Invented by Bruce M. Jelle, Joram Slager, Joseph S. McGonigle, Rick Murphy, Andrew G. Bach, Teryl L. Woodwick Sides, Ambereen Angamuthu, Sean Lundquist, Gary Opperman, Nathan A. Lockwood, Surmodics Inc
The Surmodics Inc invention works as followsThe disclosure includes insertion tools and articles to facilitate the entry of medical devices, such as balloon catheters, into the human body. In some embodiments, the insertion tool has an elongate, hollow body (50), which can protect a part of a medical instrument, such as the balloon of a catheter balloon, during an inserting procedure. In one embodiment, the insertion tool includes an elongated hollow body (131), tapered distal tip (135), and locking mechanism (133), which can secure a part of a catheter balloon. A distal opening can be used to allow the balloon to pass in an uninflated, folded state.
Background for Insertion Tools for Medical Devices
The invention describes insertion tools and articles for introducing medical devices into the vasculature. The insertion tool can be used to package and protect an implantable or insertable device during storage and deployment. The insertion tool can be used to facilitate and protect the insertion medical devices like balloon catheters. The insertion tool can facilitate guidewire insertion in a catheter lumen. It may also protect the surface of the balloon member of a stent or balloon catheter during guide wire loading.
The insertion tool may be part of a system or kit used to perform a medical procedure. These are embodiments of the invention. The kit may include, for example, one or several delivery catheters as well as a balloon device, an inflation cathter, a stent or guidewire.
The present disclosure also includes “Insertion Tools” that can be used to prevent health care professionals from coming into contact with drug-coated medical devices inserted in the body of a human. In addition, insertion tool can be used to protect drug coatings that are sensitive to humidity and to prevent accidental contact with fluids containing the drug coatings before insertion into a mammal’s body. In certain situations, insertion tools may also be used in order to assist in the placement and insertion valves during transcatheter aortic replacement procedures (TAVR).
In one embodiment, an insertion device is provided to facilitate the entry of medical devices such as balloon catheters into the body. The insertion tool comprises a tubular element with a wall and proximal, distal, and length between ends. This defines a first axis. The wall of the tube member has first and second margins for separation, which are parallel to the first direction, located opposite each other on the tubular body, and situated between the proximal end and the distal end. Separation margins can be in the shape of a continuous groove, or a series of openings on the wall of the tube member. These separation margins may define the first and second halves. The tubular material is designed to break along the lengths of the margins, when forces are applied outwardly to each half of the member. At the proximal part of the tubular members, there is also a notch adjacent to the end of first separation margin. A second notch is adjacent the end of second separation margin. The notches are used as starting points to separate the tubular member. The tool also includes two separation assist members that are connected at the proximal and opposite ends of the tube member and between the notches. Separation assist members may be tabs that can be pinched and manually separated. The tool also has a tapered end, where the thickness of the wall is reduced from proximal direction to distal.
The invention also provides an insertion device for the insertion of a medical instrument, such as a catheter balloon, into the human body. This tool includes a tubular component with a wall that has an inner and outer surface. It also comprises proximal, distal, and middle ends. The outer surface or the inner surface of the wall may include a plurality ridges that run parallel to the first direction and around the circumference. The ridges define the areas of the inner wall that have a first thickening, and the areas between the ridges are areas of the inner wall with a second thickening. The material of the tubular members is designed to fracture along the length between the ridges of the wall when outward forces on each half of the tube member are applied. A first notch is located adjacent to a proximal area of a tubular section that is situated between the first and second ridges. The second notch is located adjacent to a proximal area of a tubular section that is situated between the second and third ridges. The tool includes first and a second separation assistance member connected to the tubular end and opposite each other on the tubular and between the first notches.
The invention’s insertion tool embodiments also provide methods to deliver a medical device in a patient body. The method consists of the steps (a) providing a medical device that can be implanted or inserted into the body, such as a catheter balloon, (b) moving the implantable or inserted medical device directly or indirectly from the insertion device to the patient.
The invention also provides another insertion device for the body that facilitates the entry of a catheter balloon. The tool comprises a tubular body with outer and inner surfaces, a distal portion having an opening, and defining an inner and an outer diameter, the inner diameter being sized for passage of a ballon portion of a catheter through the tubular surface, and a proximal portion also comprising an inner and an outer surface, and defining an inner and an outer diameter, the outer surface between the two ends of the hemostatic valve is sized so that it fits within the portion.
In a second embodiment, the invention provides a method to introduce a balloon catheter in the body. The method involves the use of a balloon catheter inserting tool and a hemostatic device. The method involves engaging a hemostatic device with proximal openings and distal holes in an artery. The insertion tool comprises a tubular body with outer and inner surfaces, and includes a distal opening, and an inner and an outer surface defining inner, and outer, diameters. A proximal opening is also provided. The distal tip of the insertion is moved between the first and second hemostatic openings so that the proximal hemostatic opening is tightened about the outer surface. “A balloon portion of a catheter is moved into the artery through the insertion device.
In another embodiment, this invention provides a tool that facilitates the insertion of a balloon into the body. The tool includes first and second elongate member each having a distal section with a distal tip, wherein the distal segment has an arcuate shape which gives the distal segment a trough like configuration. A proximal portion comprises a tab at an angle with the distal segment. The first and the second elongate member are connected by hinges which bias the distal end towards one another. They can be separated by pressing the tabs.
The invention also provides a method of inserting a catheter balloon into the body using a hemostatic device and a tool for doing so. The method includes the steps of: providing an hemostatic device with proximal openings and distal openings that engage an artery, providing an insertion instrument that comprises: first and two elongate member each having a distal section with a terminal end, with the distal segment comprising an arcuate form that gives the distal section a trough like configuration, and a proximal part with a tab at an angle with the distal section; the tool also comprising: a first
In one embodiment, the invention provides a second insertion tool to facilitate the entry of a catheter balloon into the body. The tool comprises an elongate hollow tube with proximal-distal ends. The distal end of the body is tapered and has an opening that is sized to allow the passage of the balloon portion of the balloon catheter in its folded, uninflated state. The tool has a locking mechanism on the proximal part of the hollow elongate body that can be used to secure a portion of balloon catheter proximal the balloon portion in order to prevent movement in the distal to proximal direction.
The tool can, therefore, be used to introduce a balloon catheter in the body of a patient. The method involves providing an insertion device with proximal, distal, and tapered ends. It also includes a proximal locking system. A balloon catheter is disposed within the tool. The elongate body has a balloon catheter within it, and the distal tip extends beyond the distal end. A balloon portion is disposed in an uninflated, folded state within the elongate body. The locking mechanism secures a portion of the catheter proximal of the inflatable portion to prevent movement in the proximal-distal direction of the balloon. The elongate hollow with the secured balloon catheter is then moved distally, so that the distal tip and tapered distal end pass through the entry point of the patient’s skin. The locking mechanism must be unlocked in order to move the balloon catheter with respect to the elongate body. “The balloon catheter is moved in relation to the elongated hollow body.
In one embodiment, the invention offers a second insertion tool to facilitate the entry of a catheter balloon into the body. The insertion tool in this embodiment includes first and second hollow elongate bodies with proximal or distal ends. The first hollow member has a proximal diameter with an outer diameter which is slideable into the inner diameter of the distal end. The first hollow member also has an opening that is sized to allow passage of the balloon portion of the balloon catheter in its folded, uninflated state.
The tool can therefore be used to introduce a balloon catheter in the body of a patient. The method comprises a step wherein the insertion tool is provided with first and a second elongate elongate bodies having proximal ends and distal endings, with the first hollow body comprising an outer diameter which is slideably movable inside an inner diameter at a distal portion of the second elongate body, and a balloon catheter disposed in the first elongate elongate body. The first elongate body’s distal end is inserted into the patient. The balloon catheter is then moved distally from the first elongate body into the patient. The first elongate body is moved outwardly from the body of the patient. The first elongate body is moved relative to the second elongate body in one or more steps.
In one embodiment, the invention offers a new insertion tool to facilitate the entry of a catheter balloon into the body. This embodiment of the tool has an elongated hollow body with a tapered distal tip that includes two or more holes and an opening. The tapered end is split along the perforations in order to increase the size and pass a balloon catheter through.
Accordingly the tool can also be used to introduce a balloon catheter in a patient’s system. The method involves providing the insertion device with an elongated hollow body, tapered distal tip with two or more holes and an opening. The tapered distal tip of the elongated hollow body is inserted into the patient’s body. The tapered distal end of the elongate hollow body is split along the perforations in order to increase the opening size and pass a balloon catheter. “The balloon catheter is moved out of the opening in the split distal distal end.
In one embodiment, the invention comprises an article of insertion for facilitating entry of a catheter balloon into the body. The article comprises a tubular article filled with liquid or gel that has an outer and inner surface that are continuously continuous and form a cavity. The article has an opening at both the proximal end and distal end. The article is made of a flexible material that encloses the liquid or the gel. Both the outer and the inner surfaces can be moved in opposite direction while the article is stationary. The article is designed to load the balloon portion of a catheter into the cavity, and then deliver it from the distal tip to the insertion site.
The article can, therefore, be used to introduce a balloon catheter in the body of a patient. The method involves loading the article with a catheter, inserting the distal tip in the patient’s body and then moving the pliable materials of the outer surface and the inner surface to cause the balloon catheter to move out of the distal.Click here to view the patent on Google Patents.