WO2011070593A1

WO2011070593A1 - Device for vascular access

Info

Publication number: WO2011070593A1
Application number: PCT/IN2010/000798
Authority: WO
Inventors: Jayant Sitaram Karve; Srinivas Kiran Jaggu; Sandeep Singh; Amit K. Sharma; Gabriel Howles Banerji; Vijaykumar Rajasekhar; Matthew Durack
Original assignee: Secretary, Department Of Biotechnology
Priority date: 2009-12-11
Filing date: 2010-12-10
Publication date: 2011-06-16
Also published as: WO2011070593A4; IN2009DE02581A

Abstract

The present subject matter relates to a device for vascular access, in particular to an intraosseous device. The device includes a penetrating unit to penetrate a penetration site, a driver unit coupled to the penetrating unit to drive the penetrating unit into the penetration site, and an aspiration unit coupled to the penetrating unit to aspirate a sample from the penetration site. The present subject matter further relates to an intraosseous device including a penetrating unit, a driver unit and a guide assembly. The penetrating unit includes a conduit hub having a fluid conduit fixed therein, and a trocar received in the fluid conduit, for penetrating the penetration site. The driver unit is coupled to the penetrating unit to drive the penetrating unit into the penetration site. The guide assembly encloses the conduit hub to prevent bending and sideways movement of the fluid conduit.

Description

DEVICE FOR VASCULAR ACCESS

TECHNICAL FIELD

The present subject matter, in general, relates to a device for vascular access, and in particular to an intraosseous device for infusion and/or aspiration.

BACKGROUND

Establishing access to human circulatory system for injecting medications or fluids is a critical part of resuscitation in patients in emergency situations. Even though intravenous access is a preferred mode of vascular access, many a times it is difficult to access veins. In emergency situations, such as during cardiac arrest, trauma, or dehydration, generally the blood volume in the patient's body is low, which may lead to vein collapse. Due to the vein collapse, precious time is lost in trying to achieve intravenous access for injecting medications. In such cases, a person/operator trying to inject the medications or fluids may use intraosseous infusion for accessing the circulatory system. The intraosseous infusion is the process of injecting medications or fluids directly into the marrow of a bone. This involves piercing a needle through a hard cortical layer of the bone into a soft marrow interior of the bone.

Conventional devices for achieving intraosseous access include a needle arrangement with a trocar that is drilled in the bone. In devices like the cook needle, jemshedi needle etc., the penetration is achieved by manual twist-drill action, which involves very high thrust force. Furthermore such mechanism is highly dependent on operator's skill, strength and hardness of the patient's bone; these factors can results in unsuccessful penetration slippage or delay in patient care. Other penetration mechanisms involve a needle arrangement that is usually drilled with a sudden impact provided either manually or using spring. The impact may result in bone fracture. Such devices have usage in limited anotomical locations like sternum or certain patient populations like pediatrics. Other devices available at present are electric devices that although solve the problem of bone fracture but can not be used in places that lack resources such as electricity or in remote areas and war fields.

Further, in conventional devices, the lack of controlled movement of the needle while accessing the bone marrow involves risk of either needle overshoot or undershoots through cortical layers of the bone. The lack of controlled movement of the needle may l further cause sideways movement, bending and/or breakage of the needle. The use of such devices often leads to clinical complications such as extravasations, i.e., leakage of fluids and/or blood from veins. This is mainly because of uncertainty or blindness associated with the procedure, as the operator is not aware of the position of the needle.

Further, the conventional devices used for the intraosseous infusion consume a substantial amount of time to complete the process of drilling, ensuring the correct location for infusion in the bone, particularly medullary sinusoids, and then infusion. U.S. patent number 5,372,583 discloses a device and method for intraosseous infusion where the operator first drills the needle with trocar of the device into the bone, removes the part of the device used for the purpose of drilling and then couples another device to the needle arrangement to verify whether the medullary sinusoid of the bone has been reached. After confirming the correct location the operator injects fluids into the medullary sinusoid using an infusion device. This process of using a separate device for verification of location results in a delay in providing medications to the patient and may result in loss of precious time during emergency situations.

U.S. patent number 7,670,328 discloses an intraosseous apparatus having a hollow portion operable to allow aspiration of fluid from a patent's brain during penetration of the brain. However, the apparatus needs to be connected to a foot-switch for providing suction required for aspiration. The apparatus further needs to be connected to an external jar for collecting the aspirated fluid. Thus, although the apparatus provides the facility of aspiration and penetration, however the apparatus needs to be actuated by an external device and is not portable. Further during the penetration the operator needs to operate the foot-switch for aspiration, thus making the operation of the device cumbersome for the operator.

SUMMARY

The subject matter disclosed herein describes a device for vascular access, in particular to an intraosseous device. The device includes a penetrating unit to penetrate a penetration site, a driver unit coupled to the penetrating unit to drive the penetrating unit into the penetration site, and an aspiration unit coupled to the penetrating unit to aspirate a sample from the penetration site. The subject matter disclosed herein further describes an intraosseous device. The device includes a penetrating unit, a driver unit and a guide assembly. The penetrating unit includes a conduit hub having a fluid conduit fixed therein, and a trocar received in the fluid conduit, for penetrating the penetration site. The driver unit is coupled to the penetrating unit to drive the penetrating unit into the penetration site. The guide assembly encloses the conduit hub to prevent bending and sideways movement of the fluid conduit.

These and other features, aspects, and advantages of the present subject matter will be better understood with reference to the following description and appended claims. This summary is provided to introduce a selection of concepts in a simplified form. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

BRIEF DESCRIPTION OF DRAWINGS

The novel features of the subject matter are set forth in the appended claims hereto. The subject matter itself, however, as well as a preferred mode of use, further objectives, and advantages thereof, will best be understood by reference to the following detailed description of illustrative embodiments when read in conjunction with the accompanying drawings, and wherein:

Figure 1 illustrates a sectional view of an exemplary device for vascular access, according to an embodiment of the present subject matter.

Figure 2 illustrates a detailed sectional view of an exemplary rotational driver element of the exemplary device of figure 1.

Figure 3a illustrates a detailed sectional view of an exemplary adjustable stopper of the exemplary device of figure 1.

Figure 3b illustrates a detailed sectional view of an exemplary adjustable stopper of the exemplary device of figure 1.

Figure 4 illustrates a perspective view of an exemplary guide assembly of the exemplary device of figure 1.

Figures 5a illustrate a perspective view of an exemplary guide assembly of the exemplary device of figure 1. Figures 5b illustrate a perspective view of the exemplary guide assembly of figure

5a.

DETAILED DESCRIPTION

The present subject matter relates to a device for vascular access, in particular to an intraosseous device. The device may be used in applications related to aspirating and/or infusing fluids from or in human body, respectively. The device includes a penetrating unit to penetrate a penetration site, a driver unit coupled to the penetrating unit to drive the penetrating unit into the penetration site, and an aspiration unit integrated within the device, coupled to the penetrating unit, to aspirate a sample from the penetration site.

In an embodiment, the device can be used to indicate penetration of the penetrating unit into a desired or target site.

The driver Unit of the device includes an axial driver element to provide an axial motion to the penetrating unit, and a rotational driver element to provide a rotational motion to the penetrating unit.

The device, according to the present subject matter, is operable by an operating thrust force from an operator in a range from about 1 to 10 kilograms. The operating thrust force is the push provided by the operator to the device for penetration. In one embodiment, the operating thrust force is applied to the axial driver element.

Further, the penetrating unit rotates at a rotational speed in a range from about 100 to 800 revolutions per minute to penetrate the penetration site.

In one embodiment, the operating thrust force in the range from about 1 to 10 kilograms rotates the penetrating unit at the rotational speed in the range from about 100 to 800 revolutions per minute.

The penetration unit of the device comprises a conduit hub having a fluid conduit fixed therein, and a trocar received in the fluid conduit, for penetrating the penetration site. The fluid conduit is fixed at its one end to the conduit hub. In an embodiment, the trocar is positioned inside the fluid conduit and extended slightly beyond a fluid conduit tip for piercing the patient's body, particular a bone. The trocar has sharp cutting edges that facilitate faster piercing. In an embodiment, the device includes a guide assembly enclosing the conduit hub to prevent bending and sideways movement of the fluid conduit.

The guide assembly includes a guide with a base having a recess. The fluid conduit passes through the recess. This prevents the fluid conduit from bending and sideways movement.

In an embodiment, the guide assembly includes a guard element enclosed in the guide and meshed with the guide. The guard element encloses the conduit hub with the fluid conduit. Further, the guard element has at least one flange. In one embodiment, the guide has protrusions on an inner surface thereof. The at least one flange of the guard element meshes with the protrusions to prevent the fluid conduit from moving in a direction opposite to a direction of penetration.

In an embodiment, the penetration unit includes an adjustable stopper coupled to the conduit hub to adjust a penetrable length of the fluid conduit. The position of the stopper is adjustable on the conduit hub. The penetrable length of the conduit is adjusted to prevent an overshoot of the fluid conduit in the patient's body, particularly in the bone.

In an embodiment, the aspiration unit of the device includes a shaft axially movable to facilitate the aspiration of the sample, and a barrel to collect the sample.

In an embodiment, the shaft is axially movable inside the barrel, creating a vacuum inside the barrel. The shaft can be pulled or pushed inside the barrel.

In an embodiment, the shaft is coupled to the penetrating unit such that the penetrating unit rotates in conjunction with the shaft.

In an embodiment, the shaft is coupled to the barrel of the aspiration unit such that the barrel rotates in conjunction with the shaft.

In an embodiment, the trocar is fixedly coupled to one end the shaft such that the trocar rotates in conjunction with the shaft. This couples the aspiration unit to the penetration unit. The other end of the shaft couples the aspiration unit to the driver unit.

In an embodiment, the trocar is integrated with the shaft.

In an embodiment, the conduit hub is coupled to the barrel such that the conduit hub rotates in conjunction with the barrel. In an embodiment, the shaft includes spiral grooves on a surface thereof. The rotational driver element is engaged with the spiral grooves of the shaft to transfer an axial motion of the driver unit to a rotational motion of the shaft.

In an embodiment, the rotational driver element includes a first clutch coupled to the axial driver element, and a second clutch engaged with the spiral grooves provided on the shaft. The axial driver element transfers the axial input motion of the driver unit to the first clutch. This axial input motion engages the first clutch with the second clutch to transfer the axial input motion of the driver unit to a rotational motion of the shaft.

In an embodiment, the axial driver element is a handle with a knob mounted thereon. The first clutch of the rotational driver element is fixed or integrated with the handle at an end away from the knob. The axial driver element further includes a spring element. The spring element is coupled to the shaft on one end and abuts the knob on the other. Further, the second clutch of the rotational driver element is engaged with the shaft. The axial input motion provided to the driver unit engages the first clutch with the second clutch that translates the axial input motion into a rotational motion of the shaft and hence of the penetrating unit.

In an embodiment, the fluid conduit is a hollow pipe having multiple openings that facilitate medications or fluid delivery and fluid aspiration in a patient's body.

In an embodiment, the fluid conduit is a conventional needle.

In an embodiment, the fluid conduit is a 12 to 20 gauge needle.

In an embodiment, the fluid conduit is a needle having multiple openings that facilitate medications or fluid delivery and fluid aspiration in a patient's body.

In an embodiment, the fluid conduit is a cannula made of plastic.

In an embodiment, the barrel includes at least one transparent section to provide visibility of the sample collected in the barrel.

In an embodiment, the guide includes at least one support element extending from the guide for supporting the device, according to the present subject matter, on an intended anatomy, such as the bone.

In an embodiment, the guide includes at least one transparent section, such that movement of the fluid conduit is visible during the penetration. In an embodiment, the guide includes an opening, such that movement of the fluid conduit is visible during the penetration.

In an embodiment, the guide includes depth gauge markings on a surface thereof, to indicate depth of the fluid conduit in the penetration site.

In an embodiment, the sample is a bone marrow.

To operate the device, according to the present subject matter, for performing intraosseous infusion an operator places the device on the patient's body part with the penetrating unit and the guide in contact with the penetration site. The operator applies a thrust force or axial input force on the driver unit, such that the driver unit starts moving in a downward direction. The axial input force engages the axial driver element with the rotational driver element. Subsequently, the rotational driver element engages with the shaft. This engagement sets a rotational motion in the shaft. The rotational motion of the shaft rotates the trocar and the conduit hub with the fluid conduit of the penetration unit, which starts penetrating the penetration site. During the penetration, when the operator gets a giveaway feeling, such as of a reduction of pressure against the penetrating unit, the operator stops applying the thrust force to stop further penetration. The operator may then aspirate the penetration site using the aspiration unit integrated in the device. The operator, for the purpose of aspiration, pulls the shaft upwards, creating a vacuum inside the barrel and the fluid conduit. The operator pulls the shaft to aspirate a sample, such as bone marrow, from the penetration site. The sample, if present at the site, will get collected in the barrel.

In an embodiment, the operator may aspirate to confirm whether a target or desired site within the intended anatomy has been reached or not. The target or desired site can be medullary sinusoids within a bone. The presence of the sample in the barrel will confirm the penetration of the target site. The driver unit, the aspiration unit, and the trocar may then be removed, leaving the conduit hub with the fluid conduit and the guide in the original position with the fluid conduit inside the penetration site. Fluids can then be infused in or aspirated from the patient's body using the conduit hub with the fluid conduit.

Thus, with the device, according to the present subject matter, the operator gets the indication of reaching the target or desired site without using any external or separate device, thus decreasing the time required for the infusion. Providing the aspiration unit with the penetrating unit also prevents leakage of first few blood drops that are essential for applications such as bone marrow aspiration. Further, providing the guide on the penetration ensures a controlled movement of the fluid conduit and the trocar while accessing the bone marrow and prevents any bending and/or sideways movement of the fluid conduit and the trocar. In addition, the guide is structured to prevent any lifting (or upward) movement of the fluid conduit during the penetration as well as after being penetrated, thus ensuring that the fluid conduit remains in the target site during aspiration and medication.

Furthermore, since the device, according to the present subject matter, uses a mechanical driving unit the device can be used in places where there is no electrical supply.

Further, the device, according to the present subject matter, is simple, easy to operate and cost-effective.

The present subject matter further relates to an intraosseous device including a penetration unit, a driver unit and a guide assembly. The penetrating unit includes a conduit hub having a fluid conduit fixed therein, and a trocar received in the fluid conduit, for penetrating the penetration site. The driver unit is coupled to the penetrating unit to drive the penetrating unit into the penetration site. The guide assembly encloses the conduit hub to prevent bending and sideways movement of the fluid conduit. The driver unit includes an axial driver element to provide an axial motion of the penetration unit, and a rotational driver element to provide a rotational motion to the penetrating unit. The device, according to the present subject matter, is operable by an operating thrust force in a range from about 1 to 10 kilograms, and the penetrating unit rotates at a rotational speed in a range from about 100 to 800 revolutions per minute. The guide assembly includes a guide with a base having a recess. The fluid conduit passes through the recess. The guide assembly further includes a guard element having at least one flange and enclosing the conduit hub. The guide comprises protrusions on an inner surface thereof and encloses the guard element. The at least one flange meshes with the protrusions to prevent the fluid conduit from moving in a direction opposite to a direction of penetration. The guide includes at least one support element extending from the guide for supporting the intraosseous device on the bone. The guide further includes at least one transparent section, such that movement of the fluid conduit is visible during the penetration. In an embodiment, the guide may include an opening, such that movement of the fluid conduit is visible during the penetration. The guide further includes depth gauge markings on a surface thereof, to indicate depth of the fluid conduit in the penetration site. The penetration unit comprises an adjustable stopper coupled to the conduit hub to adjust a penetrable length of the fluid conduit in the intended anatomy, for example bone. The intraosseous device further includes an aspiration unit coupled to the penetrating unit to aspirate a sample from the penetration site. The aspiration unit includes a shaft axially movable to facilitate the aspiration of the sample, and a barrel to collect the sample. The shaft comprises spiral grooves on a surface thereof, and the rotational driver element is engaged with the spiral grooves of the shaft to transfer the axial motion of the driver unit to a rotational motion of the shaft. The rotational driver element includes a first clutch coupled to the axial driver element, and a second clutch engaged with the spiral grooves provided on the shaft. The axial driver element transfers the axial input motion of the driver unit to the first clutch and the axial input motion engages the first clutch with the second clutch to transfer the axial input motion of the driver unit to the rotational motion of the shaft. The shaft is coupled to the penetrating unit such that the penetrating unit rotates in conjunction with the shaft. The shaft is coupled to the barrel such that the barrel rotates in conjunction with the shaft. The trocar is fixedly coupled with the shaft such that the trocar rotates in conjunction with the shaft, and the conduit hub is coupled to the barrel such that the conduit hub rotates in conjunction with the barrel. The barrel includes at least one transparent section to provide visibility of the sample collected in the barrel.

The following description describes the device, according to the present subject matter, without restricting the description to any one exemplary embodiment.

Figure 1 illustrates a sectional view of an exemplary device 100 for vascular access, according to an embodiment of the present subject matter. The device 100 is an intraosseous device. The device 100 includes a penetrating unit 102 for penetrating a penetration site in an intended anatomy, for example a bone, a driver unit 104 coupled to the penetrating unit 102 to drive the penetrating unit 102 into the penetration site, and an aspiration unit 106 coupled to the penetration unit 102 to aspirate a sample from the penetration site.

In one embodiment, the penetrating unit 102 includes conduit hub 112 having a fluid conduit 114, and a trocar 116 for penetrating the penetration site. The fluid conduit 114 hereinafter may be referred to as conduit 114 for the purpose of simplicity. The conduit 114 is fixed to the conduit hub 112 at its one end and the trocar 116 is received in the conduit 114. In an embodiment, the conduit hub 112 is transparent.

The device 100 further includes a guide assembly enclosing the conduit hub 112 to prevent bending and sideways movement of the conduit 114. The guide assembly includes a guide 108 with a base having a recess 142. The conduit 114 passes through the recess 142. This prevents bending and sideways movement of the conduit 114. Providing the guide 108 on the conduit hub 112 ensures a controlled and guided movement of the conduit 114 and the trocar 1 16 during the penetration in the penetration site.

In one embodiment, the guide assembly includes a guard element 110 enclosed in the guide 108. The guard element 110 encloses the conduit hub 112 with the conduit 114. The guard element 110, in particular, meshes with the guide 108. This meshing of the guard element 110 with the guide 108 prevents the conduit 114 from moving in a direction opposite to a direction of penetration.

In an embodiment, through the conduit 114 the trocar 116 is extended slightly beyond a tip of the conduit 114. The trocar 116 is multi-faceted and has sharp cutting edges that facilitate an efficient piercing.

In an embodiment, the fluid conduit 114 is a hollow pipe having multiple openings at distal end that facilitate medications or fluid delivery and fluid aspiration in a patient's body. Further, the fluid conduit 114 may be any needle known in the art, for example, a 12 - 20 gauge needle. Furthermore, the fluid conduit 114 may be a cannula made of plastic.

In one implementation, the penetrating unit 102 may also include a stylet, or any other component used for penetration, as known in the art.

The device 100 further includes a guide cover 136 to firmly secure the guide 108.

The aspiration unit 106 includes a barrel 118 and a shaft 120. The shaft 120 is axially movable to facilitate the aspiration process and the aspirated sample is collected in the barrel 118.

In an embodiment, the shaft 120 is inside the barrel 118. The shaft 120 can be pulled or pushed inside the barrel 118, creating a vacuum inside the barrel 118. The barrel 118 is made of a plastic or any other suitable material, in which a vacuum can be created, thus acting as a vacuum chamber. The barrel 118 has an open end and the shaft 120 can be pulled and pushed inside the barrel 118, allowing the barrel 118 to take in or expel a fluid through the open end.

In one implementation, the barrel 118 is provided with at least one transparent section to provide visibility of the sample collected in the barrel 118.

In another implementation, the barrel 118 is a transparent barrel, made of a transparent plastic or glass material to provide visibility of the sample collected in the barrel 118.

Further, the barrel 118 is provided with a multi-faced cavity for receiving a similarly structured, multi-faced stud 138 attached to a bottom end 122 of the shaft 120. In one embodiment, the multi-faced cavity is a hexagonal cavity and the similarly structured stud is a hexagonal stud attached to the bottom end 122 of the shaft 120. The multi-faced stud 138 fits in the multi-faced cavity such that, there is no relative rotational motion between the stud and the cavity, and as a result the barrel 118 rotates in conjunction with the shaft 120.

In addition, an inner surface of the lower end of the barrel 118 is provided with threads that mate with similar threads provided on an outer surface of conduit hub 112, thus coupling the conduit hub 112 with the barrel 118. This coupling of the conduit hub 112 with the barrel 118 ensures the rotation of the conduit hub 112 along with the conduit 114 in conjunction with the barrel 118.

Further, the trocar 116 is fixedly coupled to the bottom end 122 of the shaft 120 to rotate the trocar 116 in conjunction with the shaft 120. In an embodiment, the trocar 116 is integrated with the shaft 120.

In an embodiment, the shaft 120 has a rubber bulb 126 mounted near the bottom end 122 of the shaft 120, as shown in figure 1, such that the rubber bulb 126 fits tightly inside the barrel 118 and acts as a seal while creating a vacuum in the barrel 118.

In an embodiment, the shaft 120 and the barrel 118 can be the plunger and the barrel (tube), respectively, of a syringe similar to a medical syringe.

In an embodiment, the barrel 118 may be pre- vacuumed for the purpose of aspiration. Further, the driver unit 104 includes an axial driver element to provide an axial motion to the penetrating unit 102, and a rotational driver element to provide a rotational motion to the penetrating unit 102.

In an embodiment, the operating thrust provided by the operator actuates the axial driver element to move axially. This axial movement engages the axial driver element with the rotational driver element and imparts an axial motion to the rotational driver element. The rotational driver element is further engaged with the shaft 120 to transfer the axial motion of the axial driver element to a rotational motion of the shaft 120.

In another embodiment, the rotational motion is directly provided by the rotational driver element to the penetrating unit 102.

In an embodiment, the axial driver element is a handle 128 with a knob 130 mounted on one end of the handle 128, as shown in figure 1. The handle 128 with the knob 130 provides an efficient gripping of the device 100. In one embodiment, the handle 128 includes a spring element 132. The spring element 132 is coupled to the shaft 120 on one end and abuts with the knob 130 on the other.

Further, in an embodiment, the rotational driver element is a clutch unit 134, as shown in figure 1. Figure 2 shows a detailed sectional view of the clutch unit 134 in the region where the driver unit 104 couples with the aspiration unit 106, according to an embodiment of the present subject matter. The clutch unit 134 includes a first clutch 134a and a second clutch 134b. In one embodiment, the first clutch 134a is fixed inside the handle 128, at an end opposite to the knob 130. In an embodiment, the first clutch 134a is integrated with the handle 128. Further, the second clutch 134b is engaged with spiral grooves provided on the shaft 120. In an embodiment, the second clutch 134b may include one or more nuts or extensions to facilitate an efficient engagement of the second clutch 134b with the spiral grooves provided on the shaft 120 to make the clutch unit 134 wobble- free. The axial input motion provided to the driver unit 104 engages the first clutch 134a with the second clutch 134b. In an embodiment, the engagement of the clutches 134a and 134b is a toothed engagement. The engagement of clutches 134a and 134b ensures that the axial input motion provided to the driver unit 104 translates to the rotational motion of the shaft 120. Thus, the handle 128 acts as an axial driver element to provide an axial thrust to the shaft 120 and the clutch unit 134 acts as a rotational driver element to provide rotational motion of the shaft 120. Further, the rotational and axial motions of the shaft 120 rotate and translate the trocar 116, the barrel 118, and the conduit hub 112 including the conduit 114. The driver unit 104 along with the shaft 120 thus acts as a push-drill that translates the axial input motion into a rotational motion and an axial motion of the penetrating unit 102.

In another embodiment, the shaft 120 may be a hollow barrel with spiral grooves, replacing the barrel 118. The shaft 120 in this case may be provided with a plunger for facilitating the aspiration.

Although the present description describes usage a spring element 132, a clutch unit 134, and a shaft 120 for providing the driving force to the penetrating unit 102 for drilling purpose, however, other powered or non-powered units, may also be used as the driver unit 104.

In one embodiment, a motorized unit may be used as the driver unit 104 for providing the driving force to the penetrating unit 102. In an embodiment, the motorized unit can be a battery powered motor.

In another embodiment, a hydraulic unit may be used as the driver unit 104 for providing the driving force to the penetrating unit 102.

In yet another embodiment, a wound spring or string driven mechanism may be used as the driver unit 104 for providing the driving force to the penetrating unit 102.

In yet another embodiment, a compressed air/fluid unit may be used as the driver unit 104 for providing the driving force to the penetrating unit 102.

In yet another embodiment the driving force for the penetrating unit 102 may be achieved by other well known mechanisms like pull-string, corkscrewing, or "egg-beater drill" mechanisms.

Further, in an embodiment, the guide 108 includes at least one support element 140, as shown in figure 1, extending from the guide 108 for supporting the device 100 on the intended anatomy, for example a bone.

To operate the device 100, according to an exemplary embodiment, for vascular access in a patient, an operator of the device 100 places the device 100 on a body part, to be penetrated, such as a bone of the patient, with the penetrating unit 102 including the guide 108 in contact with the body part. The body part to be penetrated is also termed as the penetration site, in the specification. The penetration site is penetrated by the penetrating unit 102 to reach the target site that has been selected for infusion/aspiration. In one embodiment, the target site may be medullary sinusoids within a bone.

The operator, for performing intraosseous infusion applies an axial thrust force on the knob 130, such that the driver unit 104 starts moving in a downward direction. Downward motion of the driver unit 104 moves the first clutch 134a downwards to engage the first clutch 134a with the second clutch 134b and push the second clutch 134b downwards. The downward push on the second clutch 134b causes the second clutch 134b to axially move along the shaft 120 and also causes the shaft 120 to rotate. Further, as the driver unit 104 moves downwards, the spring 132 compress against the shaft 120. The rotational motion of the shaft 120 rotates the penetration unit 102, including the trocar 116 and the conduit hub 112 with the fluid conduit 114, for penetrating the penetration site. The penetrating unit 102, for example, may rotate with speed of rotation in a range from about 100 to 800 revolutions per minute. The rotational motion of the penetrating unit 102 together with the operating thrust force (push on handle with the knob) provided by the operator provides the necessary force required to penetrate the penetration site. In the embodiment shown in figure 1, the device 100 is operable by an operating thrust force from an operator in a range from about 1 to 10 kilograms to rotate the penetrating unit at the rotational speed in the range from about 100 to 800 revolutions per minute.

Further, as the penetrating unit 102 starts penetrating the penetration site, the operator waits for an indication such as a giveaway feeling at which the operator stops applying force on the knob 130 to stop further penetration of the penetrating unit 102. The giveaway feeling is based on reduction of pressure felt by the operator when the conduit 114 and/or trocar 116 enters, for example, from a hard cortical layer of the bone into the spongy medullary sinusoids. As the operator releases the knob 130, the spring element 132 gets decompressed and forces the handle 128 to move in an upward direction, thus disengaging the first clutch 134a from the second clutch 134b. The operator may then aspirate the penetration site using the aspiration unit 106. The operator, for the purpose of aspiration, pulls the handle 128 and the knob 130 that pulls the shaft 120 to create a vacuum inside the barrel 118 for aspirating a sample, particularly a fluid, from the penetration site. Upward movement of the shaft 120 moves the trocar 116 upwards, thus creating a space in the conduit 114 to aspirate the sample from the penetration site. As the shaft 120 is moved up, particularly after the trocar 116 is completely moved out of the conduit 114, the sample starts filling in the barrel 118. Thus, the operator is able to aspirate the penetration site without using any external device. The aspirated sample can be bone marrow.

According to an embodiment, the operator may aspirate to confirm whether the conduit 114 of the penetrating unit 102 has entered a target or desired site, particularly medullary sinusoids, in the penetration site. The sample can be bone marrow from a bone to confirm the penetration in the medullary sinusoids. Presence of the sample in the barrel 118 indicates the operator about the penetration of the target site without using any other device, thus decreasing the time required for the infusion. However, if no sample or a sample other than the required sample is collected in the barrel 118, then the operator gets the indication that the target site has not been penetrated and the process of penetration needs to be repeated at some other location to locate the target site. After the conformation of the penetration into the target site, the operator removes the driver unit 104, the shaft 120 with the trocar 116 and the barrel 118, leaving behind the conduit hub 112 and the guide 108 in the original positions and the conduit 114 penetrated in target site inside the patient's body. The operator may then connect a medication/fluid supplying tube to the conduit hub 112 for infusing the medications or fluids through the conduit 114 in the target site.

In an embodiment, the device 100 can be used for aspiration of fluids, tissues etc. from the patient's body for purposes such as bone marrow aspiration. As the aspiration unit 106 is coupled with the penetrating unit 102 within the device 100, first few droplets of blood samples, required for purposes such as bone marrow aspiration, which used to leak out while connecting an external aspiration unit to a penetrating unit in the conventional systems, are also collected.

Further, providing the guide 108 on the penetration unit 102 ensures a controlled movement of the fluid conduit 114 and prevents any bending and sideways movement of the fluid conduit 114 and the trocar 116 while penetrating the penetration site and/or accessing the bone marrow.

In one embodiment, the guide 108 may also be provided with an opening, say a small window to allow an additional visualization of the conduit 114 while the conduit 114 advances in the bone. In another embodiment, the guide 108 may be either made from a transparent material or provided with one or more transparent sections such that advancing of the conduit 114 in the bone is visible.

In an embodiment, the guide 108 may further be provided with depth gauge markings on a surface of the guide 108, indicating the depth of the conduit 114 in the bone. This depth indication may further be utilized as an indication by the operator to stop applying force on the knob for the penetrating the penetration site.

In an embodiment, the penetration unit 102 includes an adjustable stopper 150 coupled to the conduit hub 112 to prevent an overshoot of the fluid conduit 114 in the patient's body, particularly in the bone. Figures 3a and 3b show the adjustable stopper 150 coupled at different positions on the conduit hub 112. The adjustable stopper 150 hereinafter maybe referred to as stopper 150 for the purpose of simplicity. The position of the stopper 150 decides the length of the conduit 114 penetrable in the penetration site. Further, the position of the stopper 150 can be varied on the conduit hub 112 to control or limit the penetrable length of the conduit 114 depending on the application.

In an embodiment, the adjustable stopper 150 can be screwed on the conduit hub 112. In an embodiment, the adjustable stopper 150 can be fixedly clamped on the conduit hub 112.

Although the device 100 has been shown with an aspiration unit 106 as indication mechanism, however, by removing the barrel 118, the device 100 may also be used as a simple intraosseous device without an integrated aspiration unit.

Figure 4 illustrates a perspective view of the guide assembly, with an exploded view of the guide 108, according to an embodiment of the present subject matter. The guide 108 consists of guide plates, for example, a first guide plate 200 and a second guide plate 202. Both the guide plates 200 and 202 are provided with extensions 204a, 204b, 204c, and 204d, as shown in figure 4. The extensions 204a, 204b, 204c, and 204d fit inside respective slits 206a, 206b, 206c, and 206d, as shown in figure 4, to securely hold the guide plates 200 and 202 together, and enclose the penetration unit 102.

Further, the guide cover 136, shown in figure 1, firmly holds the guide plates 200 and 202 together to secure the guide 108. For example, a C shaped collar or a shrink wrap may be used to hold the guide plates 200 and 202 together. The guide 108 ensures a controlled movement of the fluid conduit 114 during the penetration.

The guard element 110, enclosed in the guide 108, is provided with a first set of flanges 208a and a second set of flanges (not visible in the figure), preferably opposite to the first set of flanges 208a. The first set of flanges 208a and the second set of flanges may be hereinafter referred to as flanges 208. Further, a first set of protrusions 210a and a second set of protrusions 210b are provided in the first guide plate 200 and the second guide plate 202, respectively, as shown in figure 4. In one implementation, the first set of protrusions 210a and the second set of protrusions 210b, hereinafter referred to as protrusions 210, have a saw tooth profile. The flanges 208 engage with the protrusions 210. This engagement allows a uni -directional movement of the guard element 110 and hence the conduit hub 112 enclosed therein. The saw-toothed protrusions 210 allow the guard element 110, and hence the conduit hub 112 with the conduit 114, to move only in the downward direction during the penetration of the penetration site. The guide 108 thus prevents the conduit 114 from jumping and/or lifting and/or moving in an upward direction during penetration as well as after being penetrated, and also ensures that the conduit 114 remains in the target site during aspiration and medication.

Further, in an embodiment, the guard element 110, axially movable, may be provided with a set of protrusions in a corresponding set of slots provided in the guide 108 to prevent any rotational movement of the guard element 110 inside the guide 108.

Further, the recess 142 in the base of the guide 108 prevents bending and sideways movement of the conduit 114 passing through the recess 142.

Figure 4 further shows support elements 140a and 140b, extending from the guide 108. In an embodiment, the device 100 can have at least one support element 140. The support elements 140a and 140b are placed by the operator on the patient's body part while placing the device 100 for penetration and for maintaining proper alignment of the device 100 during penetration. During the operation of the device 100, the operator may hold the support elements 140a and 140b by one hand, thus securing the device 100 against the patient's body. Usage of the support elements 140a and 140b further prevents any sideways movement of the device 100 during penetration.

Figures 5a and 5b illustrate a perspective view of the guide assembly, with an exploded view of the guide 108, according to another embodiment of the present subject matter. The guide 108 consists of guide plates, for example, a first guide plate 300 and a second guide plate 302. Both the guide plates 300 and 302 are provided with extensions 304a, 304b, 304c, and 304d, as shown in figure 5b. The extensions 304a, 304b, 304c, and 304d fit inside respective slots 306a, 306b, 306c, and 306d, as shown in figure 5b, to securely hold the guide plates 300 and 302 together, and enclose the penetration unit 102.

Further, the guide cover 136 firmly holds the guide plates 300 and 302 together to secure the guide 108. For example, a C shaped collar or a shrink wrap may be used to hold the guide plates 300 and 302 together. The guide 108 ensures a controlled movement of the fluid conduit 114 during the penetration. Further, the recess 142 in the base of the guide 108 prevents bending and sideways movement of the conduit 114 passing through the recess 142.

Further, in an embodiment, the guide 108 includes a guard element 308, axially and rotatably movable inside the guide 108. The guard element 308 in one embodiment is Coupled to the shaft 120 at its top end and screwed with the conduit hub 112 at its bottom end. The guard element 308 may be provided with at least one protrusion 310 near its bottom end to prevent the guard element 308 from moving out of the guide 108.

Figures 5a and 5b further shows support elements 140a and 140b, extending from the guide 108. In an embodiment, the device 100 can have at least one support element 140. The support elements 140a and 140b are placed by the operator on the patient's body part while placing the device 100 for penetration and for maintaining proper alignment of the device 100 during penetration. During the operation of the device 100, the operator may hold the support elements 140a and 140b by one hand, thus securing the device 100 against the patient's body. Usage of the support elements 140a and 140b further prevents any sideways movement of the device 100 during penetration. Other advantages of the inventive intraosseous device will become better understood from the description and claims of an exemplary embodiment of such a unit.

The inventive intraosseous device of the present subject matter is not restricted to the embodiments that are mentioned above in the description.

Although the subject matter has been described with reference to specific embodiments, this description is not meant to be construed in a limiting sense. Various modifications of the disclosed embodiments, as well as alternate embodiments of the subject matter, will become apparent to persons skilled in the art upon reference to the description of the subject matter. It is therefore contemplated that such modifications can be made without departing from the spirit or scope of the present subject matter as defined.

Claims

I/We claim:

1. An intraosseous device (100) comprising:

a penetrating unit (102) to penetrate a penetration site in a bone;

a driver unit (104) coupled to the penetrating unit (102) to drive the penetrating unit

(102) into the penetration site; and

an aspiration unit (106) coupled to the penetrating unit (102) to aspirate a sample from the penetration site.

2. The intraosseous device (100) as claimed in claim 1, wherein the driver unit (104) comprises:

an axial driver element to provide an axial motion to the penetrating unit (102); and a rotational driver element to provide a rotational motion to the penetrating unit

(102).

3. The intraosseous device (100) as claimed in claim 1 or 2, wherein the intraosseous device (100) is operable by an operating thrust force in a range from about 1 to 10 kilograms.

4. The intraosseous device (100) as claimed in any of the preceding claims, wherein the penetrating unit (102) rotates at a rotational speed in a range from about 100 to 800 revolutions per minute.

5. The intraosseous device (100) as claimed in any of the preceding claims, wherein the penetrating unit (102) comprises:

a conduit hub (112) having a fluid conduit (114) fixed therein; and

a trocar (116) received in the fluid conduit (114), for penetrating the penetration site; and

wherein the intraosseous device (100) comprises a guide assembly enclosing the conduit hub (112) to prevent bending and sideways movement of the fluid conduit (114).

6. The intraosseous device (100) as claimed in claim 5, wherein the guide assembly comprises a guide (108) with a base having a recess (142), wherein the fluid conduit (114) passes through the recess (142).

7. The intraosseous device (100) as claimed in claim 6, wherein the guide assembly comprises a guard element (110) having at least one flange (208a) and enclosing the conduit hub (112), wherein the guide (108) comprises protrusions (210a, 210b) on an inner surface thereof and encloses the guard element (110), and wherein the at least one flange (208a) meshes with the protrusions (210a, 210b) to prevent the fluid conduit (114) from moving in a direction opposite to a direction of penetration.

8. The intraosseous device (100) as claimed in any of the claims 5 to 7, wherein the penetrating unit (102) comprises:

an adjustable stopper (150) coupled to the conduit hub (112) to adjust a penetrable length of the fluid conduit (114) in the bone.

9. The intraosseous device (100) as claimed in any of the preceding claims, wherein the aspiration unit (106) comprises:

a shaft (120) axially movable to facilitate the aspiration of the sample; and

a barrel (118) to collect the sample.

10. The intraosseous device (100) as claimed in claim 9, wherein the shaft (120) comprises spiral grooves on a surface thereof, and wherein the rotational driver element is engaged with the spiral grooves of the shaft (120) to transfer an axial motion of the driver unit (104) to a rotational motion of the shaft (120).

1 1. The intraosseous device (100) as claimed in claim 10, wherein the rotational driver element comprises:

a first clutch (134a) coupled to the axial driver element, wherein the axial driver element transfers the axial input motion of the driver unit (104) to the first clutch (134a); and

a second clutch (134b) engaged with the spiral grooves provided on the shaft (120), wherein the axial input motion engages the first clutch (134a) with the second clutch (134b) to transfer the axial input motion of the driver unit (104) to the rotational motion of the shaft (120).

12. The intraosseous device (100) as claimed in any of the claims 9 to 1 1, wherein the shaft (120) is coupled to the penetrating unit (102) such that the penetrating unit (102) rotates in conjunction with the shaft (120).

13. The intraosseous device (100) as claimed in any of the claims 9 to 12, wherein the shaft (120) is coupled to the barrel (118) such that the barrel (118) rotates in conjunction with the shaft (120).

14. The intraosseous device (100) as claimed in claim 12 or 13, wherein the trocar (116) is fixedly coupled with the shaft (120) such that the trocar (116) rotates in conjunction with the shaft (120), and wherein the conduit hub (112) is coupled to the barrel (118) such that the conduit hub (112) rotates in conjunction with the barrel (118).

15. The intraosseous device (100) as claimed in any of the claims 9 to 14, wherein the barrel (118) comprises:

at least one transparent section to provide visibility of the sample collected in the barrel (118).

16. The intraosseous device (100) as claimed in any of the claims 7 to 15, wherein the guide (108) comprises:

at least one support element (140a, 140b) extending from the guide (108) for supporting the device (100) on the bone.

17. The intraosseous device (100) as claimed in any of the claims 7 to 16, wherein the guide (108) comprises at least one transparent section, such that movement of the fluid conduit (114) is visible during the penetration.

18. The intraosseous device (100) as claimed in any of the claims 7 to 17, wherein the guide (108) comprises an opening, such that movement of the fluid conduit (114) is visible during the penetration.

19. The intraosseous device (100) as claimed in any of the claims 7 to 18, wherein the guide (108) comprises depth gauge markings on a surface thereof, to indicate depth of the fluid conduit (114) in the penetration site.

20. The intraosseous device (100) as claimed in any of the claims 5 to 19, wherein the fluid conduit (114) is a needle, particularly a 12 to 20 gauge needle.

21. The intraosseous device (100) as claimed in any of the preceding claims, wherein the sample is a bone marrow.

22. An intraosseous device (100) comprising:

a penetrating unit (102) comprising:

a conduit hub (112) having a fluid conduit (114) fixed therein; and a trocar (116) received in the fluid conduit (114), for penetrating the penetration site;

a driver unit (104) coupled to the penetrating unit (102) to drive the penetrating unit (102) into the penetration site; and

a guide assembly enclosing the conduit hub (112) to prevent bending and sideways movement of the fluid conduit (114).

23. The intraosseous device (100) as claimed in claim 22, wherein the driver unit (104) comprises:

an axial driver element to provide an axial motion of the penetration unit (102); and a rotational driver element to provide a rotational motion to the penetrating unit (102).

24. The intraosseous device (100) as claimed in claim 22 or 23, wherein the intraosseous device (100) is operable by an operating thrust force in a range from about 1 to 10 kilograms.

25. The intraosseous device (100) as claimed in any of the claims 22 to 24, wherein the penetrating unit (102) rotates at a rotational speed in a range from about 100 to 800 revolutions per minute.

26. The intraosseous device (100) as claimed in any of the claims 22 to 25, wherein the guide assembly comprises a guide (108) with a base having a recess (142), wherein the fluid conduit (114) passes through the recess (142)..

27. The intraosseous device (100) as claimed in claim 26, wherein the guide assembly comprises a guard element (110) having at least one flange (208a) and enclosing the conduit hub (112), wherein the guide (108) comprises protrusions (210a, 210b) on an inner surface thereof and encloses the guard element (110), and wherein the at least one flange (208a) meshes with the protrusions (210a, 210b) to prevent the fluid conduit (114) from moving in a direction opposite to a direction of penetration.

28. The intraosseous device (100) as claimed in claim 26 or 27, wherein the guide (108) comprises:

at least one support element (140a, 140b) extending from the guide (108) for supporting the intraosseous device (100) on the bone.

29. The intraosseous device (100) as claimed in any of the claims 26 to 28, wherein the guide (108) comprises at least one transparent section, such that movement of the fluid conduit (Ϊ 14) is visible during the penetration.

30. The intraosseous device (100) as claimed in any of the claims 26 to 29, wherein the guide (108) comprises an opening, such that movement of the fluid conduit (114) is visible during the penetration.

31. The intraosseous device (100) as claimed in any of the claims 26 to 30, wherein the guide (108) comprises depth gauge markings on a surface thereof, to indicate depth of the fluid conduit (114) in the penetration site.

32. The intraosseous device (100) as claimed in any of the claims 22 to 31 , wherein the penetration unit (102) comprises:

an adjustable stopper (150) coupled to the conduit hub (108) to adjust a penetrable length of the fluid conduit (114) in the bone.

33. The intraosseous device (100) as claimed in any of the claims 22 to 32, wherein the intraosseous device (100) further comprises an aspiration unit (106) coupled to the penetrating unit (102) to aspirate a sample from the penetration site.

34. The intraosseous device (100) as claimed in claim 33, wherein the aspiration unit (106) comprises: a shaft (120) axially movable to facilitate the aspiration of the sample; and a barrel (118) to collect the sample.

35. The intraosseous device (100) as claimed in claim 34, wherein the shaft (120) comprises spiral grooves on a surface thereof, and wherein the rotational driver element is engaged with the spiral grooves of the shaft (120) to transfer the axial motion of the driver unit (104) to a rotational motion of the shaft (120).

36. The intraosseous device (100) as claimed in claim 35, wherein the rotational driver element comprises:

37. The intraosseous device (100) as claimed in any of the claims 34 to 36, wherein the shaft (120) is coupled to the penetrating unit (102) such that the penetrating unit (102) rotates in conjunction with the shaft (120).

38. The intraosseous deyice (100) as claimed in any of the claims 34 or 37, wherein the shaft (120) is coupled to the barrel (118) such that the barrel (118) rotates in conjunction with the shaft (120).

39. The intraosseous device (100) as claimed in claim 37 or 38, wherein the trocar (116) is fixedly coupled with the shaft (120) such that the trocar (116) rotates in conjunction with the shaft (120), and wherein the conduit hub (112) is coupled to the barrel (118) such that the conduit hub (112) rotates in conjunction with the barrel (118).

40. The intraosseous device (100) as claimed in any of the claims 34 to 39, wherein the barrel (118) comprises: at least one transparent section to provide visibility of the sample collected in the barrel (118).

41. The intraosseous device (100) as claimed in any of the claims 22 to 40, wherein the fluid conduit (114) is a needle, particularly a 12 to 20 gauge needle.

42. The intraosseous device (100) as claimed in any of the claims 22 to 41 , wherein the sample is a bone marrow.