Patent Application
20130304051
The present invention relates to transseptal catheterization, and more specifically relates to a radiofrequency (RF) assist needle for transseptal catheterization.
The human heart contains four chambers: the right atrium, the right ventricle, the left atrium, and the left ventricle. The right atrium is in fluid contact with the superior vena cava (SVC) and the inferior vena cava (IVC). The right atrium is separated from the right ventricle by the tricuspid valve, while the left atrium is separated from the left ventricle by the mitral valve. The right atrium and left atrium are separated by the interatrial septum, while the right ventricle and left ventricle are separated by the interventricular septum.
There are a multitude of therapeutic and diagnostic procedures in which a catheter is passed within a guide sheath or over a guide wire to access the chambers of the heart. The right atrium can be accessed from the superior vena cava or inferior vena cava. The right ventricle can be accessed from the right atrium. The left ventricle can be accessed from the aorta. The left atrium can be accessed directly from the left ventricle (through the mitral valve); however, such an approach is a relatively difficult maneuver due in part to the tortuous path that must be navigated with the catheter. Such a maneuver is problematic for various reasons, including a bleeding risk and a clotting risk to the patient (because it is the arterial side, it has a relatively high pressure, which exacerbates such risks). In addition, this approach may cause arrhythmias. Therefore, another approach for accessing the left atrium was developed. In this approach, a small hole is placed in the interatrial septum, so that the left atrium can be accessed from the right atrium. This hole is typically created by a needle puncture and is referred to as transseptal catheterization.
In the standard transseptal catheterization procedure, three separate tools are involved: a sheath with a sheath hub, a dilator with a dilator hub, and a needle assembly including a cannula, a needle hub and a stylet. The stylet is usually a small, guidewire-like device that is threaded through the needle cannula and attaches to the needle hub proximally. The distal tip of the stylet extends beyond the distal tip of the needle. The distal section of the needle has a shoulder or tapered section that corresponds with an internal taper at the distal tip of the dilator. When the needle is fully inserted into the dilator, the needle shoulder functions as a hard stop that limits the distance that the tip of the needle can exit from the dilator.
The typical transseptal procedure entails numerous steps. First, right femoral vein access is gained via the Seldinger technique. Second, a guidewire is passed through an introducer sheath, which was placed in the first step, into the femoral vein and threaded up the IVC to the SVC. Third, a sheath and dilator assembly is maneuvered to the SVC by being passed over the guidewire. Fourth, the guidewire is removed. Fifth, the needle assembly, usually including the stylet, is advanced through the inner lumen of the dilator until the distal tip of the needle (or stylet) is just proximal of the distal tip of the dilator. Sixth, the stylet, if present, is removed, and the needle is advanced until the tip of the needle is just proximal of the distal tip of the dilator. Seventh, the dilator/sheath/needle assembly is pulled caudally until the distal tip of the dilator is just resting on the fossa ovalis, which is a relatively thin area in the interatrial septum. Eighth, the needle is advanced forward through the dilator to puncture the septal wall (fossa ovalis). Ninth, and finally, the sheath and dilator assembly is fed through the septal wall over the needle, thereby gaining access to the left atrium.
One risk associated with transseptal needle use occurs if the patient presents with either a fibrotic or aneurismal septum. In the case of the fibrotic septum, the septum is very thick. In the case of the aneurismal septum, the septum is very thin. Both cases are difficult to puncture with the standard transseptal needle. Physicians typically do not know how successful the transseptal procedure will be until they perform it, especially in cases of aneurismal or fibrotic septums. If a standard mechanical transseptal puncture fails, physicians may need to replace the mechanical needle with an RF needle, which can be relatively expensive, in order to complete the procedure.
This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application.
The present inventors have recognized, among other things, that the subject matter can be used to selectively assist in puncturing a tissue layer, for instance, puncturing of a septal wall during transseptal catheterization. The present inventors have further recognized, among other things, that the subject matter can be used to inhibit formation of an embolus or inhibit the release of an embolus into the bloodstream. To better illustrate the apparatuses and methods described herein, a non-limiting list of examples is provided here:
Example 1 can include subject matter that can include a needle cannula including a proximal end and a distal end. The needle cannula includes a lumen extending from the proximal end to the distal end. A handle is disposed at the proximal end of the needle cannula. An electrocautery receiver is associated with the handle and electrically coupled to the needle cannula, wherein, with an electrocautery device activated and placed within the electrocautery receiver, electrical energy is conducted from the electrocautery device to the distal end of the needle cannula to selectively electro cauterize tissue in contact with the distal end of the needle cannula.
In Example 2, the subject matter of Example 1 is optionally configured such that the electrocautery receiver includes a port in the handle. The port is sized to receive a portion of the electrocautery device to allow the electrocautery device to directly contact a portion of the proximal end of the needle cannula.
In Example 3, the subject matter of Example 2 is optionally configured such that the electrocautery receiver includes at least two ports in the handle.
In Example 4, the subject matter of Example 3 is optionally configured such that each of the ports is located at an angular location in the handle that is different from the angular location of each of the other one or more ports.
In Example 5, the subject matter of any one of Examples 3-4 is optionally configured such that at least two of the at least two ports are diametrically opposed to one another.
In Example 6, the subject matter of any one of Examples 1-5 is optionally configured such that the electrocautery receiver includes a conductive surface electrically coupled to the needle cannula. The conductive surface is configured to be contacted by the electrocautery device.
In Example 7, the subject matter of Example 6 is optionally configured such that the conductive surface includes an annular surface disposed on the handle.
In Example 8, the subject matter of Example 7 is optionally configured such that the conductive surface includes a ring disposed around the handle.
In Example 9, the subject matter of any one of Examples 1-8 is optionally configured such that the electrocautery receiver includes a receptacle spaced from the handle.
In Example 10, the subject matter of Example 9 is optionally configured such that the receptacle is electrically coupled to the needle cannula with a wire.
In Example 11, the subject matter of Example 10 is optionally configured such that the receptacle is movable with respect to the handle.
In Example 12, the subject matter of any one of Examples 1-11 is optionally configured such that the electrical energy conducted from the electrocautery device to the distal end of the needle cannula includes radiofrequency energy.
In Example 13, the subject matter of any one of Examples 1-12 optionally includes a plug disposed within the lumen of the needle cannula. The plug is movable within the lumen between a first position disposed proximate the distal end of the needle cannula and a second position spaced proximally from the first position.
In Example 14, the subject matter of Example 13 is configured such that the plug includes a removable tube removably disposed within the lumen.
In Example 15, the subject matter of Example 14 is optionally configured such that the removable tube includes a polymeric material.
Example 16 can include, or can optionally be combined with any one of Examples 1-15 to include subject matter that can include an apparatus including a needle cannula including a proximal end and a distal end. The needle cannula includes a lumen extending from the proximal end to the distal end. A handle is disposed at the proximal end of the needle cannula. An electrocautery receiver is associated with the handle and electrically coupled to the needle cannula, wherein, with an electrocautery device activated and placed within the electrocautery receiver, radiofrequency energy is conducted from the electrocautery device to the distal end of the needle cannula to selectively electrocauterize tissue in contact with the distal end of the needle cannula. The apparatus includes an anti-embolus feature configured to inhibit formation during electrocautery of an embolus within or exiting of an embolus from within the lumen of the needle cannula.
In Example 17, the subject matter of Example 16 is optionally configured such that the anti-embolus feature includes a plug disposed within the lumen of the needle cannula. The plug is movable within the lumen between a first position disposed proximate the distal end of the needle cannula and a second position spaced proximally from the first position. The plug in the first position substantially occludes an opening at the distal end of the needle cannula to inhibit formation during electrocautery of an embolus within the lumen of the needle cannula.
In Example 18, the subject matter of any one of Examples 16-17 is optionally configured such that the anti-embolus feature includes a continuous pressure source fluidly coupled to the needle cannula to inhibit formation during electrocautery of an embolus within or exiting of an embolus from within the lumen of the needle cannula.
In Example 19, the subject matter of Example 18 is optionally configured such that the anti-embolus feature includes a continuous positive pressure source fluidly coupled to the needle cannula to inhibit formation during electrocautery of an embolus within the lumen of the needle cannula.
In Example 20, the subject matter of any one of Examples 18-19 is optionally configured such that the anti-embolus feature includes a continuous negative pressure source fluidly coupled to the needle cannula to inhibit exiting of an embolus from within the lumen of the needle cannula.
The present patent application relates to apparatuses and methods for selectively providing assistance in puncturing a tissue layer, such as a septal wall, with a needle assembly, such as a transseptal needle assembly, or to inhibit formation of an embolus or releasing of an embolus into the bloodstream during such puncturing of a tissue layer. For instance, the apparatuses and methods of the present patent application are used, in some examples, to selectively use radiofrequency energy to assist in puncturing a septal wall. In some examples, the apparatuses and methods include one or more anti-embolus features, which inhibit formation of emboli or release of emboli into the bloodstream. The apparatuses and methods, in some examples, are used in various procedures, including, but not limited to, tissue puncture procedures, interatrial septum puncture procedures, or transseptal catheterization procedures.
In various examples, the present patent application includes apparatuses which assist physicians or other users to puncture a tissue layer, such as a septum, when mechanical puncturing means alone are ineffective. For instance, a fibrotic or aneurismal septum can prove difficult to puncture with only a mechanical transseptal needle. However, in some examples, a transseptal needle assembly of the present patent application includes a handle including an electrocautery receiver configured to selectively receive an electrocautery device to allow the physician or other user to use an electrocautery device to assist in puncturing a tissue layer, such as a septum. In some examples, the electrocautery receiver allows the physician or other user to selectively apply radiofrequency (RF) energy to and conduct RF energy through a cannula with an RF energy source, such as, for instance, an electrocautery pen. This allows physicians to selectively burn or cut a hole in a tissue layer, for instance, should a fibrotic or aneurismal septum be encountered, without having to switch from a mechanical needle to an RF needle.
In some examples, the present patent application includes apparatuses with an anti-embolus feature, which inhibits formation or release of an embolus into the bloodstream. In some examples, such an embolus can form from tissue or blood charring from using RF energy to assist in puncturing of tissue with a needle. In other examples, an embolus can form using just a mechanical needle to puncture tissue (for instance, coring of the tissue). That is, in various examples, examples of the anti-embolus feature can be used in addition to or separate from the puncture assist examples (for instance, the RF assist examples).
Referring to
In some examples, the transseptal needle assembly 20 includes a proximal end 20A and a distal end 20B. At the proximal end 20A, the transseptal needle assembly 20, in some examples, includes a handle 22. In some examples, the transseptal needle assembly 20 includes a needle cannula 26 extending from the handle 22. The needle cannula 26, in some examples, includes a proximal end 26A engaged with the handle 22 and a distal end 26B configured to puncture a tissue layer. In various examples, a portion of the proximal end 26A of the needle cannula is attached to the handle 22. In some examples, a portion of the proximal end 26A is disposed within the handle 22. In some examples, the proximal end 26A is non-detachably retained within the handle 22, for instance, being molded within the handle 22. In other examples, the needle cannula 26 can be detachably coupled to the handle 22 using a threaded coupling or other such mating connector coupling. In some examples, the needle cannula 26 includes a lumen 26C extending from the proximal end 26A to the distal end 26B.
Referring now to
In some examples, the handle 22 includes an insulating material, for instance, to guard against injury of the physician or other user or the patient during use of the electrocautery device 32 with the transseptal needle assembly 20. In some examples, the needle cannula 26 is insulated to guard against injury of the physician or other user or the patient during use of the electrocautery device 32 with the transseptal needle assembly 20. In further examples, a length of the needle cannula 26 is insulated, leaving the distal end 26B uninsulated to lessen the likelihood of charring tissue, fluids, or the like along the length of the needle cannula 26 but allowing the distal end 26B to impart energy (for instance, RF energy) to the tissue to selectively burn or cut the tissue in contact with the distal end 26B and assist in puncturing of the tissue with the needle cannula 26. In some examples, the needle cannula 26 includes insulating material covered, coated, or otherwise applied to an outside surface of the needle cannula 26.
In some examples, the transseptal needle assembly 20 includes a stopcock 28 or other coupling assembly attached to the handle 22 or otherwise fluidly coupled with the lumen 26C of the needle cannula 26. In various examples, the stopcock 28 or other coupling assembly can be used to fluidly couple to devices, such as, but not limited to, a syringe 30, a positive pressure source, a negative pressure source, or a combination thereof. In some examples, the physician or other user can couple the syringe 30 to the stopcock 28 or other coupling assembly, for instance, to pass a substance down the lumen 26C of the needle cannula 26 and into the patient. In some examples, the syringe 30 can be used to inject a contrast agent into the patient, for instance, to better visualize the tissue being punctured under fluoroscopy. In other examples, the positive pressure source or the negative pressure source can be coupled to the stopcock 28 or other couple assembly in order to pass a fluid or other material out of the needle cannula 26 or draw a fluid or other material into the needle cannula 26, respectively. In further examples, the stopcock 28 or other coupling assembly can be configured to selectively couple to more than one device at a time, thereby enabling, for instance, a combination of the syringe 30, the positive pressure source, and the negative pressure source to be coupled to the transseptal needle assembly 20 at the same time. It is contemplated in some examples that the stopcock 28 or other coupling assembly be configured to allow only one of the connected devices to actually fluidly couple to the needle cannula 26. In this way, some or all of the devices can be attached to the transseptal needle assembly 20 at once. Such a configuration allows the physician or other user to just start operating the desired device rather than having to disconnect one device and/or connect another device prior to using the desired device, while also inhibiting the various devices from competing against each other (for instance, the positive and negative pressure sources counteracting each other or the negative pressure source preventing the contrast agent from the syringe 30 making it into the patient). In various examples, the stopcock 28 or other coupling device can include a selector control to allow the physician or other user to select which device coupled to the stopcock 28 or other coupling assembly to fluidly couple to the needle cannula 26.
Referring now to
Referring to
In some examples, the handle 122 includes an insulating material, for instance, to guard against injury of the physician or other user or the patient during use of the electrocautery device 132 with the transseptal needle assembly 120. In some examples, the needle cannula 126 is insulated to guard against injury of the physician or other user or the patient during use of the electrocautery device 132 with the transseptal needle assembly 120. In further examples, a length of the needle cannula 126 is insulated, leaving the distal end uninsulated to lessen the likelihood of charring tissue, fluids, or the like along the length of the needle cannula 126 but allowing the distal end to impart energy (for instance, RF energy) to the tissue to selectively burn or cut the tissue in contact with the distal end and assist in puncturing of the tissue with the needle cannula 126. In some examples, the needle cannula 126 includes insulating material covered, coated, or otherwise applied to an outside surface of the needle cannula 126.
Referring to
In some examples, the handle 222 includes an insulating material, for instance, to guard against injury of the physician or other user or the patient during use of the electrocautery device 232 with the transseptal needle assembly 220. In some examples, the needle cannula 226 is insulated to guard against injury of the physician or other user or the patient during use of the electrocautery device 232 with the transseptal needle assembly 220. In further examples, a length of the needle cannula 226 is insulated, leaving the distal end uninsulated to lessen the likelihood of charring tissue, fluids, or the like along the length of the needle cannula 226 but allowing the distal end to impart energy (for instance, RF energy) to the tissue to selectively burn or cut the tissue in contact with the distal end and assist in puncturing of the tissue with the needle cannula 226. In some examples, the needle cannula 226 includes insulating material covered, coated, or otherwise applied to an outside surface of the needle cannula 226.
In various examples, conducting energy (for instance, RF energy) along the needle cannula 26, 126, 226 allows for selective burning of tissue. However, there is also the chance of charring of blood or other tissue located within the hollow needle cannula 26, 126, 226, which could potentially result in an embolus being released into the patient. While this potential exists with respect to using the transseptal needle assembly 20, 120, 220 with the electrocautery device 32, 132, 232, the potential of embolus creation also exists when using the transseptal needle assembly 20, 120, 220 without the electrocautery device 32, 132, 232. For instance, the needle cannula 26, 126, 226 can core tissue that it punctures, essentially creating a plug of tissue within the needle cannula 26, 126, 226 that can potentially be released into the patient as an embolus. For at least these reasons, the present description further contemplates anti-embolus features, as described herein, associated with the transseptal needle assembly 20, 120, 220. These anti-embolus features, in some examples, can be used in conjunction with the described configurations for selectively using energy (for instance, RF energy) to assist in puncturing of tissue. However, these anti-embolus features, in other examples, can be used in independently from the described configurations for selectively using energy (for instance, RF energy) to assist in puncturing of tissue. That is, the anti-embolus features described herein are not required to be used with transseptal needle assemblies 20, 120, 220 including the electrocautery receptacles 24, 124, 224, and can be used either with such transseptal needle assemblies 20, 120, 220 including the electrocautery receptacles 24, 124, 224 (or otherwise the ability to selectively assist puncturing using energy, electrical energy, or RF energy) or with transseptal needle assemblies not including electrocautery receptacles (or otherwise the ability to selectively assist puncturing using energy, electrical energy, or RF energy).
Referring to
Referring to
In some examples, a handle 422 (or another aspect of the transseptal needle assembly 420) can include a plug control 444 operatively connected to the actuatable plug 440, actuation of the plug control 444 being configured to at least move the plug 440 in a first direction within the lumen 426C. In some examples, the plug control 444 includes a knob 444, such that rotation of the knob 444 in a first direction (for instance, rotation in the direction of arrow A of
In some examples, actuation of the plug control 444 (for instance, in an opposite direction to the arrow A of
In some examples, an anti-embolus feature of the transseptal needle assembly 20, 120, 220, 420 includes a continuous pressure source fluidly coupled to the needle cannula 26, 126, 226, 326, 426 to inhibit formation of an embolus within or exiting of an embolus from within the lumen 26C, 126C, 226C, 326C, 426C of the needle cannula 26, 126, 226, 326, 426. In such examples, the substantially continuous movement of material into or out of the needle cannula 26, 126, 226, 326, 426 flushes the needle cannula 26, 126, 226, 326, 426 and inhibits formation of an embolus within or exiting of an embolus from within the lumen 26C, 126C, 226C, 326C, 426C.
In some examples, the anti-embolus feature includes a continuous positive pressure source fluidly coupled to the needle cannula 26, 126, 226, 326, 426 (for instance, using the stopcock 28, 128, 228, 428 or other coupling assembly) to inhibit formation of an embolus within the lumen 26C, 126C, 226C, 326C, 426C of the needle cannula 26, 126, 226, 326, 426. In some examples, a continuous flow of material (for instance, saline) can be selectively expelled from the needle cannula 26, 126, 226, 326, 426 using the positive pressure source. By flushing the lumen 26C, 126C, 226C, 326C, 426C of the needle cannula 26, 126, 226, 326, 426, the formation of an embolus (by coring of tissue, burning or charring of tissue, blood, or other substances within the lumen 26C, 126C, 226C, 326C, 426C (if selectively using energy, electrical energy, or RF energy with the needle cannula 426, for instance, as described with respect to transseptal needle assemblies 20, 120, 220 herein), or the like) is lessened by inhibiting materials (such as tissue, blood, or other materials) to enter the lumen 26C, 126C, 226C, 326C, 426C.
In some examples, the anti-embolus feature includes a continuous negative pressure source fluidly coupled to the needle cannula 26, 126, 226, 326, 426 (for instance, using the stopcock 28, 128, 228, 428 or other coupling assembly) to inhibit exiting of an embolus from within the lumen 26C, 126C, 226C, 326C, 426C of the needle cannula 26, 126, 226, 326, 426. In some examples, a continuous flow of material can be selectively drawn into the needle cannula 26, 126, 226, 326, 426 using the negative pressure source. By drawing material into the lumen 26C, 126C, 226C, 326C, 426C of the needle cannula 26, 126, 226, 326, 426, the formation of an embolus (by coring of tissue, burning or charring of tissue, blood, or other substances within the lumen 26C, 126C, 226C, 326C, 426C (if selectively using energy, electrical energy, or RF energy with the needle cannula 426, for instance, as described with respect to transseptal needle assemblies 20, 120, 220 herein), or the like) is lessened by inhibiting materials (such as tissue, blood, or other materials) to flow distally out of the lumen 26C, 126C, 226C, 326C, 426C and enter the patient.
The present inventors have recognized various advantages of the subject matter described herein. For instance, in some examples, the needle assemblies described herein can be used to puncture a tissue layer (for instance, a septal wall) and, if the tissue layer proves to be difficult to puncture through purely mechanical means, an electrocautery device can be used with the needle assembly already inserted within the patient to impart RF energy to the distal end of the needle cannula to assist with the puncturing of the tissue layer, wherein the RF energy assists in burning or cutting through the tissue layer. This can be done without removing the needle assembly or swapping the needle assembly for a specialized RF needle assembly, thereby saving time and cost of the procedure. In various examples, the needle assemblies described herein allow for selective RF assistance in puncturing a tissue layer with a decreased risk of harming the patient and the physician or other user performing the procedure. Additionally, in various examples, the needle assemblies described herein include anti-embolus features that inhibit emboli from forming or being released into the bloodstream, thereby decreasing the likelihood that an embolus will present a potentially dangerous situation for the patient. While various advantages of the example needle assemblies are listed herein, this list is not considered to be complete, as further advantages may become apparent from the description and figures presented herein.
Although the subject matter of the present patent application has been described with reference to various examples, workers skilled in the art will recognize that changes can be made in form and detail without departing from the scope of the subject matter recited in the below claims.
The above Detailed Description includes references to the accompanying drawings, which form a part of the Detailed Description. The drawings show, by way of illustration, specific examples in which the present apparatuses and methods can be practiced. These embodiments are also referred to herein as “examples.”
The above Detailed Description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more elements thereof) can be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. Also, various features or elements can be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter can lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
In this document, the terms “a” or “an” are used to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “about” and “approximately” or similar are used to refer to an amount that is nearly, almost, or in the vicinity of being equal to a stated amount.
In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, an apparatus or method that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.
This application claims the benefit of priority to U.S. Provisional Application Ser. No. 61/644,180, filed on May 5, 2012, entitled “TRANSSEPTAL NEEDLE,” which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61644180 | May 2012 | US |
