Tissue cutting device and system

• US 10,610,249 B2
• Filed: 04/29/2016
• Issued: 04/07/2020
• Est. Priority Date: 04/30/2015
• Status: Active Grant

• Current Assignee: Septulus AB
• Original Assignee: Septulus AB
• Inventors: Bjursten, Henrik
• Primary Examiner(s): Tanner, Jocelin C
• Application Number:
  US15/570,451
• Publication Number:
  US 20180146974A1
• Time in Patent Office: 1,439 Days
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/320028 with reciprocating movements

Abstract

The present disclosure relates to a tissue cutting system for cutting tissue of a heart, such as tissue of a septum of a heart, comprising: an outer tubular member having a proximal portion and a distal portion, said distal portion comprising a tissue resection window; a resection element axially slidably arranged inside the outer tubular member configured to resect tissue extending through the tissue resection window; at least one pressure sensor; wherein the outer tubular member and resection element are arranged to establish: a first fluid flow channel suitable for transporting resected tissue away from an area adjacent to the resection element; at least one second fluid flow channel configured to assist the first fluid flow channel in transporting resected tissue. The present disclosure further relates to a method for resecting tissue using the disclosed tissue cutting system.

Claims

1. A tissue cutting system for cutting tissue of a heart, such as tissue of a septum of a heart, comprising:

an outer tubular member having a proximal portion and a distal portion, said distal portion comprising a tissue resection window;

a resection element axially slidably arranged inside the outer tubular member configured to resect tissue extending through the tissue resection window;

at least one pressure sensor;

wherein the outer tubular member and resection element are arranged to establish;

a first fluid flow channel suitable for transporting resected tissue away from an area adjacent to the resection element;

at least one second fluid flow channel configured to assist the first fluid channel in transporting resected tissue; and

a processor configured to determine whether the measured pressure is below a predetermined pressure threshold and whether the tissue to be resected fills the resection window when vacuum is applied in the first fluid flow channel based on the measured pressure.

2. The tissue cutting system according to claim 1, further comprising an actuator for controlling a sliding movement of the resection element along the outer tubular member to resect tissue extending through the resection window.

3. The tissue cutting system according to claim 1, wherein the at least one pressure sensor is in connection with the first fluid flow channel.

4. The tissue cutting system according to claim 1, wherein the at least one pressure sensor is configured to measure a pressure inside the outer tubular member in a region adjacent to the tissue resection window.

5. The tissue cutting system according to claim 1, further comprising a vacuum generator in connection with the first fluid flow channel.

6. The tissue cutting system according to claim 1, wherein the processor is configured to determine whether the measured pressure is below a predetermined pressure threshold for longer than a predefine period of time when vacuum is applied in the first fluid flow channel based on the measured pressure.

7. The tissue cutting system according to claim 1, further comprising an inner tubular member.

8. The tissue cutting system according to claim 7, wherein the inner tubular member is axially slidably arranged inside the outer tubular member.

9. The tissue cutting system according to claim 1, wherein the resection element is configured to cut tissue backwards towards a direction from the distal portion towards the proximal portion.

10. The tissue cutting system according to claim 1, wherein the resection element is located distally to the resection window when the resection window is open.

11. The tissue cutting system according to claim 1, further comprising a plunger sealingly engaged inside the outer tubular member.

12. The tissue cutting, system according to claim 11, wherein the plunger is an integral part of the resection element.

13. The tissue cutting system according to claim 11, further comprising a resection element control channel incorporated into a sidewall of the outer tubular member, wherein the resection element control channel is fluid connection with a closed chamber defined by the outer tubular member and the plunger.

14. The tissue cutting system according to claim 1, wherein the system is configured to control a fluid in a closed chamber such that when a chamber pressure in the closed chamber is increased a backwards movement of the resection element is produced and when the chamber pressure is decreased a forwards movement of the resection element is produced.

15. The tissue cutting system according to claim 1, further comprising a guidewire channel incorporated into a sidewall of the outer tubular member.

16. The tissue cutting system according to according to claim 15, further comprising a guidewire arranged inside the guidewire channel extending from a proximal end of the outer tubular member to a distal end of the outer tubular member.

17. The tissue cutting system according to claim 1, further comprising a flexible catheter connected to the outer tubular member and a control device.

18. The tissue cutting system according to claim 17, wherein the control device is configured to control the resection element and/or a vacuum generator and/or application of the vacuum generator and/or application of fluid into the second fluid flow channel.

19. The tissue cutting system according to claim 1, further comprising a flex channel incorporated into a sidewall of the outer tubular member.

20. The tissue cutting system according to claim 1, wherein a control device is configured to control a flex wire in a flex channel.

21. The tissue cutting system according to claim 1, wherein the resection element is an integrated part of the inner tubular member.

22. The tissue cutting system according to claim 1, wherein an upper side of the resection element is configured to slide smoothly along the inside of the outer tubular member, thereby cutting tissue extending through the tissue resection window.

23. The tissue cutting system according to claim 1, wherein the at least one second fluid flow channel is a space between the outer tubular member and a inner tubular member.

24. The tissue cutting system according to claim 1, wherein a cutting device has a device outer diameter between 2 mm and 20 mm, or between 2 mm and 15 mm, or between 2 mm and 10 mm, or between 5 mm and 10 mm, or between 5 mm and 15mm, or 2 mm, or 3 mm, or 4 mm, or 5 mm, or 6 mm, or 7 mm, or 8 mm, or 9 mm, or 10mm, or 11 mm, or 12 mm, or 13 mm, or 14 mm, or 15 mm, or 16 mm, or 17 mm, or 18 mm, or 19mm, or 20 mm.

25. The tissue cutting system according to claim 1, wherein the at least one second fluid flow channel is configured to uphold a pressure in the distal portion such that the pressure is substantially equal to the pressure outside a tissue cutting device when the resection window is open.

26. The tissue cutting system according to claim 1, wherein the at least one second fluid flow channel is configured to be connected to a pressure regulator, and wherein the at least one second fluid flow channel is configured to flush resected tissue away from the distal portion through the first fluid flow channel, wherein the pressure regulator is configured to generate a flow of liquid through the at least one second fluid flow channel towards the distal portion, the flow of liquid continuing from the distal portion away from the distal portion through the first fluid flow channel.

27. The tissue cutting system according to claim 1, further comprising a collector for collecting the resected tissue.

28. The tissue cutting system according to claim 1, further comprising a housing.

29. A method for resecting tissue using the tissue cutting system according to claim 1, comprising the steps:

positioning the resection window adjacent to tissue to cut;

generating a vacuum pressure;

connecting the vacuum pressure t the first fluid flow channel, thereby aspirating tissue through the resection window;

providing a processor for determining the pressure in the first fluid flow channel;

measuring and analyzing the pressure in the first fluid channel for a predefined period of time;

determining by using the processor whether the tissue to be resected has filled the resection window after the vacuum pressure is connected to the first fluid channel;

if the measured period remains below a predefined pressure threshold for longer than a predefined period of time, sliding the resection element thereby cutting tissue, otherwise disconnecting the vacuum pressure to the first fluid flow channel; and

providing a second fluid flow channel for assisting the first fluid flow channel and transporting the resected tissue via the first fluid flow channel.

30. A tissue cutting system for cutting tissue of a heart, such as tissue of a septum of a heart, comprising:

an outer tubular member having a proximal portion and a distal port on, said distal portion comprising a tissue resection window;

a resection element axially slidably arranged inside the outer tubular member configured to resect tissue extending, through the tissue resection window;

a plunger sealingly engaged inside the outer tubular member;

at least one pressure sensor;

wherein the outer tubular member and resection element are arranged to establish;

a first fluid flow channel suitable for transporting resected tissue away from an area adjacent to the resection element; and

at least one second fluid flow channel configured to assist the first fluid floe channel in transporting resected tissue.