The present invention generally relates to a fastening device for an implant device and more specifically to a fastening device for an adjustable implant device connected to an implant device feed member. The present invention also relates to methods for locking and implanting a medical implant.
Implant devices are devices that are adapted for being placed in e.g. human bodies or animals, and that e.g. replace body parts that have been damaged or removed e.g. due to cancer.
In order to keep the implant device in place so that it does not move freely within e.g. a human body cavity, it is known to fasten the implant device in position using a fastening device. A known fastening device is a band type device having two ends, where a first end has a hole, and a second end has a protruding part arranged to be placed in said hole in order to lock the two ends of the band type device together after having been looped around an implant device and a body part such as an intestine, thereby fastening the implant device in place. In order for the band ends not to be separated when e.g. a person carrying the implant moves around, the protruding part is of flexible material and has a ball shaped outer end of somewhat larger cross-section than the diameter of the hole, whereby the ball shaped end is elastically deformed when pushed through the hole and regains its shape when leaving the hole, thus keeping the band ends locked to each other.
The problem of keeping an implant in place so that it does not move freely is solved according to the invention: by a fastening device for an implant device as stated in claim 1, by an implant device comprising a fastening device as stated in claim 48, by a method for securely locking a first fastening section of a fastening device for an implant device to a second section of a fastening device for an implant device, as stated in claim 49, and by an operation method as stated in the characterizing portion of claims 50 and 51.
By providing a protruding part on the second fastening section arranged with a trough channel having an inlet and an outlet, said through channel being arranged to receive the implant device feed member, wherein the implant device feed member is arranged to be a locking member and for being involved in the adjustment of the implant device by feeding at least one of a hydraulic or pneumatic fluid, electrical energy and an electrical signal to the implant device, wherein said inlet and outlet is accessible from the exterior of the fastening device in said fastening device locking state, wherein the first fastening section is detachably and securely locked to the second fastening section when, in said fastening device locking state, said implant device feed member is in place in the trough channel and protrudes from both the inlet and the outlet of said trough channel, wherein said fastening device is adapted to be reversible in two steps, involving to remove said implant device feed member from the through channel and thereafter detaching the first fastening section from the second fastening section, the above mentioned problems are avoided or at least mitigated.
Further preferred exemplary embodiments are defined in the dependent claims.
In one embodiment, the first fastening section has e.g. a cylindrical, tubular or band shaped cross-section.
In one embodiment, the first fastening section has a tubular cross-section, and that the trough hole is arranged at least through one wall of the tubular first fastening section.
In one embodiment, the second fastening section has e.g. a cylindrical, tubular or band shaped cross-section.
In one embodiment, the first and the second fastening sections are arranged on the same fastening unit.
In one embodiment, the fastening unit is attached to the implant device.
In one embodiment, the implant device feed member is attached to the fastening unit.
In one embodiment, the first and the second fastening sections are arranged on separate fastening units.
In one embodiment, the at least one of the fastening units is attached to the implant device.
In one embodiment, the implant device feed member is attached to a fastening unit.
In one embodiment, the inlet and the outlet of the trough channel arranged in the protruding part on the second fastening section are arranged on the same side of the first fastening section in the fastening device locking state.
In one embodiment, the inlet and the outlet of the trough channel arranged in the protruding part on the second fastening section are arranged on different sides of the first fastening section in the fastening device locking state.
In one embodiment, the outlet of the trough channel arranged in the protruding part on the second fastening section is arranged to connect to an inlet of a trough hole arranged in the second fastening section, wherein the inlet of the trough channel arranged in the protruding part on the second fastening section and the outlet of the trough hole in the second fastening section are arranged on different sides of the first fastening section in the fastening device locking state.
In one embodiment, the inlet and the outlet of the trough channel arranged in the protruding part on the second fastening section are arranged on opposite sides of the first fastening section in the fastening device locking state.
In one embodiment, the inlet and the outlet of the trough channel arranged in the protruding part on the second fastening section are arranged adjacent the surface of the first fastening section in the fastening device locking state.
In one embodiment, the protruding part arranged on the second fastening section is arranged to protrude substantially axially from one end of the second fastening section.
In one embodiment, the inlet and the outlet of the trough channel arranged in the protruding part on the second fastening section are arranged on different sides of the second fastening section.
In one embodiment, the protruding part arranged on the second fastening section is arranged to protrude substantially perpendicular to the longitudinal axis of the second fastening section, and from one end of the second fastening section.
In one embodiment, the protruding part arranged on the second fastening section is arranged to protrude substantially perpendicular to the longitudinal axis of the second fastening section.
In one embodiment, the protruding part arranged on the second fastening section is arranged adjacent to one end of the second fastening section.
In one embodiment, the trough hole arranged in the first fastening section is arranged at an angle to the longitudinal axis of the first fastening section.
In one embodiment, the protruding part arranged on the second fastening section is arranged at an angle to the longitudinal axis of the second fastening section.
In one embodiment, the trough hole arranged in the first fastening section is arranged substantially perpendicular to the longitudinal axis of the first fastening section.
In one embodiment, the implant device feed member is arranged to feed hydraulic fluid, pneumatic fluid, or electrical energy or electrical signals between the implant device and a remote unit.
In one embodiment, the implant device feed member is arranged to feed hydraulic fluid, pneumatic fluid, or electrical energy or electrical signals to the implant device.
In one embodiment, the implant device feed member is arranged to feed hydraulic fluid, pneumatic fluid, or electrical energy or electrical signals from the implant device.
In one embodiment, the first fastening section is detachably securely locked to the second fastening section when said implant device feed member is in place in the trough channel and protrudes from both the inlet and the outlet of said trough channel.
In one embodiment, the implant device feed member is attached to the implant device.
In one embodiment, the implant device feed member is detachably attached to the implant device.
In one embodiment, the protruding part is an integrated part of the second fastening section.
In one embodiment, the implant device is arranged to be fastened around a body part or another implanted device or member.
In one embodiment, the first fastening section is arranged with more than one trough hole in order to be able to lock the fastening device in more than one fastening device locking state.
In one embodiment, the first fastening section is arranged with more than one trough hole, and in that the second fastening section is arranged with more than one protruding part in order to be able to lock the fastening device in more than one fastening device locking state, i.e. the fastening device is adapted to create two or more locking positions, said fastening device comprising two or more protruding parts and two or more through going holes wherein a first through going hole is placed more distal to the second or more through going hole to include anyone of the protruding parts inside said first through going hole, thus creating two or more locking positions.
In one embodiment, the implant device is arranged to be fastened around at least one of a stomach or divided part of the stomach, an intestine, a closing sphincter and other part of the food passageway.
In one embodiment, the implant device is arranged to be fastened around at least one of an urethra and other part of the urinary tract.
In one embodiment, the implant device is arranged to be fastened around a blood vessel or heart.
In one embodiment, the implant device is arranged to be fastened around a vas deferens or uterine tube.
In one embodiment, the implantable implant device comprises a restriction device and wherein the fastening device is adapted to create a closed loop by fastening said restriction device.
In one embodiment, the implant device comprising at least two implant device parts placed remote from each other, and wherein said implant device feed member is adapted to be connected to at least said two parts, when said implant is implanted in a mammal body. In one embodiment, at least one of said implant device parts comprises an internal energy source.
In one embodiment, at least one of said implant device parts comprises an internal wireless energy receiver adapted to receive wireless energy for supplying energy to any of the energy consuming parts of said implant device.
In one embodiment, at least one of said implant device parts comprises a pump.
In one embodiment, at least one of said implant device parts comprises a motor.
In one embodiment, said implant device is an adjustable hydraulically implant device, comprising a restriction device, and a pump for moving hydraulic fluid to and from said restriction device, wherein said fastening device is adapted to fasten said first and second fastening sections included in said restriction device into a closed loop and wherein said restriction device and said pump is hydraulically connected by a hydraulic tube, wherein said tube comprising the implant feed member.
In one embodiment, the implant feed device member is arranged to be in contact with said first fastening section, when locked in said locking state.
In one embodiment, said first and second fastening members are in contact with each other when locked in said locking state.
The invention also relates to a fastening device, wherein said implant device is an adjustable electrically powered implant device, comprising a restriction device, and a power supply for powering an adjustment of said restriction device, wherein said fastening device is adapted to fasten said first and second fastening sections included in said restriction device into a closed loop and wherein said restriction device and said power supply is electrically connected by a electric cable, wherein said cable comprising the implant feed member
In one embodiment, the invention further relates to a method for securely locking a first fastening section of a fastening device for an implant device to a second fastening section of a fastening device for an implant device, the fastening device comprising at least two fastening sections, where the first fastening section is arranged with a through hole and the second fastening section is arranged with a protruding part, and where a fastening device locking state is defined by said protruding part being placed in place in said trough hole, where the method comprises the steps of:
arranging, on the protruding part on the second fastening section, a trough channel having an inlet and an outlet, said through channel being arranged to receive an implant device feed member, said inlet and outlet being accessible from the exterior of the fastening device in said fastening device locking state,
placing said implant device feed member in the trough channel, and
securely locking the first fastening section to the second fastening section by arranging, in said fastening device locking state, said implant device feed member to protrude from both the inlet and the outlet of said trough channel.
In one embodiment, the invention also relates to an operation method for implanting a medical implant comprising a fastening device according to claim 1, the method comprising the steps of
inserting a needle or tube-like instrument into a cavity of a mammal patient;
inflating said cavity by introducing a fluid through said needle or tube-like instrument and thereby expanding said cavity;
placing at least two laparoscopic trocars in said cavity;
inserting a camera through one of said laparoscopic trocars into said cavity;
inserting at least one dissecting tool through one of said at least two laparoscopic trocars; dissecting an area of the body;
placing the implant with the fastening device in the dissected area;
locking a first fastening section of a fastening device for the implant device to a second fastening section of the fastening device, the fastening device comprising at least two fastening sections, where the first fastening section is arranged with a through hole and the second fastening section is arranged with a protruding part, and where a fastening device locking state is defined by said protruding part being placed in place in said trough hole, arranging, on the protruding part on the second fastening section, a trough channel having an inlet and an outlet, said through channel being arranged to receive an implant device feed member, said inlet and outlet being accessible from the exterior of the fastening device in said fastening device locking state,
placing said implant device feed member in the trough channel, and
securely locking the first fastening section to the second fastening section by arranging, in said fastening device locking state, said implant device feed member to protrude from both the inlet and the outlet of said trough channel,
In one embodiment, the invention also relates to an for implanting a medical implant comprising a fastening device according to claim 1, the method comprising the steps of cutting the skin of a human patient;
dissecting an area of body;
placing the implant in the dissected area; locking a first fastening section of a fastening device for the implant device to a second fastening section of the fastening device, the fastening device comprising at least two fastening sections, where the first fastening section is arranged with a through hole and the second fastening section is arranged with a protruding part, and where a fastening device locking state is defined by said protruding part being placed in place in said trough hole, arranging, on the protruding part on the second fastening section, a trough channel having an inlet and an outlet, said through channel being arranged to receive an implant device feed member, said inlet and outlet being accessible from the exterior of the fastening device in said fastening device locking state,
placing said implant device feed member in the trough channel, and
securely locking the first fastening section to the second fastening section by arranging, in said fastening device locking state, said implant device feed member to protrude from both the inlet and the outlet of said trough channel.
In one embodiment, the invention also relates to a method of treating a mammal patient according to any one of above described operation methods, further comprising the step of withdrawing the instruments.
In one embodiment, the invention also relates to a method of treating a mammal patient according to any one of above described operation methods, further comprising the step of closing the skin using sutures or staples.
In one embodiment, the invention also relates to a method of treating a mammal patient according to any one of above described operation methods, wherein the step of dissecting includes dissecting an area of the abdomen or thorax or retroperitoneal space or pelvic region, comprising, dissecting an area of at least one of the following organs esophagus, stomach, intestine, colon, rectum, anus, anal spincter, cardia sphincter, pylori sphincter, urethra, ureter, urine bladder, vas deferens, uterine tube, blood vessel, and heart.
In one embodiment, the invention also relates to a method of treating a mammal patient according to any one of above described operation methods, wherein the implantable device comprise a restriction device and the fastening device is adapted to create a closed loop by fastening said restriction device, wherein the method comprising the step of fastening said fastening device creating a closed loop.
In further embodiments, the invention also relates to an implant device comprising a fastening device as described in any of the above embodiments above, or possible combinations thereof.
Please note that all the embodiments or features of an embodiment as well as any method or step of a method could be combined in any way if such combination is not clearly contradictory. Please also note that the description in general should be seen as describing both an apparatus or device adapted to perform a method as well as this method in itself.
Briefly described, the present invention provides a solution for enabling an easy and fully, i.e. 100%, reversible way of keeping an implant in place so that it does not move freely, by providing and placing a fastening device for an implant device into e.g. a body of a patient, where the “patient” is a living creature such as e.g. a human or an animal.
The invention is now described, by way of example, with reference to the accompanying drawings, in which:
It is preferred that the implant feed device member 20 is arranged to be in contact with the first fastening section, when locked in said locking state.
Said trough channel 14 may be of any length, i.e. if the protruding part 12 is very thin, said trough channel 14 could be similar to a hole.
Said inlet 16 and outlet 18 are accessible from the exterior of the fastening device 2 in said fastening device locking state, i.e. said inlet 16 and/or outlet 18 may be accessible from one or more sides of the fastening device 2 in said fastening device locking state, e.g. from one of or from some of the following sides: the outer side, the inner side, or any other side not belonging to the outer side and the inner side, of the fastening device 2, see e.g.
The first fastening section 6 of the fastening device 2, and the second fastening section 8 of the fastening device 2, may have any cross-section, e.g. a cylindrical, tubular or band shaped cross-section, where a band shaped cross-section is shown in the figure for both the first fastening section 6 and the second fastening section 8, and where the cross-section of the first fastening section 6 does not have to be the same as the cross-section of the second fastening section 8.
The first and the second fastening sections 6, 8 may be arranged on the same fastening unit or on separate fastening units, where an embodiment where the first and the second fastening sections 6, 8 are arranged on the same fastening unit 22, is shown in the figure.
None or at least one of the fastening units may be attached to the implant device 4, and the implant device feed member 20 may be or not be attached to a fastening unit, where an embodiment where no fastening unit 22 is attached to the implant device 4 by attachment means, e.g. by chemical or mechanical means such as adhesive or suturing, and where the implant device feed member 20 is not attached to a fastening unit 22, is shown in the figure.
The inlet 16 and the outlet 18 of the trough channel 14 arranged in the protruding part 12 on the second fastening section 8 may be arranged on the same side of the first fastening section 6 in the fastening device locking state, or on different sides of the first fastening section 6 in the fastening device locking state, where an embodiment where the inlet 16 and the outlet 18 of the trough channel 14 arranged in the protruding part 12 on the second fastening section 8 is arranged on the same side of the first fastening section 6 in the fastening device locking state, is shown in the figure.
It could also be possible to arrange the outlet of the trough channel arranged in the protruding part on the second fastening section to connect to an inlet of a trough hole arranged in the second fastening section, wherein the inlet of the trough channel arranged in the protruding part on the second fastening section and the outlet of the trough hole in the second fastening section are arranged on different sides of the first fastening section in the fastening device locking state, whereby the inlet and the outlet of the trough channel arranged in the protruding part on the second fastening section might be arranged on opposite sides of the first fastening section in the fastening device locking state (not shown in the figure).
As shown in both the embodiment according to
The first fastening section 6 is preferably detachably securely locked to the second fastening section 8 when said implant device feed member 20 is in place in the trough channel 14 and protrudes from both the inlet 16 and the outlet 18 of said trough channel 14, by that it is possible to remove the implant device feed member 20 from the trough channel 14, where after it is possible to detach the first fastening section 6 from the second fastening section 8, this without any substantial effort and without having to deform any parts of the fastening device 2.
The implant device feed member 20 may or may not be detachably or non-detachably attached to the implant device 4.
The implant device feed member 20 may be arranged to feed hydraulic fluid, pneumatic fluid, or electrical energy or electrical signals between the implant device 4 and a remote unit 24, e.g. that the implant device feed member 20 is arranged to feed hydraulic fluid, pneumatic fluid, or electrical energy or electrical signals to and/or from the implant device 4.
As can be seen from the figure, the implant device 4 may be arranged to be fastened around a body part or another implanted device or member 26. Said body part may e.g. be at least one of a stomach or divided part of the stomach, an intestine, a closing sphincter and other part of the food passageway. Said body part may e.g. be at least one of an urethra and other part of the urinary tract. Said body part may e.g. be a blood vessel or heart. Said body part may e.g. be a vas deferens or uterine tube.
According to the embodiment shown in
As shown in both the embodiment according to
As can be seen from the figure, in this embodiment the inlet 16 and the outlet 18 of the trough channel 14 arranged in the protruding part 12 on the second fastening section 8 are arranged on opposite sides of the second fastening section.
The embodiment shown in
As seen in the figure, the trough channel 14 does not have to be linear, in this embodiment the trough channel 14 is bent in order to arrange the inlet 16 of the trough channel 14 arranged in the protruding part 12 on the second fastening section 8 adjacent to the surface of the first fastening section 6 in the fastening device locking state for minimizing any play in the locking device between the first fastening section 6 and the second fastening section 8. This may also be achieved by arranging a depression 44 in the surface of the first fastening section 6, thereby providing a “channel” for the implant device feed member 20 in said surface. A combination of these two separate embodiments is shown in the figure.
The invention further relates to a method for securely locking a first fastening section 6 of a fastening device 2 for an implant device 4 to a second fastening section 8 of a fastening device 2 for an implant device 4, the fastening device 2 comprising at least two fastening sections 6, 8, where the first fastening section 6 is arranged with a through hole 10 and the second fastening section 8 is arranged with a protruding part 12, and where a fastening device locking state is defined by said protruding part 12 being placed in place in said trough hole 10, where the method comprises the steps of:
arranging, on the protruding part 12 on the second fastening section 8, a trough channel 14 having an inlet 16 and an outlet 18, said through channel 14 being arranged to receive an implant device feed member 20, said inlet 16 and outlet 18 being accessible from the exterior 1, 3 of the fastening device 2 in said fastening device locking state,
placing said implant device feed member 20 in the trough channel 14, and
securely locking the first fastening section 6 to the second fastening section 8 by arranging, in said fastening device locking state, said implant device feed member 20 to protrude from both the inlet 16 and the outlet 18 of said trough channel 14.
The invention also relates to an operation method for implanting a medical implant comprising a fastening device as described herein, the method comprising the steps of
inserting a needle or tube-like instrument into a cavity of said mammal patient;
inflating said cavity by introducing a fluid through said needle or tube-like instrument and thereby expanding said cavity;
placing at least two laparoscopic trocars in said cavity;
inserting a camera through one of said laparoscopic trocars into said cavity;
inserting at least one dissecting tool through one of said at least two laparoscopic trocars; dissecting an area of the body;
placing the implant with the fastening device in the dissected area;
locking a first fastening section of a fastening device for the implant device to a second fastening section of the fastening device, the fastening device comprising at least two fastening sections, where the first fastening section is arranged with a through hole and the second fastening section is arranged with a protruding part, and where a fastening device locking state is defined by said protruding part being placed in place in said trough hole, arranging, on the protruding part on the second fastening section, a trough channel having an inlet and an outlet, said through channel being arranged to receive an implant device feed member, said inlet and outlet being accessible from the exterior of the fastening device in said fastening device locking state,
placing said implant device feed member in the trough channel, and
securely locking the first fastening section to the second fastening section by arranging, in said fastening device locking state, said implant device feed member to protrude from both the inlet and the outlet of said trough channel,
The invention also relates to an for implanting a medical implant comprising a fastening device as described herein, the method comprising the steps of
cutting the skin of said human patient;
dissecting an area of body;
placing the implant in the dissected area;
locking a first fastening section of a fastening device for the implant device to a second fastening section of the fastening device, the fastening device comprising at least two fastening sections, where the first fastening section is arranged with a through hole and the second fastening section is arranged with a protruding part, and where a fastening device locking state is defined by said protruding part being placed in place in said trough hole, arranging, on the protruding part on the second fastening section, a trough channel having an inlet and an outlet, said through channel being arranged to receive an implant device feed member, said inlet and outlet being accessible from the exterior of the fastening device in said fastening device locking state,
placing said implant device feed member in the trough channel, and
securely locking the first fastening section to the second fastening section by arranging, in said fastening device locking state, said implant device feed member to protrude from both the inlet and the outlet of said trough channel.
The invention also relates to a method of treating a mammal patient according to any one of above described operation methods, further comprising the step of withdrawing the instruments.
The invention also relates to a method of treating a mammal patient according to any one of above described operation methods, further comprising the step of closing the skin using sutures or staples.
The invention also relates to a method of treating a mammal patient according to any one of above described operation methods, wherein the step of dissecting includes dissecting an area of the abdomen or thorax or retroperitoneal space or pelvic region, comprising, dissecting an area of at least one of the following organs esophagus, stomach, intestine, colon, rectum, anus, anal sphincter, cardia sphincter, pylori sphincter, urethra, ureter, urine bladder, vas deferens, uterine tube, blood vessel, and heart.
The invention also relates to a method of treating a mammal patient according to any one of above described operation methods, wherein the implantable device comprise a restriction device and the fastening device is adapted to create a closed loop by fastening said restriction device, wherein the method comprising the step of fastening said fastening device creating a closed loop.
The invention also relates to an implant device 4 comprising a fastening device 2 as described in any of the above embodiments, or possible combinations thereof.
Please note that all the embodiments or features of an embodiment as well as any method or step of a method could be combined in any way if such combination is not clearly contradictory. Please also note that the description in general should be seen as describing both an apparatus or device adapted to perform a method as well as this method in itself.
While specific embodiments of the invention have been illustrated and described herein, it is realized that numerous other embodiments may be envisaged and that numerous additional advantages, modifications and changes will readily occur to those skilled in the art without departing from the spirit and scope of the invention. Therefore, the invention in its broader aspects is not limited to the specific details, representative devices and illustrated examples shown and described herein. Accordingly, various modifications may be made without departing from the spirit or scope of the general inventive concept as defined by the appended claims and their equivalents. It is therefore to be understood that the appended claims are intended to cover all such modifications and changes as fall within a true spirit and scope of the invention. Numerous other embodiments may be envisaged without departing from the spirit and scope of the invention.
Number | Date | Country | Kind |
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0901391-3 | Oct 2009 | SE | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/SE2010/051177 | 10/29/2010 | WO | 00 | 1/17/2012 |
Number | Date | Country | |
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61255991 | Oct 2009 | US |