Patent Application
20180344987
Surgical and/or medical devices are placed in several different ways, one such way being through an introducer sheath. A splittable introducer sheath is used to make removal of a medical device, such as a needle, dilator, or catheter easier and less disruptive to the patient. The splittable introducer sheath is capable of being split and removed without having to remove the inserted medical device from the patient.
Typically, prior art splittable introducer sheaths are formed by two pieces with two diametrically opposed score lines located on the sheath shaft. The two diametrically opposed score lines facilitate the splitting of the sheath when the user pulls on the sheath tabs in opposite directions, but the score lines also weaken the shaft structure, resulting in increased kinking potential and difficulty advancing the introducer sheath to the target site. Additionally, since the score lines are usually perforated, jagged edges are created along the score lines when the shafts are split and separate. These jagged edges could cause problems when the user is removing the introducer sheath from the target site.
There are numerous problems with the current splittable introducer sheaths known in the art. For example, current introducer sheaths can be too flexible, resulting in the sheaths becoming kinked, accordioned or even broken while accessing the vessel or organ to be treated. Moreover, upon being initially split, the splittable sheaths can break near the top of the sheath, making it difficult to fully peel the sheath away from the implanted medical device.
Therefore, there is a need in the art for an introducer sheath device that has a structure resulting in a more rigid sheath that is easily inserted into the vessel or organ of the patient.
The current invention has several advantages over the prior art. First, the current invention is comprised of an inner shaft structured to overlap with an outer shaft, resulting in a more rigid introducer sheath. The increased rigidity of the device's overlapping inner shaft and outer shaft structure reduces unwanted flexibility, increases kink resistance, and provides for more torqueability and control as compared to prior art introducer sheaths. The increased rigidity of the current device also makes the introducer sheath more stable when inserting into the patient and when co-axially inserting a medical device, such as a dilator or needle, through the sheath's lumen. In addition to the increased rigidity, the current invention is easier to split or separate, as the only portion of the device that the user has to split is the hub, rather than having to split down the entire prior art splittable sheath. The current invention also does not have the problems with jagged edges that plagued the prior art splittable introducer sheath.
The present invention generally relates to vascular access devices. In particular, the invention is related to splittable introducer sheaths used to gain access to a vessel or other treatment site within a human body.
The present invention provides devices and methods for accessing a vessel and/or target area of a patient using an introducer sheath device, placing a medical device at the vessel and/or target area, and then removing the introducer sheath device from the medical device without having to remove the medical device from the vessel and/or target area of the patient. The introducer sheath device comprises an inner shaft and outer shaft. The inner shaft is coaxially situated within the outer shaft in an overlapping arrangement. The introducer sheath device further comprises a hub comprising a first hub portion, a second hub portion, and a valve. The hub is attached to the proximal end of the inner shaft and outer shaft.
Referring now to
Referring to
Referring to
The inner shaft 10 and/or outer shaft 30 may be made of the following materials including, but not limited to, poletetrafluoroethylene (PTFE), Teflon, high-density polyethylene (HDPE), or any other material known in the art. The introducer sheath device 1 may accommodate medical devices co-axially inserted through the introducer sheath device lumen 8 ranging in size from 5-12 French, and may have an inner diameter (ID) of ranging from 0.070″-0.162″ and an outer diameter (OD) ranging from 0.086″-0.178″. The inner diameter and outer diameter of the introducer sheath device 1 may be larger or smaller than the ranges expressed above and is not limited to the ranges above.
The inner shaft 10 and outer shaft 30 are formed by first co-extruding the inner shaft 10 and outer shaft 30 with an inner shaft reinforcement element (not shown) and outer shaft reinforcement element (not shown). The inner shaft 10 and outer shaft 30 are then cut to a desired length, creating an inner shaft proximal end 12 and outer shaft proximal end 32, an inner shaft distal end 14 and outer shaft distal end 34, and an inner shaft length 16 that extends between the inner shaft proximal end 12 and the inner shaft distal end 14 and an outer shaft length 36 that extends between the outer shaft proximal end 32 and outer shaft distal end 34. After the inner shaft 10 and outer shaft 30 are cut to the desired length, a tip portion 80 is then attached to the inner shaft distal end 14 and outer shaft distal end 34 via a tip portion proximal end 81. The tip portion 80 may be comprised of a single piece of material, including, but not limited to, nylon or another elastomeric material. The tip portion 80 can be made of a radiopaque material, a non-radiopaque material, or a hydrophilically coated material. The tip portion 80 may be attached to the inner shaft distal end 14 and outer shaft distal end 34 by any method known in the art, including, but not limited to heat welding.
Next, an inner shaft tab 24 and outer shaft tab 44 are formed along the inner shaft proximal end 12 and outer shaft proximal end 32. The inner shaft tab 24 may extend for a selected distance distal from the inner shaft proximal end 12 and the outer shaft tab 44 may extend for a selected distance distal from the outer shaft proximal end 32. One method of forming the inner shaft tab 24 and outer shaft tab 44 is by removing a selected amount of material of the inner shaft proximal end 12 and outer shaft proximal end 32 to form the tab profiles. After the inner shaft tab 24 and outer shaft tab 44 are formed, the inner shaft 10 and outer shaft 30 are cut along a longitudinal axis of the inner shaft length 16 and outer shaft length 36 and opposite of the inner shaft tab 24 and outer shaft tab 44. The cut made along the longitudinal axis of the inner shaft length 16 and outer shaft length 36 creates an inner shaft first edge 18 and outer shaft first edge 38, and an inner shaft second edge 20 and outer shaft second edge 40. The inner shaft first edge 18 and inner shaft second edge 20 extend along substantially the entire inner shaft length 16. The outer shaft first edge 38 and outer shaft second edge 40 extend substantially the entire outer shaft length 36. When the inner shaft 10 and outer shaft 30 are cut, the tip portion 80 is cut as well. Cutting the tip portion 80 aids in removal of the medical device 90 from the introducer sheath device 1. When the inner shaft 10 and outer shaft 30 are cut this results in an inner shaft space 22 between the inner shaft first edge 18 and inner shaft second edge 20, and an outer shaft space 42 between the outer shaft first edge 38 and the outer shaft second edge 40.
The inner shaft reinforcement element and outer shaft reinforcement element are typically made of a wire, but can also be any material known in the art that adds strength to the inner shaft 10 and/or outer shaft 30, including, but not limited to nylon, steel, nitinol, and any known polymer fibers. The inner shaft reinforcement element and outer shaft reinforcement element may be round, flat, or any other shape known in the art. The inner shaft reinforcement element and outer shaft reinforcement element may comprise any pattern known in the art that would add strength to the inner shaft 10 and outer shaft 30, including, but not limited to a braided pattern or a spiral pattern. The pitch of the pattern of the inner shaft reinforcement element and outer shaft reinforcement element may also be configured to make the inner shaft 10 and outer shaft 30 either more or less flexible, depending on the intended use of the introducer sheath device 1. If the pitch of the pattern of the inner shaft reinforcement element and outer shaft reinforcement element is tighter, the inner shaft 10 and outer shaft 30 will become less flexible. Conversely, if the pitch of the pattern of the inner shaft reinforcement element and outer shaft reinforcement element is looser, the inner shaft 10 and outer shaft 30 would be more flexible. The pitch of the pattern of the inner shaft reinforcement element and outer shaft reinforcement element may be customized depending on the place in the body that the user is trying to place the introducer sheath device 1. Harder to access areas would benefit from having a looser reinforcement element pattern, as the introducer sheath device 1 would be more flexible and be able to access these areas more easily. If the user is intending to place the introducer sheath device 1 in a straight vessel, a tighter reinforcement element pattern would be beneficial, as the introducer sheath device 1 may be more pushable. In order to reduce the occurrence of sharp edges resulting from the inner shaft reinforcement element and/or outer shaft reinforcement element when the inner shaft 10 and outer shaft 30 are cut, heat or any method known in the art can be applied to the inner shaft first edge 18, inner shaft second edge 20, outer shaft first edge 38, or outer shaft second edge 40.
In an alternate embodiment, a reinforcement element may only be used on one of either the inner shaft 10 or outer shaft 30, but not both shafts. The benefit of this embodiment is that the introducer sheath device 1 may be more flexible on one side than the other side and can be used to access harder to access target sites in the patient.
Referring now to
Referring now to
The first hub portion 62 is overmolded and thereby securely attached to the inner shaft tab 24. Similarly, the second hub portion 66 is overmolded and thereby securely attached to the outer shaft tab 44. There are several advantages of overmolding the first hub portion 62 so to be securely attached to the inner shaft tab 24 and overmolding the second hub portion 66 so to be securely attached to the outer shaft tab 44. For example, such a structure may add strength to the introducer sheath device 1; facilitate splitting of the introducer sheath device 1; make it easier to move the inner and outer shaft 30 relative to one another before removing the introducer sheath from the medical device 90; and facilitate in removal of the introducer sheath device 1 from the medical device 90.
In an alternative embodiment shown in
In another alternate embodiment (not shown), the inner shaft 10 and/or outer shaft 30 may include one or more rib(s) that extend substantially the entire inner shaft length 16 and/or outer shaft length 36. A stretchable material may be placed between each of the at least one rib(s). The at least one rib extending along substantially the entire inner shaft length 16 and/or outer shaft length 36 provides for added structure and rigidity. The stretchable material extending between the at least one rib(s) provides for added flexibility and supports expansion of the inner shaft 10 and/or outer shaft 30. One advantage of this embodiment is to provide the introducer sheath device 1 the ability to accommodate a range of different sized medical devices to be introduced using the sheath. The at least one rib(s) may be made of a variety of strengthening material including, but not limited to plastic, metal, etc.
A method of placing the introducer sheath device 1 of the current invention is described herein. First, a vessel or target site of a patient is accessed using a needle having a needle proximal end, a needle distal end, and an accessible lumen. Next, a guidewire having a guidewire distal end and a guidewire proximal end is placed through the lumen of the needle used to access the vessel or target site of the patient. The needle is then removed over the guidewire proximal end. The introducer sheath device 1 is then placed over the guidewire proximal end and advanced distally, providing the introducer sheath device 1 with access to the vessel or target site. Once the introducer sheath device 1 has accessed the vessel or target site of the patient, the guidewire is removed proximally through the introducer sheath device proximal end. After the introducer sheath device 1 is placed and the guidewire has been removed, a medical device 90 can be placed through the valve 70 and into the introducer sheath device lumen 8. The medical device 90 may include, but is not limited to, a dilator, catheter, or ablation device. In another embodiment, the medical device 90 may come preassembled within the introducer sheath device 1 in a form of a kit. The valve 70 of the introducer sheath device 1 prevents unwanted flow of blood and air through the introducer sheath device 1. As described above, one advantage for the overlapping configuration of the inner shaft 10 and outer shaft 30 of the introducer sheath device 1 is that the added rigidity aids in the pushability of the introducer sheath device, making it easier to access the vessel or target area of the patient.
Now referring to
This application claims priority to and the benefit of U.S. Provisional Application 62/513,506, filed Jun. 1, 2017 and is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62513506 | Jun 2017 | US |
