MANUAL SUCTION DEVICE FOR THROMBUS CAPTURE AND REPERFUSION

A medical device is adapted for use in assisting with mechanical thrombectomy. The medical device may include a housing that is adapted to be held within a user's hand and a pump that is secured within the housing. A fluid inlet is adapted to receive fluid that is pulled towards the pump and is fluidly coupled with the pump. A fluid outlet is adapted to expel fluid away from the pump and is fluidly coupled with the pump. As the pump is operated by the user, fluid is alternatively pulled into the fluid inlet and expelled through the fluid outlet. In some cases, the fluid may be blood or other bodily fluids.

TECHNICAL FIELD

The disclosure is directed to suction devices and more particularly to manual suction devices that can be used for capturing thrombi from a patient's vasculature while returning blood to the patient.

BACKGROUND

There are a variety of medical procedures and medical conditions that may result in unwanted material within a patient's bloodstream. A patient may have thrombolytic material within their bloodstream. There are medical devices intended for removal of thrombolytic material. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.

SUMMARY

The disclosure is directed to several alternative designs, materials and methods of manually operated mechanical suction devices. An example of the disclosure may be found in a medical device that includes a housing and a pump secured within the housing. A fluid inlet is fluidly coupled with the pump and is adapted to receive fluid pulled towards the pump. A fluid outlet is fluidly coupled with the pump and is adapted to expel fluid away from the pump. A fluid path extends from the fluid inlet to the fluid outlet. As the pump is operated by the user, fluid is alternatively pulled into the fluid inlet and expelled through the fluid outlet.

Alternatively or additionally, the pump may include a manually operated pump.

Alternatively or additionally, the pump may include a cylinder formed within the housing, a piston slidingly disposed within the cylinder, a connecting rod pivotably secured to the piston and a rotating disk having a handle to rotate the disk, the connecting rod pivotably secured to the rotating disk at a position offset from a center of the rotating disk such that when the rotating disk is rotated, the connecting rod causes the piston to translate back and forth within the cylinder.

Alternatively or additionally, the pump may further include a handle adapted to be coupled with the rotating disk such that rotating the handle causes the rotating disk to rotate.

Alternatively or additionally, the handle may be adapted to be releasably coupled with the rotating disk.

Alternatively or additionally, the handle may be adapted to form an interference fit with the rotating disk.

Alternatively or additionally, the medical device may further include a one way inlet valve disposed within the fluid inlet such that fluid is allowed to flow into the fluid inlet when the piston is moved away from the fluid path but is prevented from flowing out of the fluid inlet when the piston is moved towards the fluid path and a one way outlet valve disposed within the fluid outlet such that fluid is allowed to flow out of the fluid outlet when the piston is moved towards the fluid path but is prevented from flowing into the fluid outlet when the piston is moved away from the fluid path.

Another example of the disclosure may be found in a medical device that is adapted to facilitate mechanical thrombectomy. The medical device includes a housing adapted to be held within a user's hand and a pump secured within the housing, the pump including a handle that is adapted to be engaged by a user's other hand. A fluid inlet is fluidly coupled with the pump and is adapted to accommodate a first fluid line bringing fluid to the fluid inlet. A fluid outlet is fluidly coupled with the pump and is adapted to accommodate a second fluid line taking fluid away from the fluid outlet. As the pump is operated by the user, fluid is alternatively pulled into the fluid inlet and expelled through the fluid outlet.

Alternatively or additionally, the pump may include a piston slidingly disposed relative to the housing, a connecting rod pivotably secured to the piston and a rotating disk having a handle to rotate the disk, the connecting rod pivotably secured to the rotating disk at a position offset from a center of the rotating disk such that when the rotating disk is rotated, the connecting rod causes the piston to translate back and forth relative to the housing.

Alternatively or additionally, the medical device may further include a handle that is adapted to be releasably coupled with the rotating disk.

Alternatively or additionally, the medical device may further include a handle that handle is adapted to form an interference fit with the rotating disk.

Alternatively or additionally, the medical device may further include a one way inlet valve that is disposed within the fluid inlet and is adapted to only allow fluid to flow into the fluid inlet and a one way outlet valve that is disposed within the fluid outlet and is adapted to only allow fluid to flow out of the fluid outlet.

Alternatively or additionally, the piston may include a rubber feature that seals against an interior of the housing.

Another example of the disclosure may be found in a system for capturing unwanted materials within blood flowing through a patient's vasculature. The system includes a blood filter adapted to capture the unwanted materials and a medical device that is adapted to facilitate mechanical thrombectomy. The medical device includes a housing adapted to be held within a user's hand and a pump secured within the housing, the pump including a handle that is adapted to be engaged by a user's other hand. A fluid inlet is fluidly coupled with the pump and is adapted to accommodate a first fluid line bringing fluid to the fluid inlet. A fluid outlet is fluidly coupled with the pump and is adapted to accommodate a second fluid line taking fluid away from the fluid outlet. As the pump is operated by the user, fluid is alternatively pulled into the fluid inlet and expelled through the fluid outlet. The blood filter is adapted to be fluidly coupled with the fluid inlet and blood exiting the fluid outlet is directed back to the patient.

Alternatively or additionally, the blood exiting the fluid outlet may be returned directly to the patient.

Alternatively or additionally, the blood exiting the fluid outlet may be captured and stored for subsequent return to the patient.

Alternatively or additionally, the unwanted materials may include embolic material.

Alternatively or additionally, the unwanted materials may include foreign matter not normally part of the patient's blood.

Another example of the disclosure may be found in a medical device adapted for removing unwanted materials within blood flowing through a patient's vasculature. The medical device includes a housing that is adapted to be held within a user's hand and a pump that is secured within the housing. The pump includes a cylinder formed within the housing, a piston slidingly disposed within the cylinder, a connecting rod pivotably secured to the piston and a rotating disk having a handle to rotate the disk, the connecting rod pivotably secured to the rotating disk at a position offset from a center of the rotating disk such that when the rotating disk is rotated, the connecting rod causes the piston to translate back and forth within the cylinder. A fluid inlet is fluidly coupled with the pump and is adapted to receive fluid pulled towards the pump. A fluid outlet is fluidly coupled with the pump and is adapted to expel fluid away from the pump. As the pump is operated by the user, fluid is alternatively pulled into the fluid inlet and expelled through the fluid outlet.

Alternatively or additionally, the medical device may further include a handle that is releasably securable relative to the rotating disk.

DESCRIPTION

Definitions of certain terms are provided below and shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

The recitation of numerical ranges by endpoints includes all numbers within that range (e.g.,1to5includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

FIG.1is a perspective view of an illustrative medical device10. In some cases, the illustrative medical device10may be used as a source of suction in order to pull a fluid such as blood or other bodily fluids into the medical device10as well as to pump the fluid such as blood or other bodily fluids out of the medical device10for subsequent return to the patient. The overall system will be discussed with respect toFIG.4. InFIG.1, the medical device10can be seen having a housing12that fits into a user's hand H. The medical device10may also be used while resting or even being mounted on a table or other surface, for example. The medical device10includes a handle14that is adapted to permit the user to actuate the handle14using their other hand. As illustrated, the user is holding the medical device10in their right hand H, meaning that they can actuate the handle14with their left hand (not shown). It will be appreciated that the medical device10can easily be held in a user's left hand, meaning that the user would then use their right hand H to actuate the handle14. This may be determined based on whether the user is left-handed or right-handed, for example.

The medical device10, which may be considered as including or even being a fluid pump, includes a fluid inlet16and a fluid outlet18. In some cases, as shown, the medical device10may include a one way inlet valve20that is disposed proximate the fluid inlet16and a one way outlet valve22that is disposed proximate the fluid outlet18. A fluid path24may be considered as extending between the fluid inlet16and the fluid outlet18. As shown, the fluid inlet16, the fluid outlet18and the fluid path24extending therebetween is illustrated as being transparent. In some cases, the fluid inlet16, the fluid outlet18and the fluid path24extending therebetween may be formed of a transparent or substantially transparent polymeric material in order to allow the user to visualize the flow of fluid through the medical device10. As will be discussed with respect toFIG.3, the fluid path24also extends down into the medical device10.

The one way inlet valve20may be adapted to permit fluids such as blood or other bodily fluids to flow into the fluid inlet16in a direction indicated by an arrow26but not allow fluids such as blood or other bodily fluids to flow in an opposite direction, opposing the arrow26. The one way outlet valve22may be adapted to permit fluids such as blood or other bodily fluids to flow out of the fluid outlet18in a direction indicated by an arrow28but not allow fluids such as blood or other bodily fluids to flow in an opposite direction, opposing the arrow28.

The housing12includes recessed areas30and32on either side of the housing12that facilitate the user easily holding the medical device12in their hand H. As can be seen, the recessed area30enables the user's finger F to fit into the recessed area30while the recessed area32enables the user's thumb T to fit into the recessed area32. It will be appreciated that if the user was holding the medical device10in their left hand (not shown), the recessed area30would accommodate the user's thumb T while the recessed area32would accommodate the user's finger F.

FIG.2provides a plan view of the medical device10. The plan view further illustrates the recessed areas30and32. The handle14has been removed in this view. The housing12may include a cover34that is fixed relative to the housing12but may include an aperture36that accommodates a drive mechanism38that extends through the aperture36in the cover34. The drive mechanism38is adapted to rotate relative to the cover34when the handle14is secured to the drive mechanism38and the user rotates the handle14. In some cases, there may be an interference fit formed between the handle14and the drive mechanism38. As illustrated, the drive mechanism38includes a square aperture40that is adapted to accommodate a corresponding square peg formed on the handle14, as will be shown inFIG.3. While a square aperture40is shown, it will be appreciated that the drive mechanism38may include an aperture having any desired shape, such as square, rectangular, hexagonal or other polygonal shape, triangular or the like, as long as the handle14includes a complementary shaped peg, and as long as the particular shape and the corresponding interaction between the aperture and the peg enables an interference fit. For example, a round aperture and corresponding round peg would not work as well.

FIG.3shows that the handle14includes a square peg42that is adapted to fit snugly into the square aperture40. As noted, the peg42may have any of a variety of different shapes, as long as that shape is complementary to that of the aperture40and the interaction therebetween facilitates an interference fit. In some cases, as shown, the handle14may include a knob44that rotates relative to the handle14. This facilitates actuating the handle14because as the user grasps the knob44and thus rotates the handle14, the knob44is able to remain at a fixed position relative to the user's hand as the user actuates the handle14. It will be appreciated that the particular size and shape of the handle14shown is merely illustrative, as any of a variety of different handle shapes could be used. As will be discussed with respect toFIG.4, the handle14may be turned in either direction in order to pump fluids such as blood or other bodily fluids through the medical device10.

FIG.4is a plan view of the medical device10. IfFIG.3is considered to be a “front” view of the medical device10, thenFIG.4may be considered as being a “back” view, with one or more cover elements removed to show features of a pump mechanism46. The pump mechanism46includes several components, including a rotating disk48. While not seen in this view, it will be appreciated that the drive mechanism38(FIG.3) is coupled with the rotating disk48such that when the drive mechanism38is rotated, the rotating disk48is caused to rotate in response. While not illustrated, in some cases it is contemplated that an electric motor may instead be used to rotate the rotating disk48. If an electric motor is used, the medical device would also include an on/off switch or other mechanism to control operation of the electric motor. In some cases, an air driven motor, driven for example by compressed air interacting with a rotor, may alternatively be used.

A cylinder50is formed within the housing12. The cylinder50may be a separate piece that is separately formed and then disposed within the housing12. In some cases, the cylinder50may be integrally formed as part of the housing12. A piston52, which may include a rubber component such as an O ring in order to form a better seal against a wall of the cylinder50, is slidingly disposed within the cylinder50. A connecting rod54extends from the rotating disk48to the piston52in order to convert rotation of the rotating disk48into translation back and forth of the piston52within the cylinder50. The connecting rod54may be considered as including several components. A first connecting rod portion56is pivotably coupled to the rotating disk48at a pivot point58. A second connecting rod portion60extends up to the piston52and couples to the first connecting rod portion56at a pivot point62. In some cases, the coupling between the second connecting rod portion60and the piston52may include another pivot mechanism.

As the handle14is rotated, causing the rotating disk48to rotate, it will be appreciated that the piston52translates back and forth (or up and down, in the illustrated orientation) within the cylinder50. As the piston52moves downward, or away from the fluid path24, a resulting suction causes fluids such as blood or other bodily fluids to enter the fluid inlet16in the direction indicated by the arrow26. The one way outlet valve22prevents fluid from flowing in a direction opposite that of the arrow28. As the piston52moves upward, or towards the fluid path24, a resulting pressure causes fluids such as blood or other bodily fluids to exit the fluid outlet18in the direction indicated by the arrow28. The one way inlet valve20prevents fluids such as blood or other bodily fluids from exiting the fluid inlet16in a direction opposing that of the arrow26.

As the handle14is rotated, therefore, the medical device10will alternately pull fluids such as blood or other bodily fluids into the medical device10via the fluid inlet16and push fluids such as blood or other bodily fluids out of the medical device10via the fluid outlet18. The medical device10is insensitive to orientation. The medical device10will work equally well whether held in the illustrated orientation, or upside down, or any other orientation. The medical device10can be stopped or started, meaning the user either stops rotating the handle14or starts rotating the handle14, at any handle orientation.

FIG.5is a schematic view, showing a possible use for the medical device10. A patient P is shown. A first fluid line64can be seen exiting the patient P. There may be a hemostatic valve disposed between the patient P and the first fluid line64, for example. The first fluid line64extends to a filter assembly66. As the medical device10is actuated, and blood is pulled through the first fluid line64into and through the filter assembly66, the filter assembly66may capture any unwanted material within the blood, such as but not limited to thrombolytic material. A second fluid line68fluidly couples the filter assembly66with the fluid inlet16of the medical device10. A third fluid line70fluidly couples the fluid outlet18of the medical device18with the patient P for reperfusion. The third fluid line70may extend to the patient P via a hemostatic valve, for example. In some cases, the third fluid line70may instead be coupled with a blood bag or other structure that is adapted to collect the blood before the blood is subsequently returned to the patient P.