US20210205580A1 - Vessel cannulation device and method of use - Google Patents

Abstract

Devices and methods are provided for automatic vascular access. An automatic vessel cannulation device, mechanical or electronic, has a sensor configured to detect a physiologic parameter of a needle tip, and a blunting device advancing member released in response to the sensor. The sensor may measure pressure or any other physiological parameter. A processor is configured to analyze data sent by the sensor and is pre-set to identify parameters unique to arteries, veins, or other body cavities or organs. A method may include comparing a physiologic parameter with pre-determined parameters to deploy a blunting element if the physiologic parameter is within a range of the pre-determined parameters. An expandable sheath may be included. A device can be provided having a motor controlling the cannulation device orientation to scan tissue with the tip of the needle by moving the cannulation device through the ultrasound transducer.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application claims priority to U.S. Provisional Application Nos. 62/311,249 (filed Mar. 21, 2016) and 62/183,554 (filed Jun. 23, 2015), both of which are hereby incorporated herein by reference in their entirety.
BACKGROUND
• Vascular access is a crucial element of medical therapy in a vast majority of clinical settings and procedures. This is true in both elective and in emergent situations. In a specific type of emergency, hemorrhagic shock, there may further be a need to perform aortic occlusion. Both these clinical needs, vascular access and aortic occlusion, are the subject of the current invention.
• Vascular Access
• A large part of medical interventions, both elective and emergent, are endovascular procedures. These procedures have become very common and continue to grow in numbers due to both the increase in cardiovascular patient absolute numbers and to the trend of shifting from open surgery to endovascular surgery.
• Once vascular access is secured, delivery of treatment is quick and easy, be it the administration of fluids, analgesics, sedative medications, vasopressors, inotropics, percutaneous endovascular trans-catheter treatments or other interventions. Patient monitoring is also aided by central vascular access, as it enables direct arterial or venous pressure measurements and blood sampling.
• Vascular Access in Elective Situations
• Although extremely common, the ways to establish vascular access remain very basic and are often inadequate. This is especially unfortunate in elective settings, as it is the older and sicker individuals who usually have more “difficult blood vessels”, and must frequently endure additional suffering caused by painful repeated attempts at blood vessel cannulation, even when performed by experienced personnel.
• Vascular Access in Emergency Situations
• In emergency situations, the importance of vascular access is increased, as stabilization of patients often requires administration of fluids or blood and medications. However, the emergency setting also increases the obstacles to successful blood vessel cannulation. Possible impediments include environmental factors such as darkness (night), cold and wet weather, unstable surroundings (wind, waves, bumpy vehicle or aircraft), patient factors such as shock which may cause collapse of veins and an impalpable arterial pulse, burns, or movements due to shivering or convulsions, care provider factors such as stress caused by the need to deliver therapy urgently in a dying patient, additional patients, imminent danger from warfare or natural hazards, or lack of expertise, and finally equipment factors such as the absence of expensive ultrasound guidance. A venous cut down may be performed using simple tools by an experienced physician, but this too takes time and requires certain expertise, making it impractical in many cases.
• In performing an endovascular procedure, access into the vasculature must be established and maintained for the duration of the procedure. This is most commonly done by placing an introducer sheath in the blood vessel to enable passage of the interventional instruments in and out without losing the entry point or causing damage to the vessel.
• Placement of an endovascular sheath is usually performed using the modified Seldinger technique. This entails puncture of the vessel with a needle, passage of a guidewire through the needle, removal of the needle, incision of the skin, placement of a sheath with a dilator in it over the guidewire, removal of the guidewire and dilator.
• The Seldinger technique, although useful, suffers from several drawbacks. First, it requires significant experience in order to be successfully performed, especially when circumstances are suboptimal such as in emergency and trauma situations. As it is mainly used for placement of large bore catheters, which are less common than regular small-medium bore venous catheters, the exposure to it (and hence the procedure practice) is less than that of over the needle venous catheter placement. Second, there are several points during the procedure which may lead to its failure.
• One such point is after entry of the needle into the blood vessel, which is evident by the flow of blood out of the needle. At this point, the physician must thread a guidewire into the needle. Holding the needle absolutely still, while bringing the guidewire and threading it with the other hand requires a certain level of coordination, which not all physicians possess. Even the slightest movement of the needle at this stage might cause it to move forward and exit the artery through its posterior wall, or withdraw out of the lumen through the anterior wall of the artery. This will prevent the guidewire from entering the lumen and will require an additional puncture attempt. Additionally, this might cause blood to leak around the vessel causing an internal hematoma, which might compress the vessel and make repeat cannulation more difficult. Worse yet, unintended movement of the needle might place it within one of the arterial walls, and attempted insertion of the guidewire can then damage the arterial wall, possibly leading to large hematomas or other complications.
• Another sensitive point in the procedure is after the guidewire insertion and needle removal. The physician must now thread the guidewire edge into the dilator, which has a very small aperture the size of the guidewire, while at the same time compressing the puncture site to prevent hematoma and make sure the guidewire is not pulled out. Exit of the guidewire from the artery at this stage will cause the sheath to be placed into tissues instead of into the artery, which besides tissue damage usually causes the guidewire to bend, necessitating its replacement.
• Additional drawbacks of the Seldinger technique are related to the use of a long guidewire, which carries with it an increased risk of contamination of its proximal end, as well as a danger of splashing blood on the physician. Also, during the time between needle entry into the vessel and until the guidewire is inserted into it, either profuse bleeding or entry of air into the circulation might occur, depending on whether pressure within the vessel is higher or lower than ambient pressure.
• In contrast to the above, regular small to medium bore venous cannulas are usually placed using the “over-the-needle” technique. With this technique, the cannula, which has an inner diameter (“ID”) matched to the outer diameter (“OD”) of the needle, is inserted into the artery together with the needle. When blood is observed in a “flash” chamber connected to the needle lumen, the needle is held in place and the cannula is manually advanced and slid over the needle into the vessel. Not only is this technique technically simpler than the Seldinger technique, it is also more commonly used, and there is a greater possibility of exposure to it for training, so the learning curve is significantly shorter and competence in it is easier to maintain.
• In the “over-the-needle” method, the cannula must have an ID matched to the OD of the needle, in order for it to enter the vessel with the needle. Therefore, the diameters of cannulas inserted using this technique are limited to the outer diameters of needles that can be used for these purposes, which are usually 21 G-18 G (0.8 mm-1.3 mm). Endovascular procedures often require insertion of instruments having ODs of 8 fr-14 fr (2 mm-4.6 mm) or more.
• Since the “over-the-needle” technique is not adequate for placing large bore catheters or sheaths, the Seldinger technique is used in these cases, which as mentioned, include most endovascular interventions.
• The WAND, manufactured by Access Scientific of San Diego, Calif., is a device intended to provide a solution for the above drawbacks of the Seldinger technique. This device includes a needle, guidewire, dilator, and sheath in an all-in-one assembly, which is intended for easier and safer over-the-wire sheath insertion. Use of the WAND requires manual advancement of both the guidewire and the sheath by the operator. The WAND mainly addresses safety issues such as needle-stick injury and air embolism, but the technique is still rather complicated and requires significant training.
• Expandable sheaths were described in the art in various contexts, mainly for retrieval of large devices such as heart valve delivery systems, aortic balloon catheters etc. usually having self-expanding and balloon expandable components. Such solutions are cumbersome and expensive and are not appropriate for direct over-the-needle vascular access.
• Another drawback of existing sheaths related to their having a fixed diameter, is that the arterial puncture site remains dilated to the maximum size for the whole duration of the procedure. The duration of puncture site dilation is one of the factors affecting the chances of its closure. With the current invention, the artery would only be exposed to maximal dilation when the largest instruments are used, while during the rest of the procedure, it will be only slightly dilated. This will increase the successful closure rates and reduce puncture site complication rates.
• It is therefore an aspect of the current invention to provide a simple, safe, easy to use, and low cost solution for establishing vascular access.
BRIEF SUMMARY OF THE INVENTION
• In one aspect of the invention, improved devices and methods are provided for vascular access, including various mechanical and electronic vessel cannulation devices, some of which comprise both disposable and reusable parts.
• In one aspect of the invention, new blunting devices are provided for vessel cannulation needles, as well as improved expandable sheaths for use alone or in combination with the above devices. The blunting devices in accordance with the present invention may be advanced either inside or outside a needle to cover the tip of the needle, thus preventing or reducing the chance of the needle puncturing through the blood vessels.
• In one aspect of the invention, a cannulation device is provided, whether mechanical or electronic, that may be capable of (1) advancing a guidewire through a needle, (2) advancing a sheath over a needle, (3) both of the above, together or in succession, (4) deploying other “blunting” elements; and (5) providing an indication to the user, or to an automatic system preforming the cannulation.
• An embodiment of the invention is an automatic vessel cannulation device including housing, a lumen, a needle, a sensor, and a blunting device advancing member. The housing may have a distal end with a distal tip and a proximal end. The lumen may pass through the distal end and the proximal end. The needle may be at the distal tip of the housing, wherein the needle having a needle tip. The sensor may be operably coupled to the lumen, wherein the sensor may be configured to detect a physiologic parameter at the needle tip. The blunting device advancing member may be configured to advance a blunting device through the lumen, wherein the blunting device advancing member may be operably coupled to the sensor. The blunting device advancing member may be configured to automatically advance the blunting device when the sensor detects that the physiologic parameter within a pre-determined range. The sensor may be selected from the group consisting of pressure sensors, temperature sensors, conductivity sensors, flow sensors, ultrasound sensors, pH sensors, and optical sensors.
• In another embodiment, the vessel cannulation device may further include a trigger mechanism. The trigger mechanism may include a sear and a lever, wherein the trigger mechanism may be configured to release the blunting device advancing member when the sensor detects that the physiologic parameter is within the pre-determined range. The lever may include a hinge located at the distal end of the device, a lever tooth at the proximal end, and a lever base between the hinge and the lever tooth. The sear may be located at the proximal end of the lever and engages the lever tooth. The lever may include a hinge at the proximal end of the device, a lever base at the distal end of the device, and a lever tooth between the hinge and the lever base; wherein the lever operably coupled to and moveable by the sensor. The sear may be located between the proximal end and the distal end of the lever and engages the lever tooth. The distance from the center of the sensor to the hinge is twice the distance from the lever tooth to the hinge.
• In some embodiments, the sensor may be a membrane. In some embodiments, the sensor is an electronic sensor. In some embodiments, the sensor may comprise multiple sensors.
• In another embodiment, the vessel cannulation device may further include an adjustment mechanism configured to be in contact with the trigger mechanism, wherein the adjustment mechanism adjusts force applied on the lever.
• In another embodiment, the vessel cannulation device may further include a CPU. The CPU may be in electrical communication with the sensor and may be configured to execute instructions, wherein when executed, the CPU may be configured to compare the physiologic parameter from the needle tip with predetermined values to determine whether the needle tip has punctured a blood vessel.
• In another embodiment, the vessel cannulation device may further include a solenoid in communication with the CPU and connected to the trigger mechanism. The solenoid may activate the trigger mechanism when it is determined that the physiologic parameter from the needle tip matches the predetermined parameter of the blood vessel. The solenoid may be configured to activate outside of a predetermined time window, wherein the predetermined time window for a vein is between 0.05-0.3 seconds, and the predetermined time window for an artery the window is between 0-0.05 seconds.
• In another embodiment, the vessel cannulation device may further include an input device for choosing a blood vessel type, wherein the blood vessel type is an artery or a vein. The artery has a predetermined parameter of lower threshold (LTH) of 20 mmHg, upper threshold (UTH) of 300 mmHg, and range of pressure change rate of +/−400 mmHg/sec. The vein has a predetermined parameter of lower threshold (LTH) of 5 mmHg, upper threshold (UTH) of 20 mmHg, and range of pressure change rate of +/−100 mmHg/sec.
• In another embodiment, the blunting device advancing member may be coaxial with a large spring. The blunting device and the blunting device advancing member may be covered by a sterile cover within the device.
• In another embodiment, the vessel cannulation device may further include a blunting element configured to expand to cover the needle tip when deployed. The blunting element may be stent-like. The blunting element may be selected from the group consisting of an external sheath, an internal sheath, a sandwich sheath, a tip covering sheath, and a tip completing sheath. The internal sheath may be a guidewire with an uncoiled segment or a coiling guidewire. The internal sheath may be deployed by pushing the internal sheath towards the needle tip with a cannulation device. The internal sheath may be configured to be positioned within the needle in its crimped state without substantially blocking the needle lumen.
• In another embodiment, the vessel cannulation device may further include a fluid passageway coupling the sensor to the lumen; and wherein the fluid passageway is substantially straight and has an internal diameter of 0.5 mm-2.5 mm, and a length no longer than 4 cm.
• In another embodiment, the vessel cannulation device may further include an impact absorbing element for dampening noise and recoil during advancement of the blunting device.
• In another embodiment, the vessel cannulation device may further include a cocking mechanism configured to bring the device to a cocked state.
• In another embodiment, the vessel cannulation device may further include a cover comprising a safety latch slot and a safety latch.
• In another embodiment, the vessel cannulation device may further include a disposable part and of a reusable part.
• In another embodiment, the vessel cannulation device may further include a barrier allowing sensing of pressure to be performed while keeping the sensor sterile, and wherein the sensor is reusable.
• In another embodiment, the vessel cannulation device may further include a guidance element. The guidance element may be selected from a group consisting of a linear mechanical guide or a rotary mechanical guide. The guidance element may include imaging means. The imaging means may consist of an ultrasound transducer. The ultrasound transducer may be located proximal to the needle tip, and wherein the needle can slide through the transducer. The ultrasound transducer may allow replacement or removal of the needle.
• In another embodiment, the vessel cannulation device may further include a mat including: a position sensors, a processor, and an indicator. The processor may be configured to gather ultrasound signals received by the ultrasound transducer simultaneously with the position information from the position sensors. The processor may activate the indicator to signal when the cannulation device is pointed at a blood vessel.
• An embodiment of the invention is an automatic system for vessel cannulation including: a mat, a motor, a processor, a vessel cannulation device, and an ultrasound transducer. The mat may have position sensors and a sliding strip. The motor may control a movement of the sliding strip. The processor may be in electronic communication with the mat. The vessel cannulation device as described above, which may be slideably positioned within a housing and pivotally connected to the mat through the sliding strips. The vessel cannulation device includes a needle. The ultrasound transducer may be slideably positioned over the tip of the needle of the vessel cannulation device. The motor may control an orientation of the cannulation device through the sliding strip. The system may scan tissue with the tip of the needle by moving the cannulation device through the ultrasound transducer. The processor may detect a target vessel and advance the vessel cannulation device towards the target vessel until the vessel cannulation device deploys the guidewire within the vessel or until a maximum depth is reached.
• An embodiment of the invention is an expandable sheath system including: an expandable outer layer sheath and an inner rigid layer. The expandable outer layer sheath may include longitudinal beams and a step. The inner rigid layer may comprise a bulb and a shoulder which engages with a step of the outer layer sheath. The inner rigid layer sheath may be configured to fit over a needle shaft; and after removal of the needle, the bulb may be collapsed and the inner rigid layer sheath may be removed from the outer layer sheath, while leaving the outer layer sheath in its position within a vessel. The inner rigid layer may be an integral part of the needle.
• An embodiment of the invention is an expandable sheath configured to be inserted into a patient's body over a needle. The expandable sheath may comprise rigid longitudinal beams and an expandable elastic layer. The longitudinal beams may be bridged by connections creating a spiral pattern along and around the sheath. The expandable sheath may comprise an external sheath slideably positioned over the expandable outer layer sheath.
• The external sheath may include a handle and a support element connecting to the expandable outer layer sheath. The external sheath may be tearable. The expandable sheath may further include a rigid large diameter sheath that is configured to be inserted into the expandable outer layer sheath, to maintain and expand the expandable outer layer sheath.
• An embodiment of the invention is an expandable sheath configured to be inserted into a patient's body over a needle, including: a sheath having a single substantially inelastic layer and an inner diameter. In a crimped state, the sheath inner diameter may be in a tight fit with a needle. In the expanded state, the sheath inner diameter may be at least double the sheath inner diameter in the crimped state. The inelastic layer may have multiple micro-corrugations. The inelastic layer may have between 2 and 6 large corrugations folded around the sheath. The expandable sheath may have one corrugation, and wherein this corrugation is folded around the sheath at least once. The expandable sheath may include: the distal end of the inelastic layer comprises a part that is perpendicular to the longitudinal axis of the sheath, and a part that is at an angle relative to the longitudinal axis of the sheath, configured to create a smooth distal taper for the sheath in its crimped state. The expandable sheath may further include a hub configured to overlap with a needle hub.
• An embodiment of the invention is a method of using a vessel cannulation system including: calibrating the system by selecting a target vessel type having pre-determined parameters; penetrating a body with a needle to detect a physiologic parameter, wherein the needle is in electronic communication with the system; comparing the physiologic parameter with the pre-determined parameters; and deploying a blunting element into the target vessel if the physiologic parameter is within a range of the pre-determined parameters. The method may further include pushing forward the inner sheath from an inner lumen of the needle towards a distal tip of the needle. The deploying step further comprises activating a solenoid to trigger a trigger mechanism to advance the blunting element. The method may further include placing a mechanical guide on the body with a central marking above an estimated location of the target vessel.
• In some embodiments, the blunting element may be configured to be positioned within the needle in its crimped state without substantially blocking the inner lumen, and to cover a distal tip when the blunting element is deployed. The blunting element may be selected from the group consisting of an external sheath, an internal sheath, a sandwich sheath, a tip covering sheath, and a tip completing sheath. The blunting element may be pulled back following deployment to cover the needle tip.
• In some embodiments, the mechanical guide may be an ultrasound transducer.
• In some embodiments, the calibrating step may comprise choosing a target vessel type, wherein the target vessel type is an artery or a vein. The artery may have a pre-determined parameter of lower threshold (LTH) of 20 mmHg, upper threshold (UTH) of 300 mmHg, and range of pressure change rate of +/−400 mmHg/sec. The vein may have a pre-determined parameter of lower threshold (LTH) of 5 mmHg, upper threshold (UTH) of 20 mmHg, and range of pressure change rate of +/−100 mmHg/sec.
• In some embodiments, the penetrating step may include using sensors to detect the physiologic parameter at a needle tip.
• In some embodiments, the method may further include inserting a central catheter into the target vessel through the blunting element, wherein the blunting element is an expandable sheath.
• In some embodiments, the method may further inserting a peripheral IV catheter into the target vessel through the blunting element, wherein the blunting element is an expandable sheath.
• In some embodiments, the method may further drawing blood sampling through the blunting element.
BRIEF DESCRIPTION OF THE DRAWINGS
• The foregoing summary, as well as the following detailed description of the invention, will be better understood when read in conjunction with the appended figures. For the purpose of illustrating the invention, the figures demonstrate embodiments of the present invention. It should be understood, however, that the invention is not limited to the precise arrangements, examples, and instrumentalities shown.
• FIG. 1A is a longitudinal cross section of a mechanical cannulation device in accordance with embodiments of the invention, which depicts the guidewire advancement mechanism in a cocked position.
• FIG. 1A′ is a longitudinal cross section of a mechanical cannulation device in accordance with embodiments of the invention, which depicts the guidewire advancement mechanism in a deployed position.
• FIG. 1B is a top view of a mechanical cannulation device in accordance with embodiments of the invention.
• FIG. 1C is a top view ofmembrane60 of a mechanical cannulation device in accordance with embodiments of the invention.
• FIG. 1D is a longitudinal mid-section of a membrane of a mechanical cannulation device in accordance with embodiments of the invention.
• FIG. 1E is a cross section of a membrane of a mechanical cannulation device in accordance with embodiments of the invention.
• FIG. 2A is a longitudinal cross section of a mechanical cannulation device in accordance with one embodiment of the invention.
• FIG. 2B is a longitudinal cross section of a mechanical cannulation device in accordance with another embodiment of the invention.
• FIG. 2C is a longitudinal cross section of a mechanical cannulation device in accordance with an alternate embodiment of the invention.
• FIG. 2D is a longitudinal cross section of a mechanical cannulation device in accordance with yet another alternate embodiment of the invention.
• FIG. 2Di is a perspective view ofcannulation device1000.
• FIG. 2E is a longitudinal cross section of a mechanical cannulation device in accordance with yet another alternate embodiment of the invention.
• FIG. 2F is a top view of the device inFIG. 2E in accordance with an alternate embodiment of the invention.
• FIG. 3A is a schematic longitudinal section of an electronic vessel cannulation device in accordance with embodiments of the invention.
• FIG. 3B is a schematic longitudinal section of a trigger mechanism in accordance with embodiments of the invention.
• FIG. 4 is a schematic longitudinal section of an electronic vessel cannulation device in accordance with embodiments of the invention.
• FIG. 5A is an exemplary flowchart that may be implemented using the devices of the invention in accordance with certain embodiments of the invention.
• FIG. 5B is a graph produced using a device in accordance with embodiments of the invention.
• FIG. 5C is a theoretical graph depicting possible multiple physiologic parameter measurement values during puncture through a patient's tissues and blood vessels, which may be used in accordance with embodiments of the invention.
• FIG. 5D is a simplified theoretical graph depicting various possible pressure measurement contours.
• FIGS. 6A-6D show a stent like “tip covering” blunting element in accordance with an embodiment of the invention.FIG. 6A is a 3D depiction of a blunting element in accordance with an embodiment of the invention.FIG. 6B is a longitudinal section of a blunting element in a crimped state in the lumen in accordance with an embodiment of the invention.FIG. 6C is a longitudinal section of a blunting element in its deployed state in accordance with an embodiment of the invention.FIG. 6D is an isometric depiction of a bluntingelement600 in its deployed state in accordance with an embodiment of the invention.
• FIGS. 7A and 7B show a coiling “tip covering” blunting element in accordance with an embodiment of the invention.FIG. 7A is a longitudinal section of a blunting element in its crimped state in accordance with an embodiment of the invention.FIG. 7B is a longitudinal section of a blunting element in its deployed state in accordance with an embodiment of the invention.
• FIGS. 8A-8E show a “tip completing” blunting element in accordance with an embodiment of the invention.FIG. 8A is a 3D depiction of a blunting element in accordance with an embodiment of the invention.FIG. 8B is a longitudinal section of a blunting element in its crimped state in accordance with an embodiment of the invention.FIG. 8C is a longitudinal section of blunting element in its deployed state in accordance with an embodiment of the invention.FIGS. 8D and 8E are 3D drawings showing the same asFIGS. 8B and 8C, respectively.
• FIGS. 9A-9D show an “internal sheath” blunting element in accordance with an embodiment of the invention.FIG. 9A is a longitudinal section of a blunting element in its crimped state in accordance with an embodiment of the invention.FIG. 9B is a longitudinal section of a blunting element in its deployed state in accordance with an embodiment of the invention.FIGS. 9C and 9D are 3D drawings showing perspective views ofFIGS. 9A and 9B, respectively.
• FIGS. 10A-10D show an “internal sheath” blunting element in accordance with an embodiment of the invention.FIG. 10A is a longitudinal section of a blunting element in its crimped state in accordance with an embodiment of the invention.FIG. 10B is a longitudinal section of bluntingelement900 in its deployed state in accordance with an embodiment of the invention.FIG. 10C is a 3D drawing of a deployed blunting element without a needle in accordance with an embodiment of the invention.FIG. 10D is a 3D drawing of a deployed blunting element with a needle in accordance with an embodiment of the invention.
• FIGS. 11A and 11B show a “sandwich sheath” blunting element in accordance with an embodiment of the invention.FIG. 11A is a longitudinal section of a blunting element in its crimped state in accordance with an embodiment of the invention.FIG. 11B is a longitudinal section of a blunting element in its deployed state in accordance with an embodiment of the invention.
• FIG. 12A shows a simple linear mechanical guide used for guiding the cannulation procedure in accordance with an embodiment of the invention.
• FIG. 12B shows a simple rotary mechanical guide used for guiding the cannulation procedure in accordance with an embodiment of the invention.
• FIGS. 13A-13D show an ultrasonic transducer used as part of a cannulation device in embodiments of the invention.FIG. 13A is a simplified 3D drawing of a cannulation device having a transducer in accordance with an embodiment of the invention.FIG. 13B shows a transducer used as part of a cannulation device in embodiments of the invention.FIGS. 13C and 13D are simplified side views of cannulation devices having a transducer in accordance with embodiments of the invention.
• FIG. 14 shows a cannulation device having a guidance system in accordance with embodiments of the invention.
• FIG. 15A shows a longitudinal cross section of a cannulation device in accordance with one embodiment of the invention.
• FIG. 15B shows a longitudinal cross section of a cannulation device in accordance with one embodiment of the invention.
• FIG. 16 shows a cannulation device having a robotic system in accordance with embodiments of the invention.
• FIG. 17 shows an expandable sheath in accordance with an embodiment of the invention.
• FIG. 18 shows another expandable sheath in accordance with an embodiment of the invention.
• FIG. 19 shows yet another expandable sheath in accordance with an embodiment of the invention.
• FIG. 20 shows an expandable sheath in accordance with an embodiment of the invention.
• FIG. 21A shows a 3D schematic depiction of a tube in accordance with an embodiment of the present invention.
• FIG. 21B depicts a spirally folded sheath in accordance with an embodiment of the present invention.
• FIGS. 22A-22D show a sheath with multiple micro-corrugations in accordance with an embodiment of the present invention.
• FIGS. 23A-23C show a sheath with larger corrugations in accordance with an embodiment of the present invention.
• FIGS. 24A-24G show a sheath with a single longitudinal corrugation in accordance with an embodiments of the present invention.
• FIG. 25 shows the distal end of a cannulation device in accordance with embodiments of the invention where a catheter is placed over the needle at the distal end of the cannulation device.
• FIG. 26 illustrates an example of a computer system1600 that may be configured to practice an embodiment of the invention.
DETAILED DESCRIPTION
• The invention relates to devices and methods for the cannulation of body lumens, in particular blood vessels, with the goal of placing intravascular catheters such as Central Venous Catheters (CVCs), Peripherally Inserted Central Catheters (PICVs), midlines, and Peripherally Inserted Venous Catheters (PIVCs). The invention also relates to devices and methods for temporary vessel cannulation without placing an indwelling catheter, with the goal of blood sampling, cardiovascular monitoring, or administration of drugs or fluids. Various body lumens and/or cavities and/or various indications for use involving blood, cardiovascular, drugs or fluids are contemplated.
• Mechanical Vessel Cannulation Device
• FIG. 1A is a longitudinal cross section of themechanical cannulation device1000 of the invention, which depicts the guidewire advancement mechanism in a cocked position.FIG. 1A′ is a longitudinal cross section of a mechanical cannulation device in accordance with embodiments of the invention, which depicts the guidewire advancement mechanism in a deployed position.FIG. 1B is a top view ofFIG. 1A. In these figures, distal refers to the left side, and proximal refers to the right side.
• More particularly,FIG. 1A is a longitudinal section ofdevice1000 along its midline, which passes along the line marked1 in the top view shown inFIG. 1B.FIG. 1A showsdevice1000 which may include from left to right the following main parts:needle adapter10,seal16,body20,guidewire advancement mechanism30a(shown in cocked position),large spring40, andbackplate50. Each of the main parts has a central lumen andguidewire1 may be slideably positioned within the central lumen of all the above parts.
• Device1000 may further includemembrane60,lever70, sear80,cover90, cockinghandle100, andadjustment element110. Each main part ofdevice1000 is further described below.
• Needle adapter10 may includeluer adapter11,lumen12, o-ring slots13 and14,distal fluid passageway15, and seal16, which may optionally be an integral part ofneedle adapter10. O-rings may be placed in o-ring slots13 and14 to prevent pressure within fluid passageways from escaping aroundneedle adapter10.
• Body20 may includeslider slot21, cockinghandle slot22, handlegroove23,insertion groove24, opening25,protrusion26,proximal fluid passageway27,membrane groove28, andstopper29.Distal fluid passageway15 andproximal fluid passageway27 may be connected and may be in fluid communication withlumen12 such that when fluid enterslumen12 at the distal end, fluid may travel todistal fluid passageway15 and toproximal fluid passageway27.
• Guidewire advancement mechanism30 (shown as30ain the cocked position inFIG. 1A and 30bin the deployed position inFIG. 1A′) may includeslider31, which may have sliderproximal end32 and sliderdistal end33,gripper34, which may have gripperdistal end39, gripperdistal end35, and gripper lumen36,ring37, and small spring38.Gripper34 may comprise a tubular structure, longitudinally divided into two or more parts. Gripperdistal end35 may comprise the distal ends of these longitudinal parts, which may be made with a tendency to expand radially. Small spring (or “gripper spring”)38 may typically be a compression spring having a force of 1-2 N at its free state. In an embodiment, the gripper spring38 may include a free length of approximately 20 mm, a solid length of 9.5 mm, 8 active coils out of 20 total, 0.45 mm diameter ss 312 wire, and a coil outer diameter of ˜4.5 mm.Ring37 may be slideably disposed withinslider31, and overgripper34, such that when positioned over gripperdistal end35, it may prevent radial expansion of gripperdistal end35, thus decreasing the diameter of gripper lumen36 (marked36a), andgripping wire1. Conversely, whenring37 is pushed proximally relative toslider31,distal end35 ofgripper34 may radially expand, enlarging the diameter of gripper lumen36 (marked36b), and releasingguidewire1.
• As shown inFIG. 1A, when in its cocked (proximal) position,guidewire advancement mechanism30amay comprise compressedgripper lumen36a,gripping guidewire1 so that it can be advanced by thedevice1000. More particularly, in the cocked position, with a guidewire loaded withingripper lumen36a,ring37 may be pushed bysmall spring38atowarddistal end35aofgripper34 such that37 protrudes distally beyond sliderdistal end33, and compresses the longitudinal part which includesgripper end35a.
• Large spring40 is positioned betweenguidewire advancement mechanism30 andbackplate50, such that in the cocked position large spring40ais compressed and exerts forward pushing force onguidewire advancement mechanism30 relative tobackplate50. In the deployed position,large spring40 exerts a smaller force onguidewire advancement mechanism30b, but such a force that is sufficient to compresssmall spring38band cause release ofguidewire1 fromgripper34. Large spring (or “slider spring”)40 may be a compression spring having a force of ˜10 N at its solid length and ˜3 N at the deployed state, which may typically be at a length of ˜78 mm. Typical specifications may further include a free length of approximately 98 mm, a solid length of ˜33 mm, 34 active coils, 0.8 mm diameter ss 312 wire, and a coil outer diameter of ˜9.7 mm.
• Backplate50 has a throughhole51 for passage ofguidewire1.
• Membrane60 may be a thin membrane having an oblong fold which fits intomembrane groove28 ofbody20.Membrane60 may be held in place byframe65 which pressesmembrane60 ontobody20.Proximal fluid passageway27 may be in direct contact withmembrane60 such that when fluid enters proximal fluid passage way,membrane60 may sense the change of pressure.Membrane60 may be a diaphragm.
• Lever70 is an elongate member with alever hinge71 running throughprotrusion26 ofbody20, alever tooth72, and alever base73.Lever base73 fits insidemembrane frame65, and sits flat onmembrane60 while deflated. If pressurized fluid enters betweenmembrane60 andbody20 viafluid passageways15 and27,membrane60 can inflate and rise, andlever70 can rotate aroundlever hinge71, such thatlever tooth72 moves upwards. The exact angle of the contact surface oflever tooth72 withsear80, relative to the line perpendicular to the long axis ofslot21, can be very important. This angle, combined with other parameters which include the position ofhinge71, position of uppersear tooth83, position oflever tooth72, govern the size and direction of a moment which tends to turnlever arm70 aroundhinge71. To keep this moment at a clockwise direction, the resultant reaction force of sear80 throughlever70 may be directed abovehinge71. The distance between the vector of this force and the hinge multiplied by the vector size, is the rotating moment. The desirable rotating moment is governed by the location of the membrane relative to hinge71, the size ofmembrane60, and the desired triggering fluid pressure.Adjustment mechanism110 also effects, and preferably adjusts, the desired rotating moment. In some embodiments, the resultant rotating moment from the sear reaction onlever tooth72 can be between 1250 and 7500 gf-mm (gram force millimeter).
• Sear80 has ahinge81 running throughbody20, and around which it can rotate.Sear80 also has lowersear tooth82, uppersear tooth83, andsear hole84.Sear80 is positioned inside opening25 ofbody20, such that lowersear tooth82 protrudes intoslot21 when sear is upright as inFIG. 1A, and no part of sear80 protrudes intoslot21 when it is sufficiently rotated to either side (approximately 30-90 degrees).
• A spiral spring (not shown) may be placed with its coils aroundsear hinge81, one leg insear hole84, and the other leg in a hole inbody20, such that sear80 can be slightly rotated aroundsear hinge81, but tends to flexibly return to the same angle relative tobody20. This allows movingguidewire advancement mechanism30 alongslot21 from the deployed (distal) position to the cocked (proximal) position without sear80 obstructing its passage.
• Cover90 can be a thin walled shell covering the upper part ofdevice1000, includinglever70,membrane60, sear80, andadjustment mechanism110.Cover90 may prevent a user from inadvertently touching the sensitive parts ofdevice1000 and interfering with device operation. It may also provide convenient grips for holding the device.Cover90 may optionally includecover slot91. A safety latch (not shown) in the form of a rigid, semi-rigid, or flexible thin rod may be placed throughcover slot91, to presslever70 clockwise, and enable cocking ofdevice1000 as explained below.
• Cocking handle100 may compriseplate101, handle102, andhook103.Plate101 may fit intohandle groove23, but may be slightly wider than cockinghandle slot22, and therefore needs to be inserted intohandle groove23 viainsertion groove24. Cocking handle100 may be placed withhook103 distal to guidewireadvancement mechanism30, so that when cockinghandle100 may be moved proximally,hook103 may pullguidewire advancement mechanism30 proximally.
• Optional adjustment element110 may includeknob111, casing112,cap113, andknob spring114.Knob111 andknob spring114 may enclose withincasing112 andcap113, such thatknob111 may push upwards byknob spring114. Casing112 may have an external thread withbody20, and an internal thread withcap113.Adjustment element110 may be placed in an opening inbody20 such thatknob111 may apply upwards force onlever70, reducing the force required for release ofguidewire advancement mechanism30, thereby reducing the blood pressure threshold at whichdevice1000 may deploy. The force applied byadjustment mechanism110 may be adjusted by changingknob spring114, by screwingcap113 tighter or weaker, or by screwingcasing112 upward or downward relative tobody20.
• Adjustment element110 may have an end force of 50-300 grams, preferably 100-200 grams, and a travel of 1-5 mm, preferably 2-4 mm.
• Access toadjustment element110 may be from either the bottom part ofdevice1000, for example by inserting a screwdriver throughslot22 and turningcap113, or by removingcover90, androtating casing112, which may be accessed from either side oflever70. These actions may be performed as part of the precalibration process described below.
• A needle (not shown) may be coupled to theluer adapter11 ofneedle adapter10 at the distal end ofdevice1000. The needle may be fluidly coupled to thedistal fluid passageway15 and/or may include a lumen for passingguidewire1 and fluid.Device1000 may also be adapted to receive bodily fluid through the needle into the anterior lumen.
• An internal or external sheath (not shown) or other blunting elements may also be coupled to the needle. Sheaths and blunting elements are further discussed below.
• FIG. 1A′ showsdevice1000 in its deployed state. More particularlyFIG. 1A′ is a longitudinal section ofdevice1000 along its midline, which passes along the line marked1 in the top view shown inFIG. 1B. Shown inFIG. 1A′ are the same elements shown inFIG. 1A with the following differences:advancement mechanism30 is shown in its distal, deployed state,30b, andlarge spring40 is shown in its deployed state,40b.
• At the moment of deployment,membrane60 may extend upwards and pushlever base73 andlever70 upwards, so thatlever tooth72 may move beyond the edge ofsear tooth83, and allow sear80 to rotate clockwise, allowingadvancement mechanism30 to be pushed distally bylarge spring40 andadvance guidewire1. The extent to whichlever70 may move upwards during deployment is marked by dashed line DL, and the extent to which sear80 may rotate is marked by dashed line DS.
• As shown inFIG. 1A′, whenguidewire advancement mechanism30bis in its deployed (distal) position,large spring40bmay pushring37 againststopper29 ofbody20, so thatring37 may be pressed intoslider31, anddistal end35bofgripper34 may protrude distally beyondring37, such that its longitudinal parts may expand radially and enlarge the diameter ofgripper lumen36a, thus releasingguidewire1 to slide undisturbed withingripper lumen36b.
• Moving now toFIG. 1B, which is a top view ofdevice1000 withcover90 removed, the following parts are seen, from left to right:guidewire1,luer adapter11,body20,protrusion26,lever70,membrane60,membrane frame65,lever base73,adjustment mechanism110, optional fluid port, opening25,ring37, sear80,slider31, andbackplate50.Fluid port120 may be a port in fluid communication with the area betweenmembrane60 andbody20, and which may consist of a unidirectional valve, and may include a luer connector or any other connector. This port may be used to fill fluid in the fluid passageways, either immediately prior to use, or as part of device assembly and preparation during manufacturing. Also, this port may be useful for cleaning the device after use.
• In operation,device1000 may be precalibrated, it may be cocked before use, and then used to access a blood vessel.
• FIG. 1C is a top view of an embodiment ofmembrane60 ofdevice1000. More particularly,FIG. 1C showsmembrane60, which may be substantially oblong, although it may have other, preferably elongate shapes, such as elliptical. Such shapes are compatible with the general elongate structure ofdevice1000.Membrane60 may typically comprise oblong fold OF, which may be designed to fit withinmembrane groove28 ofbody20.Membrane60 may typically extend around oblong fold OF, to enable it to tightly and sealably be attached tobody20 byframe65, preventing leakage around its edges. Typically,membrane60 may further comprise multiple holes H which may allow tighteningframe65 tobody20, using screws, pins, pegs, or other components as known in the art. Longitudinal midline LM and cross-section midline CM are further show inFIG. 1C.
• FIG. 1D is a longitudinal section view ofmembrane60 ofdevice1000. More particularly,FIG. 1D is a longitudinal section along line LM shown inFIG. 1C. Oblong fold OF is shown, defining an effective membrane length L.
• FIG. 1E is a longitudinal section view ofmembrane60 ofdevice1000. More particularly,FIG. 1E is a cross section along line CM shown inFIG. 1C. Oblong fold OF is shown, defining an effective membrane width W.
• Membrane60 may typically be made of a thin layer of elastic material such as silicone, polyurethane, latex, etc.Membrane60 may typically have a durometer of 5 to 30 shore A, preferably 10 to 20 shore A. The thickness ofmembrane60 may typically range between 0.05 mm and 0.5 mm, preferably 0.2 to 0.4 mm.
• Effective membrane length L and effective membrane width W define the effective membrane surface area, which define the force it may apply overlever base73. Oblong fold OF ofmembrane60 may allowmembrane60 to rise without being elastically stretched. This may be beneficial as it may reduce the pressure required for triggering the trigger mechanism ofdevice1000. Ifmembrane60 did not have OF, pressure would initially need to work against the elasticity ofmembrane60, stretch it, and only then would it act uponlever base73.
• Precalibration
• The needle and guidewire to be used withdevice1000 are assembled on the device. A needle is placed with its hub overluer adapter11, and guidewire1 is loaded throughlumen12,guidewire advancement mechanism30, andhole51, and the device is in a cocked position. Increasing fluid pressures may be intermittently applied todevice1000 through the needle, and the pressure at which deployment occurs instantaneously is noted as the threshold pressure.Adjustment mechanism110 may be adjusted as described above to increase or decrease the threshold pressure.
• Cocking Action
• During cocking action, a safety latch as described above may preferably be placed incover slot91 to holdlever70 in the proper position.Guidewire1 may be loaded through a needle (not shown),lumen12,guidewire advancement mechanism30, andhole51, and may be positioned such that its distal tip protrudes approximately 2-5 cm distal to the distal tip of the needle. Cocking handle100 may be moved proximally by the user, such as by placing a user's thumb in front ofhandle102 and pulling it proximally to a marking onbody20, or all the way untillarge spring40 may become completely compressed. At that point,guidewire advancement mechanism30amay be proximal to sear80, and cockinghandle100 may be returned forward to its distal location. One or more additional spring may be added to perform this return movement by releasing the handle. Asguidewire advancement mechanism30 is pushed distally bylarge spring40, sliderdistal end33 may engage lowersear tooth82, and may attempt to rotate sear80 clockwise. Since a safety latch may be placed insidecover slot91,lever70 may be held in a position such thatlever tooth72 engages with uppersear tooth83. Thus,guidewire advancement mechanism30 may remain in its cocked position, anddevice1000 may become ready for use. The safety latch may then be removed from thecover slot91.
• Vascular Access
• An over the needle sheath in accordance with the present invention may optionally be placed over the needle ofdevice1000, preferably prior to cocking the device.
• The target vessel and puncture area may be chosen, optionally using imaging, and the skin may be prepped as customary. The safety latch may be removed prior to skin puncture.
• The user may then puncture the skin and attempt to puncture the target vessel. Once a vessel with intravascular pressure above a precalibrated threshold pressure is punctured, pressure may be transmitted tomembrane60 which may rise and pushlever70 upward away from the advancement mechanism and automatically triggering release ofguidewire advancement mechanism30 by allowing sear80 to rotate sufficiently clockwise, thus advancingguidewire1 into the vessel, and preventing the needle from exiting through the back side of the vessel. The user can then further advanceguidewire1 into the vessel, slide the over the needle sheath into the vessel, and removedevice1000 and guidewire. As further provide below, the needle sheath may be an external sheath over the needle or an internal sheath within the needle. In some embodiments, the needle sheath may be an expandable sheath to aid the placement of central catheter.
• Additional features of the current invention are described below.
• Fluid Passageways
• For optimal function ofdevice1000,fluid passageways15 and27 should be as short and straight as possible, without bends, and with a diameter that is small enough to keep total volume small, but large enough so as not to increase resistance to fluid pressure transmission. For example, in some embodiments, thefluid passageways15 and27 may have a capacity for 5 cubic millimeters to 25 cubic millimeters total fluid, or from 5 to 20 cubic millimeters, or from 5-10 cubic millimeters. In some embodiments, the fluid passageways diameter may be 0.5 mm-2.5 mm, preferably 0.75 mm-2 mm, and their length may be less than 4 cm, preferably less than 2.0 cm. Prefilling the fluid passageway with a biological acceptable fluid, such as saline, may further improve function of the device.
• Trigger Mechanism
• The trigger mechanism includeslever70 and sear80. In order to keep response times low, these parts should have low inertia. Additionally, in order to achieve high accuracy, parts should be rigid and have low friction, and be built to tight tolerances. Possible materials for these parts may include, among others, aluminum, stainless steel, titanium, and PEEK. Polishing of the contact areas betweenlever70 and sear80 may further decrease friction and reduce triggering force and pressure threshold.
• Adjustment Mechanism
• The adjustment mechanism adds a rotating moment to the lever, changing the moment balance in such a way that either reduces or increases the required force from the membrane to trip the trigger mechanism.
• The adjustment mechanism may includeadjustment element110 and be used as described above in the pre-calibration section. The adjustment mechanism may alternatively comprise other elements that may apply forces to the lever or sear from other directions, for example fromcover90 downwards. Regardless of the exact mechanism of adjustment mechanism, it may comprise a scale, which may allow recording of adjustments and comparison between devices.
• In some embodiments, adjustments of the adjustment mechanism may be performed during manufacturing. Preferably, tolerances of the system are such that once a specific model of device is manufactured and precalibrated, all similar devices may be adjusted to the same settings, and will all function similarly. Alternatively, each device may be precalibrated individually during manufacturing.
• Advancement Mechanism
• Advancement mechanism30 described above, may allow forguidewire1 to be gripped bygripper34 at all times, until the end of the deployment stroke. Once fully deployed, the guidewire may be released and can be moved freely by the user. The advantage of such an advancement mechanism is that advancement of the wire is controlled, i.e., it is known that the wire may advance at least the distance of the stroke of the advancement mechanism, 2-10 cm, preferably 3-6 cm. In addition, at the end of motion, the guidewire may be moved without friction with the device, so the user can both assess that it is within a vessel, and decide to insert it further or pull it back if required.
• Conversely, other advancement mechanisms described in the art may release the guidewire at an earlier point during advancement, which may decrease control over the insertion distance.
• Noise/Recoil Dampening
• In an embodiment, at least the distal end ofring37 is made of, or is covered by, a soft material such as silicone. This may dampen the impact that may occur betweenring37 andstopper29 ofbody20 whendevice1000 deploys andguidewire advancement mechanism30 moves to its distal position (30b). In another embodiment, such soft material may be positioned onstopper29, instead of, or in addition to, overring37. Such impact absorbing elements may optionally further have a shape improving their impact absorbing properties such as a c-shaped cross section or accordion-like longitudinal section.
• Alternatively or additionally, the impact-absorbing element may be made of an aerated material such as sponge, and may have an elongate shape, for example a cylindrical shape.
• In yet another embodiment, the impact absorbing element and seal16 may be connected to each other or made as one part.
• Lowering the mass ofguidewire advancement mechanism30 is an additional measure for decreasing recoil and noise during deployment.
• Cocking Mechanism
• The above described cocking mechanism has the advantage of simplicity in both mechanism and in the cocking action performed by the user. In addition, no parts that move during deployment are exposed, so that the user may not inadvertently interfere with movement of the advancement mechanism.
• Preferred components for this mechanism include sear80 (protruding intoslot21 only in the cocked position), its springy recoil to an angle wheresear tooth82 protrudes into theslot21, preferably ˜45 degrees in the direction from distal superior to proximal inferior (the angle between sear teeth longitudinal axis to slot21 longitudinal axis), downward (clockwise) force over lever70 (in some embodiments exerted by the above described safety latch, but can be exerted by different safety latches), and the cocking handle.
• More particularly, a spiral spring for ensuring the sear tooth angle that was described above, having coils aroundsear hinge81, one leg insear hole84, and the other leg in a hole inbody20, such that sear80 can be slightly rotated aroundsear hinge81, but tends to flexibly return to the same angle relative tobody20. This spiral spring may typically be a torsion spring with two legs, having a torque force of ˜4.2 Nmm at its free state. Typical specifications may further include 2.5 coils, 0.4 mm diameter ss 312 wire, and a coil outer diameter of ˜5.4 mm.
• Cover
• Described above, cover90 can be made of various materials such as ABS, polycarbonate, other plastics, stainless steel, aluminum, or other metals, or any other appropriate material, or combination of these. Beneficially, it may be transparent to allow viewing of mechanism movement. It may be connected tobody20 using glue, screws, a snap design or combination thereof.
• The current design incorporates a safety latch or inserted pin into thecover90 incover slot91. Said safety latch preventing inadvertent actuation of the trigger mechanism.
• Disposable/Reusable
• In many situations, it may be beneficial that the parts of the device in contact with the patient's blood are disposable, while those not in contact with blood remain reusable.
• Four preferred embodiments of a mechanical vessel cannulation device consisting of a combination of reusable and disposable parts are shown inFIGS. 2A-2D.
• FIG. 2A is a longitudinal cross section ofdevice1000 whereinlever70, sear80, andadjustment mechanism110 are reusable, and all other main components are disposable. Line A is a possible separationline dividing device1000 into a reusable section (above line A), and a disposable section (below line A). The two parts may be slideably positioned over each other, and locked together using a latch, a snap element, or other means as known in the art. In this embodiment,lever70 and sear80 that require high precision may be manufactured using expensive materials and processes. However,large spring40 andadvancement mechanism30 are still disposable, which adds to the disposable cost.
• FIG. 2B is a longitudinal cross section ofdevice1000 whereinlever70, sear80,adjustment mechanism110,large spring40,advancement mechanism30, andbody20 are reusable, and all other main components are disposable. Line B is a possible separationline dividing device1000 into a reusable section (to the right of line B), and a disposable section (to the left of line B). In this embodiment, a guidewire is not used; instead, an external sheath may be used to blunt the needle. It may be pushed forward bypush element200, which is part of the disposable section, and may be advanced byadvancement mechanism30. In this embodiment a valve is not required as no element is pushed through the needle.
• FIG. 2C is a longitudinal cross section ofdevice1000 whereinlever70, sear80,adjustment mechanism110,large spring40,slider31, andbody20 are reusable, and all other main components are disposable. Part C includesmembrane60,membrane frame65, and that part ofbody20 supportingmembrane60 and includingproximal fluid passageways27. Part C may be slid in from the side and locked tobody20. Part D comprisesneedle adapter10,seal16, andstopper29. Parts ofadvancement mechanism30, includingring37,gripper34, and small spring38, together withguidewire1 and part D are plugged intodevice1000 from its front (distal) side. Anylon sheath201 connectsstopper29 withring37, and anothernylon sheath202 covers guidewire1 from the proximal end ofgripper34 to the proximal end ofguidewire1, to keepguidewire1 sterile at all times. In this embodiment, opening51 ofbackplate50 is made larger to accommodate passage ofsheath202 andguidewire1. Incase slider31 is made disposable such that alladvancement mechanism30 is disposable, hook103 of cockinghandle100 is able to fold to one side, enabling insertion ofadvancement mechanism30, and still enabling pulling it back for cockingdevice1000.
• FIG. 2D is a longitudinal cross section ofdevice1000 whereinlever70, sear80,adjustment mechanism110,large spring40,slider31, andbody20 are reusable, and all other main components are disposable. This embodiment has two separate slots for advancement.Slot21, wherein slidesslider31 pushed bylarge spring40, and aseparate slot210, wherein slides gripper34, pushed byarm211 extending fromslider31. An embodiment of adevice1000 comprising disposable and reusable components as described inFIG. 2D, is shown inFIG. 2Di.
• More particularly,FIG. 2Di is a perspective view ofcannulation device1000 having a disposable componentE comprising membrane60,membrane frame65, and that part ofbody20 supportingmembrane60,proximal fluid passageways27,needle adapter10,seal16, andstopper29.Needle2 is seen connected toluer adapter11 and extending distally from it.Guidewire1 is seen protruding proximally fromgripper34, and covered bysterile cover202. Asocket220 is located in the front ofbody220. Whereas inother embodiments socket220 may comprise a thread enabling connection ofneedle adapter10 tobody20 using a screw, in some embodiments such as the one inFIG. 2Di, a spring loaded pin221 in the disposable part E may be used to temporarily connect part E tobody20. Alternatively other easily removable connecting means as known in the art may be used such as various forms of buttons and fasteners.
• Part E includesmembrane60,membrane frame65, and that part ofbody20 supportingmembrane60,proximal fluid passageways27,needle adapter10,seal16, andstopper29. Parts ofadvancement mechanism30, includingring37,gripper34, and small spring38, together withguidewire1 and part E are plugged intodevice1000 from its front (distal) end.Nylon sheath202 covers guidewire1 from the proximal end ofgripper34 to the proximal end ofguidewire1, to keepguidewire1 sterile at all times. In use, part E complete with the needle and guidewire is plugged intodevice1000 from its front end as shown by the arrow inFIG. 2Di, such thatguidewire1 covered bysterile cover202 protrudes out ofhole51 at the back end of the device.
• A similar combination of disposable and reusable parts may be used for some electronic variations of thedevice1000 which are described below.
• By separatingslider31 fromgripper34 such thatlarge spring40 is not coaxial with the needle andguidewire1, it is possible to make almost all of the advancement mechanism includinglarge spring40 reusable, thus lowering the cost of the disposable parts, while keeping the blunting element (in this case a guidewire, but possibly a different intravascular element) sterile.
• InFIG.2D slot21 is depicted aboveslot210, but these can be one next to the other or in any other configuration.
• A cocking handle is not shown inFIG. 2D, but it can be placed for example on the side ofslot21.
• Aft Hinge Design
• In another embodiment shown inFIGS. 2E and 2F, the direction of the lever is reversed, so that the membrane force has a significantly greater torque than does the friction force between the lever and sear teeth, leading to a more predictable activation pattern.
• More particularly,FIG. 2E is a longitudinal cross section ofdevice1000′, which is identical in most details todevice1000 as shown inFIG. 1A, with the following differences: lever70′ hashinge71′ which runs throughprotrusion26′, located at the rear (proximal) part ofdevice1000′, so thatlever tooth72′ is betweenhinge71′ andlever base73.
• FIG. 2F is a top view ofdevice1000′, showing the same elements.
• In this embodiment, the force exerted bymembrane60 onlever base73 has a longer arm fromhinge71′ than does the friction force betweenlever tooth72′ andsear tooth83, whereas in the embodiment shown inFIG. 1, the situation is the opposite. Therefore, in the current embodiment, the moment of force created bymembrane60 for liftinglever70′ is much larger than that of the opposing friction forces atlever tooth72′. In other words, in this embodiment themembrane60 is given an advantage over friction forces.
• In this embodiment, changes in friction force between the lever and sear teeth have a minor effect on the force required for release of the trigger mechanism, and consequently on threshold pressure. Such changes in friction force may occur often due to various reasons such as variations in ambient temperature or humidity, in material properties, or in the forces applied byspring40 and the spiral spring onsear80. Thus, the current embodiment provides means for increasing the accuracy of deployment threshold.
• This embodiment differs from previous embodiments in that because thehinge71′ is located further away frommembrane60 thanhinge71, even if the distance to whichlever tooth72′ must move to activate the trigger mechanism is the same aslever tooth72′ indevice1000, the volume of fluid that must entermembrane60 in order to produce this movement could be slightly larger, and might cause a different trigger response time.
• The design can be modified by shortening the length of overlap betweenlever tooth72′ andsear tooth83. This would decrease the required distance of movement and consequently the volume of fluid that must enter the membrane.
• In an embodiment, the distance between the center of membrane60 (or lever base73) to hinge71′ is approximately double the distance betweenlever tooth72′ to hinge71′. The ratio between these distances may be 1.2 to 4, preferably 1.5 to 3.
• Electronic Vessel Cannulation Device
• In another embodiment of the present invention, a vessel cannulation device utilizing electronic sensing and triggering is provided.
• FIG. 3A is a schematic longitudinal section of electronicvessel cannulation device2000 that can include or be utilized in conjunction with a processor, such as a computer. The structure of this device is generally similar to the mechanical device described above.Body320 containslarge spring340, which pushesadvancement mechanism330 distally to advanceguidewire1, passing throughvalve316 and needle.Fluid passageway315 may lead from the lumen of the needle adapter to anelectronic sensor400, which may be a pressure sensor. The sensor may transmit its output to aCPU410 which controls solenoid420 (or other type of actuator), which is operably connected to triggermechanism430.
• FIG. 3B is a schematic longitudinal section of anexemplary trigger mechanism430 ofdevice2000.Slider331 is seen withinslot321.Solenoid420 is located outside the slot, and is connected such that it can pull lever483 which may movelevers482,481, and sear480.Sear480 has a tooth protruding intoslot321, which may engage withslider331 in its cocked position, preventing its forward movement.Sear480 and the levers are structured such that all the force oflarge spring340 may transfer to the hinge of lever481 without any torque around it, and therefore very little force is required to be exerted bysolenoid420 to release this trigger.
• Whendevice2000 is used to puncture a vessel,sensor400 may measure pressure or any other physiological parameter of blood or other fluid or gas at the needle tip or entering the needle.CPU410 may be configured to execute computer-readable instructions to cause the device to analyze data sent bysensor400. As further detailed below,device2000 may be configured to be pre-set to identify parameters unique to arteries, veins, or other body cavities or organs, for example a specific pressure threshold or range. If predetermined criteria are met,CPU410, when executed, may be configured to activatesolenoid420, which pullslever483, which eventually leads to clockwise rotation ofsear480, and release ofslider331, with advancement ofadvancement mechanism330 and guidewire1 or other blunting element.
• In another embodiment shown inFIG. 4, the same trigger mechanism described above for the mechanical cannulation device may be used, while sensing and activation of the trigger mechanism are electronic.
• FIG. 4 is a longitudinal section ofdevice2000 similar in structure to the one shown inFIG. 1A. In some embodiments,membrane60 andframe65 may be replaced withsensor400, which is connected toproximal fluid passageways315.Sensor400 may also be connected toCPU410, which may also be connected tosolenoid420.
• In the current embodiment,solenoid420 is connected to arod500 with a wedge shaped tip, which is positioned at the meeting point ofsear380 andlever370.
• In operation, when fluid entersfluid passageways315,CPU410 activatessolenoid420, androd500 is pushed distally (i.e. left in this figure), and disengageslever370 fromsear380, causing sear380 to turn clockwise and releasesadvancement mechanism330.
• Electronic Advancement Mechanisms
• In the above embodiments, advancement of the blunting element may be done mechanically. However, in some embodiments this may be achieved by electronic means. For example, a linear motor, large solenoid, or any other electronically activated device capable of linear motion could be used to advanceadvancement mechanism330. Alternatively, rotary motors could roll the wire or advancement mechanism forward.
• Sensor
• Sensors used in the embodiments of the invention may be pressure sensors, temperature sensors, conductivity sensors, flow sensors, ultrasound sensors, pH sensors, optical sensors, or any other sensors as known in the art.
• In some embodiments, at least a pressure sensor may be used. Sampling rate and communication speed between the sensor and CPU are of utmost importance, as a low sampling rate, or delayed communications might lead to delayed device responses, which could cause deployment outside of the vessel or other malfunctions.
• As the relevant time scale of pressure changes in this application are several milliseconds, a sampling rate of 10 KSPS (Kilo samples per second) may be sufficient for most embodiments described herein, while for embodiments requiring more advanced signal analysis, a higher sampling rate is preferred.
• The delay between the time of sampling to receipt of data by the CPU should be kept to a minimum, as response time to the pressure change should be short to avoid deployment outside of the vessel or other malfunctions.
• A differential pressure sensor is preferred, as only the relative pressure between the internal pressure of the vessel and the ambient pressure is relevant to the measurement. A+/−400 mbar (300 mmHG) differential pressure measurement is sufficient, as the pressure inside the vessel will always be within this range.
• A suitable sensor for this application may for example be the Honeywell Amplified Basic Pressure sensor #X210907, with a differential pressure+/−400 mbar (300 mmHG) and 0.42 ms response time.
• The sensor may be located as close to the target tissue as possible, that is, at the needle tip if possible, at the needle hub, or on the device as close as possible to the needle hub. Placing the sensor on the device has the advantage of using standard needles, thus reducing disposable costs.
• In some embodiments, a combination of several sensors may be used. This may enable using a combination of physiological parameters at the needle tip to more accurately identify a specific body cavity, and initiate action.
• Flow Chart
• FIG. 5A is a flow chart of a process which may be implemented by the device of embodiments of the invention.
• Step3000:
• The process may begin with calibration of the sensor to ambient pressure and temperature, which is performed prior to skin puncture. This is not always necessary, and depends on the specifications of the sensor used.
• Step3001:
• The user may then optionally select whether the target vessel is an artery or a vein. This can be performed by any input device for example using a simple button on the device, or any input device described below. Optionally, the device has a user interface allowing choice of the target vessel type, and optionally input of additional information such as patient personal or clinical data. Alternatively, in some embodiments each device is either arterial or venous, i.e. it is preset to suit a specific vessel type.
• Steps3002 and3003:
• Selection of the vessel type defines parameters analyzed by the device. These may include a pressure range, for which a Lower Threshold (LTH), and an Upper Threshold (UTH) are defined. Additional parameters may for example include a Range of Pressure Change Rate (RPCR).
• Settings for an artery may be:
• LTH 20 mmHg
• UTH 300 mmHg
• RPCR+/−400 mmHg/sec
• Window 0.01 sec
• Settings for a vein may be:
• LTH 5 mmHg
• UTH 20 mmHg
• RPCR+/−100 mmHg/sec
• Window 0.16 sec
• These ranges are given as an example mainly used in trauma scenarios, and may be defined differently. Ranges may also be defined according to the patient's clinical condition. For example, in a patient with right heart failure, the range of central venous pressures may be higher and overlap with arterial pressures. In such a case the range for a venous cannulation may for example be 5-40 mmHg, and additional measures such as rate of pressure change and possibly other physiological parameters may need to be taken into account.
• Optionally a user will input the patient's characteristics including age, gender, habitus, clinical situation, and possibly the purpose of intervention, and the device may suggest an appropriate pressure range, or may choose the pressure range automatically.
• Step3004:
• The CPU may be configured to process a received pressure measurement from the sensor, an average of measurements, or several measurements and in some embodiments may perform a running average, or other calculation to remove noise from the data. The CPU may be configured to compare the current pressure value to the predefined range. If not within that range, the CPU may be configured to repeat thisstep3004 until a vessel with this pressure range is penetrated, which allows moving to the next step.
• Step3005:
• A timer, such as a clock, may be used to start measuring time from penetration of the vessel. This time measurement may serve as a time window during which the solenoid is not activated, and measurements continue, in order to confirm that the right type of vessel was penetrated. This is mainly because when an artery is punctured, pressure in the sensor transitions between ambient to the arterial pressure, passing through the venous pressure range.
• For example, if a pressure reading of 8 mmHg was received, this may be from a vein, but could also just be a transitional pressure while the sensor goes from ˜0 mmHg to say ˜100 mmHg. If an artery was penetrated, sensor pressure may equilibrate with the arterial pressure very soon, so that if pressure remains in the venous range after the time window has ended, this serves as an indication that a vein was punctured.
• In some embodiments, ranges for the time window for a vein may be 0.05-0.3 seconds, preferably 0.08-0.2 seconds. In some embodiments, ranges for the time window for an artery may be shorter, e.g., 0-0.2 seconds, 0-0.1 seconds, or 0-0.05 seconds.
• Step3006:
• The CPU may be configured to inquire the same question as instep3004. If the pressure value is outside the range, this means the needle has exited the vessel, and the process may return tostep3004.
• If the pressure value is within the range, this means the needle is probably still in the vessel, and the process may continue to step3007.
• Step3007:
• The CPU may be configured to analyze the pressure change rate between successive measurements and/or over a certain time period.
• The range of pressure change rate mentioned instep3002 for a vein (+/−100 mmHg) may vary with system design, and may be between +/−50 mmHg/sec to +/−150 mmHg/sec, preferably between +/−80 mmHg/sec to +/−120 mmHg/sec.
• The range of pressure change rate mentioned instep3002 for an artery (+/−400 mmHg) may vary with system design, and may be between +/−350 mmHg/sec to +/−450 mmHg/sec, preferably between +/−380 mmHg/sec to +/−420 mmHg/sec.
• These ranges may also vary with clinical condition, and may optionally be calibrated according to pulse rate, arterial pressure, patient characteristics, and clinical status.
• If the current pressure change rate is outside the predefined range, this probably means that despite the current pressure reading being within the predefined pressure range, the needle has either exited the vessel, or entered the wrong vessel type (artery instead of vein) and the process may return tostep3004.
• If the current pressure change rate is within the predefined range, this means the needle is probably still in the vessel, and the process may continue to step3008.
• Step3008:
• Optionally, the CPU may configure to compare various additional physiologic parameter values, measured by sensors as previously mentioned, to predefined ranges. If these parameters are found to be outside the predefined ranges (in some embodiments, these would be compatible with intravascular conditions), the process may return tostep3004. If within range, the process may continue to step3009.
• This step may optionally consist of multiple such stages, using multiple inputs, for example verifying intravascular conditions by measuring impedance, pH, temperature, reflectance, and any other parameter enabling distinguishing between blood and extravascular tissues, or identifying any other target tissue or fluid.
• In some embodiments only if all parameters are within predetermined ranges, will the process continue to step3009. Alternatively in other embodiments, each parameter may receive a “grade” (e.g.10 for within range, and decreasing as distance from range increases), and an average or other function of these grades serves as the basis for the process's decision making. In yet other embodiments, each parameter may be further assigned a weight according to its accuracy, signal to noise ratio, or importance, and a weighted average may be calculated.
• Such use of multiple physiologic parameters, or multiple inputs, for verifying correct vessel penetration, may increase sensitivity and specificity of the device.
• Step3009:
• The CPU may be configured to check whether the time window has expired. If it has, this means that all measured parameters remained within their predefined ranges for a sufficient period of time, which in very high likelihood means that the needle has penetrated, and is still in the lumen of the correct type of vessel.
• If the time window has not yet expired, the process may return to step3006, and may continue monitoring the parameters as described above.
• If the time window has expired, or in other words if the time falls outside a predetermined time window, the process may continue to step3010 to activate the solenoid.
• In some embodiments, the pressure versus time graph curve contour may be analyzed to determine whether a needle is in the correct cavity. Parameters of the pressure curve that may be analyzed, may include for example the complete shape of the pressure-time graph, degree and rate of pressure change since assumed penetration into the vessel, the pressure change gradient, area under the pressure curve, etc.
• In some embodiments, the pressure curve may be monitored for a very short period and it can be predicted how the curve should look before and after the monitoring period. Further, the shape of the measured pressure curve can be compared to the predicted shape, thus identifying pressure changes that are a result of entering/exiting a vessel, and not natural pressure changes within the vessel.
• In some embodiments, simultaneous ECG monitoring, which may be performed through the needle, or through external electrodes, is correlated with the pressure curve, to identify “real” pressure changes within a vessel vs those resulting from entering/exiting a vessel.
• In an embodiment, a bank of measurements may be used from past patients, to compare with the measured pressure curve.
• In an embodiment, rapid measurements at the very start of an initial pressure rise may be used, to extrapolate whether the final pressure would reach a venous or an arterial level. Because this is done extremely rapidly, preferably within less than 50 milliseconds, the assumption is that in this case the needle would not have time to exit the vessel before the solenoid is activated and the blunting device is deployed.
• In an embodiment, all or any combination of the above methods may be used, or shifts between them according to various stages of the procedure.
• FIG. 5B is a graph produced using a prototype device similar in structure to the one described inFIG. 4, and the process similar to that described inFIG. 5A. Pressure measurements from the device's sensor were constantly recorded on a laptop computer. In the graph, pressure (Y axis, mmHg) is plotted against time (X axis, seconds), from right to left. LTH and UTH are plotted as straight lines, and solenoid activity is plotted as well, with a value of 0 representing its “OFF” state, and 18 representing its “ON” state.
• In this experiment, the device was used to puncture silicone tubes containing water in known pressure. LTH was set to 5 mmHg, UTH to 20 mmHg. The time window was set to 100 milliseconds, and the duration of solenoid activation was set to 3 seconds.
• During the first four punctures, at times ˜5 sec, ˜13 sec, 19 sec, and 25 sec, the pressure was ˜36 mmHg, simulating arterial pressure in a hypotensive patient. During the fifth puncture, at time ˜56 sec, the pressure was ˜17 mmHg, simulating venous pressure. Nothing was changed in the device between the punctures.
• As seen in the graph, the solenoid was not activated in any of the first four punctures into the “artery” tube, despite the measured pressure briefly passing within the predetermined venous range, both while increasing, and while decreasing. However, in the fifth puncture, this time into the “vein” tube, the solenoid was activated immediately upon end of the time window, because the measured pressure remained within the LTH-UTH range.
• FIG. 5C is a theoretical graph depicting the concept of using multiple physiological parameters as inputs for the process described inFIG. 5A, and specifically instep3008, in order to provide an example of how the system may function.
• More particularly,FIG. 5C is a graph showing possible real time measurements of fluid pressure, PO2 (oxygen tension), and PCO2 (Carbon Dioxide tension) at the tip of a needle during puncture of body tissue and blood vessels. The horizontal axis represents time, and the vertical axis represents the values of the measured parameters (fluid pressure, PO2, PCO2). Additional or other physiological parameters not shown in this graph may be used, including but not limited to pH, temperature, flow, glucose content, optical reflectance, etc.
• Scales on the right side of the graph show possible typical ranges of each parameter for venous blood. These may be 5-20 mmHg for fluid pressure, 30-50 mmHg for PO2, 40-54 mmHg for PCO2. These venous ranges are marked by wide bars, to the right of each of the scales. Typical arterial ranges for these parameters may be approximately above 20 mmHg for fluid pressure, 75-10 mmHg for PO2, 25 to 45 mmHg for PCO2.
• In the graph, the continuous line represents fluid pressure, the dashed line represents PO2, and the dotted line represents PCO2. Depicted are two events, A and B, in which parameters change significantly due to puncture of a body lumen or vessel.
• Event A represents possible measurements during arterial puncture: fluid pressure may rapidly rise to well above 20 mmHg, PO2 may rise from a level of ˜25 mmHg in muscle or other tissue to 75-100 mmHg, and PCO2 may decrease from 30-40 mmHg up to 25 mmHg. Altogether, these values, especially when compared to the values measured in tissue before the rapid change at the time of vessel puncture, indicate that the punctured vessel may be an artery. If the chosen vessel type was a vein, the system's CPU may analyze these data and refrain from deploying the blunting element in this vessel. Comparing the values measured during event A to the venous ranges (wide bars to the right of the scales) shows that all parameters are outside the venous ranges. Following exit of the needle tip from the vessel, values return to their levels in surrounding tissue.
• Event B represents possible measurements during venous puncture: fluid pressure may (less rapidly than before) rise to well 5-20 mmHg, PO2 may rise from a level of ˜25 mmHg in muscle or other tissue to 30-50 mmHg (significantly less than arterial), and PCO2 may rise from 30-40 mmHg 40-52 mmHg. Altogether, these values, especially when compared to the values measured in tissue before the rapid change at the time of vessel puncture, indicate that the punctured vessel may be a vein. If the chosen vessel type was a vein, the system's CPU may analyze these data, recognize the parameters are within the venous ranges (compare values to the wide bars at the right of each scale), and deploy the blunting element in this vessel. Otherwise, following exit of the needle tip from the vessel, values return to their levels in surrounding tissue.
• FIG. 5D is a simplified theoretical graph depicting various possible pressure measurement contours, for describing examples of pressure curves which may be measured at the needle tip of adevice2000, and their contour analysis as may be performed by the process described inFIG. 5B. The described curves and analyses are examples, and are not meant to cover all possible uses of the data within the scope of the current disclosure.
• More particularly,FIG. 5D is a simplified, schematic, theoretical graph of fluid pressure (in mmHg) at the needle tip, plotted against time (in seconds). During the first second of measurement, a graph G is shown, depicting pressure which may be measured in tissues such as skin or subcutaneous tissue, before puncture of a blood vessel. A segment of the pressure curve marked P is shown.
• Attime 1 second, a theoretical puncture into a vessel occurs. Three possible graphs are shown from this point: G1—“artifact”—including segment Q, G2—“venous puncture”—including segments R, S, T, U, and G3—“arterial puncture”—including segments V, W, X, Y, Z. Of course only one such graph may be measured by one device at its needle tip at a single time, however the three are brought herein together in order to exemplify various possible pressure contours.
• Segment P shows pressure slightly fluctuating around 1 mmHg. This may be typical of measurements within body tissue that is not under pressure, i.e. for example skin or subcutaneous tissue, fat, and muscles of the limbs, without external pressure or edema. Typically pressure in these tissues may be close to zero, however slight fluctuations as shown in segment P may be common and may result from “noise” caused by movements of the patient or device, changes in device position and height, electromagnetic interference etc. Various methods of analysis as known in the art may be used to minimize this “noise” including running averages etc.
• At second 1 there is an abrupt change in the pressure curve. G1 is an example of such change, which may be caused not by puncture of a vessel, but for example by extreme movement of the patient. Such an artifact may be recognized when analyzing the graph, for example by identifying the rate of change, which may not be as abrupt, and the contour may not be as smooth, as in the case of true vessel puncture. Typically, such a change may be short standing, and may not reach high pressure levels.
• G2 and G3 are graphs describing typical pressure measurements upon puncture of a vein or an artery, respectively. When puncturing a vein, pressure would typically rise abruptly, however not as abruptly as in the case of arterial puncture, so the rate of change, as seen by the slope of the graph in segment R (venous), is lower than that in segment V (arterial). Typically this rate of change in pressure may be sufficient to distinguish between venous and arterial puncture, as described in the process ofFIG. 5B. Pressure buildup within the needle, fluid passageways, and sensor may take time, typically several tens of milliseconds, depending on the vessel pressure, and therefore the pressure graph rises along that period of time. Arterial pressure may typically be sufficient to reach measured pressure levels above the upper threshold for veins (which may typically be chosen as above 20 mmHg), within 100-200 milliseconds from the time of puncture. After that time, if pressure is still within the venous range, the punctured vessel may be identified as venous. This is exemplified by segment T which may be a typical pressure measurement in a central vein, around 15-16 mmHg. This pressure may be relatively high for most patients, however the important point is the fluctuations in pressure shown in segment T. Such fluctuations are typical of venous pressure, and may be caused by reasons as described previously for segment P, and in addition, by the patient's respiratory activity, and/or cardiac activity. Such fluctuations typically have a known rhythm, and can therefore be identified, and may typically not be mistaken for changes in the position of the needle (i.e. will typically not be assumed to be caused by the needle exiting the vessel or entering an artery).
• Even before the pressure graph reaches the venous “stable state” (segment T), segment S shows a significant decrease in the rate of pressure rise, which can be identified by the process ofFIG. 5B, especially when compared to segment R, and considering the time lapse between the two segments. In other words, a decrease in the slope of the curve within a short time, and without a significant rise in absolute pressure, enables predicting the final pressure level, by extrapolation.
• In contrast, segment W in graph G3 (arterial) still shows a very steep slope, i.e. pressure continues to rise quickly. The maximal pressure shown in this sample graph as seen in segment X, is very low for an arterial pressure (˜40 mmHg), but may be consistent with a patient in shock, which is an indication for use of the devices of the current disclosure. Of note, segment X includes the peak arterial pressure and may show an abrupt fall in pressure after the peak, which is typical of an arterial pressure contour. There are various other known features of the arterial pressure graph, depending on where the pressure is measured, such as the dicrotic notch. However the important point for the current embodiment is that such abrupt changes as shown in segments X and Y of G3 wherein the slope changes from very positive to very negative or the opposite, are typical of arterial pressure and enable distinguishing between vessel types. Importantly, these typical contours may enable identifying the vessel type within a very short time, e.g. within less than 100 ms, which may advantageously occur before passing of several heart beats of the patient, and before the respective pulsatile blood pressure contour is recorded. That is to say, waiting the required time until pulsatile pressure can be identified, may be too long for optimal function of the cannulation device, and therefore rapid identification (within 50-200 ms) of the vessel type by a short segment of the contour is beneficial.
• At second 2, a theoretical measurement of pressure at a time of exit of the needle tip from the vessel lumen is depicted. Both G2 and G3 show an abrupt fall in measured pressure as seen in segments U and Z respectively. However, due to the large difference in pressure between the lumen and surrounding in the arterial case, and the smaller difference in the venous case, the slope of pressure decrease is much steeper for the artery as seen in segment Z versus the vein as seen in segment U. This steeper slope may enable the system to distinguish between exit of the needle tip from an artery as opposed to the typical pressure fall during diastole (as seen for example at the end of segment X).
• Some or all of the above may be used within the software for analysis of the pressure curve contour for identifying the location of a needle tip—in tissue, in an artery, or in a vein. Similar considerations and calculations may be applied to multiple other physiologic parameters which may be measured by embodiments of the current disclosure.
• Reusable and Disposable Combinations
• Various embodiments of reusable and disposable combinations of the electronic device are described below. These are generally similar to those described for the mechanical device inFIGS. 2A-2D. Of note, in each of the following electronic sensor embodiments, the sensor may either be disposable or reusable. If the sensor is reusable, there may be a separation between it and biological fluid, that on the one hand allows pressure transmission, and on the other hand prevents sensor contamination by patients' body fluids. Such a separation may for example consist of a gel plug, a thin polymeric membrane, or other appropriate partition.
• In an embodiment, the solenoid and trigger mechanism are reusable and the rest (body, large spring, slider, seal, and passageways) are disposable. As mentioned above, the sensor may be either disposable or reusable (analogous toFIG. 2A).
• In another embodiment, in a device that advances only an external sheath (no guidewire), where there is no seal and possibility of blood entry into mechanism. Therefore, only the needle, the adapter and/or the sensor are disposable (analogous toFIG. 2B).
• In another embodiment, the guidewire may be coaxial with the large spring, but the inner part of the advancement mechanism may be replaceable. Therefore, only the guidewire, the gripper, the needle adapter, the needle, and/or the sensor may be disposable (analogous toFIG. 2C).
• In yet another embodiment, the guidewire is not coaxial with the large spring. Therefore, only the guidewire, the gripper, the needle adapter, the needle, and/or the sensor may be disposable (analogous toFIG. 2D).
• Blunting Elements
• In some embodiments of the present invention, the cannulation devices of the present invention may include blunting elements, which may comprise one or more guidewires, or other elements advanced through the needle and/or a sheath advanced over the needle. In some embodiments, the blunting element may be operable to cover the tip of a needle. In some embodiment, the blunting element may be positioned close to the needle tip prior to vessel puncturing, such that the blunting element may be quickly deployed into the vessel to cover the needle tip and prevent injuries to the vessel wall.
• An advantage of using a sheath over the needle as the blunting element of the cannulation device, is that a non-hollow needle can be used. Such a non-hollow needle may have a relatively small diameter. In addition, a needle that has a sensor at its tip may be used (usually this will be a non-hollow needle, or hollow but with a small inner diameter). The sensor may be a pressure sensor or a different type of sensor (flow, impedance, etc.). The sensor may be in electronic communication with the vessel cannulation device and operable to transmit pressure information to the processor for automatic deployment of the blunting element.
• FIGS. 6-11 show various “blunting” elements in accordance with embodiments of the invention.
• FIGS. 6A-6D depict an embodiment of a stent like “tip covering”internal blunting element600. More particularly,FIG. 6A is a 3D depiction of bluntingelement600 havingproximal part604 which may be a guidewire or similar to a guidewire, divergingarea606 which may be an area configured to project forward and outward, then inward, downward, and backward, convergingarea608, which may be configured to project forward and inwards,distal area610, gradually becoming softer, anddistal tip602.
• FIG. 6B is a longitudinal section of bluntingelement600 in its crimped state, insidelumen6 ofneedle2.Needle2 hasdistal end3,lumen6, andbevel point7. Bluntingelement600 is seen slideably positioned withinlumen6 ofneedle2, with itsdistal tip602 positioned neardistal end3 ofneedle2, not protruding out oflumen6. Of note,areas606 and608 of bluntingelement600 are flexible and therefore assume a relatively straightened configuration withinlumen6.
• FIG. 6C is a longitudinal section of bluntingelement600 in its deployed state. Bluntingelement600 is seen partially protruding out oflumen6 ofneedle2.Area606 of bluntingelement600 may extend forward and outward out oflumen6, then backwards inwards and downwards along and around the outer surface ofdistal end3 ofneedle2, continued byareas608 which extend forward and inward, converging intoarea610, which may be a guidewire or similar.
• FIG. 6D is an isometric depiction of bluntingelement600 in its deployed state, showing the same features as inFIG. 6C.
• In operation, bluntingelement600 may be advanced by any of the vessel cannulation devices of the invention, other cannulation devices, or manually, immediately following puncture of the target lumen. The bluntingelement600 may be advanced to an exact position, such thatareas606 and608 cover the inferior aspect ofbevel point7, thus preventing it from inadvertently puncturing through the vessel wall and exiting the vessel lumen.
• In some embodiments, additional struts or wires connect any ofproximal part604 and divergingarea606 with convergingarea608 anddistal area610, thus covering also the superior aspect ofbevel point7.
• In an embodiment, bluntingelement600 may be made of a cable or braid, andareas606 and608 consist of a segment of the cable, which may be unwound or uncoiled, and its strands diverge outwards. Other embodiments of bluntingelement600 are possible. The bluntingelement600 has an extendable segment (areas606 and608) configured to coverbevel point7 in its deployed state, and which in its crimped state, does not substantially obstructneedle lumen6.
• In an embodiment,vessel cannulation device1000 or2000 may advance bluntingelement600 or any of the following blunting elements (to be described below) to a specific position, then may pull it slightly backwards (proximally), to makesure areas606 and608cover bevel point7.
• FIGS. 7A and 7B depict an embodiment of a coiling “tip covering” bluntingelement700. More particularly,FIG. 7A shows a longitudinal section of bluntingelement700 in its crimped state, insidelumen6 ofneedle2. Bluntingelement700 is seen slideably positioned withinlumen6 ofneedle2, with itsdistal tip702 positioned neardistal end3 ofneedle2, not protruding out oflumen6.Area706 of bluntingelement700 may be flexible and therefore assume a relatively straightened configuration withinlumen6.
• FIG. 7B shows a longitudinal section of bluntingelement700 in its deployed state. Bluntingelement700 is seen partially protruding out oflumen6 ofneedle2.Area706 of bluntingelement700 may extend out oflumen6, coiling arounddistal end3 ofneedle2, thus coveringbevel point7, and continues asdistal part710, which is a soft relatively guidewire.
• In some embodiments, bluntingelement700 may be made of a guidewire, which has been pretreated by heat treatment, mechanical treatment, or other method, to confer a coiling tendency toarea706.
• FIGS. 8A-8E depict an embodiment of a “tip completing” bluntingelement800, shaped as a longitudinally cut tube segment with a shape that fits with and complements the needle bevel into a blunt end.
• More particularly,FIG. 8A shows a 3D depiction of bluntingelement800 showingdistal tip802, slit808,inferior fit806,superior fit805, andproximal part804, which may be a guidewire or strip or other long element, extending proximally from the proximal end of the slit tube, and enabling pushing bluntingelement800 distally.
• FIG. 8B shows a longitudinal section of bluntingelement800 in its crimped state, insidelumen6 ofneedle2. Bluntingelement800 is seen slideably positioned withinlumen6 ofneedle2, with itsdistal tip802 positioned neardistal end3 ofneedle2, not protruding out oflumen6. The bluntingelement800, which is longitudinally slit atslit808, may coil upon itself such that its ends overlap to some extent, reducing its outer diameter sufficiently for it to be inserted intolumen6 ofneedle2.
• FIG. 8C shows a longitudinal section of bluntingelement800 in its deployed state. Bluntingelement800 is seen partially protruding out oflumen6 ofneedle2. Once pushed out oflumen6 by any of a cannulation device or manually, bluntingelement800 may pop out to its original outer diameter, which may be identical or close to that ofneedle2.Bevel point7 may be positioned withininferior fit806, andsuperior fit805 sits at the upper end of the needle bevel. In this position, bluntingelement800 has adistal end802 which may be round and blunt, whilesuperior fit805 andinferior fit806 prevent it from being pushed back proximally. Thus, a blunt needle end may be created.
• FIGS. 8D and 8E are 3D drawings showing the same asFIGS. 8B and 8C.
• FIGS. 9A-9D depict an embodiment of a “internal sheath” bluntingelement900, in some embodiments, comprising a thin tube with a blunt, atraumatic tip.
• More particularly,FIG. 9A shows a longitudinal section of bluntingelement900 in its crimped state, insidelumen6 ofneedle2. Bluntingelement900 is seen slideably positioned withinlumen6 ofneedle2, with itsdistal tip902 positioned neardistal end3 ofneedle2, not protruding out oflumen6. Although in thisdrawing blunting element900 is depicted as a short sheath, it may be a longer sheath with a more rigid proximal part to be positioned at the needle tip when deployed, and a softer distal tip. The change between these areas may be gradual, but may also be in steps. Note also that in this embodiment,bevel point7 ofneedle2 may be preferably shaped such that it is at the inner side of the needle wall, to ensure a smooth taper from bluntingelement900.
• FIG. 9B shows a longitudinal section of bluntingelement900 in its deployed state. Bluntingelement900 is seen partially protruding out oflumen6 ofneedle2. Once pushed out oflumen6 by any of a cannulation device or manually, bluntingelement900 may extend beyond needledistal end3, and provides a blunt end atdistal tip902 with a smooth taper toneedle2.
• FIGS. 9C and 9D are 3D drawings showing the same asFIGS. 9A and 9B.
• FIGS. 10A-10D depict another embodiment of an “internal sheath” bluntingelement1100, which is different from the previous one in that it covers the needle bevel point.
• More particularly,FIG. 10A shows a longitudinal section of bluntingelement1100 in its crimped state, insidelumen6 ofneedle2. Bluntingelement1100 may be seen slideably positioned withinlumen6 ofneedle2, with itsdistal tip1102 positioned neardistal end3 ofneedle2, not protruding out oflumen6.Opening1106 may be a cross slit in the sheath of bluntingelement1100. The sheath may be preshaped with a curve towards the side of thebevel point7, but the sheath may be straightened within the needle lumen in this figure.
• FIG. 10B shows a longitudinal section of bluntingelement1100 in its deployed state. Bluntingelement1100 is seen partially protruding out oflumen6 ofneedle2. Once pushed out oflumen6 by any of a cannulation device or manually, bluntingelement900 may extend beyond needledistal end3, and provides a blunt end atdistal tip1102 within the vessel lumen. Additionally, the bluntingelement900 may curve towardsbevel point7, and is may be pulled slightly backwards such thatbevel point7 enters into opening1006, thus rendering the needle tip blunt.
• FIG. 10C shows a 3D drawing of deployed bluntingelement1100 without the needle.
• FIG. 10D shows a 3D drawing of deployed bluntingelement1100 with the needle.
• FIGS. 11A-11D depict an embodiment of a “sandwich sheath” bluntingelement1200, may comprise two layers of over-the-needle sheaths.
• More particularly,FIG. 11A shows a longitudinal section of bluntingelement1200 in its crimped state, positioned overneedle2. Bluntingelement1200 may compriseouter sheath1202 andinner sheath1204.Inner sheath1204 may have inner sheathdistal tip1206 andinner sheath protrusions1208.Outer sheath1202 may havedistal tip1210. The proximal end ofouter sheath1202 may be connected toneedle hub5, and may have slots through which protrudeprotrusions1208.Inner sheath1204 may be slideably positioned betweenneedle2 andouter sheath1202. Thedistal tips1206 and1210 of bothinner sheath1204 andouter sheath1202 may be proximate to each other and together create a taper towardsdistal end3 ofneedle2.
• FIG. 11B shows a longitudinal section of bluntingelement1200 in its deployed state.Inner sheath1204 is seen partially protruding beyonddistal end3 ofneedle2, providing a blunt end coveringbevel point7 atdistal end3. Although in this drawinginner sheath1204 is depicted as protruding a short distance, it may protrude to a large distance, in some embodiments, with a more rigid proximal part to be positioned at the needle tip when deployed, and a softer distal tip. The change between these areas may be gradual, but can be in steps.
• In use, once the vessel is penetrated byneedle2,inner sheath protrusions1208 may be pushed forward by a cannulation device or a user.Inner sheath1204 slides overneedle2 and withinouter sheath1202 at least until it coversdistal tip3. An advantage of this embodiment is thatinner sheath1204 has almost no contact with tissue surrounding the needle, and so can be advanced without pushing the needle out of the vessel, as can commonly happen with sheaths over needles. At the same time it does not compromise the needle inner lumen.
• Any of the blunting elements and cannulation devices described herein and in the incorporated applications may be used interchangeably with each other.
• Guidance
• Various embodiments for guiding the puncture procedure are described below. The descriptions will usedevice1000 as example, but may relate to any ofdevices2000 or others described above and elsewhere.
• Mechanical Guidance
• In an embodiment shown inFIG. 12A, a simple linearmechanical guide1300 may be used for guiding the cannulation procedure.Mechanical guide1300 enables sliding any of the above described cannulation devices over a slope of approximately 30-45 degrees, directed at the target vessel (marked “A” in the figure), while remaining substantially parallel to the vessel's longitudinal axis. Optionally,mechanical guide1300 may be foldable. Markings at its front edge may be used to indicate distance between punctures.
• In use,mechanical guide1300 may be placed on the patient's skin, with its central marking above the estimated location of the target vessel, and pointing in the direction of the vessel's longitudinal axis. The user may begin puncturing the skin at a location approximately 1-2 cm to one side of the center marking, and performs consecutive parallel punctures, each time approximately 2 mm closer to the central marking, and continues beyond it if necessary.
• In this manner, all possible space where the target vessel can pass may be covered, and once the vessel is punctured by the needle, the cannulation device may be deployed.
• In an embodiment shown inFIG. 12B, a simple rotarymechanical guide1350 is used for guiding the cannulation procedure.Mechanical guide1350 may enable sliding any of the above described cannulation devices over a slope of approximately 30-45 degrees to the patient's skin, while rotating the needle tip at the same point, in some embodiments, 1-2 mm below the skin surface. Optionally,mechanical guide1350 may be foldable. Optionally, asurface1351 may slide up and down the slope and can be locked to it at any point. An arch1352 may be attached tosurface1351, with its center located beyond the lower edge ofsurface1351.Attachment1353 may slide around arch1352, whileslab1354 may slide back and forth overattachment1353.Device1000 may be attached toslab1354 such that it can be moved around arch1352 and back and forth with itsneedle2 pointing to the center of arch1352. Markings along arch1352 may be used to indicate angles between punctures.
• In use,mechanical rotary guide1350 may be placed on the patient's skin, with its central marking above the estimated location of the target vessel, and pointing in the direction of the vessel's longitudinal axis. Optionally, the user may determine the height ofsurface1351 such that the center of arch1352 is at any depth below the patient's skin surface, in come embodiments, 1-2 mm below the skin. Alternatively, this height may be fixed. The user may begin puncturing the skin at an angle approximately 30-45 degrees to one side of the center marking, and perform consecutive punctures, each time going a few degrees closer to the central marking, and continues beyond it if necessary.
• In this manner, most possible space where the target vessel can pass may be covered, and once the vessel is punctured by the needle, the cannulation device will deploy.
• Optionally, stops may be placed that limit sliding ofslab1354, limiting the minimum and maximum needle insertion depths, so that the needle is not accidentally pulled out of the skin, and remains inside the skin.
• Imaging Based Guidance
• In some embodiments, imaging may be used as part of any of the previously described cannulation devices.
• In some embodiments described inFIGS. 13A-13D, anultrasound transducer1400 may be slideably located at the tip ofneedle2 ofdevice1000. More particularly,FIG. 13A is a simplified 3D drawing ofdevice1000 withneedle2,transducer1400 around the tip ofneedle2,arm1401 connected totransducer1400, and slideably connected toconnector1402.FIG. 13B showstransducer1400 made of two parts, which can be separated to remove it offneedle2 or a sheath that may have been placed over the needle. This may allow the needle or the needle/sheath to be removed or replaced.FIGS. 13C and 13D are simplified side views ofdevice1000 with a longitudinal section of the tissue.FIG. 13C showsdevice1000 before skin puncture, andFIG. 13D showsdevice1000 with needle tip in the target vessel, and a deployed guidewire in the blood vessel. Although described above as being made of two parts,transducer1400 may be made of more than two parts, or alternatively of one part further comprising a longitudinal slit, such that it may be positioned with the needle at its center, slid over the needle during puncture, and easily removed following puncture.
• In an embodiment,transducer1400 is a Doppler ultrasound transducer with a narrow beam, which provides an audio or visual indication of the intensity of the sensed Doppler signal. The user may placetransducer1400 at the desired puncture site, and may tiltdevice1000 in varying angles until he identifies the angle with the strongest signal, indicating the direction of the target vessel. The user then punctures through the skin untildevice1000 deploys.
• In an embodiment shown inFIG. 14, aguidance system1500 is provided which includes the device described previously inFIGS. 13A-13D, a surface ormat1501 on which are mounted one ormore position sensors1502, connected to a processor1503, which is connected toindicator1504.Position sensors1502 may for example measure angles α and β ofdevice1000 in relation tomat1501. The distal end oftransducer1400 may be connected or secured tomat1501 at a certain point such that it can pivot but not move in relation tomat1501.
• In use, the user may change the angles α and β ofdevice1000 relative tomat1501 by moving it from side to side, and forward and backward. During this movement, processor1503 may register the position ofdevice1000 together with the corresponding signal measured bytransducer1400 at each position. Processor1503 may then analyze the data to find the position in which the maximal signal is sensed. Processor1503 can then either turn the indicator on (light, sound, or vibration) when that position is reached by the user, or it can use two or more indicators to guide the user to the correct position or angle (e.g. by directing him to move right, left, up or down).
• In an embodiment,transducer1400 may be a 3D ultrasound probe. An image of the 3D space imaged by the probe may be displayed on a screen, which may be part ofdevice1000 or separate from it. This image may be a holographic image, a 2D perspective view of the imaged 3D space, or any combination of cross sectional views derived from the 3D model. The reconstructed screen image may be created as if from the point of view of the user, the needle, or from any other angle.
• In an embodiment described inFIGS. 15A and 15B, adevice4000 may comprisecannulation device1000,transducer1400,screen4001, aspring4002, ahandle4003, and atrigger4004.Device1000 may be slideably positioned withindevice4000 withspring4002 pushing it forward.Spring4002 may be replaced by any other mechanism to pushdevice1000 forward, such as a motor or solenoid.Device1000 can be abruptly advanced upon pullingtrigger4004 by the user.
• In this embodiment, the imaging system provides an indication onscreen4001, showing where the needle will reach at the end of its travel.
• The user may decide when the indication is correctly positioned within the vessel lumen, and pulls the trigger.Device1000 may advance and deploy onceneedle2 penetrates the blood vessel.
• Robotic Systems
• Device1000 may be used in a robotic system to automatically detect the targeted blood vessel and deploy the needle, guidewire, and/or other blunting elements into the targeted blood vessel.
• In an embodiment shown inFIG. 16, asystem5000 may include imaging means, as well as means for automatically changing the orientation ofdevice1000, and for advancingdevice1000. More specifically,FIG. 16 is a schematic 3Ddrawing showing system5000 comprisingdevice1000 slideably disposed withincase5001, while being pushed forward bypush element5002, as well asneedle2 andtransducer1400, which is pivotally connected tomat5003, optionally usingpivot element5008. Onmat5003 aresensors5004, andstrip5005. Alinear motor5007 may slide overstrip5005, and over anotherstrip5006 which is pivotally connected tocase5001. ACPU5010 located onmat5003, may be connected tosensors5004,device1000,transducer1400, andlinear motor5007.Push element5002 may be an electrical motor, linear or rotary, a solenoid, or a spring with a “brake” controlling the extent of its advancement.
• In use, the system may be placed over a patient's skin, in the vicinity of a target vessel. Initially the system may perform scanning by measuring the Doppler signal returned totransducer1400 while changing the angle ofdevice1000 relative to the skin to identify the angle towards the target vessel. This may be done bylinear motor5007 sliding overstrip5005 which may change angle δ, and by slidingstrip5006 throughlinear motor5007 which changes angle γ. In some embodiments, angle γ is kept constant while angle may change over its complete range, then angle γ may change slightly, and the scanning may repeat over angle δ, and so on.
• The Doppler signal measured bytransducer1400, may be recorded byCPU5010 for each device position. Once the angle at which the signal is maximal is identified, the system may returncase5001 to that angle, andadvance device1000 straight into the patient's skin, until the device deploys.Device1000 may send a signal toCPU5010 indicating that deployment occurred, andCPU5010 may immediately stop advancement ofdevice1000.
• Alternatively or additionally, the indication of deployment fromdevice1000 toCPU5010 may prompt slight elevation of the needle tip and decrease of its angle with the vessel's long axis, thus moving the needle tip away from the distal vessel wall, and bringing the blunt side of the needle bevel closer to the proximal vessel wall.
• The system may then cease its operation and let the user continue from there, or alternatively it may automatically advance a sheath into the vessel, or draw blood from the blunted needle.
• The system may be able to distinguish between a maximal arterial signal and a maximal venous signal, and choose the maximal signal according to the user's preference of an arterial or venous target vessel.
• In an embodiment, a vessel cannulation system may comprise a 3D imaging system, a robotic arm, anddevice1000. The imaging system may scan the target area using an ultrasound probe and creates a 3D model of the vessels in it. The vessel cannulation system may choose the target vessel according to the user's preference of arterial vs venous. In contrast with other previously described robotic systems, the cannulation system may then advance the needle abruptly to the exact location of the vessel lumen, at a high acceleration and speed with the aim of puncturing the vessel within 50-200 ms of the beginning of movement towards the vessel, before the vessel has a chance to move, as often happens when the puncture takes a longer time. Optionally, the puncture process is divided into two phases, the first is skin puncture, and the second is vessel puncture, with an optional brief pause in movement between the two phases. In this case, the time mentioned above is measured from the second motion, when movement towards the vessel begins following the pause after the skin was penetrated. Optionally, the advancement mechanism is configured not to exceed a certain force, so that ifdevice1000 deploys before the estimated distance, the needle will not exert excessive force on the guidewire in the vessel.
• Any of the above described devices may optionally additionally comprise means for identifying the authenticity and/or validity of disposable components used with it. Such means may for example include an RFID or barcode reader on the capital equipment unit, and an RFID chip or barcode on the disposable unit. If the disposable is found invalid or expired, the capital equipment unit will be rendered unusable, and will not become usable again until a disposable with an authentic non-expired disposable is presented to the reader.
• Expandable Sheath
• Expandable sheaths that are known in the art suffer from various shortcomings. For example, some sheaths described in the art have rigid longitudinal beams connected by an elastic material. In such sheaths, the expansion of the sheath may occur between a specific pair of beams instead of homogenously between all beams. In some sheaths, the dilator, or catheter placed to expand the sheath, could exit via the side of the sheath. Also, some such sheaths would buckle and collapse upon removal of the catheter from within their lumen. Manufacturing cost for expandable sheaths having a complex structure may also be high.
• The expandable sheaths of embodiments of the present invention may overcome these shortcomings. In particular, the expandable sheath of embodiments of the present invention may provide axial rigidity, resistance to buckling, radial expandability, homogenous expansion around the sheath, improved sealing, and are manufactured in a much lower cost. In some embodiments of the present invention, the expandable sheath may be used in combination with cannulation devices of the invention. In fact, the expandable sheath and cannulation device may complement each other and may be considered a system for vascular access. For example, the expandable sheath may be attached to the distal end ofdevice1000, covering the needle, which may be attached toluer adapter11. After puncture of the vessel by the needle, automatic deployment of the guidewire, and insertion of the sheath into the vessel, the needle and guidewire may be removed from within the sheath shaft, leaving the expandable sheath in the vessel. In other embodiments, a rigid large diameter sheath may be used in conjunction with the expandable sheath. For example, the rigid large diameter sheath may be fitted with a mandrel, where the rigid large diameter sheath may be inserted into the expandable sheath to further expand the expandable sheath.
• Spiral Connections
• FIG. 17 shows an embodiment ofexpandable sheath6000 with spiral connections between the beams. More specifically,FIG. 17 is a simplified 3D depiction of the distal part of a single layer ofexpandable sheath6000 comprising threebeams6001 separated byslits6002.Connections6003 may bridge betweenbeams6001, and may be arranged in a spiral aroundsheath6000 as demonstrated byarrow6004. In some embodiments, at the tip of the sheath, all beams are connected at the same level. Optionally, also near the sheath hub, at the level of the transition from the hub diameter to the needle diameter, there could be a connection between all beams at the same level.
• The layer shown inFIG. 17 can be made of a relatively rigid material such as nylon or PTFE, while an additional, elastic layer, made of silicone, latex, polyurethane or other elastomer may be added to the rigid layer. The elastic layer may be either on the external, the internal or on both sides of the rigid layer. The spiral arrangement may prevent buckling of the sheath during insertion, and at the same time prevents dilation from occurring only between one pair of beams, as may happen when all connections are made at the same levels.
• Manufacturing this sheath may be done for example by laser cutting the pattern of slits shown inFIG. 17 into the rigid layer, sparing the connections. This layer can then be post processed for making the taper at the tip and flare at the hub, and then dipped to add the elastic layer. Alternatively this sheath may be manufactured by micro molding.
• Outer Support
• In an alternative embodiment, the beams are not inter-connected. Instead, external support may be provided during insertion into the tissue, to that part of the sheath which is outside the skin, thus preventing its buckling. This may be done for example by a balloon inflated around the sheath, a highly viscous pad, or a telescopic or peelable element, which may remain outside the body during insertion. In an alternative embodiment, the beams are not inter-connected. Instead, external support may be provided during insertion into the tissue, to that part of the sheath which is outside the skin, thus preventing its buckling. This may be done for example by a balloon inflated around the sheath, a highly viscous pad, or a telescopic or peelable element, which remains outside the body during insertion.
• Rigid and Elastic Layers Forces
• The force required to expand the rigid layer may be determined by the layer material, thickness, number and width of beams, distance between the connections, and the connections dimensions. This force should optimally be as small as possible, but high enough to prevent beams from disconnecting due to axial load during insertion into tissue.
• The force required to expand the elastic layer may be determined by its material and thickness. This force may optimally be high enough to prevent a dilator/catheter from exiting through the side of the sheath.
• Inner Sheath
• In an embodiment, initial expansion of the sheath may be done by insertion of a rigid inner sheath with an outer diameter equal to the internal diameter of the expanded sheath, and the maximal possible internal diameter.
• This internal sheath may be inserted over a rigid dilator, which may then be removed. This internal sheath may additionally have a valve or connector at its proximal end to serve as the valve or connector of the dilated sheath.
• Using such an internal sheath may ensure that the expandable sheath does not buckle during removal of catheters or tools from it.
• Overlapping Sheath Hub and Needle Hub
• In an embodiment shown inFIG. 18, anexpandable sheath6100 is described, in which the sheath hub overlaps with the needle hub. More specifically,FIG. 18 is a schematic longitudinal cross section throughsheath6100 comprisingsheath shaft6101,sheath valve6102, andsheath hub6103.Needle2 is shown havingneedle hub6110. Overlapping of the hubs may enable keeping theoverall needle2 length shorter while maximizing the sheath shaft length.
• Needle hub6110 may have a mechanism for locking it tocannulation device1000, such as a luer lock or a snap connector.Sheath hub6110 may have the same. Alternatively both hubs may separately lock ontocannulation device1000, or may have a connection (snap or lock) between them, while only one of them locks tocannulation device1000.
• Sheath Valve
• Hemostatic valves in large diameter sheaths usually have a complex structure due to a requirement on the one hand to provide sufficient support that may withstand blood pressure over a large valve surface area, and on the other hand may be able to compress and allow a large bore tool or catheter to pass through them.
• In this embodiment, avalve6102 shaped as a ring, a toroid, or a sphere with a central hole may be used in the expandable sheath. This valve may be placed within thehub6103 but may be connected such that when pushed by a tool or catheter, it may protrude partially or fully into the expandable area, where there is more space for it, and therefore it does not require a complex structure, and is cheaper to manufacture. The force applied by the valve against the expandable sheath shaft can also aid in the initial expanding of the sheath.
• Pull Sheath Design
• In yet another embodiment shown inFIG. 19, anexpandable sheath6200 is shown, which is based on pulling instead of pushing during insertion.
• More specifically,FIG. 19 is a schematic longitudinal cross section ofsheath6200 comprisingouter sheath shaft6201 havingdistal tip6202 andstep6203.Inner sheath6204 consists ofdistal tip6205,bulb6206, andshoulder6207.Bulb6206 is configured to be collapsible, for example by splitting it longitudinally and removing some of its material.Step6203 ofouter sheath6201 is configured to engage withshoulder6207 ofinner sheath6204.
• Sheath shaft6201 may be made of at least two layers as described above for the embodiment inFIG. 17, but does not require high axial rigidity and therefore does not require the connections between beams. Although less optimal, it can even be optionally made of just one expandable layer, but must not be longitudinally stretchable.
• Inner sheath6204 may be made of a rigid or semi rigid polymer such as nylon or PTFE, or a metal such as SS. Optionallyinner sheath6204 may be an integral part ofneedle2. In some embodiments,needle2 may havestep6203 as part of the needle itself.
• In use, all the above elements may be used as one to penetrate a lumen. Sincestep6203 is engaged withshoulder6207,distal tip6202 ofsheath6200 may be pulled into the tissue byneedle2 andinner sheath6204, both rigid structures, instead ofsheath6200 being pushed into the tissue from its proximal end (i.e. from its hub end). Stated differently, in other embodiments, because the sheath is not connected to the distal end of the needle, it must have sufficient axial rigidity to resist friction, and not collapse when inserted into the tissues, such as skin, subcutaneous fat, fasciae, etc., which may be in the way of penetrating a vessel. In an embodiment,step6203 ofouter sheath6201 is being pulled forward (into the tissue) byshoulder6207 of inner (rigid) sheath6204 (orneedle2, if it is integral to the inner sheath as described above), so that the rigidinner structure6204 or rigid needle shaft takes up all the axial load. Therefore, thesheath6200 may not buckle when inserted.
• Once inside a lumen,needle2 may be removed, allowingbulb6206 to collapse towards its center, which makes removal ofinner sheath6204 easy. After removinginner sheath6204, a dilator or catheter, or a large bore rigid inner sheath may be inserted intoexpandable sheath6200 to expand it.
• External Sheath
• In an embodiment shown inFIG. 20, an additional external sheath may be used to provide support to the expandable sheath during insertion into the tissue, in order to prevent it from buckling, without the need for creating connections between the beams.
• More particularly,FIG. 20 is a schematic 3D depiction ofsheath6300 consisting ofexpandable sheath6301, andexternal sheath6310.
• Expandable sheath6301 is similar to expandable sheaths described above, in that it may be made of one or two layers, which may be radially expandable and have a degree of axial rigidity. Howeverexpandable sheath6301 does not need to have a high degree of axial rigidity, and therefore may for example comprise several beams without any connections between them.Expandable sheath6301 has a tapereddistal tip6302, and aproximal end6303, which is flared and connects tohub6304.
• External sheath6310 may havedistal tip6311,proximal end6312, handle6313, an optionallydistal connection6314 andproximal connection6315. Anoptional support element6316 may connectproximal end6312 ofexternal sheath6310 tohub6304.
• External sheath6310 may be an elongate sheath with at least one longitudinal slit, which may be bridged byconnections6314 and6315.
• In use,sheath6300 may be inserted over a needle into the tissue prior to entering into the vessel.Support element6316 may preventsheath6310 from sliding overexpandable sheath6301. Once in a lumen,support element6316 may be removed by pulling it, andexternal sheath6310 may be pulled backwards athandle6313, tearing atconnections6315 and6314. The needle may then be removed, andexpandable sheath6301 may be ready to be expanded in the tissue.
• Tear-Away Option
• Any of the above described sheaths may optionally additionally be tearable, such that after placement of a catheter through such expandable sheath, the sheath may be torn and removed, leaving the catheter in the vessel. In some embodiments, the tearable shafts are made using tubes with a wall thickness between 0.01 mm to 0.3 mm, between 0.05 to 0.2 mm, between 0.1 to 0.15 mm. In some embodiments, the wall is less than 0.15 mm, less than 0.1 mm, less than 0.05 mm, or less than 0.01 mm.
• Various additional embodiments for improved expandable sheaths are described inFIGS. 21-24. These embodiments may be made of a single, typically inelastic material, and may provide increased axial strength while keeping total wall thickness low and minimizing manufacturing costs. Such materials may include polytetrafluoroethylene (PTFE), polyether block amid (PEBAX), polyether ether ketone (PEEK), polypropylene, etc. When referring to inelastic, it is meant that any expansion of the sheaths described inFIGS. 21-24 may be achieved by a change in their conformation, or in other words by unfolding, rather than by stretch of their material as was described for embodiments inFIGS. 17-20.
• FIGS. 21A-B depict asheath6400 made of alongitudinally cut tube6410 which may be folded spirally along the longitudinal cut.
• More particularly,FIG. 21A is a 3D schematic depiction oftube6410 from whichsheath6400 may be made.Tube6410 may be made of an inelastic polymer, which also has some shape memory, such as polypropylene. For example, for the purpose of being inserted over an18G needle and being expandable to 14 fr, an appropriate tube may have an internal diameter of 4.6 mm and a wall thickness of 0.05 mm or less. Alongitudinal slit6420 may be made along the longitudinal axis oftube6410, sparing the hub region. This longitudinal cut may be pre-cut during manufacturing or a perforated line that may be torn apart by the user prior to being inserted over a needle.Tube6410 may preferably be an inelastic layer made with inelastic polymers such as polytetrafluoroethylene (PTFE), polyether block amid (PEBAX), polyether ether ketone (PEEK), polypropylene, etc.
• FIG. 21B showsexternal sheath6400 spirally folded overneedle2 to reach an inner diameter closely fit to the outer diameter of the needle. The two sides ofcut6420 may overlap and each side ofslit6420 to create a spiral aroundneedle2.
• In some embodiments,tube6410 may be dipped in an elastic material such as polyurethane or silicone to create an elastic outer layer. This may create a smoother outer surface, and enablesheath6400 to expand while maintaining fluid seal along the sheath. As such, this process may create an expandable sheath. Alternatively, such an elastic outer layer may be manufactured by sliding an elastic tube overtube6410, shrinking a heat shrinkable tube over it, or by other methods known in the art. When expanded,sheath6400 may return to its initial diameter as inFIG. 21A. Therefore, in operation, after the insertion of the expandable sheath and needle into a vessel, the needle may be removed, allowing theexpandable sheath6400 to expand and accommodate intravascular devices, such as central catheters, balloon catheters, etc.
• In another embodiment, shown inFIGS. 22-24, longitudinal corrugations may be used in the tube to create a sheath with high axial strength.
• The corrugations of the present invention may be of various number, size, and shape, from multiple micro-corrugations, to a single large corrugation or fold.
• FIGS. 22A-22D depict a sheath with multiple micro-corrugations in accordance with embodiments of the present invention.
• More particularly,FIG. 22A is a 3D depiction oftube6510 from which expandable sheath6500 (not shown) is made.
• FIG. 22B is a transverse cross section oftube6510, in which ID1 is the internal diameter oftube6510 in its crimped state, which in some embodiments may be in a close fit to the outer diameter of the needle. In some embodiments, ID1 oftube6510 in its crimped state may be between 0.3 mm to 3 mm, preferably between 0.5 mm to 1.5 mm. For example,FIG. 22B shows an ID1 of ˜1.3 mm. In some embodiments, the expanded internal diameter of the sheath may be between 1 mm to 7 mm, preferably between 2 mm to 5 mm. For example,FIG. 22B shows a tube capable of expanding to achieve an internal diameter of 4.6 mm. The internal diameter of the tube may vary depending on the gauge of the needle and the application for which it is used.
• As shown inFIG. 22B, OD1 is the outer diameter oftube6510 in its crimped state. In some embodiments, the OD1 oftube6510 in its crimped state may be between 0.5 mm to 4 mm, preferably between 0.7 mm to 2.0 mm. For example,FIG. 22B showstube6510 having an OD1 of ˜1.9 mm. In some embodiments, the expanded outer diameter of the sheath may be between 1.2 mm to 7.5 mm, preferably between 2 mm to 5 mm. The expanded diameter of the tube may vary depending on the object (catheter) that may be inserted within it.
• Angle θ is the angle around the circumference oftube6510 occupied by each individual corrugation. In some embodiments, Angle θ is between 5 degrees to 30 degrees, between 12 degrees to 25 degrees, or between 15 degrees to 20 degrees. For example, in the case shown inFIGS. 22A-C Angle θ is 15 degrees, as there are 24 corrugations in total.
• FIG. 22C is an enlarged view of detail A fromFIG. 22B, showing angle co formed between the two strips of tube around a single corrugation. R1 is the radius of this fold, which may be 0.01 mm-0.5 mm. R2 is the radius of the fold between two corrugations, may be 0.01 mm-0.5 mm. R1 and R2 may be equal or different.
• FIG. 22D is a schematic depiction of a segment of a crimpedtube6510, showing total crimped wall thickness “a”, gap between two adjacent corrugations “b”, andtube6510 wall thickness “c”.
• In some embodiments, “a” may be between 0.1 mm and 0.4 mm, “b” may be between 0.01 mm and 0.5 mm, and “c” may be between 0.01 mm and 0.2 mm, preferably 0.02 mm to 0.05 mm.
• To attain a desired ratio of sheath expansion “t” while maintaining a defined total wall thickness, each cross sectional segment of the non-expanded sheath may be able to lengthen by the desired ratio of expansion. Therefore each cross sectional segment of the crimped tube, equal to the total crimped wall thickness “a”, may contain a length of tube wall equal to “a” times “t”, in the expanded state.
• In a case shown inFIG. 22D, the expansion ratio may be *3, as the folded sheath has a total thickness “a” of 0.3 mm, and each cross sectional segment 0.3 mm long may contain three folds of sheath, that can open to a total length of ˜0.9 mm. This may be based on a tube wall thickness “c” of 0.05 mm, and gaps “b” of the same width between the folds.
• Manufacturing oftube6510 may be by extrusion. The sheath may either be extruded expanded, optionally with larger diameter folds at radii R1 and R2, then crimped or folded. Alternatively,tube6510 may be extruded in its completely crimped state.
• In another embodiment,FIGS. 23A-23C depictsheath6600, which has larger and different type of corrugations. For example,FIG. 23A shows a foldedtube6610 with 4 corrugations.
• More particularly,FIG. 23A is a 3D depiction ofsheath6600, showingneedle2, foldedtube6610, andtaper6620. The folding oftube6610 creates a large “step” at the distal end of the tube, which necessitates creating a taper. This can be done for example by heat treatment of the distal tip oftube6610, or by adding an elastic material to the end of the tube.
• FIG. 23B is a cross section of crimpedtube6610, aroundneedle2.
• FIG. 23C is a 3D depiction oftube6610 before being folded into its crimped state.Tube6610 can be manufactured already having the corrugations, its proximal end can then be flared to fit a hub, and the rest of its length may be crimped based on the extruded folds. As shown inFIG. 23B, the large corrugations are folded aroundneedle2, to create a low profile structure.
• In another embodiment,FIGS. 24A-24G depictsheath6700, which has a single longitudinal corrugation.
• More particularly,FIG. 24A is a 3D depiction ofsheath6700 in its crimped state, overneedle2. The expanded detail in the figure is the sheath's distal tip, in which particular attention is given to creation of a smooth taper, as will be detailed below.
• FIG. 24B is a 3D depiction ofsheath6700 in its expanded state. Although in some embodiments,needle2 will not beinside sheath6700 at this stage, it is shown as reference so that the change in sheath diameter can be appreciated.
• FIG. 24C is a schematic cross sectional view of crimpedtube6710 ofsheath6700 at around mid-distance between the sheath's hub to its tip.
• A cross section ofneedle2 is seen as a circle, surrounded bytube6710, which is folded/rolled aroundneedle2, creating a first single layered loop aroundneedle2, and then continues twisting around the needle as a double layer. In some embodiments, the double layer may surround the needle for approximately one additional complete turn.
• FIG. 24D is another depiction of the embodiment, a schematic drawing of the same cross section, in whichtube6710 is less tightly folded/rolled aroundneedle2, so that the layers are more clearly seen.
• FIGS. 24E and 24F show additional details of the structure of a possible embodiment ofsheath6700.
• FIG. 24E is a schematic 3D depiction oftube6710, with one of its sides folded into a single layered cylinder with an internal diameter p, with a tight fit toneedle2. The remainder of the circumference oftube6710 is folded so that its two layers are adjacent each other, to a length of q.
• A dashedline6720 denotes an optional trimming line of the end oftube6710. Angle Ω may be the angle betweenline6720 and the straight end oftube6710.
• Angle Ω may be between 0-45 degrees, preferably 5 to 30 degrees.
• FIG. 24F shows thesame tube6710, in which the tube end was trimmed atline6720, and wherein an additional trim was performed to shorten one of the layers oftube6710 atline6730, which may be parallel toline6720, but may be at an angle to it. This additional trim may create a gap at a distance r between the ends of the two layers, so that a smoother taper can be created, as will be shown inFIG. 24G. The double-layered fold oftube6710 is folded around the needle in the direction of the arrow, so thatline6720 spirals around the previous single layered fold.
• FIG. 24G is a 3D depiction of the distal end oftube6710 ofsheath6700. The taper created by the trimmed distal end oftube6710 is seen. Using heat treatment, adhesive, or other method, the ends of the foldedtube6710 may be tightened around the needle. The longer end alongline6720 may cover the shorter end alongline6730, aiding in creation of the taper. The free folded end oftube6710 is parallel to the long axis ofneedle2 andtube6710, creatingline6740.
• As mentioned above, the procedures performed using the devices of the invention may range from placement of central lines of various types (venous or arterial), through placement of smaller, peripherally inserted venous or arterial cannulae, to short term cannulation of a vessel or lumen (without leaving an indwelling catheter) for sampling body fluids, monitoring, or delivering substances.
• Following is a description of specific features of embodiments enabling each of these.
• Central Catheter Placement (CVC, PICC, Midline Etc.)
• a. Over Guidewire—Traditional Technique
• In an embodiment, the minimal capability of the cannulation device may be utilized. A vessel cannulation device1000 (or other) may be used for placing a guidewire only in a vessel lumen. A catheter with a dilator may then be inserted over the guidewire.
• b. Through Expandable Sheath
• In an embodiment, the full capability of the cannulation device may be utilized. A vessel cannulation device1000 (or other) may be used for placing a guidewire in a vessel lumen. An expandable sheath which has been on the needle may be inserted into the vessel lumen over the needle and guidewire. The expandable sheath may be fitted over the needle prior to both being attached to the vessel cannulation device. After insertion into the vessel lumen, the cannulation device, the needle and the guidewire may be removed, leaving only the expandable sheath in the vessel. A catheter with or without a dilator is then inserted through the expandable sheath. Optionally, the expandable sheath may be torn away and removed if the catheter is to be left in place for a long time period.
• c. Rapid Exchange Over Needle
• In an embodiment, acatheter6800 having a side opening in a “rapid exchange” fashion is placed over theneedle2 ofvessel cannulation device1000, as shown inFIG. 25. Once the device deploys in the lumen,central catheter6800 is slid into the vessel lumen over the needle, and the needle and guidewire are removed with the cannulation device. In some embodiments, the sliding ofcatheter6800 over the needle may be performed manually. Optionally,catheter6800 may be inserted automatically bydevice1000.
• Optionally, a support element (not shown), consisting of a short rod, tube, or any other structure, may temporarily connect between the distal part ofcatheter6800, and the proximal end ofneedle2, its hub, or device1000 (similar to supportelement6316 ofsheath6300 inFIG. 20). This support element may assist in insertion of the needle and catheter through the tissues, preventing the catheter from being pushed backwards by friction with the tissues. Oncecatheter6800 is in the vessel, the support element may be removed.
• Peripheral IV Catheter Placement
• When inserting a peripheral IV catheter, in some embodiments, the catheter may be pre-mounted over the cannulation device needle. Insertion can follow deployment any of the above described blunting mechanisms. Insertion may be manual, following the deployment, or may at least partially be performed automatically by the vessel cannulation device, as previously described, and may occur after or simultaneously with the automatic blunting element advancement.
• Short Term Cannulation/Blood Sampling
• In another embodiment, after the needle was blunted by any of the above methods, a port in the needle hub, or a port in the vessel cannulation device (in its needle adapter or in its body), can be used as a point of access to the vascular system, for blood drawing, drug or fluid administration, or monitoring.
• Although described herein in the context of vascular cannulation, the devices and methods of the current invention may be used beneficially for cannulating any other body lumen.
• Computer System
• The term “computer” is intended to have a broad meaning that may be used in computing devices such as, e.g., but not limited to, standalone or client or server devices. The computer system may include, e.g., but is not limited to, a main memory, random access memory (RAM), and a secondary memory, etc. Main memory, random access memory (RAM), and a secondary memory, etc., may be a computer-readable medium (e.g., a non-transitory computer readable storage medium) that may be configured to store instructions configured to implement one or more embodiments and may comprise a random-access memory (RAM) that may include RAM devices, such as Dynamic RAM (DRAM) devices, flash memory devices, Static RAM (SRAM) devices, etc.
• The computer may also include an input device may include any mechanism or combination of mechanisms that may permit information to be input into the computer system from, e.g., a user. The input device may include logic configured to receive information for the computer system from, e.g. a user. Examples of the input device may include, e.g., but not limited to, a mouse, pen-based pointing device, or other pointing device such as a digitizer, a touch sensitive display device, and/or a keyboard or other data entry device (none of which are labeled). Other input devices may include, e.g., but not limited to, a biometric input device, a video source, an audio source, a microphone, a web cam, a video camera, and/or other camera. The input device may communicate with a processor either wired or wirelessly.
• The term central processing unit “CPU” is intended to have a broad meaning that includes one or more processors, such as, e.g., but not limited to, that are connected to a communication infrastructure (e.g., but not limited to, a communications bus, cross-over bar, interconnect, or network, etc.). The term CPU may include any type of processor, microprocessor and/or processing logic that may interpret and execute instructions (e.g., for example, a field programmable gate array (FPGA)). The data processor may comprise a single device (e.g., for example, a single core) and/or a group of devices (e.g., multi-core). The CPU may include logic configured to execute computer-executable instructions configured to implement one or more embodiments. The instructions may reside in main memory or secondary memory. The CPU may also include multiple independent cores, such as a dual-core processor or a multi-core processor. The data processors may also include one or more graphics processing units (GPU) which may be in the form of a dedicated graphics card, an integrated graphics solution, and/or a hybrid graphics solution. Various illustrative software embodiments may be described in terms of this illustrative computer system. After reading this description, it will become apparent to a person skilled in the relevant art(s) how to implement the invention using other computer systems and/or architectures.
• Some embodiments may comprise an article of manufacture. An article of manufacture may comprise a storage medium to store logic. Examples of a storage medium may include one or more types of computer-readable storage media capable of storing electronic data, including volatile memory or non-volatile memory, removable or non-removable memory, erasable or non-erasable memory, writeable or re-writeable memory, and so forth. Examples of storage media include hard drives, disk drives, solid state drives, and any other tangible or non-transitory storage media.
• FIG. 26 illustrates an example of a computer system1600 that may be configured to practice an embodiment of the invention. Computer system1600 may include processor1620, memory1670, storage device1640, input device1610, output device1660, and network interface1680. Processor1620 may include logic configured to execute computer-executable instructions that implement embodiments of the invention. An example of a processor that may be used with the invention includes the Pentium® processor, Core i7® processor, or Xeon® processor all available from Intel Corporation, Santa Clara, Calif. The instructions may reside in memory1670 and may include instructions.
• Memory1670 may be a computer-readable medium that may be configured to store instructions configured to implement embodiments of the invention. Memory1670 may be a primary storage accessible to processor1620 and can include a random-access memory (RAM) that may include RAM devices, such as, for example, Dynamic RAM (DRAM) devices, flash memory devices, Static RANI (SRAM) devices, etc. Storage device1640 may include a magnetic disk and/or optical disk and its corresponding drive for storing information and/or instructions.
• Interconnect1650 may include logic that operatively couples components of computer system1600 together. For example, interconnect1650 may allow components to communicate with each other, may provide power to components of computer system1600, etc. In an embodiment of computer system1600, interconnect1650 may be implemented as a bus.
• Input device1610 may include logic configured to receive information for computer system1600 from, e.g., a user. Embodiments of input device1610 may include keyboards, touch sensitive displays, biometric sensing devices, computer mice, trackballs, pen-based point devices, etc. Output device1660 may include logic configured to output information from computer system. Embodiments of output device1660 may include cathode ray tubes (CRTs), plasma displays, light-emitting diode (LED) displays, liquid crystal displays (LCDs), printers, vacuum florescent displays (VFDs), surface-conduction electron-emitter displays (SEDs), field emission displays (FEDs), etc.
• Network interface1680 may include logic configured to interface computer system1600 with a network, e.g., network1540, and may enable computer system1600 to exchange information with other entities connected to the network, such as, for example, service provider1550, target environment1560 and cluster1570. Network interface1680 may be implemented as a built-in network adapter, network interface card (NIC), Personal Computer Memory Card International Association (PCMCIA) network card, card bus network adapter, wireless network adapter, Universal Serial Bus (USB) network adapter, modem or any other device suitable for interfacing computer system1600 to any type of network.
• Some of the figures may include a flow diagram. Although such figures may include a particular logic flow, it can be appreciated that the logic flow merely provides an exemplary implementation of the general functionality. Further, the logic flow does not necessarily have to be executed in the order presented unless otherwise indicated. In addition, the logic flow may be implemented by a hardware element, a software element executed by a processor, or any combination thereof.
• It is worthy to note that any reference to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase “in one embodiment” in the specification are not necessarily all referring to the same embodiment.
• Although some embodiments may be illustrated and described as comprising exemplary functional components or modules performing various operations, it can be appreciated that such components or modules may be implemented by one or more hardware components, software components, and/or combination thereof. The functional components and/or modules may be implemented, for example, by logic (e.g., instructions, data, and/or code) to be executed by a logic device (e.g., processor). Such logic may be stored internally or externally to a logic device on one or more types of computer-readable storage media.
EMBODIMENTS
• A vessel cannulation device may include a housing having a distal end with a distal tip and a proximal end, a lumen passing through at least the distal tip, a sensor coupled to the lumen, and a blunting device advancing member configured to advance a blunting device, wherein the blunting device is operably coupled to the sensor. The sensor may be configured to sense a physiologic parameter. The blunting device advancing member may be configured to advance the blunting device when the sensor detects that the physiologic parameter within a pre-determined range. The coupling of the sensor to the lumen may be via substantially straight fluid passageways having an internal diameter of 0.5 mm-2.5 mm, and a length no longer than 4 cm.
• The vessel cannulation device may also include a trigger mechanism consisting of a sear and a lever, configured to release the blunting device advancing member when the sensor detects that the physiologic parameter within a pre-determined range. The lever has a hinge located at the proximal end of the device. The vessel cannulation device may also include an adjustment mechanism, configured to adjust the pre-determined range of the physiologic parameter. The vessel cannulation device may also include an impact absorbing element for dampening noise and recoil during advancement of the blunting element. The vessel cannulation device may also include a cocking mechanism configured to bring the device to a usable (cocked) state, prior to puncturing the skin. The vessel cannulation device may also include a cover comprising a safety latch slot and a safety latch.
• The vessel cannulation device may also include a CPU and actuator. The vessel cannulation device may include a memory that is configured to store computer-executable instructions. The CPU may be configured to execute the computer-executable instructions cause the vessel cannulation device to detect that the needle tip is in a blood vessel. The vessel cannulation device may also include an input means for choosing the target vessel type to determine predetermined values for an artery or a vein. An artery may have predetermined values ofLower Threshold 20 mmHg,Upper Threshold 300 mmHg, and Range of Pressure Change Rate +/−400 mmHg/sec. A vein has predetermined values ofLower Threshold 5 mmHg,Upper Threshold 20 mmHg, and Range of Pressure Change Rate +/−100 mmHg/sec. The computer-executable instructions can incorporate a time window during which the physiologic parameter must be within the predetermined ranges to activate trigger mechanism. The time window for a vein may be between 0.05-0.3 seconds, and for an artery the window may be between 0-0.05 seconds.
• The sensor of the vessel cannulation device may be an electronic sensor. The sensor may include multiple sensors, configured to measure physiological parameters at the needle tip.
• The device may include a disposable part and of a reusable part. The disposable part may include the sensor, housing, lumen, blunting device, blunting device advancing member, needle, needle adapter, seal, large spring, backplate, and wherein all the rest of the device may be reusable.
• When the blunting element is an external sheath, the disposable part may include the sensor, needle, and needle adapter, and the reusable part may include the rest of the device.
• When the blunting device is coaxial with the large spring, the disposable part may include the sensor, needle, needle adapter, seal, blunting device advancing member, but not the slider and large spring.
• When the blunting device and blunting device advancing member are covered by a sterile cover within the device, the rest of the device may be reusable.
• When the blunting device is not coaxial with the large spring, the disposable part may include the sensor, blunting device, gripper, needle, needle adapter, and seal.
• The sensor may be reusable when a barrier allowing sensing of pressure is used to keep the sensor sterile.
• A blunting device may be configure to be positioned within a needle in its crimped state without substantially blocking the needle's lumen, and to cover the needle's point when in its deployed state. The blunting device may be stent-like. The blunting device may be a guidewire with an uncoiled segment. The blunting device may be a coiling guidewire. The blunting device may be a tip completing element. The blunting device may be an internal sheath. The internal sheath may be configured to cover the needle point. The blunting device may be a “sandwich” sheath.
• A vessel cannulation system may include any combination of cannulation devices discussed above and blunting devices discussed above, and a guidance element.
• The guidance element may be a linear mechanical guide. The guidance element may be a rotary mechanical guide. The guidance element may include imaging means. The imaging means consists of an ultrasound transducer. The ultrasound transducer may be made of at least two parts such that it is centered around the cannulation device needle tip, and the needle can slide through the transducer, and the transducer can be opened to remove it off the needle shaft. The guidance element may also include a mat with position sensors, a processor, and an indicator. A processor may be configured to gather ultrasound signals received by the transducer simultaneously with the position information from the position sensors; the processor may then activate an indicator to indicate when the cannulation device is pointed at the target vessel.
• An autonomic system for vessel cannulation may comprise of a processor, a cannulation device discussed above, slideably positioned within a housing and pivotally connected to a mat with position sensors, strips connected to the mat and to the cannulation device and operated by linear motors, an ultrasound transducer slideably positioned over the tip of the cannulation device needle; the linear motors and strips control the orientation of the cannulation device, and wherein the system scans the tissue in front of the needle by moving the cannulation device, chooses the orientation towards the target vessel, and abruptly advances the device until it deploys within the vessel or until a maximum depth is reached.
• An expandable sheath may include at least one layer with longitudinal beams, interconnected in a spiral pattern.
• An expandable sheath may include a hub which can overlap with a needle hub.
• An expandable sheath includes at least two layers, one with longitudinal beams and a shoulder, and one elastic and radially expandable, slideably positioned over a rigid inner sheath comprising a bulb and a step; the inner sheath is configured to fit over a needle shaft; the inner sheath shoulder is configured to pull the expandable sheath step during insertion into tissue; and after removal of the needle, the bulb is collapsible and the inner sheath can be removed from within the expandable sheath, while leaving the sheath in its position within the body.
• An expandable sheath includes at least one layer with longitudinal beams, which are not interconnected, and an external tearable sheath with a handle and a support element connecting said external sheath to the expandable sheath hub. The expandable sheath may also include a rigid large diameter sheath that is configured to be inserted with a mandrel inside it into the expandable sheath, to expand it to its maximal diameter, and maintain it expanded to that diameter.
• A central vascular catheter, configured to be inserted over a needle of cannulation devices discussed above, may further include a support element connecting it to the needle hub.
• A method of placing a central vascular catheter using cannulation devices discussed above, and sheaths discussed above may include following placement of the expandable sheath in a blood vessel, the central catheter is inserted through the expandable sheath.
• A method of placing a central vascular catheter using cannulation devices discussed above, and central catheter discussed above; the central catheter is pre-mounted over the needle of the cannulation device. The method may include following deployment of a blunting device in a blood vessel, the central catheter may be pushed into the blood vessel over the needle and over the blunting device.
• A method of placing a peripheral IV catheter using cannulation devices discussed above, the peripheral IV catheter may be pre-mounted over the needle of the cannulation device. The method may include following automatic deployment of a blunting device in a blood vessel, the peripheral IV catheter is inserted into the blood vessel over the needle and blunting device.
• A method of blood sampling using cannulation devices discussed above and blunting devices discussed above, may include following automatic deployment of a blunting device in a blood vessel, where blood is drawn through the blunted needle from the needle port or a port in the cannulation device.
• An expandable sheath configured for being inserted over a needle may have at least one longitudinal corrugation. The sheath may have multiple micro-corrugations. The sheath may have one corrugation, and the corrugation is folded around the sheath at least once.
• Only exemplary embodiments of the present invention and but a few examples of its versatility are shown and described in the present disclosure. It is to be understood that the present invention is capable of use in various other combinations and environments and is capable of changes or modifications within the scope of the inventive concept as expressed herein.
• Although the foregoing description is directed to the preferred embodiments of the invention, it is noted that other variations and modifications will be apparent to those skilled in the art, and may be made without departing from the spirit or scope of the invention. Moreover, features described in connection with one embodiment of the invention may be used in conjunction with other embodiments, even if not explicitly stated above.
• While the invention has been described and illustrated herein by references to various specific materials, procedures and examples, it is understood that the invention is not restricted to the particular combinations of material and procedures selected for that purpose. Numerous variations of such details can be implied as will be appreciated by those skilled in the art. It is intended that the specification and examples be considered as exemplary, only, with the true scope and spirit of the invention being indicated by the following claims. All references, patents, and patent applications referred to in this application are herein incorporated by reference in their entirety.

Claims (16)

1-41. (canceled)

42. An expandable sheath system comprising:

an expandable outer layer sheath comprising longitudinal beams and a step, and

an inner rigid layer comprises a bulb and a shoulder which engages with a step of the outer layer sheath.

43. The expandable sheath system ofclaim 42, wherein the inner rigid layer sheath is configured to fit over a needle shaft; and wherein after removal of the needle, the bulb is collapsed and the inner rigid layer sheath is removed from the outer layer sheath, while leaving the outer layer sheath in its position within a vessel.

44. The expandable sheath system ofclaim 42, wherein the inner rigid layer is an integral part of a needle.

45. An expandable sheath configured to be inserted into a patient's body over a needle, comprising rigid longitudinal beams and an expandable elastic layer, wherein the longitudinal beams are bridged by connections creating a spiral pattern along and around the sheath.

46. The expandable sheath ofclaim 45, further comprising an external sheath slideably positioned over the expandable sheath.

47. The expandable sheath ofclaim 46, wherein the external sheath comprises a handle and a support element connecting to the expandable sheath, wherein the external sheath is tearable.

48. The expandable sheath ofclaim 46, further comprising a rigid large diameter sheath that is configured to be inserted into the expandable sheath, to maintain and expand the expandable sheath.

49. An expandable sheath configured to be inserted into a patient's body over a needle, comprising: a sheath having a single substantially inelastic layer and an inner diameter, and wherein in a crimped state, a sheath inner diameter is in a tight fit with a needle, and wherein in an expanded state, the sheath inner diameter is at least double the sheath inner diameter in the crimped state.

50. The expandable sheath ofclaim 49, wherein the inelastic layer has multiple micro-corrugations.

51. The expandable sheath ofclaim 49, wherein the inelastic layer has between 2 and 6 large corrugations folded around the sheath.

52. The expandable sheath ofclaim 49, further comprising a hub configured to overlap with a needle hub.

53. The expandable sheath ofclaim 49, wherein the expandable sheath has one corrugation, and wherein this corrugation is folded around the sheath at least once.

54. The expandable sheath ofclaim 53, wherein a distal end of the inelastic layer comprises a part that is perpendicular to a longitudinal axis of the sheath, and a part that is at an angle relative to the longitudinal axis of the sheath, configured to create a smooth distal taper for the sheath in its crimped state.

55. The expandable sheath ofclaim 53, further comprising a hub configured to overlap with a needle hub.

56-76. (canceled)

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