巴西专利BR112015029752A2 access needle and catheter mounts

专利PDF首页>>巴西专利

专利附录

专利说明

权利要求

类似技术

同族专利

引用文献

法律状态

优先权

专利摘要:
Summary of the invention for "access needle and catheter assemblies" The present invention relates to access needles and methods for using the needles. the needles may include a handle and a cannula (102) having a proximal end operably connected to the handle, a distal end and a lumen extending through the cannula body. a protective sheath (101) may surround the cannula. Additionally, a catheter 205 may be removably disposed within the lumen of the cannula. The catheter includes a piercing tip (104, 404) at a distal end and a flexible body length extending proximally from the piercing tip to the cable. The flexible catheter body provides a fluid communication path through the cannula lumen so that a contrast fluid can effectively pass through the cannula lumen. Methods for introducing cannulas at target locations within a patient's body are also presented in this disclosure.
公开号:BR112015029752A2
申请号:R112015029752
申请日:2014-05-14
公开日:2020-04-28
发明作者:Toomey Ciaran；Keady Fionan；Dunning Michael
申请人:Cook Medical Technologies Llc；
IPC主号:

专利说明:

ACCESS NEEDLE
[0001] This request claims priority to the Provisional Application under the serial ^Q US 61 / 829,421, filed on January 13, 2011, the disclosure of which is incorporated herein in its entirety for reference.
BACKGROUND OF THE INVENTION:
1. FIELD OF THE INVENTION
[0002] This disclosure relates, in general, to medical devices. More particularly, the present disclosure relates to access needles that have distinctly configured stylets that allow the passage of contrast fluid.
2. DESCRIPTION OF RELATED TECHNIQUE
[0003] The development of minimally invasive methods and devices in recent years has revolutionized the practice of medicine. These methods and devices allow medical professionals to perform a wide variety of procedures while minimizing trauma to the patient. Access needles are used in conjunction with certain minimally invasive medical procedures. Such needles can include a tubular cannula body that can form a conduit between a target location within a patient's body and a location outside the patient's body. This conduit can be used subsequently by a medical professional to perform certain procedures in conjunction with the target site or to pass a wire guide through it.
[0004] An access needle may include a stylus in the lumen of its cannula to prevent inadvertent sample collection at the distal end of the cannula, to provide a sharp tip capable of puncturing and to provide some reinforcement to the cannula as it travels to the target location within the body. After the distal end of the needle reaches its target location within the body, the stylet can be removed, thereby freeing a space through the cannula lumen where, for example, a thread guide can
Petition 870170031849, of 5/15/2017, p. 5/30
2/20 be placed. A medical professional who performs such a procedure needs to be able to determine the exact location of the distal end of the cannula to ensure that it has reached the precise target location within the patient's body.
[0005] A useful method for determining the location of the distal end of the cannula within the patient's body is performed using endoscopic ultrasound (EUS). EUS provides medical professionals with the ability to view the location of the distal end of the needle within the patient's body without requiring an open incision, the use of large hole needles or percutaneous trocars. If this method is used for localization purposes, an access needle may comprise an echogenic tip at its distal end. Ideally, EUS can then be used to determine the location of the echogenic tip. However, EUS technology is not always able to provide accurate location data to the medical professional. As such, it may be advantageous to combine EUS with a different form of location technology to supplement EUS data or provide location data in the event that EUS is unsuccessful.
[0006] In this sense, fluoroscopy can be used as an additional method to determine the location of the distal end of a needle within a patient's body. In one aspect, fluoroscopy can be used to detect the dye or contrast fluid that has been placed inside the patient's body. Specifically, x-rays are emitted through the patient's body to determine the exact location of the contrast fluid. The resulting image can be transmitted to a monitor and a medical professional performing the procedure can then determine whether the distal end of the needle is at the target location.
[0007] When this form of location technology is used, it is necessary to have the capacity to supply the radiopaque dye (for example,
Petition 870170031849, of 5/15/2017, p. 6/30
3/20 (contrast fluid) through the lumen of the cannula and out of its distal end. This can be problematic, especially when a stylus is located inside the lumen of the cannula. Most of the prior art stylets are formed by a solid thread and substantially occupy the entire inner diameter of the lumen. Thus, they effectively block or seriously impede the flow of contrast fluid through the cannula lumen. Thus, it is desirable to provide stylus configurations that will allow contrast fluid to pass through the cannula lumen without the need to provide a larger cannula and / or additional lumen (s).
BRIEF DESCRIPTION OF THE INVENTION
[0008] Access needles are revealed in this document. In one aspect, the access needle comprises an elongated hollow cannula that has a proximal end, a distal end and a lumen that extends between them; and a stylus removably disposed within the lumen of the cannula, the stylet comprising a piercing tip at a distal end of the stylet; and a length of flexible body extending proximally from the piercing tip towards the proximal end, whereby the stylet's flexible body provides a fluid communication path through the entire lumen of the cannula, so that a contrast fluid can pass effectively through the lumen of the cannula.
[0009] In another aspect, an access needle comprises an elongated hollow cannula that has a proximal end, a distal end and a lumen that extends between them; and a stylus removably disposed within the lumen of the cannula, the stylet comprising a piercing tip at a distal end of the stylet; and a length of flexible body that extends proximally from the drill tip towards the proximal end, whereby the flexible body of the stylus provides a fluid communication path through the
Petition 870170031849, of 5/15/2017, p. 7/30
4/20 entire lumen of the cannula, so that a contrast fluid can pass effectively through the lumen of the cannula, where the stylet comprises a coiled wire and the distal end of the coiled wire is connected to a proximal end of the drill tip.
[0010] In an additional aspect, the access needle comprises an elongated hollow cannula that has a proximal end, a distal end and a lumen that extends between them; and a stylus removably disposed within the lumen of the cannula, the stylet comprising a piercing tip at a distal end of the stylet; and a length of flexible body extending proximally from the piercing tip towards the proximal end, whereby the stylet's flexible body provides a fluid communication path through the entire lumen of the cannula, so that a contrast fluid can pass effectively through the lumen of the cannula, where the stylet comprises a wound wire and a distal end of the wound wire is connected to a proximal end of the drill tip.
[0011] Methods for introducing a cannula into a target location within a patient's body through an endoscope are also disclosed. In one aspect, the method comprises providing any of the access needles mentioned above; loading the distal end of the cannula and stylet into a lumen of the endoscope; pierce the target location with the drill tip, the distal end of the cannula and the distal end of the stylet; directing the contrast fluid to flow through the cannula lumen and out of the distal end of the cannula; fluoroscopically visualize the patient's body to determine a location of the contrast fluid; confirm, through the location of the contrast fluid, that the distal end of the cannula is at a target location; remove the stylus; and leaving the cannula in place with the distal end of the cannula at a target location.
Petition 870170031849, of 5/15/2017, p. 8/30
5/20
[0012] The aspects mentioned above have largely highlighted the features and technical advantages of the present disclosure so that the following detailed description is better understood. The additional features and benefits of the disclosure will be described hereinafter and form the subject of the claims in this application. It should be verified by those skilled in the art that the specific design and modalities disclosed can be readily used as a basis for modifying or designing other modalities to accomplish the same purposes as the present disclosure. It should also be understood by an individual skilled in the art that such equivalent modalities do not depart from the spirit and scope of the invention as presented in the appended claims.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0013] Hereinafter, a detailed description of the invention is made with specific reference to the drawings in which:
[0014] Figure 1 depicts an aspect of the access needle disclosed herein;
[0015] Figure 2 depicts a longitudinal section of a stylized coiled yarn modality;
[0016] Figure 3 depicts a longitudinal section of a stylized coiled yarn modality;
[0017] Figure 4 shows a cross-section of a multi-filament yarn stylus;
[0018] Figure 5 depicts an aspect of a multiple thread filament stylus;
[0019] Figure 5A depicts an aspect of a multi-thread filament stylus with crossed lines showing attachment to a drill tip; and
Petition 870170031849, of 5/15/2017, p. 9/30
6/20
[0020] Figure 6 shows a cross-section of a modality of a multi-filament yarn stylus;
DETAILED DESCRIPTION OF THE INVENTION
[0021] As will be more fully described later in this document, the present disclosure relates to access needles and stylets configured in different ways. Although the stylets are described in conjunction with access needles, the present disclosure is intended to cover the use of the stylets disclosed herein in conjunction with other medical devices, such as standard EUS needles and percutaneous needles. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by the person skilled in the art to which this invention belongs. In the event of a conflict, this request, including definitions, will prevail. Preferred systems, components, methods and materials are described below, although systems, methods, components and materials similar or equivalent to those described in this document may be used in the practice or testing of the present disclosure. The materials, methods and examples described herein are illustrative only and are not intended to be limiting.
[0022] In the present disclosure, the terms "proximal" and "distal" will be used to describe the opposing axial ends of particular components of the medical devices disclosed herein that include the various components of the access needles described herein. The term “proximal” is used in its conventional sense to refer to the end of the device (or component thereof) that is closest to the operator or medical professional when using the device. The term “distal” is used in its conventional sense to refer to the end of the apparatus (or component thereof) that is
Petition 870170031849, of 5/15/2017, p. 10/30
7/20 initially inserted into the patient's body or that is further away from the operator or medical professional using the device.
[0023] As used in this document, the term "echogenic" is defined as a component that has marked echogenicity. Specifically, the term is used to refer to materials or portions of materials that are constructed or treated to have better reflectivity of ultrasonic waves than the standard materials used for a cannula, cannula and / or stylus. It is known in the art that most materials used for the cannula, cannula and / or stylus will reflect some ultrasonic waves, but the term "echogenicity," as used herein, includes treating the surface with cavities, lacerations or the like (and / or, when specifically referenced, using a known material to provide a pronounced echogenic profile) configured to provide a clear ultrasound view at a resolution that allows accurate location and navigation of the device on a patient's body.
[0024] The term "cannula" mentioned in this document is defined to include tubular bodies that can be rigid or flexible. The bodies have a tubular wall in general or a substantially tubular wall that defines a lumen. The term “cannula” is also intended to cover needles (for example, medical devices that have a tip configured to penetrate or otherwise pass through tissue), as well as catheters that have a lumen through which structures and / or materials can be targeted. Such needles and catheters can comprise polymeric, metallic and / or plastic materials. In much of the aspects disclosed in this document, an access needle includes a flexible cannula combined with a stylus.
[0025] The term "catheter" mentioned in this document is intended to cover any catheter known in the field of medical devices.
Petition 870170031849, of 5/15/2017, p. 11/30
8/20
As an illustrative non-limiting example, the catheter may have a twisted configuration, so that the catheter associated with the product number CXI-4.035-150-P-NS-0 manufactured by Cook Inc., which is available as of the date of deposit of this request.
[0026] Various aspects of access needles are described in the present disclosure. Access needles can be produced from any available material known in the art. In some aspects, an access needle comprises a polymeric and / or plastic material. In other respects, an access needle comprises a metal, such as stainless steel. In additional aspects, an access needle comprises any combination of a metallic, plastic and polymeric material.
[0027] Referring to Figure 1, an access needle may include a cable (not shown) operatively connected to a proximal end of an elongated flexible cannula (102). In certain embodiments, the cable may be configured as disclosed in US Patent No. 6,976,955 by Hardin, et al., Which is incorporated by reference in this document, although in other embodiments the cable may be constructed in any case appropriate for a biopsy needle (noting that the structure of the particular cable is not immediately claimed and a variety of cable designs can be readily practiced by those who are skilled in the use and design of medical biopsy needles). The cannula (102) includes a lumen that extends from its proximal end to its distal end. In certain aspects, the distal end of the cannula can be configured to include an echogenic tip (103). In certain embodiments, a protective sheath (101) can surround the outside of the cannula and the removable stylus can be placed inside the lumen of the cannula (102). The stylus can include a piercing tip (104), configured to penetrate through an occlusion. A drill tip includes any beveled, pointed, or configured tip
Petition 870170031849, of 5/15/2017, p. 12/30
9/20 otherwise known in the art that is effective for perforating and / or penetrating tissue. A drilling tip (104) can be solid or hollow. [0028] The flexibility of at least a portion of the cannula provides the ability to push and track sufficiently to allow navigation through a body lumen or other passages without significant risk of crimp or otherwise obstruction of the lumen. In one aspect, the cannula may be a plastic material comprising, for example, polyimide, a polyether block amide (PEBA), PEBAX, polyether etherketone (PEEK), ePTFE, PTFE, thermoplastic polyurethane (TPU) or PET . It will be understood that other polymeric materials which include polymers with braided construction and / or with metallic components, such as stainless steel, can also be used within the scope of this disclosure. [0029] In some respects, the distal end of the cannula may include an echogenic tip. In some respects, the distal end of the cannula can be constructed from or coated with an echogenic polymer. In other respects, the distal end of the cannula can be produced echogenicly, providing cavities, ruptures, etc., on its external surface. The cavities can reflect enough ultrasound waves to provide an image from, for example, an endoscopic ultrasound. Regardless of whether the distal end of the cannula has recesses, coated with or constructed of an echogenic polymer, it will have an ultrasound-visible member that can provide location and navigation data.
[0030] The ability to push and the ability to crawl from the cannula can be further enhanced by placing a stylus inside its lumen. Once the distal end of the cannula and the stylus reaches the target location within the patient's body and a perforation is made, the stylus can be removed, thereby creating an access channel through the cannula lumen inside of the injury. A camera tip
Petition 870170031849, of 5/15/2017, p. 13/30
10/20 soft null allows the coated wire guide to be inserted through the cannula lumen without extracting the wire coating.
[0031] The stylus can be constructed from an alloy, such as a titanium and nickel alloy that includes shape memory alloy, stainless steel, NiTi steel, or can be constructed from a polymer, such as PEEK. The distal end of the stylus can include a chamfered tip, which can be chamfered in a scalpel configuration or any other number of chamfered configurations configured to effectively pierce the fabric. The stylus tip can be hollow or solid.
[0032] Regarding the Figures. 2 and 3, in certain aspects of the present disclosure, a stylus (105) is provided in the form of a coiled thread. Such a wound wire stylus (105) differs from a typical stylus configuration. A single strand or multiple strands / strands of thread can be used. A support mandrel or lead wire (106) can also be provided within the lumen of the coiled wire stylus (105) to add strength. This type of stylus has numerous advantages over the prior art stylets, which generally consist of a solid thread that occupies the entire lumen of the cannula.
[0033] For example, the coiled wire stylus disclosed here provides increased flexibility. An access needle is often used in a very contorted and convoluted way. Therefore, the use of the flexible coiled wire stylus disclosed here would allow a remarkable ease of use in these twisted and convoluted environments, such as, for example, lumens of sinuous bodies (for example, blood vessels), passage through a duodenoscope inside a patient's biliary tree or other uses that require a high degree of flexibility to reach a target location. As used in this document, the terms "flexible" and "flexible body length" are defined and will be understood by those skilled in the art as non-rigid, yet maintaining integrity
Petition 870170031849, of 5/15/2017, p. 14/30
11/20 near enough to be pushed and traceable in a generally predictable guided way through a needle cannula lumen, gastric endoscope working channel, sinuous body lumen or any other lumen or path. As such, the embodiments disclosed herein provide advantages over previous stylets (e.g., longitudinal and columnar needle holder), although they include additional advantages described in this document.
[0034] A medical professional will need to try to locate the distal end of the cannula as that end is navigating through the body to the target location (for example, by viewing the tip's location and orientation). It is desirable to keep the stylus in place during navigation and therefore the stylus will need to be constructed in a way that will allow the contrast fluid to pass through the cannula lumen. The coiled wire stylus disclosed here (105) will allow the contrast fluid to pass through the lumen of the cannula, as well as through the lumen of the coiled wire stylus, as long as the conductive wire (106), if used, does not sufficiently fill the lumen of the coiled wire stylus (105). If a prior art solid wire stylus were used and the stylus outer diameter was essentially the same as the inner diameter of the cannula lumen, it would not be possible to inject the contrast fluid through the cannula lumen or, at most, it would take a period of substantial time for the contrast fluid to flow through the cannula lumen and out of the distal end at which it can be detected. This characteristic is desirable so that fluoroscopic visualization can be performed with a minimum of exposure time (maintaining the best practices aimed at minimizing the exposure of the treatment team and the patient to the radiation used during fluoroscopy).
[0035] However, through the use of the coiled wire stylus disclosed here, the contrast fluid can be easily injected into a
Petition 870170031849, of 5/15/2017, p. 15/30
12/20 port on the cable and flow freely to the proximal end of the cannula through the lumen of the cannula and / or the lumen of the coiled wire stylet and out of the distal end of the cannula. If a stylus tip is hollow (see reference number 304 in Figure 3), the contrast fluid can flow freely through it. If a distal end of the stylet is solid (see reference number 204 in Figure 2), the contrast fluid will flow freely through the cannula or stylus lumen until it reaches the solid stylet tip. However, the solid stylus tip may be of minimum length, potentially as short as about 5 mm in length, and would not form a liquid impermeable seal with the distal end of the cannula. In this way, the contrast fluid can leach from the distal end of the cannula lumen. Suitable lengths for the stylus tip can be from about 5 mm to about 50 mm. In addition, if the stylus tip is solid, the coil gap at the distal end of the coiled wire can be increased (see distal stylet end (105) shown in Figure 2) to allow the contrast fluid to pass out of the lumen stylus and the solid tip at the distal end of the cannula.
[0036] If the stylus tip is hollow, the tip can be welded to the coiled wire. If the stylus tip is solid, it can also be welded to the coiled wire. In addition, if the stylus tip is solid, a conductive wire (106) can be passed through the lumen of the wound wire and the distal end of the conductive wire can be welded to the proximal end of the stylus tip.
[0037] With reference to Figures 4, 5, 5A and 6, a multi-wire stylus (205) can be used according to the disclosed access needle. In that respect, the stylet may comprise a plurality of yarn filaments (205). For example, the stylus can comprise two strands of yarn, three strands of yarn, four strands of yarn, five strands of yarn,
Petition 870170031849, of 5/15/2017, p. 16/30
13/20 six strands of yarn, seven strands of yarn, etc. The present disclosure is intended to cover a stylus comprising any number of strands of yarn.
[0038] As can be seen clearly in Figures 4 and 6, in a particular aspect, the stylus can comprise three strands of thread. Each yarn filament can be produced from the same materials mentioned together with the previously described coiled yarn stylus. Each wire filament can be joined by welding, brazing or the like, to a cannula with a sharp tip (see reference number 108 in Figure 5 or 208 in Figure 5A). The tip of the cannula can be hollow or it can be solid. The stylus can take up space from the proximal end of the cannula to its distal end. With such a configuration, the stylet does not substantially occupy the entire lumen of the cannula, thereby allowing the passage of contrast fluid through the cannula lumen. As you can see, for example, in Figure 4, the multi-filament yarn stylus leaves the empty space in the cannula lumen where the contrast fluid can flow freely.
[0039] The distal end of one or more of the wire filaments of the multi-wire stylet can be joined to a hollow or solid tip by welding, brazing or the like. An adhesive can also be used. In one embodiment, as shown in Figure 5A, at the distal end of the stylus, each of the plurality of yarn filaments (205) passes within the inner diameter of the stylus tip (404). A brazed or soldered joint (208) can then be formed at the proximal end of the stylus tip, thereby fixing the stylet to the tip. In some embodiments, the attachment of the wire filaments to the cannula may still allow space for the contrast fluid to pass through the stylus tip and in other modalities, the attachment of the wire filaments to the tip can be seen.
Petition 870170031849, of 5/15/2017, p. 17/30
14/20 give the proximal end of the tip, which means that the contrast fluid will leach around the tip of the stylet to emerge from the catheter.
[0040] In addition, with reference to Figure 5, the multiple wires can be joined (107) by brazing or welding in certain portions of the stylet body for additional reinforcement. When an access needle is navigating through an endoscope, it can travel through winding positions while en route to the target site. Since the stylus does not occupy the entire lumen of the cannula, it can tend to recede inside the cannula lumen against the perforation of the target. However, if the yarn filaments are joined at certain locations along the stylet body, this would add additional reinforcement and strength and prevent the stylus filaments from receding into the cannula lumen. Similarly, the wire filaments will preferably be dimensioned in relation to the diameter of the cannula lumen, but through the use of multiple wire filaments instead of a single solid wire, there will be sufficient spaces where a contrast fluid can pass (see Figures 1, 4 and 6).
[0041] When the multiple wire filaments join along the stylet body, a heat shrink tube can be used (see reference number 109 in Figure 6) as well as brazing, welding and the like. The entire length of the multi-strand yarn stylus may be joined or, alternatively, the multi-strand filaments may be joined periodically along the stylet body as described above. In some embodiments, the multiple yarn filaments may be joined periodically at repeated intervals along the length of the yarn filaments. The intervals can be of any length, such as intervals about 1 inch (2.54 centimeters) at intervals of about 20 inches (50.8 centimeters). For example, along the length of the multi-strand filaments, the filaments can
Petition 870170031849, of 5/15/2017, p. 18/30
15/20 must be joined at an interval of about every 12 inches (30.48 centimeters) or at an interval within the range of about every 8 inches (20.32 centimeters) to about every 16 inches ( 40.64 centimeters).
[0042] At the proximal end of the access needle disclosed here, the cannula can be connected to a double port luer cable / adapter. The contrast fluid can be injected through a side port of the luer adapter and can flow freely through the stylet, be it a coiled wire stylus or a multi-wire stylus, through the cannula lumen and in some respects, through the stylus lumen and out of the distal end of the cannula through the tip of the stylus. Fluoroscopy can then be used to determine the location of the contrast fluid and thereby the location of the distal end of the cannula. Unless the stylus tip is hollow, the larger the stylus tip, the greater the impediment of the flow of contrast fluid, thereby increasing the amount of time required for leaching to occur. As such, the stylus tip should be kept reasonably short in length, such as from about 5 mm to about 50 mm, from about 5 mm to about 25 mm, from about 5 mm to about 15 mm, or from about 5 mm to about 10 mm.
[0043] It can then be understood that all aspects of the stylets disclosed herein will allow the effective passage of contrast fluid through the lumen of the cannula and some aspects will allow the effective passage of contrast fluid through the lumen of the stylet. The contrast fluid can be highly viscous and, therefore, sufficient space is required in the cannula lumen, which can be difficult to reach due to the stylus that is located inside it. However, all aspects of stylets disclosed here allow sufficient space for the contrast fluid to pass. That is, all the stylets revealed here can have lengths of
Petition 870170031849, of 5/15/2017, p. 19/30
16/20 flexible body extending proximally from the drill tip to the handle, whereby the flexible stylus body does not sufficiently occupy the entire lumen of the cannula, so that a contrast fluid can pass effectively through the lumen of the cannula . In order for a stylus not to occupy sufficiently a lumen of a cannula, there must be enough unoccupied space in the cannula lumen for the contrast fluid to pass unimpeded, at least until the fluid reaches a tip of the stylus.
[0044] With reference to Figures 2 and 3, it can be seen that if the contrast fluid were injected into a cannula lumen containing these stylets, there would be a greater amount of unoccupied space within the cannula lumen in which the fluid contrast can flow. For example, the contrast fluid can flow freely below the center of the lumen in the stylet. Referring to Figure 4, it can easily be seen that this stylus modality does not sufficiently occupy the entire lumen of the cannula, thereby allowing a contrast fluid to pass effectively through the lumen of the cannula. This figure shows a stylus that comprises three strands of yarn. As can be seen in the Figure, there is enough unoccupied space within the cannula lumen in which a contrast fluid can pass freely.
[0045] In an attempt to quantify the amount of free space within the cannula lumen for the contrast fluid to pass, it can be determined, at least with reference to Figures 2, 3, 4, and 6, that a cross section of the cannula lumen, when it contains one of the stylets disclosed here, is about 70% to about 10% unoccupied by the stylus. In certain aspects, the cannula lumen can be from about 20% to about 50% unoccupied. Thus, in all aspects disclosed in this document, it can be understood that the flexible body of the stylus provides a fluid communication path through the entire lumen of the cannula, so that a contrast fluid can pass effectively
Petition 870170031849, of 5/15/2017, p. 20/30
17/20 through the lumen of the cannula. Alternatively, it can be said that since the stylet's flexible body does not sufficiently occupy the entire cannula lumen, the stylet's flexible body provides a fluid communication path through the entire cannula lumen, so that a contrast fluid can pass effectively through the lumen of the cannula.
[0046] Unlike the stylets disclosed herein, it should be understood that a prior art stylus of solid thread would sufficiently occupy the entire lumen of the cannula, so that a contrast fluid could not pass effectively through the lumen of the cannula. Thus, prior art stylets would not provide a fluid communication path through the stylus lumen. With a solid wire stylus that has a diameter essentially equal to the diameter of the cannula lumen, only about 1% to about a maximum of 5%, and probably less, the cannula lumen would be vacated by the stylus. This would seriously impede the flow of contrast fluid through the lumen. Although it may be possible to inject contrast fluid into a cannula that has a prior art solid wire stylus, the amount of time that would have to wait for the fluid to travel the length of the cannula would make the procedure impractical. Although certain aspects of the stylets disclosed herein have a solid tip that can, similarly to the prior art solid wire stylets, have diameters that are almost equal to the diameter of the cannula lumen, these tips are very short, potentially about 5 mm in length, so that the amount of time required to wait for the contrast fluid to pass such a short distance would be minimal.
[0047] The appropriate contrast fluid is known in the art and the device disclosed herein is not particularly limited to any type of contrast fluid. Telebrix® is an illustrative example of a type of fluid
Petition 870170031849, of 5/15/2017, p. 21/30
18/20 contrast that can be used in conjunction with the access needle disclosed here.
[0048] The methods of placing a cannula at a target location within a patient's body are also disclosed in this document. In one aspect, a target location within a patient's body is visualized with an ultrasound endoscope. The access needle disclosed here can be inserted into the ultrasound endoscope and fixed to the scope. The handle of an access needle may be advantageous for piercing the distal end of the cannula / stylet assembly within the target location within the patient's body. With the stylus still in place, in the lumen of the cannula, the contrast fluid can be injected through a port on the handle. The contrast fluid can travel through the cannula lumen and, as previously described in conjunction with certain modalities, through the stylus lumen. The contrast fluid will come out at the distal end of the cannula and a medical professional who operates the device will be able to fluoroscopically confirm the anatomical location of the distal end of the cannula prior to removal of the stylet. Once confirmation is received that the distal end of the cannula is in the correct location, the stylet can be removed. According to the methods disclosed in this document, the coiled yarn stylus or the multi-filament yarn stylus can be used.
[0049] Upon removal of the stylus, the cannula will be left in place with its distal end at the target location. The next steps in the method depend on the needs of the medical professional and the patient. For example, a syringe can be connected to the handle of an access needle to draw fluid from the target location. As an additional illustrative example, a wire guide can be passed through the cannula lumen within the target site within the patient's body. The handle of an access needle can then be retracted to bring the needle back into den
Petition 870170031849, of 5/15/2017, p. 22/30
19/20 section of the sheath surrounding the cannula. The device can then be removed from the endoscope that leaves the wire guide in place to further access the target site.
[0050] All the modalities revealed and claimed in this document can be carried out and executed without unnecessary experiments in the light of the present disclosure. Although this disclosure may belong to many different aspects or modalities, the specific and preferred embodiments of the invention will be described in detail in this document. The present disclosure is an example of the principles of the invention and should not limit the invention to particular illustrated modalities or aspects. In addition, unless expressly stated otherwise, the use of the term "one" is intended to include "at least one (1)" or "one (1) or more." For example, "one device" is intended to include "at least one (1) device" or "one (1) or more devices".
[0051] Any ranges given in absolute terms or in approximate terms are intended to cover both or any definitions used in this document are intended to be illuminating and not limiting. Although the ranges and numerical parameters that establish the broad scope of the invention are approximations, the numerical values established in the specific examples are reported as accurately as possible. Any numerical value, however, inherently contains certain errors that necessarily result from the standard deviation found in their respective test measurements. In addition, all ranges disclosed in this document are to be understood as covering any and all sub-ranges (including all integer and fractional values) contained therein.
[0052] Additionally, the invention covers any and all possible combinations of some or all of the various modalities described in this document. It must also be understood that
Petition 870170031849, of 5/15/2017, p. 23/30
20/20 changes and modifications present in the preferred modalities described in this document will be evident to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention and without diminishing its intended advantages. Therefore, it is intended that such changes and modifications are covered by the attached claims.

权利要求:
Claims (13)
[1]
1. Access needle characterized by the fact that it comprises:
an elongated hollow cannula having a proximal end, a distal end and a lumen extending between them; and a catheter removably disposed within the lumen of the cannula, the catheter comprising:
a piercing tip at a distal end of the catheter; and a flexible body length comprising a plurality of wire filaments that extend longitudinally proximally from the piercing tip towards the proximal end, whereby the flexible catheter body occupies less than an entire transverse volume of the lumen and thus it provides a fluid communication path through the entire lumen of the cannula so that a contrast fluid can pass effectively through the lumen of the cannula, through and around the catheter.
[2]
2. Access needle, according to claim 1, characterized by the fact that the catheter's piercing tip is hollow, allowing passage through a fluid, or is solid.
[3]
Access needle according to claim 1, characterized by the fact that the plurality of yarn filaments are parallel to each other and with a longitudinal central axis of the cannula.
[4]
Access needle according to claim 1 characterized by the fact that the plurality of yarn filaments comprises three yarn filaments.
[5]
5. Access needle according to claim 1, characterized by the fact that the plurality of wire filaments are joined periodically along the catheter body.
Petition 870170031849, of 5/15/2017, p. 25/30
2/3
[6]
6. Access needle, according to claim 1, characterized by the fact that the catheter's piercing tip comprises stainless steel.
[7]
Access needle according to claim 1, characterized in that the distal end of each strand of yarn comprising the plurality of yarn filaments is connected to a proximal end of the piercing tip.
[8]
8. Access needle according to claim 1, characterized by the fact that the plurality of yarn filaments are joined in at least one location along the length of the yarns.
[9]
Access needle according to claim 1, characterized in that the distal end of the elongated hollow cannula comprises a recessed surface configured to accentuate echogenicity.
[10]
10. Access needle characterized by the fact that it comprises:
an elongated hollow cannula that has a proximal end, a distal end, and a lumen that extends between them; and a catheter removably disposed within the lumen of the cannula, the catheter comprising:
a hollow piercing tip at a distal end of the catheter; and a length of flexible body extending proximally from the piercing tip towards the proximal end, whereby the flexible catheter body occupies less than an entire cross-sectional area of the lumen and thus provides a fluid communication path through the entire lumen of the cannula so that a contrast fluid can pass through
Petition 870170031849, of 5/15/2017, p. 26/30
3/3 effective through the lumen of the cannula, through and around the catheter, where the catheter comprises a plurality of wire filaments that are parallel with each other and with the central longitudinal axis of the catheter, and a distal end of each yarn filament comprising the plurality of yarn filaments is connected to a proximal end of the hollow drill tip.
[11]
11. Access needle according to claim 10, characterized by the fact that the plurality of wire filaments comprises three wire filaments that are periodically joined along the catheter body and in which, in addition, the drill tip is hollow, chamfered and comprises stainless steel.
[12]
12. Access needle according to claim 10, characterized in that the elongated hollow cannula is non-rigid, yet maintaining sufficient linear integrity to be pushed and traceable in a generally predictable guided way through a cannula lumen needle, a gastric endoscope working channel.
[13]
13. Access needle according to claim 1, characterized by the fact that the elongated hollow cannula is non-rigid, yet maintaining sufficient linear integrity to be pushed and traceable in a generally predictable guided way through a cannula lumen needle, a gastric endoscope working channel.

类似技术:

公开号 | 公开日 | 专利标题

BR112015029752A2|2020-04-28|access needle and catheter mounts

US20140188108A1|2014-07-03|Energy Assisted Tissue Piercing Device and Method of Use Thereof

US20080275466A1|2008-11-06|Dual cannula system and method for using same

JP5775689B2|2015-09-09|Ultrasound guided echogenic catheter and related methods

US10405943B2|2019-09-10|Kit and method for reduced radiation procedures

US20100274129A1|2010-10-28|Apparatus And Methods for Separating Pericardial Tissue From The Epicardium of the Heart

JP6835809B2|2021-02-24|Electrosurgical device with lumens

AU2013331334B2|2016-05-19|Self-coiling stylet needle device

US20110270090A1|2011-11-03|Needle having ultrasound opaque elements

US9610411B2|2017-04-04|Wire-embedded polymer-body needle

JP5833776B2|2015-12-16|Fiducial deployment system

KR20210096130A|2021-08-04|Endoscopic system for energy delivery

JP2015510432A|2015-04-09|Catheter, catheter for use in ultrasound guided procedures, and related methods

US20210085385A1|2021-03-25|Electrode loop assembly including shaped support tube and method of assembling same

JP2018537180A|2018-12-20|Sheath for needle delivery

KR101579694B1|2015-12-23|Medical device for solitary pulmonary nodule marking

同族专利:

公开号 | 公开日

CN105377324A|2016-03-02|

CN105377324B|2018-12-21|

EP3003423A1|2016-04-13|

WO2014204593A1|2014-12-24|

AU2014281178B2|2017-05-18|

JP6340415B2|2018-06-06|

AU2014281178A1|2015-12-24|

US9750532B2|2017-09-05|

JP2016519982A|2016-07-11|

US20140357983A1|2014-12-04|

引用文献:

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

US4582061A|1981-11-18|1986-04-15|Indianapolis Center For Advanced Research, Inc.|Needle with ultrasonically reflective displacement scale|

US4869259A|1988-05-17|1989-09-26|Vance Products Incorporated|Echogenically enhanced surgical instrument and method for production thereof|

US4977897A|1988-08-17|1990-12-18|Robert Hurwitz|Amniocentesis needle with improved sonographic visibility|

US4986279A|1989-03-01|1991-01-22|National-Standard Company|Localization needle assembly with reinforced needle assembly|

US7549424B2|1991-10-18|2009-06-23|Pro Surg, Inc.|Method and apparatus for tissue treatment with laser and electromagnetic radiation|

US20040002647A1|1991-10-18|2004-01-01|Ashvin Desai|Gel injection treatment of body parts|

US5370675A|1992-08-12|1994-12-06|Vidamed, Inc.|Medical probe device and method|

US5357961A|1993-05-12|1994-10-25|Hdc Corporation|Catheter guidewire and flushing apparatus and method of insertion|

US5490521A|1993-08-31|1996-02-13|Medtronic, Inc.|Ultrasound biopsy needle|

US5554114A|1994-10-20|1996-09-10|Micro Therapeutics, Inc.|Infusion device with preformed shape|

WO1996027329A1|1995-03-08|1996-09-12|Terwilliger Richard A|Echogenic needle|

US20050182297A1|1996-10-04|2005-08-18|Dietrich Gravenstein|Imaging scope|

GB9622711D0|1996-10-31|1997-01-08|British Tech Group|Instrument having enhanced ultrasound visibility|

US6106473A|1996-11-06|2000-08-22|Sts Biopolymers, Inc.|Echogenic coatings|

AU6251798A|1997-01-30|1998-08-25|Boston Scientific Limited|Pneumatically actuated tissue sampling device|

AU712738B2|1997-09-24|1999-11-18|Eclipse Surgical Technologies, Inc.|Steerable catheter|

US6053870A|1997-11-08|2000-04-25|Angiodynamics, Inc.|Ultrasonic visible surgical needle|

US6371963B1|1998-11-17|2002-04-16|Scimed Life Systems, Inc.|Device for controlled endoscopic penetration of injection needle|

AU5924099A|1998-12-31|2000-07-24|Jeffrey E. Yeung|Tissue fastening devices and delivery means|

US6689142B1|1999-04-26|2004-02-10|Scimed Life Systems, Inc.|Apparatus and methods for guiding a needle|

US6871086B2|2001-02-15|2005-03-22|Robin Medical Inc.|Endoscopic examining apparatus particularly useful in MRI, a probe useful in such apparatus, and a method of making such probe|

GB0011568D0|2000-05-15|2000-06-28|Nycomed Amersham Plc|Grooved medical devices|

US6607496B1|2000-09-12|2003-08-19|Medtronic, Inc.|Steerable stylet with enhanced torsional transfer strength|

WO2002078611A2|2001-03-30|2002-10-10|Drexel University|Echogenic polymer microcapsules and nanocapsules and methods for production and use thereof|

US6524247B2|2001-05-15|2003-02-25|U-Systems, Inc.|Method and system for ultrasound imaging of a biopsy needle|

US7087212B2|2001-08-17|2006-08-08|Mallinckrodt, Inc|Multicomponent assemblies having enhanced binding properties for diagnosis and therapy|

EP1420702B1|2001-08-31|2005-04-20|Boston Scientific Limited|Percutaneous pringle occlusion device|

WO2003030756A2|2001-10-12|2003-04-17|Ams Research Corporation|Surgical instrument and method|

US6860856B2|2002-01-11|2005-03-01|Scimed Life Systems, Inc.|Echogenic surface for enhanced ultasonic visibility|

US6895282B2|2002-10-04|2005-05-17|Boston Scientific Scimed, Inc.|Induction heating for the delivery of thermal therapy|

US6936048B2|2003-01-16|2005-08-30|Charlotte-Mecklenburg Hospital Authority|Echogenic needle for transvaginal ultrasound directed reduction of uterine fibroids and an associated method|

US6875219B2|2003-02-14|2005-04-05|Yves P. Arramon|Bone access system|

US6976955B2|2003-06-19|2005-12-20|Wilson-Cook Medical Inc.|Handle for medical devices, and medical device assemblies including a handle|

CA2536041A1|2003-11-10|2005-05-26|Angiotech International Ag|Medical implants and fibrosis-inducing agents|

AU2004289362A1|2003-11-10|2005-05-26|Angiotech International Ag|Intravascular devices and fibrosis-inducing agents|

US20050256426A1|2004-05-12|2005-11-17|William Brugge|Apparatus and method for collecting tissue samples|

US20050261571A1|2004-05-21|2005-11-24|Willis Nathaniel P|3-D ultrasound navigation during radio-frequency ablation|

US8241315B2|2004-06-24|2012-08-14|Boston Scientific Scimed, Inc.|Apparatus and method for treating occluded vasculature|

US7335155B2|2004-09-14|2008-02-26|Boston Scientific Scimed, Inc.|Unitary formulation delivery device|

US8656928B2|2004-10-14|2014-02-25|Cook Medical Technologies Llc|Echogenic medical device and method of forming echogenic surface|

AU2006218584A1|2005-02-28|2006-09-08|Wilson-Cook Medical Inc.|Echogenic markers on GI medical devices|

EP1871238A2|2005-04-14|2008-01-02|Biomedix S. A.|Article, system, and method for securing medical device to tissue or organ|

US20070021767A1|2005-07-25|2007-01-25|Breznock Eugene M|Steerable endoluminal punch|

US7867169B2|2005-12-02|2011-01-11|Abbott Cardiovascular Systems Inc.|Echogenic needle catheter configured to produce an improved ultrasound image|

US20070179508A1|2005-12-12|2007-08-02|Cook Critical Care Incorporated|Hyperechoic stimulating block needle|

EP1973461A2|2005-12-16|2008-10-01|Galil Medical Ltd|Apparatus and method for thermal ablation of uterine fibroids|

WO2008062451A2|2006-09-07|2008-05-29|Gautam Allahbadia|Echogenic surface for surgical instrument|

WO2008048573A2|2006-10-16|2008-04-24|Medtronic, Inc.|Vessel tensioning handle and method of vessel harvesting|

US7713215B2|2008-01-31|2010-05-11|Shriver Edgar L|Steering, piercing, anchoring, distending extravascular guidewire|

US20100160731A1|2008-12-22|2010-06-24|Marc Giovannini|Ultrasound-visualizable endoscopic access system|

WO2010144362A1|2009-06-12|2010-12-16|Wilson-Cook Medical Inc.|Endoscopic ultrasound-guided stent placement device and method|

JP2012000143A|2010-06-14|2012-01-05|Olympus Corp|Drug administration needle|AT424879T|2005-07-06|2009-03-15|Vascular Pathways Inc|DEVICE FOR INTRAVENOUS CATHETER INTRODUCTION AND USE METHOD|

AT548972T|2007-05-07|2012-03-15|Vascular Pathways Inc|INTRAVENOUS CATHETER INTRODUCTION AND BLOOD SPECIMENS|

US9872971B2|2010-05-14|2018-01-23|C. R. Bard, Inc.|Guidewire extension system for a catheter placement device|

US10384039B2|2010-05-14|2019-08-20|C. R. Bard, Inc.|Catheter insertion device including top-mounted advancement components|

US8932258B2|2010-05-14|2015-01-13|C. R. Bard, Inc.|Catheter placement device and method|

US9950139B2|2010-05-14|2018-04-24|C. R. Bard, Inc.|Catheter placement device including guidewire and catheter control elements|

US8690833B2|2011-01-31|2014-04-08|Vascular Pathways, Inc.|Intravenous catheter and insertion device with reduced blood spatter|

ES2750035T3|2011-02-25|2020-03-24|Bard Inc C R|Medical component insertion device including a retractable needle|

CN108607150B|2013-01-30|2021-01-12|血管通路股份有限公司|Systems and methods for venipuncture and catheter placement|

US10232146B2|2014-09-05|2019-03-19|C. R. Bard, Inc.|Catheter insertion device including retractable needle|

CN113350614A|2015-05-15|2021-09-07|C·R·巴德股份有限公司|Catheter placement device including extendable needle safety feature|

US10493262B2|2016-09-12|2019-12-03|C. R. Bard, Inc.|Blood control for a catheter insertion device|

WO2018156107A1|2017-02-22|2018-08-30|Spiration, Inc. D.B.A.Olympus Respiratory America|Improved jacket flexible needle assembly|

US10960147B2|2018-04-20|2021-03-30|Flextronics Ap, Llc|Flex needle|

WO2021055617A1|2019-09-18|2021-03-25|Merit Medical Systems, Inc.|Osteotome with inflatable portion and multiwire articulation|

法律状态:
2018-03-27| B15K| Others concerning applications: alteration of classification|Ipc: A61M 5/00 (2006.01), A61M 31/00 (2006.01), A61M 25 |

2018-11-06| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2020-06-02| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2021-07-20| B350| Update of information on the portal [chapter 15.35 patent gazette]|

2021-10-19| B350| Update of information on the portal [chapter 15.35 patent gazette]|

2021-12-07| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

2022-03-08| B08F| Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]|Free format text: REFERENTE A 8A ANUIDADE. |

优先权:

申请号 | 申请日 | 专利标题

US201361829421P| true| 2013-05-31|2013-05-31|

PCT/US2014/037992|WO2014204593A1|2013-05-31|2014-05-14|Access needles and stylet assemblies|

[返回顶部]