Patent Application
20130096428
The present invention relates generally to the field of medical devices to be used for cardiological procedures. More specifically, the invention is in the subfield of vascular access devices and other tools to be used for cardiac and endovascular catheterizations, including, for example, ablation and in electrophysiological procedures.
The femoral artery is the predominant site of vascular access for the performance of cardiac catheterizations, percutaneous coronary interventions and many other vascular related procedures. The operator's goal is to safely and reliably puncture a certain part of the common femoral artery. Several palpable anatomic landmarks are used to guide the operator, however, these landmarks are notoriously imprecise and the exact puncture site is not known until after a sheath is inserted and an angiogram performed. Failure to properly puncture the common femoral artery may result in several important and potentially life-threatening complications. In the event of a puncture above the inguinal ligament (i.e. in the external iliac artery), a retroperitoneal bleed may result. If the puncture is too low and in one of the branches of the common femoral artery, then a hematoma, femoral artery pseudoaneurysm or arteriovenous fistulae may arise. All together, these events complicate up to 5% of cardiac procedures and cause significant morbidity, patient discomfort, increased mortality, greater hospital costs and prolonged length of stay.
There are many examples of access devices or systems that are used to carry out
percutaneous puncture of a femoral artery or vein for the purpose of catheterizing the heart or some other part of the body. However, despite a myriad of prior art, access to the femoral vein and artery are complicated in 5% of all cases by hematoma or other vascular complication, especially during cardiac interventions when large doses of anticoagulants (blood thinners) are used. This is often because the prior needle systems routinely access the femoral vein or artery either too high (leading to retroperitoneal bleeding) or too low (leading to femoral vein or artery bleeds, pseudoaneurysms, or arteriovenous fistulae). The ideal location of the access in the vein or artery can be seen by injecting contrast from a needle inside the structure and then using fluoroscopy. However, a major limitation of the prior art is that it does not allow for an easy method to inject a contrast material into the artery to confirm the needle position in the common femoral artery or vein while simultaneously maintaining a method for introducing a guide wire. Under the prior art, the operator would have to access the vein, then inject contrast agent, remove the contrast injection means (being hopeful that the needle doesn't move) and then insert a wire through the needle. Introducing this wire would be difficult since the needle opening is so small.
A further limitation of the prior art is that such introducer means are generally not small enough to easily reposition the needle during the process of insertion of it into and passage through the body tissues. The smaller the needle the smaller the potential damage, as Pouiselle's Law suggests the damage and potential for bleeding is dependent on the inverse fourth power of the needle's radius. However, in the prior art the smaller needle requires an even smaller guide wire to be loaded.
Still another limitation of the prior art is that such introducer means can cause unnecessary and dangerous bleeding during usage or may led to catheter placement either into one of the smaller branches of the common femoral artery or in a deeper, more proximal artery (e.g. the external iliac artery), potentially resulting in an increased rate of serious vascular complications or bleeding.
An additional limitation of the prior art is that after the chamber has been loaded with contrast agent, the chamber cannot be cleared of air in the chamber. The injection of contrast fluid with air bubbles can cause serious medical complications.
An additional limitation of the prior art is that the needle means incorporated into the introducer system kits generally do not have markings on them to indicate depth of insertion, nor do the needles have markings that are usually visible on fluoroscopic means for monitoring the needle insertion process.
The prior art is silent on the teaching of a means and method for overcoming these limitations and thus achieving an improved technique for percutaneous puncture of the common femoral artery for the purpose of passing a catheter through the vasculature to a target location in the heart or some other part of the body.
An aspect of an embodiment of the present invention relates to, but not limited thereto, the class of medical devices used to obtain access to the interior vascular structures or other regions or collections of fluid or fluid-filled cavities inside the body. More specifically, an aspect of an embodiment of the present invention relates to, but not limited thereto, that class of percutaneous puncture means that allow for the injection of contrast agents (to confirm ideal position), the passage of guide wires, and the eventual catheterization of the heart and other parts of the body via the pathway established through the puncture of a femoral artery. Therefore, an aspect of an embodiment of the present invention relates to, but not limited thereto, percutaneous access devices that target entry into a vascular structure (such as the femoral artery and vein) or another region or part of the body, and that have the ancillary means to enable safe and efficacious accomplishment thereof.
An aspect of an embodiment of present invention provides a means and method for, but not limited thereto, the injection of a contrast material and the passage of a guide wire through the same introducer device simultaneously (without necessarily moving it or removing any parts), with the device designed so as to prevent the backflow of the contrast material through the guide wire port during the contrast injection process. The needle or related components of the access system may be fabricated in such a way that the user can measure the insertion depth by visual inspection of markings on it during the insertion process. For needles made of materials not other wise readily visible by fluoroscopy, the markings would be radio-opaque and thus the needle location and depth could be determined by reference to fluoroscopic imaging.
An aspect of an embodiment of the present invention provides the capability of injecting a contrast agent while simultaneously navigating a guide wire into an artery. The access system is not limited to accessing an artery. The access system may be used to access the vicinity of a vasculature, the vasculature, or the non-vasculature structure of a subject. The non-vasculature structure includes, but is not limited to, a gall bladder, kidney, cyst, pus collection, or some other normal or diseased organ, body part, or other element of the body. Additionally, the vasculature includes arteries and veins within the endovascular system. This includes the femoral artery and a radial artery. The access system can be designed so that the components of the system are transparent so that the user of the system can see a backsplash of blood regurgitating through the access needle following successful insertion of the access needle into a vasculature. The access system can also be designed so that the components of the access system are MRI compatible so that the access system can be used with MR-guided interventional procedures. The assembly is leak-tight to the contrast agent, blood, saline irrigants, and other fluids.
Another aspect of an embodiment of the present invention is, but not limited thereto, the ability to reduce the probability that a user will access the femoral vein or artery either too high (leading to retroperitoneal bleeding) or too low (leading to femoral vein or artery bleeds, pseudoaneurysms, or arteriovenous fistulae). The ideal location of the access in the vein or artery can be seen by injecting contrast from a needle inside the structure and then using fluoroscopy. An aspect of an embodiment of the present invention allows a user to minimize the probability of unnecessary and dangerous bleeding during usage and minimize the probability of catheter placement either into one of the smaller branches of the common femoral artery or in a deeper, more proximal artery (e.g. the external iliac artery), potentially resulting in an increased rate of serious vascular complications or bleeding.
Another aspect of an embodiment of the present invention is that a user can reposition the needle during the process of inserting the needle into and through the body tissues. An additional advantage of an embodiment of the present invention is that after the chamber has been loaded with contrast agent, the chamber can be cleared of air in the chamber to minimize the likelihood of injecting contrast fluid with air bubbles. An aspect of an embodiment of the present invention can also be equipped with a needle that includes markings to indicate depth to assist in locating and guiding the needle
Another aspect of an embodiment of the present invention is the capability of injecting a contrast agent while simultaneously navigating a guide wire into an artery. The contrast agent can be loaded into the syringe body and the plunger can be advanced to push the contrast agent through a chamber and out of the access needle. The chamber can be, for example but not limited thereto, a y-tube connector or a syringe body. The chamber may be configured to allow the guide wire to pass through the chamber and the access needle while simultaneously injecting the contrast agent from the chamber into the subject to guide the access needle beneath the skin, in a non-vasculature structure, in the vicinity of a vasculature and/or in the vasculature. Fluoroscopy can be used to determine the location of the access needle and guide wire. The access needle can be equipped with markings so that the user can determine how far the access needle has been inserted into the subject.
Another aspect of an embodiment of the present invention is the ability to, but not limited thereto, seal off one of the arms of the y-tube when the chamber is implemented with, for example, a y-tube (or elbow or arm). A valve can be used to accomplish this task. The valve can be designed to allow a user to manually open and close the value and allow the valve to be closed when the guide wire is passed through the valve. When the valve is closed, contrast agent will not leak out of the valve when the contrast agent is being injected into the subject. Additionally, the valve effectively holds the guide wire in place when it is closed. A septum can also be used in combination with an introducer conduit to accomplish substantially the same task as the valve.
An another aspect of an embodiment of the present invention is, but not limited thereto, that the assembly of components, when properly configured, provides for a means and method of injecting a contrast agent through the access needle and also passing a guide wire through the same needle simultaneously in such a way that the contrast agent does not back-flow through the port into which the guide wire enters the assembly and does not require removing of any parts once access is obtained. The assembly can be leak-tight to the contrast agent, blood, saline irrigants, and other fluids.
Another aspect of an embodiment of the present invention is the ability to, but not limited thereto, use of a sheath. The sheath may be designed to prevent damage to the vasculature or non-vasculature structure when the access needle and/or other devices are inserted into, moved within, or removed from the vasculature or non-vasculature structure.
Another aspect of an embodiment of the present invention is, but not limited thereto, the ability to at least partially fill the chamber with contrast agent and then clear the chamber of air. This prevents air bubbles from potentially being injected into the subject when the contrast agent is injected.
Another aspect of an embodiment of the invention present is the use of, for example finger loops or ergonomic grips or handles. Finger loops allow for easy ergonomic use of the access system during procedures. The finger loop fittings make it possible to either inject or withdraw the plunger using only one hand, because the fingers can work against either the upper or lower inner surfaces of the finger loops.
Another aspect of an embodiment of the present invention is the use of a slip fitting or other releasable fittings for attaching the access needle to the access system. This allows for rapid and easy attachment and detachment of the access needle from the system.
Another aspect of an embodiment of the present invention is a third arm on the y-tube when a y-tube is used to implement the chamber. This permits another material, device or another liquid to be injected or another device to be passed into the body in conjunction with the delivery of the contrast agent and passage of the guide wire.
Another aspect of an embodiment of the present invention provides, but not limited thereto, a cardiological approach for vascular access devices and other tools to be used for cardiac and endovascular catheterizations.
Another aspect of an embodiment of the present invention provides, but not limited thereto, the ability to safely and reliably puncture a certain part of the common femoral artery.
An aspect of an embodiment of the present invention provides, but not limited thereto, an access system that provides the capability to inject a contrast agent while simultaneously navigating a guide wire into a vicinity of a vasculature, a non-vasculature structure, and/or the vasculature of a subject through a tip of an access needle. The access system may comprise: the access needle; the guide wire; and a chamber. The chamber may be configured to allow the guide wire to pass through the chamber and the access needle while simultaneously injecting the contrast agent from the chamber into the subject to guide the access needle beneath the skin, in the vicinity of a vasculature, the non-vasculature structure, and/or in the vasculature.
An aspect of an embodiment of the present invention provides, but not limited thereto, a method for using an access system that provides the capability to inject a contrast agent while simultaneously navigating a guide wire into a vasculature, a non-vasculature structure, and/or a vicinity of a vasculature of a subject through a tip of an access needle. The method may comprise: advancing the access needle of the system through the skin of a subject; determining if the access needle is in the correct location; and a) if the access needle is in the correct location then further advancing the access needle of the system until the access needle has accessed the vasculature, the non-vasculature structure, and/or the vicinity of the vasculature of the subject; or b) if the access needle is not in the correct location withdrawing or repositioning the access needle and then determining if the access needle in the correct location.
An aspect of an embodiment of the present invention provides, but not limited thereto, a method for using an access system that provides the capability to inject contrast agent while simultaneously navigating a guide wire into a vicinity of a vasculature, a non-vasculature structure, and/or the vasculature of a subject through a tip of an access needle. The access method may comprise: passing the guide wire through a chamber and the access needle while simultaneously injecting contrast agent from the chamber into the subject to guide the access needle that is inserted beneath the skin, in the vicinity of a vasculature, non-vasculature and/or in the vasculature.
These and other objects, along with advantages and features of various aspects of embodiments of the invention disclosed herein, will be made more apparent from the description, drawings and claims that follow.
The foregoing and other objects, features and advantages of the present invention, as well as the invention itself, will be more fully understood from the following description of the embodiments, when read together with the accompanying drawings.
The accompanying drawings, which are incorporated into and form a part of the instant specification, illustrate several aspects and embodiments of the present invention and, together with the description herein, serve to explain the principles of the invention. The drawings are provided only for the purpose of illustrating select embodiments of the invention and are not to be construed as limiting the invention.
Fluoroscopy can be used with the contrast agent to navigate the guide wire 3 and any components of the access system 1 beneath the skin, in a non-vasculature structure, in the vicinity of a vasculature, and/or in the vasculature. Additionally, an optical guide wire can be used.
It should be appreciated that connectors/fittings used in the access system 1 may be integral to the components themselves or the connectors/fittings may be separate components. It should also be appreciated that any of the components may be attached directly or integral with other components to avoid a particular fitting/connector.
It should be appreciated that as discussed herein, a subject may be a human or any animal. It should be appreciated that an animal may be a variety of any applicable type, including, but not limited thereto, mammal, veterinarian animal, livestock animal or pet type animal, etc. As an example, the animal may be a laboratory animal specifically selected to have certain characteristics similar to human (e.g. rat, dog, pig, monkey), etc. It should be appreciated that the subject may be any applicable human patient, for example.
As shown in
In an approach, the access needle 13 may be in communication with the chamber distal end 31 via a Luer slip fitting or other type of fitting or connector for rapid and easy attachment and detachment of the access needle 13 from the system 1. Any other type of fitting known in the art can be used to attach the access needle 13 to the chamber distal end 31. The access needle 13 can be chosen from any of a number of commercially available such needles, for instance, but not limited thereto, the model NDL-100-22 from Galt Medical. The syringe body 15 and plunger 17 can be chosen from any of a number of commercially available syringes, for instance, but not limited thereto, the model 309642 from Becton Dickinson. The tube 57 can be chosen from any of a number of commercially available tubes, for instance, but not limited thereto, the model 536040 from Medex. The chamber can be chosen from any of a number of commercially available Y-connectors, for instance, but not limited thereto, the model 84044 from Qosina.
The access needle 13 may include marks located along the length of the needle. For example, the marks may be located at approximately 1 cm intervals or any desired intervals. The marks can be put in place by a number of means and methods, for instance, the placement of 1-cm long segments of silicone tubing along the needle's shaft, with the subsequent marking (e.g., via a biocompatible paint) of the 1-cm intervals. In some embodiments, the shaft of the access needle 13 may be made from a material that is un-opaque to x-rays and which would thus have little visibility upon fluoroscopic imaging. In such a case, the fiducial marks along the shaft of the access needle 13 could be of a radio-opaque material thus being clearly visible upon fluoroscopic or CT imaging. The access needle 13 can also include more than 1 internal lumen to facilitate the simultaneous or sequence delivery of more than one diagnostic or therapeutic agent, fluid, or device.
The chamber proximal end 33 may be configured to receive a plunger 17. The plunger 17 includes an introducer conduit 19 that extends from the plunger proximal end 23 to the plunger distal end 21. The introducer conduit includes a proximal end configured to receive the guide wire 11 and a distal end configured to pass the guide wire 11 into the chamber 51 and through the access needle 13. The chamber distal end 31 can be designed to have conical shape nose. The conical shape nose on the chamber distal end 31 guides the guide wire from the chamber 51 into the access needle 13 and can prevent the guide wire 11 from turning back on itself and getting jammed in the chamber 15.
The chamber 51 is configured to allow the guide wire 11 to pass through the chamber 51 and the access needle 13 while simultaneously injecting the contrast agent from the chamber 51 into the subject to guide the access needle beneath the skin, in a non-vasculature structure, in the vicinity of a vasculature and/or in the vasculature. A septum 61, a Luer-locked septum in one embodiment, may be attached to the chamber first proximal end 33. It should be appreciated that a variety of fittings may be implemented. In an approach, fixed onto the distal entry port of the septum 61, closest to the chamber 51, is a seal (not shown) that serves as the seat against which the lower outside bowl of an introducer conduit 63 is seated following insertion of the tip of the introducer conduit 63 through the seal internal to the septum 61. The introducer conduit 63 allows a guide wire 11 to be passed through the septum 61, the seal, and into the chamber 51. As shown in
A cap 65 can be used to seal the chamber first proximal end 33. The cap 65 can include a stylet 67, which can be advanced through the introducer conduit 63. In an exemplary operation, a guide wire 11 may be placed next to the assembly of the system and is ready to be inserted into the introducer conduit 63 and passed through the distal tip of the access needle 13. The chamber first proximal end 33 is configured to review the guide wire 11 to allow for the guide wire 11 to be passed through the chamber distal end 31 and into the access needle 13. The guide wire 11 can then be passed though the tip of the access needle 13. The chamber distal end 31 can be designed to have conical shape nose. The conical shape nose on the chamber distal end 31 guides the guide wire 11 from the chamber 51 into the access needle 13 and can prevent the guide wire 11 from turning back on itself and getting jammed in the chamber 15. In an approach, the access needle 13 may be in communication with the chamber distal end 31 via a Luer slip fitting or other connection type for rapid and easy attachment and detachment of the access needle 13 from the system. Any other type of fitting known in the art can be used to attach the access needle 13 to the chamber distal end 31.
The septum 61 may be chosen from among any of a number of commercially available septums, for instance, but not limited thereto, model 84039 from Qosina. The seal (not shown) of the septum 61 may be a o-ring that may be chosen from any of a number of commercially available o-ring means, for instance, but not limited thereto, model KNW-876 from GC Electronics. The introducer conduit 63 might be chosen from any of a number of commercially available needle stubs, for instance, but not limited thereto, model 6710A28 from McMaster-Carr. The stylet 67 can be fabricated from any of a number of commercially available small gauge tubes or wires, for instance, but not limited thereto, model HTX-26R-12 from Small Parts, Inc. The cap 65 can be chosen from any of a number of commercially available stylet caps, for instance model 71301 from Qosina.
Still referring to
Unless clearly specified to the contrary, there is no requirement for any particular described or illustrated activity or element, any particular sequence or such activities, any particular size, speed, material, duration, contour, dimension or frequency, or any particularly interrelationship of such elements. Moreover, any activity can be repeated, any activity can be performed by multiple entities, and/or any element can be duplicated. Further, any activity or element can be excluded, the sequence of activities can vary, and/or the interrelationship of elements can vary. Moreover, any activity or steps can be done in various orders, as well as sequentially, simultaneously or some combination thereof. It should be appreciated that aspects of the present invention may have a variety of sizes, contours, shapes, compositions and materials as desired or required.
It should be appreciated that various sizes, dimensions, contours, rigidity, shapes, flexibility and materials of any of the embodiments discussed throughout may be varied and utilized as desired or required.
It should be appreciated that any of the components or modules referred to with regards to any of the present invention embodiments discussed herein, may be a variety of materials and/or composites as necessary or required. Still further, it should be appreciated that any of the components or modules (or combination thereof) may provide shape, size and volume contoured by adjusting its geometry and flexibility/rigidity according to the target location or anatomy (or region, including structure and morphology of any location) being treated.
Contrast fluid is then injected 310 and fluoroscopy is used to determine the location of the guide wire and the access needle 315. If the guide wire and the access needle are in the correct location, the method of using the invention to obtain percutaneous puncture of a vasculature or non-vasculature structure can continue. If the guide wire and/or access needle is not in the correct location, the needle and guide wire are repositioned and the location is determined again 320. The guide wire allows the user to determine approximately where the access needle would puncture the target vasculature or non-vasculature structure. The access needle can then be advanced over the guide wire so that the access needle punctures the target vasculature or non-vasculature structure approximately where the guide wire was located when the location of the guide wire and the access needle was determined.
The various embodiments of the present invention provide, but not limited thereto, an easy, easy and safe method to inject a contrast material into the artery to confirm the needle position in the common femoral artery or vein while simultaneously maintaining a method for introducing a guide wire. The various embodiments of the present invention provide, but not limited thereto, a needle system that reduces the probability that a user will not access the femoral vein or artery either too high (leading to retroperitoneal bleeding) or too low (leading to femoral vein or artery bleeds, pseudoaneurysms, or arteriovenous fistulae). The ideal location of the access in the vein or artery can be seen by injecting contrast from a needle inside the structure and then using fluoroscopy. The various embodiments of the present invention allow, but not limited thereto, a user to minimize the probability of unnecessary and dangerous bleeding during usage and minimize the probability of catheter placement either into one of the smaller branches of the common femoral artery or in a deeper, more proximal artery (e.g. the external iliac artery), potentially resulting in an increased rate of serious vascular complications or bleeding.
The various embodiments of the present invention also allows, but not limited thereto, a user to reposition the needle during the process of insertion of it into and passage through the body tissues. An additional advantage of the various embodiments of the present invention is that after the chamber has been loaded with contrast agent, the chamber can be cleared of air in the chamber to minimize the likelihood of injecting contrast fluid with air bubbles. The various embodiments of the present invention can also be, but not limited thereto, equipped with a needle that includes markings to indicate depth to assist in locating and guiding the needle
Practice of an aspect of an embodiment (or embodiments) of the invention will be still more fully understood from the following examples, which are presented herein for illustration only and should not be construed as limiting the invention in any way.
Example 1 includes an access system that provides the capability to inject a contrast agent while simultaneously navigating a guide wire into a vicinity of a vasculature, a non-vasculature structure, and/or the vasculature of a subject through a tip of an access needle, the access system comprising:
the access needle;
the guide wire; and
a chamber, wherein the chamber is configured to allow the guide wire to pass through the chamber and the access needle while simultaneously injecting the contrast agent from the chamber into the subject to guide the access needle beneath the skin, in the vicinity of a vasculature, the non-vasculature structure, and/or in the vasculature.
Example 2 may optionally include at least in part the system of example 1, wherein fluoroscopy is used with the contrast agent to navigate the guide wire and the access needle beneath the skin, in the vicinity of a vasculature, the non-vasculature structure, and/or in the vasculature.
Example 3 may optionally include at least in part the system of example 1, wherein the access needle comprises markings at intervals along its shaft for the purpose of indicating depth of insertion into the subject.
Example 4 may optionally include at least in part the system of example 1, wherein the vasculature comprises arteries and/or veins within the endovascular system.
Example 5 may optionally include at least in part the system of example 1, wherein the vasculature further comprises a femoral artery.
Example 6 may optionally include at least in part the system of example 1, wherein the vasculature further comprises a radial artery.
Example 7 may optionally include at least in part the system of example 1, wherein the non-vasculature structure comprises a gall bladder, kidney, cyst, pus collection, or some other normal or diseased organ, body part, or other element of the body.
Example 8 may optionally include at least in part the system of example 1, wherein the access needle has more than one internal lumen to facilitate the simultaneous or sequential delivery of more than one diagnostic or therapeutic agent, fluid, or device.
Example 9 may optionally include at least in part the system of example 1, wherein the access system further comprises:
a sheath, wherein the sheath is configured for sliding over the access needle.
Example 10 may optionally include at least in part the system of example 9, wherein the sheath is configured for insertion into the vasculature after the access needle punctures the vasculature, to prevent damage to the vasculature when the access needle and/or other devices are inserted into, moved within, or removed from the vasculature.
Example 11 may optionally include at least in part the system of example 1, wherein the chamber comprises a distal end and a first proximal end and a second proximal end;
the access needle is in communication with the chamber distal end;
the chamber first proximal end is configured for receiving the guide wire to allow for the passing of the guide wire through the chamber distal end and into the access needle.
Example 12 may optionally include at least in part the system of example 11, further comprising a contrast agent reservoir, wherein the contrast agent reservoir is in communication with the chamber.
Example 13 may optionally include at least in part the system of example 12, wherein the chamber second proximal end is in communication with the contrast agent reservoir.
Example 14 may optionally include at least in part the system of example 13, wherein the contrast agent reservoir comprises:
a plunger, wherein the plunger comprises a distal end and a proximal end; and
a syringe, wherein the syringe comprises a distal end and a proximal end, whereby the proximal end has an opening configured for receiving the plunger.
Example 15 may optionally include at least in part the system of example 12, wherein the communication between the chamber and the contrast reservoir comprises a tube.
Example 16 may optionally include at least in part the system of example 11, wherein the chamber distal end comprises a conical shape nose.
Example 17 may optionally include at least in part the system of example 16, wherein the conical shape nose comprises a Luer slip fitting on the conical shape nose, the Luer slip fitting capable of receiving the access needle for rapid and easy attachment and detachment of the access needle from the system.
Example 18 may optionally include at least in part the system of example 11, wherein at least one of the following components of the system are optically transparent so that a user can see a backsplash of blood regurgitating through the access needle following successful insertion of the access needle into the vasculature:
the access needle;
the chamber; or
the guide wire.
Example 19 may optionally include at least in part the system of example 11, wherein the chamber is a y-tube, the chamber first proximal end and the chamber second proximal end correspond to a first proximal arm and a second proximal arm of the y-tube respectively and the chamber distal end corresponds to a distal arm of the y-tube.
Example 20 may optionally include at least in part the system of example 19, wherein an angle between the first proximal arms and the second proximal arms is less than about 90 degrees.
Example 21 may optionally include at least in part the system of example 20, wherein the angle between the first proximal arms and the second proximal arms is approximately 30 degrees.
Example 22 may optionally include at least in part the system of example 11, wherein at least one of the following components of the system are MRI compatible so that the system can be used with MR-guided interventional procedures:
the access needle;
the chamber; or
the guide wire.
In Example 23 may optionally include at least in part the system of example 11, wherein the chamber further comprises a third proximal end for applications where other material or other liquid is injected or other device must be passed into the body in conjunction with the delivery of the contrast agent and passage of the guide wire.
Example 24 may optionally include at least in part the system of example 23, wherein:
the other material further comprises at least one of powders of diagnostic or therapeutic agents or slurries of diagnostic or therapeutic agents;
the other liquids further comprises at least one of antibiotics, anticoagulants, or thrombolytic agents; and
the other device further comprises at least one of thrombectomy devices, closure devices, dilators, or sheaths.
Example 25 may optionally include at least in part the system of example 11, further comprising a seal disposed in the chamber first proximal end and an introducer conduit in communication with the seal, whereby the introducer conduit configured to allow passing of the guide wire through the seal and into the chamber.
Example 26 may optionally include at least in part the system of example 25, wherein the seal comprises a septum.
Example 27 may optionally include at least in part the system of example 25, wherein the introducer conduit comprises a needle stub.
Example 28 may optionally include at least in part the system of example 25, further comprising a cap for sealing off the introducer conduit, the seal, or the chamber first proximal end.
Example 29 may optionally include at least in part the system of example 25, wherein the seal comprises a barrier material made from one of a number of different substances, including latex, silicone, or other such materials appropriate for use in injection site fittings.
Example 30 may optionally include at least in part the system of example 11, further comprising a valve disposed on the chamber first proximal end.
Example 31 may optionally include at least in part the system of example 30, wherein the valve disposed in the chamber first proximal end can be closed to seal off the chamber first proximal end.
Example 32 may optionally include at least in part the system of example 31, wherein the valve can be closed by the user manually.
Example 33 may optionally include at least in part the system of example 31, wherein the valve comprises a Tuohy-Borst connector.
Example 34 may optionally include at least in part the system of example 30, wherein the valve disposed in the chamber first proximal end can be closed to seal off the chamber first proximal end when the guide wire or other tool is being passed through the valve.
Example 35 may optionally include at least in part the system of example 34, wherein the valve can be closed by the user manually.
Example 36 may optionally include at least in part the system of example 35, wherein the valve comprises a Tuohy-Borst connector.
Example 37 may optionally include at least in part the system of example 1, wherein the chamber comprises a distal end and a proximal end;
the access needle is in communication with the chamber distal end; and
the chamber proximal end is configured for receiving the guide wire to allow for the passing of the guide wire through the chamber distal end and into the access needle.
Example 38 may optionally include at least in part the system of example 37, wherein the chamber distal end comprises a conical shape nose.
Example 39 may optionally include at least in part the system of example 38, wherein the conical shape nose comprises a Luer slip fitting on the conical shape nose, the Luer slip fitting capable of receiving the access needle for rapid and easy attachment and detachment of the access needle from the system.
Example 40 may optionally include at least in part the system of example 37, wherein the chamber proximal end is configured to receive a plunger; wherein the plunger comprises a distal end and a proximal end.
Example 41 may optionally include at least in part the system of example 40, wherein the plunger comprises a introducer conduit extending from the plunger proximal end to the plunger distal end, wherein the introducer conduit comprises a proximal end configured to receive the guide wire and a distal end configured to pass the guide wire into the chamber.
Example 42 may optionally include at least in part the system of example 41, wherein at least one of the following components of the system are transparent so that a user of the system can see a backsplash of blood regurgitating through the access needle following successful insertion of the access needle into the vasculature:
the access needle;
the chamber;
the introducer conduit;
the plunger; or
the guide wire.
Example 43 may optionally include at least in part the system of example 41, wherein at least one of the following components of the system are MRI compatible so that the system can be used with MR-guided interventional procedures:
the access needle;
the chamber;
the introducer conduit;
the plunger; or
the guide wire.
Example 44 includes a method for using an access system that provides the capability to inject a contrast agent while simultaneously navigating a guide wire into a vasculature, a non-vasculature structure, and/or a vicinity of a vasculature of a subject through a tip of an access needle, the method comprising:
advancing the access needle of the system through the skin of a subject;
determining if the access needle is in the correct location; and:
Example 45 may optionally include at least in part the method of example 44, wherein the determining if the access needle is in the correct location further comprises passing the guide wire through a chamber and the access needle while simultaneously injecting the contrast agent from the chamber into the subject to guide the access needle beneath the skin, in the vicinity of the vasculature, the non-vasculature structure, and/or in the vasculature.
Example 46 may optionally include at least in part the method of example 44, further comprising advancing a sheath over the access needle after advancing the access needle through the skin, wherein the sheath is accessing the vasculature, the non-vasculature structure, and/or the vicinity of the vasculature of the subject.
Example 47 may optionally include at least in part the method of example 46, further comprising advancing the sheath towards a vasculature after the access needle has punctured the vasculature or the non-vasculature structure, wherein the sheath is accessing the vasculature, the non-vasculature structure, and/or the vicinity of the vasculature of the subject.
Example 48 may optionally include at least in part the method of example 47, further comprising advancing the sheath over the access needle after the access needle has punctured the vasculature or the non-vasculature structure, wherein the sheath is advanced until the vasculature or the non-vasculature structure is entered by the sheath.
Example 49 may optionally include at least in part the method of example 44, further comprising advancing the guide wire through the access needle after the access needle punctures the skin.
Example 50 may optionally include at least in part the method of example 49, wherein advancing the guide wire through the access needle after the access needle punctures the skin further comprises passing the guide wire through a chamber and the access needle while simultaneously injecting contrast agent from the chamber into the subject to guide the access needle beneath the skin, in the vasculature, the non-vasculature structure, and/or the vicinity of the vasculature of the subject.
Example 51 may optionally include at least in part the method of example 49, wherein the determining if the access needle is in the correct location further comprising:
injecting the contrast agent into the vasculature, the non-vasculature structure, and/or the vicinity of a vasculature of a subject through the tip of the access needle;
determining the location of the access needle using fluoroscopy; and
verifying that the access needle is in the correct location.
Example 52 may optionally include at least in part the method of example 51, wherein the injecting the contrast agent into the vasculature, the non-vasculature structure, and/or the vicinity of a vasculature of a subject through the tip of the access needle further comprises injecting the contrast agent into the vasculature, the non-vasculature structure, and/or the vicinity of a vasculature of a subject through the tip of the access needle while a guide wire is passing through the chamber.
Example 53 may optionally include at least in part the method of example 52, wherein the verifying that the access needle is in the correct location further comprises verifying that the guide wire and the access needle are in the correct location.
Example 54 may optionally include at least in part the method of example 49, wherein the advancing the access needle of the system until the access needle has accessed the vasculature, the non-vasculature structure, and/or the vicinity of the vasculature of the subject further comprises advancing the access needle over the guide wire until the access needle has punctured a vasculature.
Example 55 may optionally include at least in part the method of example 54, further comprising:
advancing a sheath over the access needle after advancing the access needle through the skin, wherein the sheath is accessing the vasculature, the non-vasculature structure, and/or the vicinity of the vasculature of the subject; and
removing the access needle from the subject and skin after advancing the sheath over the needle, wherein the sheath is still accessing the vasculature, the non-vasculature structure, and/or the vicinity of the vasculature of the subject.
Example 56 may optionally include at least in part the method of example 55, wherein the sheath is accessing the vasculature.
Example 57 may optionally include at least in part the method of example 55, wherein the guide wire remains below the skin after the access needle is removed.
Example 58 may optionally include at least in part the method of example 44, wherein the access system is accessing a vasculature structure such as a femoral artery or radial artery.
Example 59 may optionally include at least in part the method of example 44, wherein the access system is accessing the non-vasculature structure such as a gall bladder, kidney, cyst, pus collection, or some other normal or diseased organ, body part, or other element of the body.
Example 60 includes a method for using an access system that provides the capability to inject contrast agent while simultaneously navigating a guide wire into a vicinity of a vasculature, a non-vasculature structure, and/or the vasculature of a subject through a tip of an access needle, the access method comprising:
passing the guide wire through a chamber and the access needle while simultaneously injecting contrast agent from the chamber into the subject to guide the access needle that is inserted beneath the skin, in the vicinity of a vasculature, non-vasculature and/or in the vasculature.
Example 61 may optionally include at least in part the method of example 60, wherein the method further comprises:
sliding a sheath over the access needle.
Example 62 may optionally include at least in part the method of example 61, further comprising:
puncturing the vasculature with the access needle; and
inserting the sheath into the vasculature after the access needle punctures the vasculature, to prevent damage to the vasculature when the access needle and/or other devices are inserted into, moved within, or removed from the vasculature.
Example 63 may include a method of manufacturing the access system according to example 1. The method may be implemented with any technique or process (or combinations thereof) available to a practitioner in the field of manufacturing.
Example 64 may optionally include at least in part the system of example 1, further comprising a contrast agent reservoir, wherein the contrast agent reservoir is in communication with the chamber.
Example 65 may optionally include at least in part the system of example 1, wherein at least one of the following components of the system are MRI compatible so that the system can be used with MR-guided interventional procedures:
the access needle;
the chamber; or
the guide wire.
Example 66 can include, or can optionally be combined with any portion or combination of any portions of any one or more of Examples 1-65 to include, subject matter that can include means for performing any one or more of the functions of Examples 1-65, as well devices, systems, structures, components, compositions, materials, shapes, contours, and sizes. Moreover, any of the means discussed through out examples 1-65 may optionally be performed by any structure, component, device or system discussed throughout this disclosure or any disclosure incorporated by reference herein.
An aspect of an embodiment of the present invention solves the clinical need to improve the method used to obtain femoral access and precisely guide the operator to puncture the common femoral artery. This device and methodology allows the operator to locate the initial puncture site using fluoroscopically defined bony landmarks (e.g., middle of the femoral head) followed by puncture of the artery with a small, 21 gauge needle while allowing the operator to confirm the location within the common femoral artery by injecting contrast under fluoroscopy. If the operator confirms the proper site in the common femoral artery, a small guide wire can then be advanced through a channel installed in the plunger of the contrast-delivery syringe, into the barrel of the syringe, and then out the distal tip of the needle. Thereafter, the needle and syringe can be removed and replaced by a sheath. However, if the angiogram demonstrates improper position, the needle can be withdrawn and another attempt made leaving behind only a 21 gauge needle puncture and thus minimizing the likelihood of a significant bleed. The entire unit is easy to manipulate and does not add significant time to the procedure, an important feature that will appeal to the temperament of invasive cardiologists.
Design Principles:
1. Start with a 10 ml syringe.
2. A needle is incorporated into the plunger of the syringe. A needle with dimensions suitable for this purpose is Galt catalog number NDL-100-21. The plungers of most disposable plastic syringes have an x-shaped cross section, so the needle is bonded into one of the axial channels, with the proximal end of the hub flush with the top of the plunger. The distal end of the needle pokes through the bottom of the plunger.
3. The distal end of the barrel is modified to have a deeper conical shape, in order to funnel the guide wire out of the port first time, every time. The Luer lock on the end of the syringe is replaced with a Luer slip fitting to allow for rapid attachment/detachment of the needle. In the prototype device, a plastic funnel was used for this purpose,
Qosina catalog number 20046.
4. Finger loop fittings are slid onto the proximal ends of the barrel and the plunger, to make for easy ergonomic use of the syringe during access procedures.
Design Details
We began the prototyping process using a 10 ml plastic syringe. A syringe of a different volume is also easily used. The idea is to have a Luer slip fit on the output port of the syringe rather than a Luer lock, in order to minimize the time needed for attaching needles, etc. to it. Therefore, when the relatively flat distal end of the syringe is cut off, the funnel-shaped replacement must have the same kind of Luer slip port on it. A funnel angle on the order of about 45 to 50 degrees is satisfactory. Steeper or shallower angles will also work. The reason for the angulation is to cause the guide wire to pass easily through the syringe exit port without doubling back on itself inside the bottom of the syringe. Shown here are the syringe barrels with (upper) and without (lower) the tapered funnel attached.
The next step is to install a 21 Gauge Galt (or equivalent) introducer needle in the plunger. The plungers of such syringes typically have a simple cruciform shape and a flat plastic top against which the user presses their thumb during an injection. We forced the tip of the needle all the way through the seal at the bottom of the syringe, such that the upper lip of the needle's female entry port was flush with the top of the plunger. We then cut out one quadrant of the plunger's top so that the needle's entry port would be contained within the cruciform's cross sectional area. We then glued it in place.
Plungers with and without the needle installed are shown here.
The plunger can then be inserted inside the barrel of the syringe. Since the tip of the needle integral to the plunger sticks only 2 or 3 mm past the distal end of the plunger's seal, it does not bottom out on the inside surface of the tapered funnel at the distal end of the syringe. Hence, the guide wire cannot bind inside of that region of the barrel when the plunger is pushed down to near or at the end of its internal travel within the barrel.
Finger loops can then be press fitted onto the proximal ends of the barrel and plunger of the modified syringe. The finger loops are helpful to the operator, since they make it possible to either inject or withdraw the plunger using only one hand, because the fingers can work against either the upper or lower inner surfaces of the finger loops. A 21 gauge Galt needle can be slip-fitted onto the distal end of the tapered funnel and the device will be ready for femoral access.
The devices, systems, compositions, computer program products, and methods of various embodiments of the invention disclosed herein may utilize aspects disclosed in the following references, applications, publications and patents and which are hereby incorporated by reference herein in their entirety:
Unless clearly specified to the contrary, there is no requirement for any particular described or illustrated activity or element, any particular sequence or such activities, any particular size, speed, material, duration, contour, dimension or frequency, or any particularly interrelationship of such elements. Moreover, any activity can be repeated, any activity can be performed by multiple entities, and/or any element can be duplicated. Further, any activity or element can be excluded, the sequence of activities can vary, and/or the interrelationship of elements can vary. It should be appreciated that aspects of the present invention may have a variety of sizes, contours, shapes, compositions and materials as desired or required.
In summary, while the present invention has been described with respect to specific embodiments, many modifications, variations, alterations, substitutions, and equivalents will be apparent to those skilled in the art. The present invention is not to be limited in scope by the specific embodiment described herein. Indeed, various modifications of the present invention, in addition to those described herein, will be apparent to those of skill in the art from the foregoing description and accompanying drawings. Accordingly, the invention is to be considered as limited only by the spirit and scope of the following claims, including all modifications and equivalents.
Still other embodiments will become readily apparent to those skilled in this art from reading the above-recited detailed description and drawings of certain exemplary embodiments. It should be understood that numerous variations, modifications, and additional embodiments are possible, and accordingly, all such variations, modifications, and embodiments are to be regarded as being within the spirit and scope of this application. For example, regardless of the content of any portion (e.g., title, field, background, summary, abstract, drawing figure, etc.) of this application, unless clearly specified to the contrary, there is no requirement for the inclusion in any claim herein or of any application claiming priority hereto of any particular described or illustrated activity or element, any particular sequence of such activities, or any particular interrelationship of such elements. Moreover, any activity can be repeated, any activity can be performed by multiple entities, and/or any element can be duplicated. Further, any activity or element can be excluded, the sequence of activities can vary, and/or the interrelationship of elements can vary. Unless clearly specified to the contrary, there is no requirement for any particular described or illustrated activity or element, any particular sequence or such activities, any particular size, speed, material, dimension or frequency, or any particularly interrelationship of such elements. Accordingly, the descriptions and drawings are to be regarded as illustrative in nature, and not as restrictive. Moreover, when any number or range is described herein, unless clearly stated otherwise, that number or range is approximate. When any range is described herein, unless clearly stated otherwise, that range includes all values therein and all sub ranges therein. Any information in any material (e.g., a United States/foreign patent, United States/foreign patent application, book, article, etc.) that has been incorporated by reference herein, is only incorporated by reference to the extent that no conflict exists between such information and the other statements and drawings set forth herein. In the event of such conflict, including a conflict that would render invalid any claim herein or seeking priority hereto, then any such conflicting information in such incorporated by reference material is specifically not incorporated by reference herein.
The present application claims priority from U.S. Provisional Application Ser. No. 61/305,152, filed Feb. 17, 2010, entitled “Access Device for Femoral Vasculature Catheterization and Method of Use;” the disclosure of which is hereby incorporated by reference herein in its entirety.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US10/61413 | 12/21/2010 | WO | 00 | 12/24/2012 |
| Number | Date | Country | |
|---|---|---|---|
| 61305152 | Feb 2010 | US |
