Patent Application
20250072881
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 63/579,083 filed on Aug. 28, 2023, the disclosure of which is incorporated herein by reference.
The present disclosure pertains to medical devices, and methods for using medical devices. More particularly, the present disclosure pertains to devices and methods for occluding an opening formed into a patient
A wide variety of medical devices have been developed for medical use, for example, intravascular use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.
This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. A method for closing an opening formed during a medical procedure is disclosed. The method comprises: advancing a needle through patient tissue to form an opening into a bile duct region; performing an intervention within the bile duct region; and advancing an embolic gel into the opening to close the opening.
Alternatively or additionally to any of the embodiments above, performing an intervention within the bile duct region includes injecting a contrast agent into the bile duct region.
Alternatively or additionally to any of the embodiments above, performing an intervention within the bile duct region includes draining the bile duct region.
Alternatively or additionally to any of the embodiments above, performing an intervention within the bile duct region includes dilation of a biliary stricture.
Alternatively or additionally to any of the embodiments above, performing an intervention within the bile duct region includes delivery of a stent.
Alternatively or additionally to any of the embodiments above, performing an intervention within the bile duct region includes a tissue biopsy.
Alternatively or additionally to any of the embodiments above, further comprising disposing a stop member within the opening.
Alternatively or additionally to any of the embodiments above, disposing a stop member within the opening includes disposing the stop member adjacent to the bile duct region.
Alternatively or additionally to any of the embodiments above, disposing a stop member within the opening includes disposing the stop member within the opening prior to advancing the embolic gel into the opening.
Alternatively or additionally to any of the embodiments above, the stop member includes a stop pin having a head and a shaft extending from the head.
Alternatively or additionally to any of the embodiments above, the embolic gel includes a shear thinning material.
Alternatively or additionally to any of the embodiments above, the embolic gel includes a gelatin, a layered silicate mixture, and a radiopaque material.
A method for occluding an opening formed during a percutaneous transhepatic cholangiography procedure is disclosed. The method comprises: advancing a needle through patient tissue to form a drainage tract into a bile duct region; performing an intervention within the bile duct region; disposing a stop member within the drainage tract; and advancing a conformable embolic material into the drainage tract to occlude the drainage tract.
Alternatively or additionally to any of the embodiments above, the conformable embolic material includes a shear thinning material.
Alternatively or additionally to any of the embodiments above, the conformable embolic material includes a gelatin, a layered silicate mixture, and a radiopaque material.
Alternatively or additionally to any of the embodiments above, the stop member includes a stop pin having a head and a shaft extending from the head.
A system for occluding a drainage tract formed into a bile duct region as part of a percutaneous transhepatic cholangiography procedure is disclosed. The system comprises: a stop member configured to be disposed adjacent to the drainage tract formed into the bile duct region; a conformable embolic material configured to occlude the drainage tract; and a delivery device for delivering the conformable embolic material.
Alternatively or additionally to any of the embodiments above, the conformable embolic material includes a shear thinning material.
Alternatively or additionally to any of the embodiments above, the conformable embolic material includes a gelatin, a layered silicate mixture, and a radiopaque material.
Alternatively or additionally to any of the embodiments above, the stop member includes a stop pin having a head and a shaft extending from the head.
The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.
The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:
While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.
The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
Percutaneous transhepatic cholangiography (PTC) is an interventional radiologic procedure that is usually performed when either endoscopic biliary access via endoscopic retrograde cholangiography is technically limited, the patient is not a good candidate for a typical biliary drainage procedure, or there is altered anatomy. PTC involves transhepatic insertion of a needle into a bile duct, followed by injection of contrast material to opacify the bile ducts. PTC localizes the site of obstruction and facilitates therapeutic interventions, such as biliary drainage, removal of bile duct stones, dilation of biliary strictures, stent placement, and tissue biopsies. A drainage procedure (e.g., percutaneous transhepatic biliary drainage) typically precedes the intervention. After a PTC has been performed a drainage catheter is re-inserted into the tract to avoid leakage of bile. After removing the drainage catheter, an opening into the biliary tract (e.g., the drainage tract) may still exist. It can be appreciated that closing and/or sealing the drainage tract may be desirable, for example in order to avoid leakage. Disclosed herein are systems and methods for closing and/or sealing a drainage tract, for example following a PTC procedure.
Following an intervention, it may be desirable to close and/or seal the drainage tract 18. A variety of procedures and devices are contemplated for achieving such closure/sealing. For examples,
The embolic gel 26 may be delivered to the drainage tract 18 using a suitable delivery device such as a catheter, syringe, a syringe coupled to a delivery tube or catheter, and/or the like. For example,
The transition to a stable, occlusive form of the embolic gel 26 may occur in near real-time, meaning that sealing can be achieved quickly. After providing sufficient time for sufficient healing of the drainage tract 18, the embolic gel 26 will eventually hydrolyze within the patient. Therefore, no further procedures are necessary in order to remove objects implanted in the patient, nor are any long-term implants used. The use of the embolic gel 26 (e.g., where the embolic gel 26 is a shear thinning and/or conformable material) may be desirable for a number of reasons. For example, delivery of the embolic gel 26 to the drainage tract 18 may sufficiently close and/or seal the drainage tract 18 relatively quickly and stably. Thus, a patient treated with the embolic gel 26 may recover from a PTC procedure more quickly that patients that are treated with embolic coils and/or glues.
The positioning of the stop member 20 may vary, depending on the needs of the procedure and/or the preference of the clinician. For example, the stop member 20 may be arranged so that the head 24 is disposed at the junction of the drainage tract 18 and the bile duct region 12 (e.g., as shown in
Some example methods are contemplated including methods for closing an opening formed during a medical procedure (e.g., methods for occluding an opening formed during a percutaneous transhepatic cholangiography procedure). The methods advancing a needle or catheter (e.g., the needle 16) through patient tissue to form an opening (e.g., the drainage tract 18) into a bile duct (e.g., the bile duct region 12). An intervention may be performed within the bile duct region. The intervention may include injecting a contrast agent into the bile duct region 12, draining the bile duct region 12, dilation of a biliary stricture (e.g., within the bile duct region 12), delivery of a stent (e.g., within the bile duct region 12), a tissue biopsy, combinations thereof, and/or the like. An embolic gel and/or conformable embolic material (e.g., the embolic gel 26) may be advanced into the opening (e.g., into the drainage tract 18) to close the opening. In some instances, a stop member (e.g., the stop member 20) may be disposed within the opening (e.g., the drainage tract 18), for example prior to advancing the embolic gel into the opening.
It can be appreciated that the devices and/or methods disclosed herein may also be applied to other interventions where an opening is formed in a patient. One example procedure may include a biopsy. Other procedures where the devices and/or methods disclosed herein may also be applied are contemplated.
U.S. Pat. No. 10,034,958 is herein incorporated by reference.
U.S. Pat. No. 11,083,780 is herein incorporated by reference.
U.S. Pat. No. 11,426,450 is herein incorporated by reference.
U.S. Patent Application No. US 2022/0192974 is herein incorporated by reference.
U.S. Patent Application No. US 2023/0093831 is herein incorporated by reference.
U.S. Patent Application No. US 2023/0094016 is herein incorporated by reference.
It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
| Number | Date | Country | |
|---|---|---|---|
| 63579083 | Aug 2023 | US |
