Granted Patent B2

US 12,582,430 · App. 16/967,646 · Granted Mar 24, 2026

Inventors: Tim Kovac (Anderslöv, SE); Henrik Bjursten (Lund, SE); Matthias Gotberg (Lund, SE); Magnus Dencker (Höllviken, SE)

Assignee: Septulus AB

A61B17/30A61B17/0469A61B17/068A61B2017/00292A61B2017/0243A61B2017/0409A61B2017/0441A61B2017/0649A61B2017/306A61B2090/064A61B2217/005

Abstract

Claims (56)

1 . A negative pressure-based gripping system for gripping and retaining a target, preferably a moving target, in a fixed position, comprising:

a catheter having a tubular body; a proximal end; and a remotely operable and flexible distal end section with at least one distal opening;

a negative pressure generator in connection with the tubular body configured to generate a negative pressure in the tubular body to grip the target by the at least one distal opening of the catheter upon positioning of the at least one distal opening adjacent to the target; and

a control unit comprising a processor that is configured to position the distal end of the catheter, wherein said control unit is further configured to control an operation of the negative pressure generator to automatically disconnect or disable the negative pressure if a measured pressure in the tubular body does not exceed a predetermined pressure threshold for a predetermined period of time.

2 . The negative pressure-based gripping system according to claim 1 , further comprising at least one pressure sensor for measuring a pressure in the catheter.

3 . The negative pressure-based gripping system according to claim 1 , wherein the system is configured to retain the target in a fixed position in relation to the tubular body.

4 . The negative pressure-based gripping system according to claim 1 , wherein the system is configured to retain at least a portion of a heart in a fixed position over several cardiac cycles.

5 . The negative pressure-based gripping system according to claim 1 , further comprising a flush container for carrying a fluid suitable for being transferred into the human or animal, said container connected to the tubular body of the flexible catheter.

6 . The negative pressure-based gripping system according to claim 5 , wherein said system is configured such that the fluid can be mechanically and/or manually pushed into the tubular body after a gripping and releasing procedure, thereby flushing blood aspirated blood back into the human or animal.

7 . The negative pressure-based gripping system according to claim 5 , wherein the control unit is further configured to control the flush container such that blood aspirated during a gripping procedure is flushed back into the human or animal after a successful or unsuccessful gripping procedure.

8 . The negative pressure-based gripping system according to claim 1 , the distal end section comprising an end section chamber for further tools arranged to operate on the target.

9 . The negative pressure-based gripping system according to claim 1 , further comprising a puncturing mechanism inside the tubular device, wherein the puncturing mechanism is arranged to puncture tissue, drawn in by generated negative pressure, wherein the puncturing mechanism is remotely operable.

10 . The negative pressure-based gripping system according to claim 1 , further comprising an inner tubular member.

11 . The negative pressure-based gripping system according to claim 10 , wherein the inner tubular member is adapted to be inserted through the proximal end of the catheter.

12 . The negative pressure-based gripping system according to claim 10 , wherein the inner tubular member is a snare and wherein the negative pressure-based gripping system further comprises a lock pusher sheath outside the snare, wherein the lock pusher sheath can be pushed along the snare to lock a suture relative to a fastening mechanism.

13 . The negative pressure-based gripping system according to claim 1 , further comprising an operation unit configured for holding an inner tubular member and/or for operating a tool or function inside the catheter or protruding from the catheter.

14 . The negative pressure-based gripping system according to claim 1 , further comprising a stapling or fastening mechanism at the distal opening.

15 . The negative pressure-based gripping system according to claim 14 , wherein the stapling or fastening mechanism comprises a helical anchor and/or further comprising a suture attached to the fastening mechanism.

16 . The negative pressure-based gripping system according to claim 15 , wherein the suture comprises a first side arranged in the inner tubular member, and a second side arranged outside the inner tubular member.

17 . The negative pressure-based gripping system according to claim 1 , wherein the control unit is configured to disconnect or disable the negative pressure via a valve arranged between the negative pressure generator and the tubular body.

18 . A method for gripping and retaining a target, preferably a moving target, in a fixed position in relation to at least a part of a device, comprising the steps of:

providing a device having a catheter having a tubular body; a proximal end; and a remotely operable and flexible end section with a distal opening;

positioning the distal opening adjacent to the target by steering the distal end remotely;

generating a negative pressure in the tubular body to grip the target by the distal opening of the catheter upon positioning of the at least one distal opening adjacent to the target;

measuring the pressure in the tubular body for a predefined period of time;

maintaining the negative pressure in the tubular body to retain the target;

detecting whether the measure pressured has exceeded a predefined pressure threshold for longer than a predefined period of time; and

disabling the negative pressure based on the detection.

19 . A method for performing a surgical process to a target in the form of a heart, comprising the steps of:

a) inserting, transfemorally, a device having a catheter having a tubular body; a proximal end; and a remotely operable and flexible end section with a distal opening;

b) positioning the distal opening of the device adjacent to the target by steering the distal end remotely;

c) generating a negative pressure in the tubular body to grip the target by the distal opening of the catheter upon positioning of the at least one distal opening adjacent to the target;

d) measuring the pressure in the tubular body for a predefined period of time;

e) detecting whether the pressure exceeds a predefined pressure threshold for longer than the predetermined amount of time;

f) disabling the negative pressure based on the detection;

g) repeating steps c) through f) until the target is retained; and

h) performing the surgical process through the tubular body of the catheter.

20 . A method for performing mitral valve chordal repair of a heart, comprising the steps of:

providing a device having a catheter having a tubular body; a proximal end; and a remotely operable and flexible end section with a distal opening;

introducing the device in a femoral or jugular vein;

positioning the distal opening adjacent to the target by steering the distal end remotely;

using a guidewire to enter a right atrium of the heart;

puncturing an atrial septum and crossing the atrial septum of the heart;

locating the device so that the end is located on a papillary muscle;

generating a negative pressure in the tubular body to grip the distal opening to a papillary muscle of the heart;

measuring the pressure in the tubular body for a first predefined period of time;

detecting, in a first detection step, whether the pressure exceeds a first predefined pressure threshold for longer than the first predetermined amount of time;

disabling the negative pressure based on the first detection;

fixating a suture in the papillary muscle;

releasing the negative pressure and moving the device to the leaflet of the mitral valve that has a ruptured chordae;

generating a negative pressure in the tubular body to grip the distal opening to the leaflet of the mitral valve;

measuring the pressure in the tubular body for a second predefined period of time;

detecting, in a second detection step, whether the pressure exceeds a second predefined pressure threshold for longer than the second predetermined amount of time;

disabling the negative pressure based on the second detection;

fixating a suture in the leaflet; and

adjusting the length of the two sutures so that the valve becomes competent.

Assignments (1)

Priority Claims (1)

Continuity (1)

References Cited (44)