IP Library Granted Patent US 12697139
Granted Patent B2
US 12697139 · App. 19/362,162 · Granted Aug 4, 2026

Methods and devices for puncturing tissue

Inventors: Gareth Davies (Toronto, CA); John Paul Urbanski (Toronto, CA); Ferryl Alley (Devonshire, BM); Bogdan Beca (Thornhill, CA)
Assignee: Boston Scientific Medical Device Limited
A61B17/3478A61B18/1492A61B90/39A61B2017/00247A61B2017/003A61B2017/22042A61B2017/3488A61B2018/00351A61B2090/3966
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Quick Facts
Patent No.
US 12697139
App. No.
19/362,162
Granted
Aug 4, 2026
Kind
B2
Abstract

Novel and unique medical devices and associated methods are disclosed, for a medical device for puncturing tissue at a tissue site. The medical device includes an elongate member having a distal section defining a distal section curved portion and a distal section straight portion. The distal section straight portion is distal to the distal section curved portion. An active tip is located at a distal end of the distal section. The active tip is operable to deliver energy to create a puncture through the tissue. The medical device includes a constant diameter layer. The distal section straight portion includes a minimum diameter portion located proximal to a constant diameter portion, and the constant diameter layer surrounds the minimum diameter portion.

Claims (65)

1 . A method for treating a medical condition on a left side of a patient's heart using a multi-function guidewire to reduce the number of exchanges required to perform a procedure, the method comprising:

advancing the multi-function guidewire into the patient's vasculature, the multi-function guidewire comprising a proximal section, a distal section, and a rail section between the proximal and distal sections, wherein at least the proximal section of the multi-function guidewire is disposed within a first tubular member;

providing access to the patient's heart by manipulating the distal section of the multi-function guidewire through the patient's vasculature toward a right side of the patient's heart when the distal section is not disposed within the first tubular member;

positioning an end portion of the distal section substantially adjacent a septum of the patient's heart;

creating a puncture in the septum using an electrode at the end portion of the distal section;

advancing the multi-function guidewire through the puncture and into the left side of the patient's heart; and

advancing the first tubular member over the multi-function guidewire into the left side of the patient's heart.

2 . The method of claim 1 , further comprising withdrawing the first tubular member from the vasculature over the multi-function guidewire.

3 . The method of claim 2 , further comprising advancing a second tubular member into the patient's vasculature, over the multi-function guidewire, and into the left side of the patient's heart.

4 . The method of claim 1 , wherein the multi-function guidewire is configured to permit the advancement thereupon of other devices into the left side of the patient's heart.

5 . The method of claim 1 , wherein the rail section of the multi-function guidewire provides:

a stiffness sufficient to provide a rail for advancing one or more other devices along the multi-function guidewire toward the left side of the patient's heart; and

a flexibility sufficient to enable access to the septum.

6 . The method of claim 1 , wherein the first tubular member comprises a sheath.

7 . The method of claim 6 , wherein the first tubular member comprises a dilator disposed within a lumen of the sheath.

8 . The method of claim 7 , further comprising advancing the dilator into the puncture toward the left side of the patient's heart.

9 . A system for treating a medical condition on a left side of a patient's heart using a multi-function guidewire to reduce the number of exchanges required to perform a procedure, the system comprising:

a multi-function guidewire comprising:

a proximal section;

a distal section; and

a rail section between the proximal and distal sections;

an electrode at an end portion of the distal section;

wherein the multi-function guidewire is configured to be advanced into a patient's vasculature;

wherein at least the distal section of the multi-function guidewire is configured to be manipulated through the vasculature to provide access to a right side of the patient's heart independently of an introducer sheath or introductory guidewire;

wherein the multi-function guidewire is configured to allow the end portion of the distal section to be positioned substantially adjacent a septum of the patient's heart;

wherein the electrode is configured to create a puncture in the septum to allow the multi-function guidewire to be advanced to the left side of the patient's heart; and

wherein the multi-function guidewire is configured to permit the advancement thereupon of one or more tubular members into the left side of the patient's heart.

10 . The system of claim 9 , wherein the distal section comprises a curved portion and a straight portion, the straight portion being distal to the curved portion.

11 . The system of claim 10 , wherein the electrode comprises an active tip proximate the distal end of the straight portion.

12 . The system of claim 11 , wherein the active tip is dome shaped.

13 . The system of claim 10 , wherein the distal section is J-shaped.

14 . The system of claim 9 , wherein the distal section is configured to automatically form a distal coil in a deployed state for anchoring the distal section being advanced through the puncture.

15 . The system of claim 9 , further comprising a radiopaque marker positioned on the distal section of the multi-function guidewire.

16 . The system of claim 15 , wherein the radiopaque marker is a helical coil surrounding the multi-function guidewire at the distal section.

17 . A method for treating a medical condition on a left side of a patient's heart using a multi-function guidewire to reduce the number of exchanges required to perform a procedure, the method comprising:

advancing the multi-function guidewire into the patient's vasculature, the multi-function guidewire comprising a proximal section, a distal section, and a rail section between the proximal and distal sections, wherein at least the proximal section of the multi-function guidewire is disposed within a sheath and dilator assembly, the sheath and dilator assembly including a sheath and dilator;

positioning the distal section of the multi-function guidewire at a right side of the patient's heart when the distal section of the multi-function guidewire is not disposed within the sheath and dilator assembly;

advancing the sheath and dilator assembly, over at least a portion of the distal section of the multifunction guidewire;

positioning an end portion of the distal section substantially adjacent a septum of the patient's heart;

applying energy to the multi-function guidewire to create a puncture in the septum;

advancing the distal section of the multi-function guidewire through the puncture and into the left side of the patient's heart;

advancing the sheath and dilator assembly over the multi-function guidewire through the puncture into the left side of the patient's heart; and

withdrawing at least the multi-function guidewire and the dilator from the patient's vasculature.

18 . The method of claim 17 , further comprising advancing one or more medical devices through the sheath toward the left side of the patient's heart.

19 . The method of claim 17 , further comprising electrically coupling a region of the proximal section of the multi-function guidewire to a radiofrequency (RF) generator.

20 . The method of claim 17 , wherein the operation of positioning the distal section of the multi-function guidewire at a right side of the patient's heart comprises advancing the distal section from a superior approach into a right atrium of the patient's heart.

21 . The method of claim 17 , wherein the operation of positioning the distal section of the multi-function guidewire at a right side of the patient's heart comprises advancing the distal section from an inferior approach into a right atrium of the patient's heart.

22 . A system for treating a medical condition on a left side of a patient's heart using a multi-function guidewire to reduce the number of exchanges required to perform a procedure, the system comprising:

a multi-function guidewire comprising:

a proximal section;

a distal section; and

a rail section between the proximal and distal sections;

wherein the multi-function guidewire is configured to allow a first sheath to be advanced thereupon;

wherein the multi-function guidewire is configured to be advanced into the patient's vasculature such that at least the distal section of the multi-function guidewire is positioned at a right side of the patient's heart independently of the first sheath;

wherein the multi-function guidewire is configured to allow an end portion of the distal section to be positioned substantially adjacent a septum of the patient's heart;

wherein the multi-function guidewire is electrically conductive to allow energy to be applied thereto to create a puncture in the septum thereby allowing the distal section of the multi-function guidewire to be advanced through the puncture into the left side of the patient's heart;

wherein the multi-function guidewire is configured to permit the advancement thereupon of the first sheath into the left side of the patient's heart.

23 . The system of claim 22 , wherein the multi-function guidewire is configured to permit the advancement thereupon of one or more other medical devices into the left side of the patient's heart.

24 . The system of claim 23 , wherein the one or more other medical devices comprises a second sheath.

25 . The system of claim 22 , wherein the rail section of the multi-function guidewire is sufficiently stiff to enable puncturing the septum of the patient's heart from either a superior approach or an inferior approach.

26 . The system of claim 22 , wherein the distal section comprises a curved portion and a straight portion, the straight portion being distal to the curved portion.

27 . The system of claim 26 , wherein the straight portion has a stiffness sufficient to puncture the septum along an axis of advancement; and wherein the curved portion has flexibility sufficient to form a coil or J-shape capable of anchoring the multi-function guidewire within the left side of the patient's heart when the distal section is advanced beyond the septum.

28 . The system of claim 22 , wherein the distal section of the multi-function guidewire comprises an electrode having an atraumatic tip.

29 . The system of claim 28 , wherein the guidewire is configured for electrical communication with a radiofrequency (RF) generator for supplying energy to the electrode.

30 . The system of claim 22 , wherein the distal section of the multi-function guidewire comprises a helical coil.