposite directions of rotation may be mounted in opposite ends of the lumen.
  • a pin, wire or foil, with a sharp edge may be placed in the side wall of the lumen and be capable of moving toward the center of the lumen in order to cut accretions of tissue.
  • a wire of varying diameter possibly with a non-stick coating, and be mounted along the length of the lumen and rotated, by a micro-motor, for example, in order to clear the lumen by a sort of drilling action.
  • a rod which is capable of opening radially outward to form a flap within the lumen and moving back and forth within the lumen, may mounted in the lumen and operated to open occlusions .
  • An ultrasonic or thermal transducer may be placed inside the lumen, and energized in order to dislodge clogs by high- frequency vibration or by heat.
  • an implant may be configured to drain excess fluid from a joint, such as the knee, into a subcutaneous region, rather than into the medullary space.
  • the excess fluid will in this case be absorbed in the subcutaneous tissues, although the speed of absorption may not be as great as in the medulla.
  • the evacuation mechanisms described above are similarly useful in relieving clogs in the device lumen in these alternative embodiments .
  • elements of the devices described above may be integrated into a functional implant, such as an artificial joint used in total knee replacement surgery.
  • the shunt may be useful in draining not only synovial fluid, but also blood that may leak into the joint following the surgery.
  • a shunt device may be implanted within one or both of the lungs in order to drain fluid into the medulla of one or more of the ribs. This sort of device can be used in relieving fluid buildup that occurs in cases of lung cancer.
  • the lumen of the shunt device may contain a membrane to prevent the passage of cancerous cells into the bone .
  • a shunt device may be implanted in the skull to drain fluid from the intracranial cavity into the medulla of the cranial bones. .This device may take the place of conventional ventriculoperitoneal (VP) shunts in relieving pressure on the brain due to conditions such as hydrocephalus. ? A shunt device may be implanted in the pelvis to drain fluid from the peritoneal cavity (which accumulates in cases of liver disease, for example) into the medulla of the pelvic bone.
  • VP ventriculoperitoneal
  • references to drainage into the medulla or medullary spaces of bones in the context of the present patent application and in the claims should be understood broadly to refer not only to the medullary spaces of long bones, but more generally to the medulla of any suitable bones in the body.
  • evacuation mechanisms may be adapted, mutatis mutandis, to relieve clogging of the device lumen in these alternative applications, as well as in other types of implanted shunts and other drains that are known in the art.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Otolaryngology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • External Artificial Organs (AREA)

Abstract

Un dispositif médical (20) comprend un boîtier de dispositif (24), qui contient une lumière (26) comportant des première et seconde extrémités et est configuré pour une implantation dans un os (34) d'un sujet, de sorte que la première extrémité débouche dans une cavité corporelle (30) à proximité de l'os et que la seconde extrémité débouche dans une moelle (32) de l'os. Une soupape (28) est contenue dans le boîtier de dispositif et est configurée pour commander un écoulement d'un fluide corporel de la cavité corporelle dans la moelle. Le dispositif peut comprendre un mécanisme d'évacuation (37) couplé au boîtier de dispositif pour évacuer de la matière particulaire de la lumière.
PCT/IL2008/001182 2007-09-05 2008-09-01 Shunt implantable Ceased WO2009031138A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US93586407P 2007-09-05 2007-09-05
US60/935,864 2007-09-05

Publications (2)

Publication Number Publication Date
WO2009031138A2 true WO2009031138A2 (fr) 2009-03-12
WO2009031138A3 WO2009031138A3 (fr) 2010-03-04

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2008/001182 Ceased WO2009031138A2 (fr) 2007-09-05 2008-09-01 Shunt implantable

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WO (1) WO2009031138A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011005206A1 (fr) * 2009-07-10 2011-01-13 Milux Holding S.A. Dispositif de lubrification implantable et méthode de traitement d'un patient humain ou mammifère au moyen dudit dispositif
CN102596104A (zh) * 2009-07-10 2012-07-18 米卢克斯控股股份有限公司 可植入式润滑装置和通过该装置治疗人类或哺乳动物患者的方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3298372A (en) * 1963-12-17 1967-01-17 Feinberg Maurice Surgical hydrocephalus shunt sleeve for placement in a vertebra
US4192342A (en) * 1978-02-16 1980-03-11 Adams Donald L Rod out valve
US4761158A (en) * 1984-03-16 1988-08-02 Pudenz-Schulte Medical Research Corp. Subcutaneous infusion reservoir and pump system
US5167615A (en) * 1990-05-15 1992-12-01 Pudenz-Schulte Medical Research Corporation Flow control device having selectable alternative fluid pathways
EP0797413B1 (fr) * 1994-12-09 2003-11-05 F. Barry Bays Ensemble de valve d'abaissement de la pression du liquide synovial
US6254563B1 (en) * 1997-12-15 2001-07-03 Cardeon Corporation Perfusion shunt apparatus and method
EP1343557B1 (fr) * 2000-12-11 2004-09-22 Christoph Miethke Gmbh & Co. KG Soupape pour hydrocephale

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011005206A1 (fr) * 2009-07-10 2011-01-13 Milux Holding S.A. Dispositif de lubrification implantable et méthode de traitement d'un patient humain ou mammifère au moyen dudit dispositif
CN102596104A (zh) * 2009-07-10 2012-07-18 米卢克斯控股股份有限公司 可植入式润滑装置和通过该装置治疗人类或哺乳动物患者的方法
US9180011B2 (en) 2009-07-10 2015-11-10 Peter Forsell Implantable circulating lubrication system for joints

Also Published As

Publication number Publication date
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