Medical Device Having a Support Structure

Patent metadata

Field	Value
Publication number	US-2022354572-A1
Application number	US-202217873734-A
Country	US
Kind code	A1
Filing date	Jul 26, 2022
Priority date	Mar 12, 2013
Publication date	Nov 10, 2022
Grant date	—

Abstract

Embodiments of medical devices and methods are disclosed. The medical devices typically comprise a flexible elongate member defining a lumen, and a support spine affixed to the distal end and extending proximally therefrom within the elongate member lumen. In some embodiments, the support spine is pre-shaped such that the support spine biases the distal region of the elongate member to adopt a straight configuration, or the support spine biases at least a portion of the distal region of the elongate member to adopt a curved shape to form a curved portion. Some embodiments include apertures at or near the distal end for enabling fluid communication between the lumen and the outside environment. In some embodiments, the support wire extends proximally from the distal end within a distal portion of the lumen such that a proximal portion of the lumen is substantially unobstructed.

First claim

1 . A medical device having a lumen for a flow of fluid, the medical device comprising:
an elongate member which flexible and configured for traversing body lumens, the elongate member defining the lumen of the medical device, the lumen being in fluid communication with a distal sideport, and the elongate member having a proximal region and a distal region; a support spine attached to and extending proximally from a distal end of the medical device within a distal portion of the lumen, the distal end of the medical device being distal of the distal sideport; a proximal end of the support spine being located within the distal portion of the lumen proximal of the distal sideport, the support spine leaving the lumen sufficiently unobstructed for the flow of fluid through the lumen; and wherein the support spine is pre-shaped such that the support spine biases at least a portion of the distal region of the elongate member to adopt a curved shape to form a curved portion.

2 . The medical device of claim 1 , wherein the lumen further comprises a proximal portion, and the lumen is sufficiently unobstructed for the flow of fluid through the proximal portion of the lumen and the distal portion of the lumen.

3 . The medical device of claim 1 , wherein a sidewall of the elongate member defines the lumen, and the support spine provides support to the sidewall of the curved portion.

4 . The medical device of claim 3 , wherein the support spine is positioned against an inner radius side of the lumen through the curved portion of the elongate member.

5 . The medical device of claim 1 , further comprising a functional tip that is distal to the curved portion, a distal tip of the functional tip comprising an electrode,
wherein the support spine biases the distal region to adopt the curved shape such that the electrode of the functional tip is directed in a desired direction.

6 . The medical device of claim 5 , wherein the curved shape is defined by a radial arc and the electrode of the functional tip is directed away from cardiac structures.

7 . The medical device of claim 6 , wherein the curved portion is configured to form a 270-degree curve.

8 . The medical device of claim 1 , wherein the curved portion defines a substantially 270-degree curve.

9 . The medical device of claim 8 , wherein a first 90 degrees of the substantially 270-degree curve has a radius of about 6.5 mm, and a last 90 degrees of the substantially 270-degree curve has a radius of about 4 mm, and the curve portion is sized for fitting inside a left atrium of a heart.

10 . The medical device of claim 1 , wherein the support spine comprises a material having a shape memory.

11 . The medical device of claim 10 , wherein the support spine comprises a nitinol.

12 . The medical device of claim 1 , further comprising an energy delivery device at the distal end of the elongate member, the energy delivery device comprising an electrode, and the energy delivery device being operable to be electrically coupled to an energy source, wherein the support spine extends proximally from the energy delivery device.

13 . The medical device of claim 12 , wherein the support spine is coupled to a center of the electrode of the energy delivery device.

14 . The medical device of claim 1 , wherein the support spine provides the medical device with a default configuration that the medical device is normally biased towards and wherein the medical device is resilient such that it returns to its default configuration after being bent or otherwise manipulated from its default configuration, whereby the curved portion is sufficiently flexible so that it may be substantially straightened out when it is inserted into a straight tube or vessel and then afterwards return to its default configuration when exiting the straight tube or vessel.

15 . The medical device of claim 1 , further comprising a distal end straight portion that is distal to the curved portion.

16 . The medical device of claim 15 , wherein a distal tip of the distal end straight portion comprises an electrode.

17 . The medical device of claim 1 , wherein the distal sideport and the lumen cooperatively define a pressure transmitting lumen.

18 . A method of surgery using a medical device, the medical device comprising an elongate member having a distal region and a proximal region, an energy delivery device which is proximate to a distal end of the elongate member, the energy delivery device capable of cutting a material, and a lumen and apertures operable to be in communication with a pressure sensing mechanism for determining pressure in a body of a patient proximate to the distal region, wherein a support spine with a bias towards a curved shape is located within a distal portion of a lumen of the elongate member whereby the distal region of the elongate member is capable of adopting a curved shape to define a curved portion, the method comprising the steps of: (i) introducing the medical device into the body of a patient; (ii) positioning the energy delivery device at a first desired location in the body substantially adjacent material to be cut; (iii) delivering energy using the energy delivery device to cut said material; (iv) measuring pressure in the body using the pressure sensing mechanism in order to determine the position of the medical device at least one of before and after step (iii); and (v) advancing the medical device through the material to a second desired location after which the support spine causes the distal region to adopt a curved shape to direct the energy delivery device in a desired direction away from cardiac structures in order to decrease a risk of unwanted injury.

19 . A medical device having a lumen for a flow of fluid, the medical device comprising:
a flexible elongate member configured for traversing body lumens, the flexible elongate member defining the lumen of the medical device, the lumen being in fluid communication with a distal sideport, and the flexible elongate member having a proximal region and a distal region; a support spine attached to and extending proximally from a distal end of the medical device within a distal portion of the lumen, the distal end of the medical device being distal of the distal sideport; a proximal end of the support spine being located within the distal portion of the lumen proximal of the distal sideport, the support spine leaving the lumen sufficiently unobstructed for the flow of fluid through the lumen; and wherein the support spine is pre-shaped such that the support spine biases the distal region of the flexible elongate member to adopt a straight configuration, the distal region not being biased by the support spine to form a substantially curved portion.

20 . The medical device of claim 19 , wherein the support spine comprises a material having a shape memory.

Assignees

• Boston Scientific Medical Device Limited

Inventors

• Davies Gareth
• Urbanski John Paul
• Abou-Marie Rund

Classifications

• A61M25/0138

  having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils · CPC title

• A61B5/6852

  Catheters · CPC title

• A61M2025/0003

  having an additional lumen transmitting fluid pressure to the outside for measurement · CPC title

• A61B2218/002

  Irrigation · CPC title

• A61M25/0041

  pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04) · CPC title